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

Thank you

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 Center New York, New York  10021