Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Chemotherapy Plus Monoclonal Antibody in Treating Patients With Acute Promyelocytic Leukemia

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed Any age NCI MSKCC-00072 NCI-H01-0073, NCT00016159

Objectives

1. Determine the disease-free and overall survival of patients with acute promyelocytic leukemia in clinical complete remission following tretinoin-based induction therapy treated with monoclonal antibody HuG1-M195, arsenic trioxide, idarubicin, and tretinoin.
2. Determine the rate of molecular complete remission in patients treated with this regimen.
3. Determine the toxicity of this regimen in this patient population.
4. Determine the number and length of hospitalizations of patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• Diagnosis of acute promyelocytic leukemia by positive RT-PCR assay for PML/RAR-alfa rearrangement or a t(15;17) karyotype
  • Achieved clinical complete remission within the past 1-2 months
  • Prior induction therapy must have contained tretinoin



• No other acute myeloid leukemia diagnosis

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics
• At least 1 week since prior retinoids

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• Not specified

Other:

• No prior postremission therapy of any form

Patient Characteristics:

Age:

• Any age

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Bilirubin less than 2 mg/dL
• Transaminases no greater than 3 times upper limit of normal

Renal:

• Creatinine less than 2 mg/dL

  OR

• Creatinine clearance greater than 60 mL/min

Cardiovascular:

• Ejection fraction normal or greater than 50% by echocardiogram or MUGA

Other:

• No other concurrent active malignancy
• No other serious or life-threatening condition that would preclude study
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for at least 4 months after study

Expected Enrollment

Approximately 35 patients will be accrued for this study within 2-3 years.

Outcomes

reverse transcriptase-polymerase chain reaction negativity

Outline

Patients receive monoclonal antibody HuG1-M195 (MOAB HuM195) IV over 40-60 minutes twice weekly for 3 weeks. Approximately 2-4 weeks after completion of MOAB HuM195, patients receive arsenic trioxide IV over 1-4 hours daily for a total of 25 days with no more than 5 days between doses.

Beginning approximately 4-6 weeks after completion of arsenic trioxide, patients receive idarubicin IV daily on days 1-3 or 1-4 and filgrastim (G-CSF) subcutaneously daily beginning on day 5 or 6 and continuing until blood counts recover. Treatment repeats every 4 weeks for patients who remain RT-PCR positive or are newly converted to RT-PCR negative (molecular complete remission) following a prior course of idarubicin for a maximum of 3 courses. Patients who remain RT-PCR positive following course 3 of idarubicin receive no further treatment on study.

Beginning 3 months after completion of idarubicin, patients in molecular complete remission receive oral tretinoin daily for 14 days. Treatment repeats every 3 months for a total of 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed monthly.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Joseph Jurcic, MD, Protocol chair		Ph: 212-639-2955; 800-525-2225 Email: jurcicj@mskcc.org

Registry Information
Official Title		Phase II Study Of Combined Modality Postremission Therapy As Determined By Molecular Response (Adaptive Regulation) In The Treatment Of Acute Promyelocytic Leukemia (APL)
Trial Start Date		2000-11-29
Registered in ClinicalTrials.gov		NCT00016159
Date Submitted to PDQ		2001-03-08
Information Last Verified		2006-04-01
NCI Grant/Contract Number		CA33049, CA08748

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