Neoplasms

Blood and Lymph Conditions

All Conditions

Rare Diseases

Leukemia

Leukemia, Myelomonocytic, Acute

Neoplasms by Histologic Type

Hematologic Diseases

Leukemia, Myeloid

Acute Graft Versus Host Disease

2 days loading dose followed by weekly 2hr infusion

XIAP antisense

Jacques Jolivet, MD

The purpose of this study is to determine if the drug, called AEG35156, can be safely given to AML patients and whether it effectively reduces levels of a protein (XIAP) to increase the sensitivity of cancer cells to chemotherapy (ara-C and idarubicin) in patients with refractory or relapsed AML.

This is a phase I/II, single-arm, open-label, study to establish the recommended dose and activity of AEG35156 administered as a daily x3 two-hour infusion prior to reinduction chemotherapy with idarubicin and ara-C followed by weekly two-hour AEG35156 infusions. Subjects eligible for study entry must have confirmed diagnosis of AML in first relapse after an initial CR that lasted less than 6 months or primary refractory AML. Fixed dose of idarubicin and ara-C will be given, plus one of eight doses of AEG35156: 12, 24, 48, 75, 110, 165, 250 and 350mg/m2. A maximum of 54 patients will be treated in cohorts of size 3, starting at 12mg/m2, and not skipping any untried dose level when escalating. Following dose escalation, approximately 20 patients will be treated at the best acceptable dose as determined by the method of Thall and Cook (2004).

Study of XIAP Antisense Given With Chemotherapy for Refractory/Relapsed AML

An Open-Label Phase I/II Study of XIAP Antisense AEG35156 Administered to Patients With Refractory/Relapsed AML in Combination With Chemotherapy

Aegera Therapeutics

Jacques Jolivet, MD, Senior VP Clinical

Leukemia, Myeloid, Acute

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Erlotinib Hydrochloride

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Erlotinib will be administered orally at 150 mg once a day, continuously. Each cycle will be 28 days and there will be no break between the cycles.

Erlotinib

S. Hamid Sayar, MD

This research study is looking for patients with newly diagnosed acute myeloid leukemia (AML), AML that has returned (relapsed), or it has not responded adequately to previous treatments. Treating certain patients with chemotherapy may not be to their benefit or may cause more harm than benefit. The purpose of this study is to find out what effects (good and bad) erlotinib has on patients and their AML.

Pilot Study of Erlotinib for the Treatment of Patients With de Novo Acute Myeloid Leukemia

The percent of patients were shown as having a partial remission or better based on definitions of response in AML. Partial remission includes a decrease of at least 50% in the percentage of blasts to 5% to 25% in the bone marrow aspirate. Complete remission includes presence of less than 5% blasts in an aspirate sample with marrow spicules and with a count of at least 200 nucleated cells. The percent and 95% exact confidence intervals will be calculated.

The duration of response is from the time of response until failure or until the end of follow-up for the patients who received complete remission. Complete remission includes presence of less than 5% blasts in an aspirate sample with marrow spicules and with a count of at least 200 nucleated cells.

Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grading scale will be from 1 (mild) to 5 (causing death). This will determine the number of unique patients who had a treatment related (possible, probable or definite) adverse event that was graded 3 or greater.

OSI Pharmaceuticals

Indiana University

Erlotinib: Erlotinib will be administered orally at 150 mg once a day, continuously. Each cycle will be 28 days and there will be no break between the cycles.

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Dr. Hamid Sayar

All patients enrolled and received treatment

Overall Response Rate (Defined as Partial Remission or Better) to 3 Months of Treatment With Erlotinib

Duration of Response (up to One Year Follow up) in Patients Who Achieve a Complete Remission

Treatment Related Adverse Events Grade 3 or Higher

Mechanistic Attributes of Erlotinib Hydrochloride in AML, Including Intracellular Quantitative Protein and Gene Expression Modifications and the in Vivo Effect of This Agent on the Differentiation of AML Blasts

Overall Study

Leukemia, Monocytic, Acute

Leukemia, Erythroblastic, Acute

Leukemia, Megakaryoblastic, Acute

Myeloproliferative Disorders

Bone Marrow Diseases

Chronic Myeloproliferative Disorders

Anti-Infective Agents

Cytarabine

Idarubicin

Antimetabolites

Antiviral Agents

Immunosuppressive Agents

Immunologic Factors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Will receive volasertib combined with idarubicin plus cytarabine in a 3+7 schedule as induction chemotherapy. Volasertib dose will be given on day 4 in a dose escalation schedule over 3 dose levels (140 mg/m2, 170 mg/m2, 200 mg/m2) in successive cohorts.

Non-hematologic toxicity will be determined using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 criteria for adverse events. Hematologic toxicity will be determined by days to absolute neutrophil count (ANC) and platelet recovery.

Addition of single dose of volasertib intravenously (IV) on Day 4 of treatment protocol.

Volasertib

Given IV daily on Days 1-3 of treatment protocol.

Given IV daily as 24-hour continuous infusion on Day 1-7 of treatment protocol.

Joseph Brandwein, MD

This is a Phase I clinical trial to determine the maximum tolerated dose (MTD) of the polo-like kinase-1 inhibitor volasertib which can be safely combined with idarubicin plus cytarabine induction chemotherapy for previously untreated patients with acute myeloid leukemia. (AML).

Main inclusion criteria:

1. AML, any subtype except acute promyelocytic leukemia (APL)
2. At least one of the following features:

   i. Age 18-75 with adverse risk cytogenetics ii. Age 18-75 with antecedent myelodysplastic syndrome (MDS) or myeloproliferative disorder (MPD), or therapy-related AML iii. Age 60-75, regardless of risk category
3. No prior therapy for AML other than hydroxyurea
4. Judged by treating physician to be medically fit for induction chemotherapy
5. Eastern Cooperative Oncology Group (ECOG) performance status score 0-2
6. Normal left ventricular ejection fraction

Subjects will receive induction chemotherapy consisting of idarubicin 12 mg/m2 on Days 1-3 plus cytarabine 200 mg/m2 (age 18-59) or 100 mg/m2 (age 60-75) as a continuous IV infusion x 7 days. Volasertib will be administered on day 4 in a dose-escalation schedule, using a standard 3+3 dose escalation design, over 3 dose levels. Once the MTD has been determined, an additional dose expansion cohort will be accrued.

A Study of Volasertib Plus Induction Chemotherapy for Acute Myeloid Leukemia

A Phase I Study of Volasertib Combined With Standard Induction Chemotherapy for Previously Untreated Patients With Acute Myeloid Leukemia (VIAC)

Anonymized data will be made available to Boehringer-Ingelheim.

Non-hematologic toxicities will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Hematologic toxicities will be assessed by determining number of days to neutrophil (ANC) recovery to \>0.5 x10(9)/L or platelet recovery to \>20 x10(9)/L.

DLT is defined as grade 3-4 non-hematologic toxicity (except grade 3 nausea, vomiting, mucositis or creatinine elevation due to tumor lysis syndrome, and grade 3-4 neutropenic infections and electrolyte abnormalities) using CTCAE version 4.0.Hematologic DLT is defined as ANC recovery to \>0.5 x10(9)/L or platelet recovery to \>20 x10(9)/L of \> 42 days.

MTD is defined as maximum dose of volasertib associated with \< 2/6 DLTs at a given dose level.

Complete response (CR) defined as \<5% marrow blasts with ANC \> 1.0 x10(9)/L and platelets \>100 x 10(9)/L, with no extramedullary disease. CRi defined as same, but ANC \<1.0 and/or platelets \<100.

University of Alberta

Director, Division of Hematology

Analgesics

Aldesleukin

Interleukin-2

The arm that will receive the target treatment.

During the consolidation chemotherapy stage, the umbilical cord blood transfusion is given twice (interval of 1 month) to support treatment. On the first day after umbilical cord blood transfusion, the proportion of NK cells in peripheral blood is detected. If it is less than 20%, the NK cells sre activated by subcutaneous injection of recombinant human interleukin-2 (rhIL-2) on the second day after infusion.

umbilical cord blood

huaiyu Wang, doctor

sha Gong, doctor

huaiyu Wang

After complete remission, elderly AML patients cannot tolerate hematopoietic stem cell transplantation and standard-dose consolidation chemotherapy, and the 5-year survival rate is around 10%. Therefore, it is necessary to explore treatment strategy that can support chemotherapy or improve immunity. Umbilical cord blood is rich in hematopoietic stem cells and immune cells. However,Cord blood transplantation for adults is still being explored. The application of cord blood in supportive treatment can be actively explored. Cord blood has low immunogenicity and is unlikely to cause Graft versus host disease (GVHD), and the infusion is relatively safe. The Department of Hematology of Shanghai Ruijin Hospital has conducted a related phase II clinical study, and found that cord blood transfusion reduced the chance of infection and increased the 2-year survival. Our subject is a prospective single-arm clinical study. It is planned to recruit 20 elderly AML patients to explore whether the application of cord blood infusion can further improve the prognosis of patients during their consolidation chemotherapy.

20 elderly AML patients who achieved complete remission (CR) after induction chemotherapy will be enrolled in this study. Baseline data are collected and informed consents are signed before consolidation chemotherapy. At the same time, HLA typing test is carried out, and the corresponding cord blood is matched from the cord blood bank. During the consolidation chemotherapy stage, the cord blood transfusion is given twice (interval of 1 month) to support treatment. On the first day after umbilical cord blood transfusion, the proportion of NK cells in peripheral blood are detected. If it is less than 20%, the NK cells are activated by subcutaneous injection of recombinant human interleukin-2 (rhIL-2) on the second day after infusion. The treatment effects are continuously monitored and followed up regularly after treatment.The intend of this trial is to explore whether cord blood transfusion in the consolidation phase can further reduce the recurrence rate of AML and improve prognosis.

Umbilical Cord Blood Transfusion in Consolidation Therapy of Elderly Patients With Acute Myeloid Leukemia

Application of Umbilical Cord Blood Transfusion in Consolidation Therapy of Elderly Patients With Acute Myeloid Leukemia

the overall survival rate of enrolled patients at the end of 2 years

DFS is measured from the date when CR is achieved. And the end includes death or relapse.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of XIAP Antisense Given With Chemotherapy for Refractory/Relapsed AML	NCT00363974	Leukemia, Myelo...	XIAP antisense	18 Years -	Aegera Therapeutics
Pilot Study of Erlotinib for the Treatment of Patients With de Novo Acute Myeloid Leukemia	NCT01174043	Leukemia, Myelo...	Erlotinib	18 Years -	Indiana University
A Study of Volasertib Plus Induction Chemotherapy for Acute Myeloid Leukemia	NCT02527174	Leukemia, Myelo... Leukemia, Monoc... Leukemia, Myelo... Leukemia, Eryth... Leukemia, Megak...	Volasertib Idarubicin Cytarabine	18 Years - 75 Years	University of Alberta
Pilot Study of Erlotinib for the Treatment of Patients With de Novo Acute Myeloid Leukemia	NCT01174043	Leukemia, Myelo...	Erlotinib	18 Years -	Indiana University
Umbilical Cord Blood Transfusion in Consolidation Therapy of Elderly Patients With Acute Myeloid Leukemia	NCT04687657	Leukemia, Myelo...	umbilical cord ...	60 Years -	First Affiliated Hospital Xi'an Jiaotong University
Umbilical Cord Blood Transfusion in Consolidation Therapy of Elderly Patients With Acute Myeloid Leukemia	NCT04687657	Leukemia, Myelo...	umbilical cord ...	60 Years -	First Affiliated Hospital Xi'an Jiaotong University

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