A Phase II Open Label Study to Determine Safety and Efficacy of Interferon-alpha in Combination With Imantinib Mesylate (Gleevec) in Patients With Chronic Phase Chronic Myelogenous Leukemia Who Have Not Achieved a Complete Cytogenetic Response to Gleevec as a Single Agent


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

Thank you

Trial Information

A Phase II Open Label Study to Determine Safety and Efficacy of Interferon-alpha in Combination With Imantinib Mesylate (Gleevec) in Patients With Chronic Phase Chronic Myelogenous Leukemia Who Have Not Achieved a Complete Cytogenetic Response to Gleevec as a Single Agent


OBJECTIVES:

- Determine whether interferon alfa in combination with imatinib mesylate adds to the
hematologic, cytogenetic, and molecular response rates in patients with chronic phase
chronic myelogenous leukemia that is newly diagnosed or has not achieved a complete
cytogenetic response to imatinib mesylate alone.

OUTLINE: Patients receive oral imatinib mesylate (STI-571) once daily for 9 months. At 9
months, patients with more than 35% Philadelphia chromosome-positive (Ph+) cells in bone
marrow receive oral STI-571 twice daily for 3 more months. At 12 months, patients with more
than 35% Ph+ cells in bone marrow receive oral STI-571 once daily and interferon alfa
subcutaneously once daily. Treatment continues for at least 1 year in the absence of disease
progression or unacceptable toxicity. Patients with an appropriate HLA-matched donor may
choose to have a bone marrow transplantation at any time during the study.

Patients are followed every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 80 patients (60 without an HLA-matched donor and 20 with an
HLA-matched donor) will be accrued for this study within 5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of chronic phase chronic myelogenous leukemia

- Cytogenetically confirmed Philadelphia chromosome-positive disease or other
variant of t(9;22)

- No secondary chromosomal abnormalities

- No more than 10% blasts in bone marrow

- Newly diagnosed OR

- Received prior imatinib mesylate as a single agent for no more than the past 9
months without achieving a complete cytogenetic response

- No evidence of extramedullary involvement except nodes, liver, or spleen

PATIENT CHARACTERISTICS:

Age

- Any age

Performance status

- ECOG 0-3

Life expectancy

- Not specified

Hematopoietic

- Platelet count greater than 100,000/mm^3

- Absolute neutrophil count greater than 1,500/mm^3

Hepatic

- Bilirubin no greater than 2 times upper limit of normal (ULN)

- SGOT no greater than 2 times ULN

- INR no greater than 1.5 times ULN*

- PTT no greater than 1.5 times ULN* NOTE: * Except patients on anticoagulants

Renal

- Creatinine no greater than 2 times ULN

Other

- Considered potentially reliable

- No history of noncompliance to medical regimens

- No other active malignancy requiring chemotherapy or radiotherapy

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective barrier-method contraception during and for at
least 3 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior interferon therapy

- No prior stem cell or bone marrow transplantation

Chemotherapy

- No prior chemotherapy (except hydroxyurea and/or anagrelide to control counts)

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- At least 4 weeks since prior major surgery and recovered

Other

- No concurrent grapefruit juice or grapefruit products

- No concurrent warfarin

- Concurrent low-molecular weight heparin allowed

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Ellin Berman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

02-013

NCT ID:

NCT00045422

Start Date:

April 2002

Completion Date:

October 2003

Related Keywords:

  • Leukemia
  • chronic myelogenous leukemia, BCR-ABL1 positive
  • chronic phase chronic myelogenous leukemia
  • childhood chronic myelogenous leukemia
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myeloid, Chronic-Phase

Name

Location
Memorial Sloan-Kettering Cancer Center New York, New York  10021