PEG Interferon Alpha 2B and Low-Dose Ara-C in Early Chronic Phase CML

Condition(s) targeted: Chronic Myeloid Leukemia

Intervention: Peg Interferon Alpha 2b (Peg Intron) (Drug); Ara-C (cytosine arabinoside) (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: M.D. Anderson Cancer Center

Official(s) and/or principal investigator(s):
Jorge E Cortes, MD, Principal Investigator, Affiliation: The University of Texas N.D. Anderson Cancer Center

The goal of this clinical research study is to see if a new interferon which is given only once a week with ARA-C works as well as standard interferon and low dose ARA-C. The safety of this treatment will also be studied. In some patients, extra blood samples will be taken to measure the effect of treatment on leukemia cells.

Official title: Therapy of Early Chronic Phase Chronic Myelogenous Leukemia (CML) With SCH54031 (PEG Interferon Alpha 2B/PEG Intron) and Low-Dose Cytosine Arabinoside (Ara-C)

Study design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study

Primary outcome: To maintain the proportion of patients achieving a major cytogenetic response in patients with Ph-positive early chronic phase CML using PEG-Intron subcutaneously weekly and Ara-C subcutaneously daily.

Detailed description: The objective of the clinical trial is to maintain the proportion of patients achieving a major cytogenetic response in patients with Ph-positive early chronic phase CML using PEG-Intron subcutaneously weekly and Ara-C subcutaneously daily.

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients age 12 years or older with a diagnosis of Ph-positive or bcr-positive CML in

early chronic phase CML (diagnosis < 12 months).

- Serum bilirubin less than 2mg%, serum creatinine less than 2mg%, and a performance

status of 2 or less on Zubrod scale.

- Patients under age 55 years should have HLA A,B,C, and DR typing performed on

themselves and their siblings. Patients under age 20 years and patients with late chronic phase, accelerated phase or blastic phase will be offered allogeneic bone marrow transplantation from a matched sibling as the first priority.

Exclusion Criteria:

- Severe heart disease (Class III, IV) Psychiatric disability (psychosis) Pregnant or

lactating females

- Women of pregnancy potential must practice birth control methods because of the

potential risk of fetal teratogenicity with these agents.

- Patients must sign an informed consent indicating they are aware of the

investigational nature of this study, in keeping with the policies of the hospital.

- Definition of CML Phases: a. Early chronic phase: time from diagnosis to therapy < 12

months Late chronic phase: time from diagnosis to therapy > 12 months b. Blastic phase: presence of 30% blasts or more in the peripheral blood or bone marrow. c.

Accelerated phase CML: presence of any of the following features: - Peripheral or

marrow blasts 15% or more - Peripheral or marrow basophils 20% or more -

Thrombocytopenia < 100 x 109L unrelated to therapy - Documented extramedullary blastic

disease outside liver or spleen

- Continuation of # 4 d. Clonal evolution defined as the presence of additional clones

other than the Ph chromosome is part of accelerated phase CML. Ph chromosome variants or complex Ph chromosome translocations are not considered to indicate disease acceleration. We have recently found clonal evolution to have a variable prognostic impact and may be suppressed with IFN-A therapy. Hence these patients will be eligible if no other therapy. Hence these patients will be eligible if no other accelerated phase signs are present.

The University of Texas M.D. Anderson Cancer Center, Houston, Texas 77030-4009, United States

M.D. Anderson's website

Starting date: January 2000
Last updated: July 20, 2007