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PHASE II TRIAL OF POST-REMISSION THERAPY WITH HuM195 AND CYTOTOXIC CHEMOTHERAPY FOR ACUTE PROMYELOCYTIC LEUKEMIA


Phase 2
12 Years
N/A
Not Enrolling
Both
Leukemia

Thank you

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