Combination Chemotherapy Followed By Filgrastim or Sargramostim in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia
NCT ID: NCT00053131
Last Updated: 2011-03-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
1999-01-31
2004-02-29
Brief Summary
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PURPOSE: Randomized phase II trial to compare the effectiveness of combination chemotherapy followed by filgrastim with that of combination chemotherapy followed by sargramostim in treating patients who have relapsed or refractory acute myeloid leukemia or acute lymphoblastic leukemia.
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Detailed Description
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* Compare amounts of dendritic cells and leukemia-associated antigen-specific T lymphocytes in patients with relapsed or refractory acute myeloid leukemia or acute lymphoblastic leukemia treated with filgrastim (G-CSF) vs sargramostim (GM-CSF) after high-dose cytarabine and mitoxantrone.
OUTLINE: This is a randomized study.
All patients receive high-dose cytarabine IV over 1 hour twice daily on days 1-6 and mitoxantrone IV over 30 minutes on days 2-4. On day 6, patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive filgrastim (G-CSF) subcutaneously (SC) daily until blood counts recover in the absence of unacceptable toxicity.
* Arm II: Patients receive sargramostim (GM-CSF) SC daily as in arm I.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 6 years.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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filgrastim
sargramostim
cytarabine
mitoxantrone hydrochloride
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of acute myeloid leukemia or acute lymphoblastic leukemia by morphology, cytochemical staining, and flow cytometry
* In first or subsequent relapse or refractory disease after at least 1 prior treatment regimen
* Antecedent hematologic disorders allowed except Philadelphia chromosome-positive chronic myelogenous leukemia
PATIENT CHARACTERISTICS:
Age
* 15 and over
Performance status
* 0-3
Life expectancy
* At least 4 weeks
Hematopoietic
* Not specified
Hepatic
* Bilirubin no greater than 2 times normal\*
* SGOT no greater than 2 times normal\* NOTE: \*Unless directly attributable to leukemia
Renal
* Creatinine no greater than 1.5 times normal\* NOTE: \*Unless directly attributable to leukemia
Cardiovascular
* Ejection fraction at least 45%\* NOTE: \*Unless directly attributable to leukemia
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other concurrent medical or psychiatric illness that would preclude study entry
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Prior autologous or allogeneic bone marrow or peripheral blood stem cell transplantation allowed
* Prior cytokines allowed
Chemotherapy
* Prior chemotherapy allowed
Endocrine therapy
* No concurrent corticosteroids except for treatment of severe vomiting that is refractory to standard agents
Radiotherapy
* Prior radiotherapy allowed
Surgery
* Not specified
15 Years
ALL
No
Sponsors
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Roswell Park Cancer Institute
OTHER
Responsible Party
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Roswell Park Cancer Institute
Principal Investigators
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Maria R. Baer, MD
Role: STUDY_CHAIR
Roswell Park Cancer Institute
Locations
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Roswell Park Cancer Institute
Buffalo, New York, United States
Countries
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Other Identifiers
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RPCI-RPC-9902
Identifier Type: -
Identifier Source: secondary_id
CDR0000269285
Identifier Type: -
Identifier Source: org_study_id
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