High Dose Cytarabine And Mitoxantrone Therapy For Relapsed And Refractory Acute Myeloid And Lymphocytic Leukemia: Effects Of GM-CSF Versus G-CSF On Dendritic Cells And Leukemia Associated Antigen-Specific T-Lymphocytes
15 Years
N/A
Both
Leukemia
Trial Information
High Dose Cytarabine And Mitoxantrone Therapy For Relapsed And Refractory Acute Myeloid And Lymphocytic Leukemia: Effects Of GM-CSF Versus G-CSF On Dendritic Cells And Leukemia Associated Antigen-Specific T-Lymphocytes
OBJECTIVES:
- 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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Maria R. Baer, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Roswell Park Cancer Institute
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000269285
NCT ID:
NCT00053131
Start Date:
January 1999
Completion Date:
February 2004
Related Keywords:
- Leukemia
- recurrent adult acute myeloid leukemia
- recurrent childhood acute myeloid leukemia
- recurrent adult acute lymphoblastic leukemia
- recurrent childhood acute lymphoblastic leukemia
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
