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Chemotherapy Plus Monoclonal Antibody in Treating Patients With Acute Promyelocytic Leukemia

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ClinicalTrials.gov Identifier: NCT00016159
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 16, 2013
Information provided by:

May 6, 2001
January 27, 2003
January 16, 2013
November 2000
March 2007   (Final data collection date for primary outcome measure)
reverse transcriptase-polymerase chain reaction negativity
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Complete list of historical versions of study NCT00016159 on ClinicalTrials.gov Archive Site
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Chemotherapy Plus Monoclonal Antibody in Treating Patients With Acute Promyelocytic Leukemia
Phase II Study Of Combined Modality Postremission Therapy As Determined By Molecular Response (Adaptive Regulation) In The Treatment Of Acute Promyelocytic Leukemia (APL)

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and monoclonal antibody in treating patients who have acute promyelocytic leukemia.


  • 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.
  • Determine the rate of molecular complete remission in patients treated with this regimen.
  • Determine the toxicity of this regimen in this patient population.
  • Determine the number and length of hospitalizations of patients treated with this regimen.

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.

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

Phase 2
Primary Purpose: Treatment
  • Biological: filgrastim
  • Biological: lintuzumab
  • Drug: arsenic trioxide
  • Drug: idarubicin
  • Drug: tretinoin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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March 2007   (Final data collection date for primary outcome measure)


  • 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



  • Any age

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Not specified


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


  • Creatinine less than 2 mg/dL OR
  • Creatinine clearance greater than 60 mL/min


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


  • 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


Biologic therapy:

  • Not specified


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

Endocrine therapy:

  • Not specified


  • Not specified


  • Not specified


  • No prior postremission therapy of any form
Sexes Eligible for Study: All
Child, Adult, Senior
Contact information is only displayed when the study is recruiting subjects
United States
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Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Joseph G. Jurcic, MD Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP