Comparing Three Different Combination Chemotherapy Regimens in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

Completed · Phase 2

Conditions studied: Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0), Adult Acute Monoblastic Leukemia (M5a), Adult Acute Monocytic Leukemia (M5b), Adult Acute Myeloblastic Leukemia With Maturation (M2), Adult Acute Myeloblastic Leukemia Without Maturation (M1), Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Acute Myelomonocytic Leukemia (M4), Adult Erythroleukemia (M6a), Adult Pure Erythroid Leukemia (M6b), Recurrent Adult Acute Myeloid Leukemia

In brief

This randomized phase II trial is comparing three different combination chemotherapy regimens to see how well they work in treating patients with relapsed or refractory acute myeloid leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating patients with relapsed or refractory acute myeloid leukemia.

Key facts

Study ID

NCT00634244

Run by

National Cancer Institute (NCI)

People needed

92

Starts

2008-10-01

Expected to finish

2014-10-01

Last updated by the study team

2015-07-07

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Induction Therapy:
• Patients must have morphologic proof (from bone marrow aspirate, smears or touch preps of marrow biopsy) of acute myelogenous leukemia (AML) with >= 10% blasts within two weeks prior to induction randomization
• NOTE: Patients must be registered to E3903 (Ancillary Laboratory Protocol for Collecting Diagnostic Material on Patients Considered for Eastern Cooperative Oncology Group [ECOG]-American College of Radiology Imaging Network [ACRIN] Treatment Trials for Leukemia or Related Hematologic Disorders) and must undergo eligibility testing for the study by multiparameter flow cytometry
• All immunodiagnoses are eligible for E1906, except acute promyelocytic leukemia (APL) (proven by the presence of promyelocytic leukemia (PML)/retinoic acid receptor (RAR) alpha); cases of APL can become eligible if the patient is ineligible for an ECOG-ACRIN APL trial or if all-trans retinoic acid or arsenic trioxide is not planned as part of the treatment regimen
• Patients must qualify for one of the following:
• Relapse =< 6 months after first CR, dated from documentation of CR to documentation of relapse
• Relapse between 6-12 months after first CR
• Refractory to conventional initial induction chemotherapy (=< 2 courses) or to first reinduction (=< 1 course)
• Normal cardiac ejection fraction by pretreatment multi gated acquisition scan (MUGA) or echocardiogram within 4 weeks prior to randomization (resting ejection fraction >= 50% or >= 5% increase with exercise), shortening fraction by echocardiogram >= 24%, or to within the normal range of values for the institution
• Prior treatment to doses of any of the following:
• < 300 mg/m\^2 of doxorubicin
• < 300 mg/m\^2 of daunorubicin
• < 100 mg/m\^2 of idarubicin
• < 100 mg/m\^2 of mitoxantrone
• Serum creatinine =< 2.0 mg/dL
• Serum direct bilirubin < 2.0 mg/dL
• Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) < 4 x upper limit of normal
• The above stipulation for normal hepatic function does not apply if liver dysfunction is due to leukemia infiltration
• Prior to study entry, patients must have recovered from toxicities of prior chemotherapy and radiotherapy; for patients refractory to induction chemotherapy (patient subgroup outlined above), marrow documentation of residual leukemia post chemotherapy and qualification for remaining eligibility criteria are needed prior to study entry (this does not require >= 30% marrow blasts to be evident but a minimum of 10% blasts must be present in the marrow)
• NOTE: Hydroxyurea is permitted within 4 weeks of study entry
• ECOG performance status 0, 1 or 2
• Patients with a history of central nervous system (CNS) leukemia are eligible if there is documentation of no current CNS involvement on cerebrospinal fluid (CSF) examination, (i.e., negative CSF by lumbar puncture)
• Consolidation therapy:
• Patients must have an ECOG performance status 0, 1 or 2
• Patients must have documented CR

You may not qualify if…

• Induction therapy:
• Patients who have relapsed > 1 year after achieving first CR or are in >= second relapse
• Patients who have had a prior allogeneic OR autologous stem cell transplant
• History of recent myocardial infarction (within three months), uncontrolled congestive heart failure, or uncontrolled cardiac arrhythmia
• Prior treatment with carboplatin, topotecan, flavopiridol, or sirolimus
• Pregnant or breast feeding. Women of childbearing potential and sexually active males should use an accepted and effective method of contraception
• Intercurrent organ damage or medical problems that would prohibit therapy; no active or unresolved infection
• Current evidence of invasive fungal infection; such evidence includes positive blood or deep tissue cultures or stains
• Have another (i.e., prior) tumor which is currently active and likely to interfere with the patient's treatment for AML or which is likely to compromise the patient's morbidity or mortality substantially
• Consolidation therapy:
• Intercurrent organ damage or medical problems that will jeopardize the outcome of therapy
• For arms B and C, patients have exceeded the following anthracycline doses or their equivalents:
• < 300 mg/m\^2 of doxorubicin
• < 300 mg/m\^2 of daunorubicin
• < 100 mg/m\^2 of idarubicin
• < 100 mg/m\^2 of mitoxantrone

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Mayo Clinic in Arizona — Scottsdale, Arizona, United States
• Mayo Clinic in Florida — Jacksonville, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• Siouxland Hematology Oncology Associates — Sioux City, Iowa, United States
• Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• The Jewish Hospital — Cincinnati, Ohio, United States
• Geisinger Medical Center — Danville, Pennsylvania, United States
• Geisinger Medical Center-Cancer Center Hazleton — Hazleton, Pennsylvania, United States
• Penn State Milton S Hershey Medical Center — Hershey, Pennsylvania, United States
• Lewistown Hospital — Lewistown, Pennsylvania, United States
• Geisinger Medical Group — State College, Pennsylvania, United States
• Mount Nittany Medical Center — State College, Pennsylvania, United States
• Geisinger Wyoming Valley — Wilkes-Barre, Pennsylvania, United States
• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
• University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States
• Froedtert and the Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• Rambam Medical Center — Haifa, Israel

Full record on ClinicalTrials.gov

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