PHASE II TRIAL OF POST-REMISSION THERAPY WITH HuM195 AND CYTOTOXIC CHEMOTHERAPY FOR ACUTE PROMYELOCYTIC LEUKEMIA
12 Years
N/A
Both
Leukemia
Trial Information
PHASE II TRIAL OF POST-REMISSION THERAPY WITH HuM195 AND CYTOTOXIC CHEMOTHERAPY FOR ACUTE PROMYELOCYTIC LEUKEMIA
OBJECTIVES: I. Evaluate the antileukemic effects of humanized anti-CD33 monoclonal antibody
M195 (HuM195) against minimal residual disease in patients with acute promyelocytic leukemia
(APL) by using a reverse transcription-polymerase chain reaction for the mutated retinoic
acid receptor-alpha to detect changes in minimal residual disease. II. Assess the disease
free and overall survival of patients with APL receiving HuM195 for minimal residual
disease. III. Evaluate the safety and toxicity of HuM195 in these patients. IV. Evaluate
whether HuM195 elicits a human anti-human antibody response, including anti-idiotype
antibody responses, in patients with APL.
OUTLINE: Patients continue retinoid therapy until 30 days after documentation of clinical
complete remission. Patients begin treatment within 10 days of documentation of clinical
complete remission, or after RT-PCR-confirmed molecular relapse, or 3-6 weeks after
chemotherapy. Patients receive HuM195 IV over 60 minutes twice a week for 6 doses. Patients
with unacceptable toxicity, in first complete remission, or ineligible for bone marrow
transplant (BMT) proceed to the next regimen. Patients receive idarubicin IV over 15 minutes
on days 1-3 and cytarabine IV continuously over days 1-5. Patients then receive 2 more
courses, given at 4-6 week intervals, consisting of idarubicin IV over 15 minutes on days
1-2 and cytarabine IV continuously on days 1-4. Patients begin maintenance therapy after
toxicity resolves or 1 week after the last dose of HuM195. This consists of HuM195 IV over
60 minutes for 2 doses (72-96 hours apart). Treatment repeats once a month for 6 courses.
Patients who have an initial molecular response but are positive on the RT-PCR assay, or who
achieve complete remission following clinical relapse of disease during treatment are
eligible for retreatment. Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 14-40 patients will be accrued for this study over 2-3 years.
Inclusion Criteria
DISEASE CHARACTERISTICS: Pathologically confirmed acute promyelocytic leukemia in one of
the following categories: First complete remission following induction retinoids First
complete remission following induction chemotherapy and not eligible for additional
consolidation chemotherapy Second or subsequent remission following induction retinoids or
chemotherapy Clinically complete remission following consolidation chemotherapy and:
Detectable minimal residual disease by reverse transcription-polymerase chain reaction
(RT-PCR) assay Not eligible for bone marrow transplant Molecular remission (i.e., negative
RT-PCR assay) with subsequent evidence of early molecular relapse (i.e., normal peripheral
blood counts, normal bone marrow morphology, and positive RT-PCR assay)
PATIENT CHARACTERISTICS: Age: 12 and over Performance status: Not specified Life
expectancy: Greater than 4 weeks Hematopoietic: See Disease Characteristics Hepatic:
Bilirubin no greater than 2.5 mg/dL AST no greater than 4 times normal Alkaline
phosphatase no greater than 4 times normal Renal: Creatinine no greater than 2.5 mg/dL
Cardiovascular: (Patients receiving idarubicin and cytarabine only) No history of cardiac
disease OR Left ventricular ejection fraction greater than 50% by MUGA or echocardiogram
Other: No uncontrolled serious infection HIV negative No active second malignancy except
basal cell carcinoma Not pregnant or nursing Negative pregnancy test Fertile women must
use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy:
See Disease Characteristics Retinoid therapy to continue until 30 days past complete
remission No other concurrent chemotherapy At least 3 weeks since any cytotoxic
chemotherapy and recovered Endocrine therapy: Not specified Radiotherapy: At least 3 weeks
since any radiotherapy and recovered No concurrent radiotherapy Surgery: Not specified
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
David A. Scheinberg, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Federal Government
Study ID:
94-088
NCT ID:
NCT00002609
Start Date:
August 1994
Completion Date:
February 2003
Related Keywords:
- Leukemia
- adult acute myeloid leukemia in remission
- childhood acute myeloid leukemia in remission
- adult acute promyelocytic leukemia (M3)
- childhood acute promyelocytic leukemia (M3)
- Leukemia
- Leukemia, Promyelocytic, Acute
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
