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

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Analgesics

Cytarabine

Daunorubicin

Interleukin-2

Antimetabolites

Antiviral Agents

Immunosuppressive Agents

Immunologic Factors

Analgesics, Non-Narcotic

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

cytosine arabinoside (ara-C)

daunomycin

interleukin-2

Richard M. Stone, MD

This study will add interleukin-2 (IL-2) to a regimen of post-remission therapy consisting of high-dose ara-C. Patients with AML in first remission will receive 3 cycles of high-dose ara-C followed by continuous infusion and bolus interleukin-2 (IL-2). We, the researchers at the Dana-Farber Cancer Institute, plan to evaluate the immunologic effects of such treatment in these patients.

Patients will receive standard remission induction therapy with daunorubicin at a dose of 45 mg/m2/day for 3 days and continuous infusion cytarabine at a dose of 200 mg/m2/day for 7 days.

Those patients who enter a remission status and have preserved liver and kidney function will then receive 3 cycles of post-remission therapy that will consist of high-dose cytarabine at a dose of 3000 mg/m2 every 12 (q12) hours on days 1, 3 and 5 (total of 6 doses).

Patients who are still in remission will receive interleukin-2 (IL-2) upon count recovery at a dose of 8.1 X 10\^5 U/m2/day by continuous infusion for 10 weeks. In addition, patients will receive bolus IL-2 at a dose of 6 X 10\^5 U/m2 by intravenous bolus weekly for 6 doses through day 63.

Patients will be seen on a weekly basis while on treatment for examination and bloodwork.

At the end of treatment, patients will have a physical exam and bloodwork performed monthly for two years, then 4 times per year for two years.

High Dose Ara-C (HDAC) and Interleukin-2 (IL-2) for Patients With Acute Myelogenous Leukemia (AML)

High-Dose Ara-C Followed by Continuous Infusion Interleukin-2 for Acute Myelogenous Leukemia in First Remission

Brigham and Women's Hospital

Dana-Farber Cancer Institute

Diseases and Abnormalities at or Before Birth

Congenital Abnormalities

Leukemia, Myelomonocytic, Acute

Leukemia, Monocytic, Acute

Leukemia, Erythroblastic, Acute

Leukemia, Megakaryoblastic, Acute

Leukemia, Basophilic, Acute

Leukemia, Eosinophilic, Acute

Acute Monoblastic Leukemia

Acute Myelomonocytic Leukemia

Acute Erythroid Leukemia

Di Guglielmo's Syndrome

Acute Megakaryoblastic Leukemia

Acute Myeloblastic Leukemia Without Maturation

Acute Myeloblastic Leukemia With Maturation

Gemtuzumab

Antineoplastic Agents, Immunological

Immunotoxins

Immunoconjugates

Patients receive gemtuzumab ozogamicin IV over 2 hours on day 1. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.

Patients receive no additional therapy. Patients are observed at days 30 and 60 after randomization.

Standard induction regimen of 7 days of Ara-C (cytosine arabinoside) and 3 days of daunomycin

Gemtuzumab (GO) added to the standard induction regimen of 7 days of Ara-C and 3 days of daunomycin

Given IV, induction Arm1 6mg/m2 D4; post-consolidation 5mg/m2 3 doses \>/= 28 days apart

gemtuzumab ozogamicin

observation

IV; induction Arms1/2 and reinduction 100 mg/m2/d days 1-7; consolidation 3gm/m2 q3hrs D1, 3, 5

Cytosine arabinoside

IV; induction Arm1 45mg/m2 D1-3; Arm2 and reinduction 60 mg/m2 D1-3;

Daunomycin

Stephen H. Petersdorf, MD

RATIONALE: Drugs used in chemotherapy, such as cytarabine and daunorubicin, work in different ways to stop cancer cells from dividing so they stop growing and die. Monoclonal antibodies, such as gemtuzumab ozogamicin, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining chemotherapy with gemtuzumab ozogamicin may kill more cancer cells. It is not yet known whether induction therapy using cytarabine and daunorubicin is more effective with or without gemtuzumab ozogamicin or whether postconsolidation therapy using gemtuzumab ozogamicin is more effective than no additional therapy in treating de novo (first occurrence) acute myeloid leukemia.

PURPOSE: This randomized phase III trial is comparing two different regimens of chemotherapy and monoclonal antibody therapy to see how well they work in treating patients with previously untreated de novo acute myeloid leukemia.

OBJECTIVES:

* Compare disease-free survival of patients with previously untreated de novo acute myeloid leukemia treated with induction therapy comprising cytarabine and daunorubicin with vs without gemtuzumab ozogamicin followed by consolidation therapy comprising high-dose cytarabine and post-consolidation therapy comprising gemtuzumab ozogamicin vs no additional therapy.
* Compare the complete remission rate in patients treated with these regimens.
* Compare the frequency and severity of the toxic effects of these regimens in these patients.

Other objectives (if funding allows):

* Determine the prognostic significance of CD33 expression on the response rate in patients receiving gemtuzumab ozogamicin.
* Determine the prognostic significance of FLT3 mutations in these patients before treatment with these regimens.
* Determine the prognostic significance of minimal residual disease in remission specimens from these patients treated with these regimens.
* Determine the prognostic significance of the flow cytometric detection of minimal residual disease in specimens collected from these patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified during induction therapy according to age (\< 35 years vs ≥ 35 years) and during post-consolidation therapy according to preinduction cytogenetic risk group.

* Induction therapy: Patients are randomized to 1 of 2 treatment arms.

  * Arm I: Patients receive daunorubicin IV on days 1-3, cytarabine IV continuously on days 1-7, and gemtuzumab ozogamicin IV over 2 hours on day 4. Patients receive filgrastim (G-CSF) or sargramostim (GM-CSF) IV or subcutaneously once daily beginning on day 15 and continuing until blood counts recover.
  * Arm II: Patients receive daunorubicin, cytarabine, and G-CSF or GM-CSF as in arm I.

Patients in both arms undergo bone marrow aspiration and biopsy on day 14 (and on day 19, if applicable) and then proceed to reinduction therapy.

* Reinduction therapy: Patients receive daunorubicin IV on days 1-3 and cytarabine IV continuously on days 1-7. Patients also receive G-CSF or GM-CSF as in induction therapy.

Patients who achieve A1 bone marrow, B1 peripheral blood, and C1 extramedullary disease status proceed to consolidation therapy.

* Consolidation therapy: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1, 3, and 5. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.

Patients who maintain A1 bone marrow, B1 peripheral blood, and C1 extramedullary disease status after consolidation therapy proceed to post-consolidation therapy.

* Post-consolidation therapy: Patients are randomized to 1 of 2 treatment arms.

  * Arm I: Patients receive gemtuzumab ozogamicin IV over 2 hours on day 1. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
  * Arm II: Patients receive no additional therapy. Patients are observed at days 30 and 60 after randomization.

Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years.

PROJECTED ACCRUAL: A total of 684 patients (342 per treatment arm) will be accrued for this study within 4.5-5 years.

S0106 Cytarabine and Daunorubicin w/ or w/o Gemtuzumab Followed By HD Cytarabine and Either Gemtuzumab or Nothing in de Novo AML

A Phase III Study of the Addition of Gemtuzumab Ozogamicin (Mylotarg®) During Induction Therapy Versus Standard Induction With Daunomycin and Cytosine Arabinoside Followed by Consolidation and Subsequent Randomization to Post-Consolidation Therapy With Gemtuzumab Ozogamicin (Mylotarg®) or No Additional Therapy For Patients Under Age 61 With Previously Untreated De Novo Acute Myeloid Leukemia (AML)

Measured from data of randomization to post-consolidation therapy until relapse from complete response or death from any cause, with observations censored at the date of last contact for patients last known to be alive without report of relapse.

Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event

National Cancer Institute (NCI)

SWOG Cancer Research Network

Regular investigator assessments are reported after each cycle of protocol treatment.

A 21 day treatment cycle of Induction 7+3+G.O. with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission (CR) during the first cycle of treatment

Induction 7 + 3 + G.O.

A 21 day treatment cycle of Induction 7+3 with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission during the first cycle of treatment

Induction 7 + 3

For patients who achieved a CR during induction, patients may receive up to 3 28 day cycles of treatment with Ara-C consolidation. Patients who relapse from CR are taken off protocol consolidation treatment.

Ara-C Consolidation

For patients who remain in CR without relapse, patients may receive up to 3 doses of G.O. 28 days apart.

Post-consolidation G.O.

Ara-C+Daunomycin+Mylotarg

ARA-C+Daunomycin

Total

Age, Continuous

Sex: Female, Male

SWOG Leukemia Statistician

Interim futility analysis of the alternative hypothesis for disease-free survival. The design specified a hazard ratio of (observation: GO) of 1.5.

Post-consolidation GO

Patients did not receive any post-consolidation therapy

Post-consolidation Observation

Eligible patients who completed induction and consolidation therapy

2-year Disease-free Survival (DFS)

Interim futility analysis alternative hypothesis based on the design specification that the 7+3+GO arm would have a 12% increase in CR rate.

Ara-C+Daunomycin

Eligible patients who did not withdraw consent

Complete Remission

ALT, SGPT (serum glutamic pyruvic transaminase)

AST, SGOT (serum glut. oxaloacetic transaminase)

Acidosis (metabolic or respiratory)

Adult respiratory distress syndrome (ARDS)

Albumin, serum-low (hypoalbuminemia)

Alkaline phosphatase

Alkalosis (metabolic or respiratory)

Allergic reaction/hypersens. (inc drug fever)

Amylase

Anorexia

Apnea

Ataxia (incoordination)

Bicarbonate, serum-low

Bilirubin (hyperbilirubinemia)

Blood/Bone Marrow-Other (Specify)

Bronchospasm, wheezing

Calcium, serum-low (hypocalcemia)

Cardiac Arrhythmia-Other (Specify)

Cardiac General-Other (Specify)

Cardiac troponin I (cTnI)

Cardiac troponin T (cTnT)

Cardiac-ischemia/infarction

Colitis

Colitis, infectious (e.g., Clostridium difficile)

Confusion

Constipation

Cough

Creatinine

DIC (disseminated intravascular coagulation)

Death not assoc with CTCAE term-Multi-organ failu

Dehydration

Diarrhea

Distention/bloating, abdominal

Dizziness

Dysphagia (difficulty swallowing)

Dyspnea (shortness of breath)

Edema, larynx

Edema: limb

Edema: viscera

Enteritis (inflammation of the small bowel)

Esophagitis

Fatigue (asthenia, lethargy, malaise)

Febrile neutropenia

Fever (in the absence of neutropenia)

Fistula, GI - Rectum

Fistula, GU - Vagina

Flu-like syndrome

GGT (gamma-glutamyl transpeptidase)

Glucose, serum-high (hyperglycemia)

Glucose, serum-low (hypoglycemia)

Hematoma

Hemoglobin

Hemolysis

Hemorrhage, CNS

Hemorrhage, GI - Abdomen NOS

Hemorrhage, GI - Jejunum

Hemorrhage, GI - Lower GI NOS

Hemorrhage, GI - Oral cavity

Hemorrhage, GI - Rectum

Hemorrhage, GU - Bladder

Hemorrhage, GU - Kidney

Hemorrhage, GU - Urinary NOS

Hemorrhage, GU - Uterus

Hemorrhage, GU - Vagina

Hemorrhage, pulmonary/upper respiratory - Lung

Hemorrhage, pulmonary/upper respiratory - Nose

Hemorrhage/Bleeding-Other (Specify)

Hepatobiliary/Pancreas-Other (Specify)

Hiccoughs (hiccups, singultus)

Hypertension

Hypotension

Hypoxia

Infec with Grade 3 or 4 neut - Abdomen NOS

Infec with Grade 3 or 4 neut - Anal/perianal

Infec with Grade 3 or 4 neut - Appendix

Infec with Grade 3 or 4 neut - Bladder (urin

Infec with Grade 3 or 4 neut - Blood

Infec with Grade 3 or 4 neut - Bone (osteomy

Infec with Grade 3 or 4 neut - Brain + Spina

Infec with Grade 3 or 4 neut - Bronchus

Infec with Grade 3 or 4 neut - Catheter-rela

Infec with Grade 3 or 4 neut - Cecum

Infec with Grade 3 or 4 neut - Colon

Infec with Grade 3 or 4 neut - Dental-tooth

Infec with Grade 3 or 4 neut - Heart (endoca

Infec with Grade 3 or 4 neut - Lip/perioral

Infec with Grade 3 or 4 neut - Liver

Infec with Grade 3 or 4 neut - Lung (pneumon

Infec with Grade 3 or 4 neut - Meninges (men

Infect with Grade 3 or 4 neut - Mucosa

Infec with Grade 3 or 4 neut - Nerve-periphe

Infec with Grade 3 or 4 neut - Oral cavity-g

Infec with Grade 3 or 4 neut - Pelvis NOS

Infec with Grade 3 or 4 neut- Pharynx

Infec with Grade 3 or 4 neut - Rectum

Infec with Grade 3 or 4 neut - Sinus

Infec with Grade 3 or 4 neut - Skin (celluli

Infec with Grade 3 or 4 neut - Small bowel N

Infec with Grade 3 or 4 neut - Upper airway

Toxicity

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
High Dose Ara-C (HDAC) and Interleukin-2 (IL-2) for Patients With Acute Myelogenous Leukemia (AML)	NCT00136448	Acute Myelogeno...	cytosine arabin... daunomycin interleukin-2	18 Years -	Dana-Farber Cancer Institute
S0106 Cytarabine and Daunorubicin w/ or w/o Gemtuzumab Followed By HD Cytarabine and Either Gemtuzumab or Nothing in de Novo AML	NCT00085709	Leukemia	gemtuzumab ozog... observation Cytosine arabin... Daunomycin	18 Years - 60 Years	SWOG Cancer Research Network
CINJALL: Treatment for Children With Acute Lymphocytic Leukemia	NCT00176462	Acute Lymphocyt...	aminopterin L-asparaginase cyclophosphamid... cytarabine daunomycin dexamethasone 6-mercaptopurin... methotrexate 6-thioguanine vincristine Triple Intrathe... Leucovorin	1 Year - 30 Years	Rutgers, The State University of New Jersey
Treatment for Patients With Stage III or IV Non-Hodgkin Lymphoma	NCT00187122	Lymphoblastic L...	Vincristine Radiation Thera... Daunomycin L-Asparaginase Cytarabine Methotrexate Mercaptopurine Etoposide Cyclophosphamid... Prednisone Dexamethasone	-	St. Jude Children's Research Hospital
Treatment for Patients With Stage III or IV Non-Hodgkin Lymphoma	NCT00187122	Lymphoblastic L...	Vincristine Radiation Thera... Daunomycin L-Asparaginase Cytarabine Methotrexate Mercaptopurine Etoposide Cyclophosphamid... Prednisone Dexamethasone	-	St. Jude Children's Research Hospital
Augmented Berlin-Frankfurt-Munster Therapy Plus Ofatumumab for Young Adults With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma	NCT02419469	Leukemia Precursor-B Acu... Lymphoblastic L... Lymphoma	Cytarabine Daunorubicin Vincristine Prednisone PEG asparaginas... Ofatumumab Rituximab Methotrexate Cyclophosphamid... Mercaptopurine Doxorubicin Dexamethasone a... Thioguanine	12 Years - 30 Years	M.D. Anderson Cancer Center
Augmented Berlin-Frankfurt-Munster Therapy Plus Ofatumumab for Young Adults With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma	NCT02419469	Leukemia Precursor-B Acu... Lymphoblastic L... Lymphoma	Cytarabine Daunorubicin Vincristine Prednisone PEG asparaginas... Ofatumumab Rituximab Methotrexate Cyclophosphamid... Mercaptopurine Doxorubicin Dexamethasone a... Thioguanine	12 Years - 30 Years	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for daunomycin

Every month we try and update this database with for daunomycin 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 daunomycin

Every month we try and update this database with for daunomycin 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 daunomycin 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.