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

NCT00303290 | Completed Phase 1

• 2 other identifiers: DM99-127NCI-2010-00887
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Myeloid Leukemia

Keywords

Early Chronic Phase CML; Peg Interferon Alpha 2b; Peg Intron; Ara-C; Cytosine Arabinoside

Outcome Measures

Primary Outcomes (1)

• Complete Cytogenetic Response Rate after One Year on Therapy

  Cytogenetic responses evaluated by routine cytogenetics.

  1 year

Study Arms (1)

PEG-Intron + ARA-C

EXPERIMENTAL

Peg Interferon Alpha 2b (Peg Intron) 4.5 micrograms/kg once a week. ARA-C 10 mg under the skin daily.

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

Interventions

Peg Interferon Alpha 2b (Peg Intron) DRUG

4.5 micrograms/kg once a week

PEG-Intron + ARA-C

Ara-C (cytosine arabinoside) DRUG

10 mg under the skin daily

Also known as: Cytosar, Cytarabine, DepoCyt, Cytosine arabinosine hydrochloride

PEG-Intron + ARA-C

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 teratogenecity 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 (22,23). Hence these patients will be eligible if no other therapy (22,23). Hence these patients will be eligible if no other accelerated phase signs are present.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Schering-Plough: collaborator

Study Sites (1)

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Chronic-Phase

Interventions

peginterferon alfa-2b; Cytarabine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Jorge E Cortes, MD

  The University of Texas N.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2006
• First Posted: March 16, 2006
• Study Start: January 1, 2000
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: November 26, 2015

Record last verified: 2015-11

Locations

US (1)