Neoplasms

Blood and Lymph Conditions

All Conditions

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Antineoplastic Agents

All Drugs and Chemicals

Gemtuzumab

Antineoplastic Agents, Immunological

Immunotoxins

Immunoconjugates

Immunologic Factors

Gemtuzumab Ozogamicin (Mylotarg) administered in any form or combination

Gemtuzumab Ozogamicin

Pfizer CT.gov Call Center

The aim of this observational study is to describe treatment patterns and effectiveness outcomes in a sample of oncology patients treated for AML with Mylotarg through up to two additional relapsed/refractory (R/R)-based lines of therapy (through third-line therapy). The study will use United States oncology electronic medical record (EMR) data. All study data are secondary data and will have been collected retrospectively from existing clinical data originally collected as part of routine care.

A Study Of Treatment Patterns And Clinical Outcomes In Patients Diagnosed With Acute Myeloid Leukemia Who Received Mylotarg in the Real-World

Characteristics, Treatment Patterns, and Clinical Outcomes in Acute Myeloid Leukemia (AML) Patients Using Mylotarg - a US Real-World Study Using Electronic Medical Record Data

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Duration of therapy was time from the initiation of Mylotarg to the last date of Mylotarg therapy, regardless of line of therapy (duration could continue into subsequent lines of therapy), study end date, or death, whichever came first.

rwEFS defined as time from treatment initiation date (for first line of Mylotarg-containing therapy) to date of treatment failure (TF), relapse from complete response (CR) or better, death from any cause, whichever came first. TF defined as failure to achieve CR or better following up to 3 cycles of Mylotarg. Time origin for rwEFS was start of Mylotarg in first line of therapy in which it was used. Terminal event for analysis of rwEFS was earlier of treatment failure, relapse from CR or better, death. CR is defined as having less than (\<) 5% blasts in the bone marrow and 0% blasts in the peripheral blood. Real-world setting signifies participants treated in clinical practice and in a non-trial setting.

rwRFS was defined as the time from the treatment initiation date (during the first line of Mylotarg-containing therapy) to the date of a relapse event, or death from any cause, whichever came first. The time origin for rwRFS was the start of Mylotarg in the first line of therapy in which it was used. Real-world setting signifies participants treated in clinical practice and in a non-trial setting.

rwOS was defined as the time from the start of the first Mylotarg use till the date of death. Participants who were not indicated to be deceased in clinical records or Social Security Disability Insurance (SSDI) records were censored for rwOS analysis as of the later of 1) the latest date known alive within the clinical record, 2) 4 months prior to the date of most recent SSDI update. Real-world setting signifies participants treated in clinical practice and in a non-trial setting.

First positive response was assessed by physician as first response from any of the following: CR, partial response (PR), stable disease (SD) and progressive disease (PD). CR is defined as having \< 5% blasts in the bone marrow and 0% blasts in the peripheral blood. PR is defined as having 5 to 25% bone marrow blasts with \> 50% reduction in blasts and peripheral blood count recovery. SD is defined as having no change in bone marrow blasts. PD is defined as having relapse following response. Participant for whom record did not indicate one of these classification classed as not evaluable (NE).

Pfizer

This study involved data that existed as structured data by the time of study start. In these data sources, individual participant data were not retrieved or validated, and it was not possible to link a particular product and medical event for any individual. Thus, the minimum criteria for reporting an adverse event (i.e., identifiable participant, identifiable reporter, a suspect product, and event) was not met, hence, safety data was not planned to be collected and reported.

Participants with confirmed diagnosis of Acute Myeloid Leukemia (AML) on or after 01 December 2014, who received Mylotarg (Gemtuzumab ozogamicin \[mean number of doses of gemtuzumab administered = 1 per participant\]) from 2017 to 2020 in real-world clinical setting (i.e. treated in clinical practice and in a non-trial setting) were included in this retrospective study and their data from definitive oncology dataset was retrospectively assessed in this study of up to 4 months.

Mylotarg

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Body Mass Index (BMI)

Here, number of participants with their insurance status as 'private only, public only, both (public and private insurance), neither (unknown or undocumented)' were reported. Private only insurance was purchased by the participants. Public only insurance was provided by the federal or state funds.

Insurance Status

Here 'number analyzed" signifies participants evaluable for this baseline measure.

Height of Participants

Body Weight

Here, number of participants were classified in 5 categories (Midwest, northeast, south, west and undocumented \[unknown\] region) according to their region of residence.

Region of Residence

Here, number of participants were classified in 4 categories (congestive heart failure, connective tissue disease, diabetes and myocardial infarction) according to different type of comorbid condition.

Here "number analyzed" signifies participants evaluable for this baseline measure.

Number of Participants With Comorbidities

Charlson Comorbidity Index scored the cumulative severity of a participant's comorbidities. Total score ranged from 0 to 9. A score of zero indicated that no comorbidities were found. The higher the score, the more likely the cumulative severity of a participant's comorbidities.

Mean Charlson Comorbidity Index of Participants

ECOG PS was used to assess physical health of participant, ranged from 0 (most active) to 5 (dead) where 0=fully active, able to carry on all pre-disease performance without restriction; 1=restricted in physically strenuous activity, ambulatory, able to carry out light or sedentary work; 2=ambulatory, capable of all self-care, unable to carry out any work activity, up greater than (\>)50 percent (%) of waking hours; 3=capable of only limited self-care, confined to bed or chair \>50% of waking hours; 4=completely disabled, cannot carry on any self-care, totally confined to bed or chair; 5=dead.

Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS)

Here, number of participants were classified according to their AML type. Index date was defined as the date of initial AML diagnosis.

AML Stage at Index Date

t(6;9)(p23:q34.1) Testing

t(v;11q23.3) Testing

t(9;22)(q34.1;q11.2) Testing

inv(3)(q21.3q26.2)³ or t(3;3)(q21.3;q26.2) Testing

-5 or del(5q); -7; -17/abn(17p) Testing

Complex karyotype Testing

Monosomal karyotype Testing

t(8;21)(q22;q22.1) Testing

inv(16)(p13.1q22)¹ or t(16;16)(p13.1;q22) Testing

Here, number of participants were classified according to positive results (if they had test result data available and denoted as "yes") and and negative results (if they did not had test result data and denoted as "no") in cytogenetic/ Fluorescence in situ Hybridization (FISH) testing. Cytogenetic/FISH testing included: t(6;9)(p23:q34.1), t(v;11q23.3), t(9;22)(q34.1;q11.2), inv(3)(q21.3q26.2) or t(3;3)(q21.3;q26.2), -5 or del(5q); -7; -17/abn(17p), complex karyotype, monosomal karyotype, t(8;21)(q22;q22.1), inv(16)(p13.1q22) and t(16;16)(p13.1;q22) tests.

Number of Participants With Results for Cytogenetic/FISH Testing at Initial AML Diagnosis

Analysis population included all eligible participants who were included in this study.

Pfizer ClinicalTrials.gov Call Center

Analysis population included all participants included in this study.

Real-World Event-Free Survival (rwEFS)

Real-World Relapse Free Survival (rwRFS)

Real-World Overall Survival (rwOS)

First line (1L) Therapy

Second line (2L) Therapy

Third line (3L) Therapy

Analysis population included all participants included in this study. Here, 'number analyzed' signifies participants evaluable for each specified category.

Number of Participants With First Positive Response

Mylotarg in 1L therapy

Mylotarg in 2L therapy

Mylotarg in 3L therapy

Duration of Therapy

rwEFS defined as time from treatment initiation date (for first line of Mylotarg-containing therapy) to date of TF, relapse from CR or better, death from any cause, whichever came first. TF defined as failure to achieve CR or better following up to 3 cycles of Mylotarg. Time origin for rwEFS was start of Mylotarg in first line of therapy in which it was used. Terminal event for analysis of rwEFS was earlier of treatment failure, relapse from CR or better, death. CR is defined as having \< 5% blasts in the bone marrow and 0% blasts in the peripheral blood. Real-world setting signifies participants treated in clinical practice and in a non-trial setting.

Analysis population included all participants included in this study. Here, 'overall number of participants analyzed' signifies participants evaluable for this outcome measure.

rwEFS in De-Novo AML Participants Using a Closer-to-Typical Combination of Mylotarg + Chemotherapy as 1L Therapy

Overall Study

gemtuzumab ozogamicin (GO) during consolidation for patients with acute myeloid leukemia (AML)

gemtuzumab

Sanz Miguel Angel, Dr

Prospective, multicenter, uncontrolled cohort study to analyze the efficacy of a risk adapted treatment strategy, including gemtuzumab ozogamicin (GO) during consolidation, for patients with acute myeloid leukemia (AML).

Patients will be stratified according to age in a first step, with a cut-point of 65 years old. For patients younger than 65 years old who achieve complete response, a second stratification will be made before first consolidation treatment. This second stratification will be performed according to the follow parameters: MDR at the end of induction, karyotype and molecular findings, including FLT3 internal tandem duplication (ITD) and NPM1 mutations. The following groups can be identified according to these parameters:

Group A:

Patients aged 65 or younger who are candidates for intensive chemotherapy.

Group A1:

Patients who are in first CR with negative MRD (less than 0.1%), good prognosis karyotype and, in the case of t(8;21) or inv(16), absence of mutations in the exon 17 of c-kit.

Group A2:

Patients who are in first CR with negative MRD (less than 0.1%), intermediate-risk karyotype, NPM1 positive and FLT3 negative.

Group A3:

Patients who are in first CR with negative MRD (less than 0.1%), intermediate-risk karyotype, absence of NPM1 mutations and who are negative for FLT3-ITD or FLT3-ITD positive with a ratio less than 0.8, regardless NPM1 status.

Group A4:

Patients who are in first CR with positive MRD (greater than 0.1%), t(8;21) or inv(16) with mutations in the exon 17 of c-kit, intermediate risk karyotype with positive FLT3-ITD and ratio greater or equal to 0.8 or high-risk karyotype.

Group B:

Patients over 65 years who are able to receive intensive chemotherapy.

TREATMENT SCHEDULE:

Treatment is tailored for each of the previously defined groups:

Group A:

Induction with Idarubicin and ARA-C in "3 +7" schedule (IDA 12 mg/m2 x 3 days and ARA-C 200 mg/m2 x 7 days).

Group A1:

Two consolidation cycles with ARA-C at a dose of 3 g/m2 on days 1, 3 and 5. Collection of peripheral blood stem cells (PBSC) after the first consolidation. Autologous stem cell transplantation (ASCT) with Busulphan 1 mg/kg/6 VO or 0,8 mg/kg/6 h IV (Busilvex®) from day -8 to -5; Etoposide 20 mg/kg/d from day -4 to -3 and ARA-C 3 g/m2/12 h from on days -3 and -2 (see criteria for HiDAC modification); and G-CSF 10 µg/kg/d from day -9 to -2 (BEA schedule). Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is not recommended in first CR in this group of patients.

Group A2:

First consolidation with Idarubicin and ARA-C at the same dose than induction plus GO 3 mg/m2 at day 1. Collection of PBSC after first consolidation. Second consolidation with ARA-C 3 g/m2 on days 1, 3 and 5 followed by ASCT with BEA conditioning. It is not recommended to perform Allo-HSCT, especially from alternative donors, in first CR.

Group A3:

First consolidation with Ida and ARA-C at the same dose than induction plus GO 3 mg/m2 at day 1. Collection of PBSC after first consolidation. Second consolidation with ARA-C 3 g/m2 on days 1, 3 and 5 followed by ASCT with BEA schedule if no HLA-identical sibling is available. Patients in this group are candidates for allo-HSCT in first CR if HLA-identical sibling is available. Allo-HSCT will be performed after first consolidation.

Group A4:

First consolidation with Ida and ARA-C at the same dose than induction plus GO 3 mg/m2 at day 1. Collection of PBSC after first consolidation. Second consolidation with ARA-C 3 g/m2 on days 1, 3 and 5 followed by ASCT with BEA schedule if no donor is available. Patients in this group are candidates for allo-HSCT in first CR, including alternative donors. Allo-HSCT will be performed after first consolidation or later if no donor is available at this time.

Group C:

Induction with Idarubicin and ARA-C "2 + 5" (IDA 12 mg/m2 x 2 days and ARA-C 200 mg/m2 x 5 days). Two consolidations with GO 3 mg/m2 day 1 and ARA-C 100 mg/m2 continuous infusion days 1 to 5.

AML CHARACTERIZATION AND SAMPLES COLLECTION:

To achieve a complete characterization of AML, inmunophenotype analysis (defining the pattern for MRD studies), cytogenetics, FISH for inv(16), t(8;21) and t(15;17), and molecular study for AML1/ETO, CBFβ/MYH11, NPM1 and FLT3-ITD will be performed in all cases. For FLT3-ITD, the ratio between the mutated and not mutated allele will be calculated.

During the phase of samples collection, DNA, RNA and viable cells will be stored.

LAM07: Study to Analyze the Efficacy of a Risk Adapted Treatment Strategy, Including Gemtuzumab Ozogamicin (GO) During Consolidation, for Patients With Acute Myeloid Leukemia (AML)

PETHEMA LAM07: Prospective, Multicenter, Uncontrolled Cohort Study to Analyze the Efficacy of a Risk Adapted Treatment Strategy, Including Gemtuzumab Ozogamicin (GO) During Consolidation, for Patients With Acute Myeloid Leukemia (AML)

PETHEMA Foundation

Josep Mª Ribera/Executive Secretary

Leukemia, Promyelocytic, Acute

Acute Promyelocytic Leukemia

Anti-Inflammatory Agents

Antiemetics

Neuroprotective Agents

Gastrointestinal Agents

Dermatologic Agents

Vasodilator Agents

Respiratory System Agents

Anti-Infective Agents

Prednisolone

Methylprednisolone

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Tretinoin

Idarubicin

Theophylline

Arsenic Trioxide

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Keratolytic Agents

All-Trans Retinoic Acid (ATRA) + Arsenic Trioxide (ATO)

ATRA 45 mg/m2 daily by mouth beginning day 1; ATO 0.15 mg/kg by vein daily beginning on day 1; Idarubicin 12 mg/m2 x 1 dose; Methylprednisolone 50 mg daily for 5 days starting on day 1.

All-Trans Retinoic Acid (ATRA) + Arsenic Trioxide (ATO)

ATO 0.15 mg/kg by vein over 2 hours Monday-Friday for 4 weeks, then a 4-week break. ATRA 45 mg/m2 by mouth every day for 2 weeks, followed by 2 additional weeks of no study drug. Continue ATRA until treatment with ATO complete.

All-Trans Retinoic Acid (ATRA) + Arsenic Trioxide (ATO) + Gemtuzumab Ozogamicin (GO)

ATRA 45 mg/m2 daily po (in 2 divided doses) beginning day 1; ATO 0.15 mg/kg IV daily beginning on day 1; GO 9 mg/m2 on day 1 Methylprednisolone 50 mg daily for 5 days followed by rapid taper starting on day 1.

Theophylline 100mg p.o. bid days 1-3, 200 mg p.o. bid days 4-6, and 300 mg p.o. bid thereafter during periods when patient is receiving ATRA or ATO. Theophylline administration continues until therapy with ATO and ATRA is completed.

Induction: 45 mg/m2 daily by mouth in 2 divided doses beginning day 1

All-Trans Retinoic Acid (ATRA)

Induction: 0.15 mg/kg daily IV beginning day 1

Arsenic Trioxide (ATO)

1. 12 mg/m2 one dose only (may be given on day 1 to 5 of induction)
2. If either ATRA or ATO are discontinued due to toxicity, idarubicin 12 mg/m2 x 2 doses will be administered once every 4 to 5 weeks (depending on the recovery of counts) until 28 weeks has elapsed from the Complete Recovery date.

Farhad Ravandi-Kashani, MD

The goal of this clinical research study is to learn if the combination of arsenic trioxide (ATO) with ATRA and possibly idarubicin is effective in treating patients with newly-diagnosed APL.

All-trans retinoic acid (ATRA) and ATO are designed to cause the APL cells to mature and function normally. Idarubicin is designed to cause breaks in both strands of DNA (the genetic material of cells).

If you are found to be eligible to take part in this study, you will begin induction. During induction, you will receive ATRA, by mouth starting on Day 1. You will also receive ATO through a needle in your vein over 2 hours starting on Day 1. You will continue receiving the drugs every day until your bone marrow no longer shows APL cells.

If you had a high white blood cell count at screening, you will receive idarubicin through a needle in your vein over about 30 minutes one dose only on any day of Day 1 through 5.

During induction, blood (about 1-3 tablespoons) will be drawn every day during Week 1, and then 2 times a week after that. This blood will be drawn for routine tests.

During induction (about 21-28 days after beginning treatment), you will have a bone marrow aspirate to check the status of the disease. This may be performed more often if the doctor thinks it is needed.

If you achieve a complete remission during the induction phase, you will continue to the maintenance phase. During the maintenance phase, you will receive ATO by vein over 2 hours Monday-Friday for 4 weeks. After the 4 weeks of receiving the study drug, you will have a 4-week period "off" (when no study drug is given). ATRA is given by mouth every day for 2 weeks. This 2 weeks is followed by 2 additional weeks when no study drug will be given. You will continue to take ATRA until treatment with ATO is complete.

During maintenance, blood (about 1-3 tablespoons) will be drawn before every 4-week cycle of ATO, and then every week for routine tests. You will also have an ECG before every 4 week cycle when you take ATO.

If you do not achieve a complete remission during induction you will be taken off study.

If at any point during the study your white blood cell count rises above 10,000, you will receive idarubicin by vein over 30 minutes.

You will remain in the hospital for about the first 7 days of induction. After that, you must remain in Houston for the next 3-4 weeks. Once in the maintenance phase, you may be treated at home, but must return to M. D. Anderson for study visits.

After maintenance is complete, you will have follow-up visits for an additional 2 years. If at any time during the active study or follow-up the disease gets worse or intolerable side effects occur, you will be taken off the study.

If you had a low or high white blood cell count when you joined the study, you will have follow-up visits every 3 months for 2 years. At these visits, blood (about 1 tablespoon) will be drawn for routine tests and you will have a bone marrow aspirate.

This is an investigational study. Idarubicin, ATRA and ATO are FDA approved and commercially available. However, their use in this study and in this combination is considered investigational. Its use in APL patients is investigational. Up to 80 patients will take part in this multicenter study. All will be enrolled at M. D. Anderson.

All-trans Retinoic Acid, and Arsenic +/- Idarubicin

Treatment of Acute Promyelocytic Leukemia (APL) With All-Trans Retinoic Acid, and Arsenic +/- Idarubicin

Response defined as CR (marrow with \<5% blasts and no abnormal promyelocytes together with neutrophil count \>1000 and platelet count \>100,000) and toxicity as Acute promyelocytic leukemia (APL) differentiation syndrome, arrhythmia, peripheral neuropathy.

Bone marrow aspirate performed to check the status of the disease.

M.D. Anderson Cancer Center

All-Trans Retinoic Acid (ATRA) + Arsenic Trioxide (ATO): Oral ATRA 45 mg/m2 daily beginning day 1; ATO 0.15 mg/kg by vein (IV) daily beginning day 1; Idarubicin 12 mg/m2 x 1 dose; Methylprednisolone 50 mg daily for 5 days. Methylprednisolone 500 mg daily for 5 days followed by rapid taper starting on day 1

Idarubicin: 1) 12 mg/m2 one dose only (day 1 to 5 of induction) as needed for WBC\>10,000. 2) If ATRA or ATO discontinued due to toxicity, idarubicin 12 mg/m2 x 2 doses administered once every 4- 5 weeks until 28 weeks elapsed from Complete Recovery date.

Post CR

1.) ATO 0.15 mg/kg IV for 5 of every 7 days on each of weeks 1-4 (course 2), 9-12 (course 3), 17-20 (course 4), and 25-28 (course 5) (thus 4 courses). 2.) Oral ATRA 45 mg/m2 daily on a "2-weeks on -2-weeks off" basis until therapy with ATO completed.

ATRA + ATO: Low Risk (WBC<10,000)

Oral ATRA 45 mg/m2 daily beginning day 1; ATO 0.15 mg/kg IV daily beginning day 1; Idarubicin (IDA) 12 mg/m2 x 1 dose; Methylprednisolone 50 mg daily for 5 days.

ATRA Induction: 45 mg/m2 daily by mouth in 2 divided doses beginning day 1; and ATO: Induction: 0.15 mg/kg daily IV beginning day 1.

Idarubicin: 1) 12 mg/m2 one dose only (day 1 to 5 of induction) 2) If ATRA or ATO discontinued due to toxicity, idarubicin 12 mg/m2 x 2 doses administered once every 4- 5 weeks until 28 weeks elapsed from Complete Recovery date.

ATRA+ATO+IDA: High Risk (WBC >10,000)

Induction ATRA 45 mg/m2 daily po (in 2 divided doses) beginning day 1 ATO 0.15 mg/kg IV daily beginning on day 1 Methylprednisolone 50 mg daily for 5 days followed by rapid taper starting on day 1 GO 9 mg/m2 on day 1 of induction Theophylline 100mg p.o. bid days 1-3, 200 mg p.o. bid days 4-6, and 300 mg p.o. bid thereafter during periods when patient is receiving ATRA or ATO. Theophylline administration continues until therapy with ATO and ATRA is completed.

Post-CR treatment ATO 0.15 mg/kg IV over 2 hours Monday-Friday for 4 weeks, then 4-week break. Oral ATRA 45 mg/m2 every day for 2 weeks, followed by 2 additional weeks of no study drug. Continue ATRA until treatment with ATO complete.

ATO+ATRA+GO

Total

Age, Categorical

United States

Region of Enrollment

Dr. Farhad Ravandi-Kashani, Professor, Leukemia

Of the 57 participants treated on the ATRA + ATO: Low Risk treatment arm, 56 participants were evaluable for response.

Complete Response (CR) Rate

ATRA 45 mg/m2 daily po (in 2 divided doses) beginning day 1 ATO 0.15 mg/kg IV daily beginning on day 1 Methylprednisolone 50 mg daily for 5 days followed by rapid taper starting on day 1 GO 9 mg/m2 on day 1 of induction Theophylline 100mg p.o. bid days 1-3, 200 mg p.o. bid days 4-6, and 300 mg p.o. bid thereafter during periods when patient is receiving ATRA or ATO. Theophylline administration continues until therapy with ATO and ATRA is completed.

Post-CR treatment ATO 0.15 mg/kg IV over 2 hours Monday-Friday for 4 weeks, then 4-week break. Oral ATRA 45 mg/m2 every day for 2 weeks, followed by 2 additional weeks of no study drug. Continue ATRA until treatment with ATO complete.

Symptoms and General Pathology

Immune System Diseases

Syndrome

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Preleukemia

Myelodysplastic Syndromes

Bone Marrow Diseases

Precancerous Conditions

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Fludarabine

Fludarabine phosphate

Melphalan

Thymoglobulin

Antilymphocyte Serum

Antimetabolites

Immunosuppressive Agents

Antineoplastic Agents, Alkylating

Alkylating Agents

Starting dose 2 mg/m\^2 over 2-hour intravenous infusion on day -12.

30 mg/m\^2 will be given intravenously daily at the same time over 30 minutes on days -5, -4, -3, -2.

140 mg/m\^2 will be given intravenously over 20 minutes starting 2 hours after the beginning of the fludarabine infusion on day -2.

Patients with an unrelated or mismatched related donor will receive 0.5 mg/kg on day -3 and 1.25 mg/Kg on days -2 and -1, following the chemotherapy.

Anti-thymocyte globulin

Allogeneic Bone Marrow and Peripheral Blood Stem Cell Transplantation: Infusion of blood stem cells or bone marrow cells on day 0.

Stem cell transplant

Marcos De Lima, MD

The goal of this clinical research study is to find the highest safe dose of Mylotarg that can be combined with chemotherapy in patients receiving allogeneic bone marrow transplantation. Researchers will study the effects of this treatment combination on patients with high-risk acute leukemia, chronic myelogenous leukemia, or myelodysplastic syndrome.

Primary Objective:

1. To determine the safety and maximum tolerated dose of Mylotarg as part of a reduced-intensity preparative regimen patients undergoing related, mismatched-related or matched unrelated donor transplantation.

Secondary Objectives:

1. To evaluate response rates, engraftment kinetics and degree of chimerism achievable with this strategy.
2. To evaluate the incidence and severity of GVHD in this population
3. To evaluate disease-free and overall survival and relapse rates.

Before treatment starts, patients will have a complete physical exam, including blood and urine tests. Patients will have a chest x-ray, heart scan, lung function test, and a bone marrow biopsy. Women who are able to have children will have a pregnancy test.

In this study, patients will receive Mylotarg twelve days before the transplant. The first patients will receive Mylotarg at the lowest dose level. As the study continues, the dose levels will be increased as long as no severe side effects occur. Mylotarg may be given in the outpatient Ambulatory Treatment Center (ATC). Patients will be monitored in the ATC for eight hours on the day of infusion. For the next 5 days, patients will be evaluated in the Clinic on a daily basis or as per physician orders. One week before the transplant, all patients will be admitted to the hospital and will continue their treatment as inpatients. Patients experiencing side effects from their leukemia or leukemia treatment may need to be hospitalized earlier.

On the 1st day of hospitalization, patients will receive fluids by vein. On the 5th, 4th, 3rd and 2nd day before the transplant, patients will receive Fludarabine, by vein. Melphalan will be given by vein on the 2nd day before transplant. Patients receiving five out of six antigen matched or unrelated bone marrow will also receive antithymocyte globulin, by vein, on the 3rd, 2nd and 1st day before transplant.

On the 7th day, healthy blood stem cells or bone marrow from the donor will be given through the central catheter. Some donor bone marrow or stem cells may be saved for future therapies.

Patients will also receive several other medications to help the treatment work and to help prevent infections while their immune system is weak. Tacrolimus and methotrexate will be given to prevent graft-versus-host disease (GVHD). GVHD occurs when the donor's immune cells fight the patient's body. The Tacrolimus will be started on the day before the transplant and will continue for up to six months. Tacrolimus is given by vein at first and then by mouth when patients are able to eat. Methotrexate is given by vein on days 1, 3, 6 and possibly on day 11 after the transplant.

Sulfamethoxazole (Bactrim) or pentamidine will be given to fight bacteria. Bactrim is given by mouth when the counts are good. Pentamidine is given by vein when the counts are low. Acyclovir will be given at first by vein and then Valtrex will be given by pill to prevent viral infections. Granulocyte colony-stimulating factor (G-CSF) will be given to help the new bone marrow grow. It is given as an injection under the skin beginning on the 7th day after the transplant. It will continue until the patient's white blood cells reach an acceptable level. Overall, some of these drugs will be given for as long as 6 months or possibly longer. Other medications may be necessary. If you are allergic to some of these drugs, changes will be made.

Patients will be in the hospital for about 3-4 weeks. Patients will have checkups every day until discharged from the hospital then 3 times a week until their blood counts improve. Patients will then be seen by their doctor at least every week until 100 days after the bone marrow transplant. Patients must stay in Houston during this time. After 100 days, patients will return at least every 3 months for the first year, then every 6 months for an additional two years.

Bone marrow samples will be taken at about 1 month, 3 months, 6 and 12 months after the transplant.

This is an investigational study. All of the drugs in this study are approved by the FDA. About 47 patients will take part in this study. All will be enrolled at M. D. Anderson.

Allo Transplantation With Mylotarg, Fludarabine and Melphalan for AML, CML and MDS

Phase I/II Evaluation of Safety and Activity of Mylotarg Plus Melphalan and Fludarabine as Preparative Therapy for Older or Medically Infirm Patients Undergoing Allogeneic Bone Marrow and Peripheral Blood Stem Cell Transplantation

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study Of Treatment Patterns And Clinical Outcomes In Patients Diagnosed With Acute Myeloid Leukemia Who Received Mylotarg in the Real-World	NCT04337138	Leukemia, Myelo...	Gemtuzumab Ozog...	18 Years -	Pfizer
LAM07: Study to Analyze the Efficacy of a Risk Adapted Treatment Strategy, Including Gemtuzumab Ozogamicin (GO) During Consolidation, for Patients With Acute Myeloid Leukemia (AML)	NCT01041040	Acute Myeloblas...	gemtuzumab	-	PETHEMA Foundation
A Study Of Treatment Patterns And Clinical Outcomes In Patients Diagnosed With Acute Myeloid Leukemia Who Received Mylotarg in the Real-World	NCT04337138	Leukemia, Myelo...	Gemtuzumab Ozog...	18 Years -	Pfizer
All-trans Retinoic Acid, and Arsenic +/- Idarubicin	NCT00413166	Acute Promyeloc...	All-Trans Retin... Arsenic Trioxid... Idarubicin Gemtuzumab Ozog...	-	M.D. Anderson Cancer Center
LAM07: Study to Analyze the Efficacy of a Risk Adapted Treatment Strategy, Including Gemtuzumab Ozogamicin (GO) During Consolidation, for Patients With Acute Myeloid Leukemia (AML)	NCT01041040	Acute Myeloblas...	gemtuzumab	-	PETHEMA Foundation
Allo Transplantation With Mylotarg, Fludarabine and Melphalan for AML, CML and MDS	NCT00038831	Acute Myelogeno... Myelodysplastic... Chronic Lymphoc...	Mylotarg Fludarabine Melphalan Anti-thymocyte ... Stem cell trans...	12 Years - 75 Years	M.D. Anderson Cancer Center
A Study Of Treatment Patterns And Clinical Outcomes In Patients Diagnosed With Acute Myeloid Leukemia Who Received Mylotarg in the Real-World	NCT04337138	Leukemia, Myelo...	Gemtuzumab Ozog...	18 Years -	Pfizer

Spots Global Cancer Trial Database for gemtuzumab

Every month we try and update this database with for gemtuzumab cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for gemtuzumab

Every month we try and update this database with for gemtuzumab cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for gemtuzumab cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.