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Phase II Study Of Combined Modality Postremission Therapy As Determined By Molecular Response (Adaptive Regulation) In The Treatment Of Acute Promyelocytic Leukemia (APL)


Phase 2
N/A
N/A
Not Enrolling
Both
Leukemia

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Trial Information

Phase II Study Of Combined Modality Postremission Therapy As Determined By Molecular Response (Adaptive Regulation) In The Treatment Of Acute Promyelocytic Leukemia (APL)


OBJECTIVES:

- 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.

Inclusion 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

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

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

reverse transcriptase-polymerase chain reaction negativity

Safety Issue:

No

Principal Investigator

Joseph G. Jurcic, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

00-072

NCT ID:

NCT00016159

Start Date:

November 2000

Completion Date:

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)
  • adult acute myeloid leukemia with t(15;17)(q22;q12)
  • Leukemia
  • Leukemia, Promyelocytic, Acute

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021