Pegasys in Patients With Chronic Myeloid Leukemia (CML)

NCT01392170 | Terminated Phase 2 Results

• 2 other identifiers: 2011-0184NCI-2011-01465
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn if adding pegylated interferon-alfa 2a (Pegasys) to the TKI that you are already receiving can help to control CML. The safety of this treatment combination will also be studied. Pegasys is a form of the drug interferon. It is designed to help the body's immune system to fight infections. It may also affect the body's response to cancer. A TKI (imatinib mesylate, nilotinib, or dasatinib) is designed to bind to and shut off a protein in tumor cells called Bcr-Abl. Shutting Bcr-Abl off may prevent CML cells from growing, and may cause them to die. You are already receiving a TKI. This consent form will describe the administration of Pegasys, any tests and procedures that need to be performed while you are receiving Pegasys, and any risks/benefits there may be from receiving Pegasys.

Conditions

Leukemia

Keywords

Leukemia; Chronic Myeloid Leukemia; CML; Tyrosine Kinase Inhibitors; TKI; Complete cytogenetic remission; CCyR; Minimal residual disease; MRD; PEG-IFNa-2a; Pegasys; Peginterferon Alpha-2a; Philadelphia chromosome (Ph)-positive; BCR-ABL1-positive

Outcome Measures

Primary Outcomes (1)

• Number of Participants Achieved of Major Molecular Response (MMR) or Complete Molecular Response (CMR)

  Molecular response defined as: major molecular response (MMR) corresponds to a BCR-ABL1/ABL1 ratio of \<=0.01. Complete molecular response (CMR) is defined as undetectable BCR-ABL1 transcripts. Molecular response measured every 3 months (a total of 4 assessments within one year of therapy).

  12 months from start of treatment with PEG-IFNá-2a

Study Arms (1)

PEG-IFNá-2a

EXPERIMENTAL

PEG-IFNá-2a (Pegasys) 45 mcg subcutaneously as single weekly dose.

Drug: PEG-IFNá-2a

Interventions

PEG-IFNá-2a DRUG

45 mcg given subcutaneously as a single weekly dose for 24 months.

Also known as: Pegasys, Peginterferon Alpha-2a

PEG-IFNá-2a

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 16 years or older with Philadelphia chromosome (Ph)-positive or BCR-ABL1-positive CML (as determined by cytogenetics, FISH, or PCR).
• Patients are receiving an FDA-approved TKI for the management of CML.
• Patients must have received TKI therapy for at least 24 months and not have increased their TKI dose in the last 6 months.
• Patients must be in complete cytogenetic remission.
• Patients must have detectable BCR-ABL1 transcript levels meeting at least one of the following criteria: 1. The patient has received therapy for at least 2 years and does not have a sustained major molecular response, or 2. The patient has received therapy for at least 5 years and does not have a sustained complete molecular response.
• Patients must not have had a known continuous interruption of TKI therapy of greater than 14 consecutive days or for a total of 6 weeks in the 6 months prior to enrollment.
• Patients must sign an informed consent indicating that they are aware of the investigational nature of this study.
• Eastern Cooperative Oncology Group (ECOG) performance status \</= 2.
• Adequate organ function defined as: bilirubin \< 2x upper limit of normal (ULN) (unless associated with Gilbert's syndrome), creatinine \</= 1.5x ULN, and serum glutamate pyruvate transaminase (sGPT) or serum glutamate oxaloacetate transaminase (sGOT) \</= 2.5x ULN.
• Men and women of childbearing potential should practice effective methods of contraception. Women of childbearing potential must have a negative serum or urine pregnancy test within 1 week of enrollment.

You may not qualify if:

• Patients receiving any non-FDA approved TKI.
• Patients who are pregnant or breast-feeding.
• Patients with clinically significant heart disease (NYHA Class III or IV).

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Leukemia; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Neoplasm, Residual; Philadelphia Chromosome

Interventions

peginterferon alfa-2a

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Early termination due to slow accrual, no analysis possible.

Results Point of Contact

• Title: Alfonso Quintas-Cardama, MD/Professor, Leukemia
• Organization: University of Texas (UT) MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

713-745-4009

Study Officials

• Alfonso Quintas-Cardama, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2011
• First Posted: July 12, 2011
• Study Start: October 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: May 4, 2015
• Results First Posted: April 14, 2015

Record last verified: 2015-04

Locations

US (1)