Study Stopped
Support issue.
Imatinib Mesylate, Busulfan, Fludarabine, and Antithymocyte Globulin for CML Patients
1 other identifier
interventional
42
1 country
1
Brief Summary
Primary Objective: To estimate the probability of molecular complete remission at one year for the described sequential treatment approach, with nonablative hematopoietic transplantation, post transplant imatinib mesylate and donor lymphocyte infusion, in patients with Ph-positive Chronic Myelogenous Leukemia (CML) not in blastic transformation. Secondary Objective: Response to post transplant Imatinib mesylate therapy for 12 weeks as treatment of residual disease, response to donor lymphocyte infusion (DLI) for residual disease following imatinib mesylate therapy, as well as engraftment, toxicity, disease free survival and survival, effect of busulfan pharmacokinetics on study outcome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 leukemia
Started Feb 2003
Typical duration for phase_2 leukemia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2003
CompletedFirst Submitted
Initial submission to the registry
July 10, 2007
CompletedFirst Posted
Study publicly available on registry
July 12, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedResults Posted
Study results publicly available
November 7, 2011
CompletedApril 23, 2012
April 1, 2012
6.8 years
July 10, 2007
September 30, 2011
April 19, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants in Complete Molecular Remission at 1 Year
Participants at 1 year in molecular remission, post transplant, post imatinib mesylate and donor lymphocyte infusion (DLI). Molecular remission is a complete remission with no evidence of disease in the blood cells and/or bone marrow using sensitive polymerase chain reaction (PCR) tests (this test is most commonly used in clinical trials).
Baseline to 1 year
Secondary Outcomes (2)
Participants' With mCR Response to Post Transplant Imatinib Mesylate Therapy
1 Year
Participants' With mCR Response to Post Transplant DLI
1 year
Study Arms (1)
Imatinib, Busulfan, Fludara + Antithymocyte Globulin
EXPERIMENTALOral Imatinib Mesylate 400 mg twice a day for 9 Days; Busulfan 130 mg/m\^2 by vein (IV) daily for 2 Days; Fludara 40 mg/m\^2 IV daily for 4 Days; Antithymocyte Globulin (ATG) 2.5 mg/kg IV daily for 3 Days; Tacrolimus levels maintained between 5-15 ng/dl, Day -2 to Day 180; Methotrexate 5 mg/m2 on days 1, 3, 6 and 11; and Donor bone marrow or blood stem cells infused on day 0 with possible donor lymphocyte infusion (DLI) for progressive disease.
Interventions
400 mg by mouth twice daily for 9 Days
40 mg/m\^2 by vein daily for 4 Days
130 mg/m\^2 by vein daily for 2 Days
2.5 mg/kg by vein daily for 3 Days
Tacrolimus levels maintained between 5-15 ng/dl, first as continuous IV infusion, and converted to oral every 12 hour dosing as tolerated. Starting day -2 until day 180.
Infusion of lymphocytes from the original bone marrow donor by vein if relapse after \>4 weeks of imatinib.
Infusion of donor bone marrow or blood stem cells by vein over approximately one hour on day 0.
Eligibility Criteria
You may qualify if:
- Diagnosis of Ph+ chronic myelogenous leukemia (CML) in first chronic phase without a complete hematologic response after 3 months of Imatinib mesylate therapy, or \>=35% Ph+ cells despite \> 6 months of Imatinib mesylate treatment, or after disease progression from a complete or partial response. Any patient with accelerated phase or blast crisis who achieves a subsequent chronic phase is eligible. Patients must have an HLA matched related or unrelated donor or one antigen mismatched related donor.
- Patients should be less than 70 years of age. Patients less than 30 years of age who achieve a hematologic remission with imatinib therapy are eligible regardless of cytogenetic response.
- Patients are stratified as Group 1: First chronic phase, Group 2 Accelerated phase or blast crisis that achieved a hematologic remission with imatinib mesylate-based treatment.
You may not qualify if:
- Zubrod Performance Scale (PS) \>=2, uncontrolled infection, Creatinine \> 2.0 mg/dl; Ejection fraction \< 40%; Carbon Monoxide Diffusing Capacity (DLCO) \< 45% of predicted; Serum bilirubin \> 2 gm/dl; GPT (Glutamic-pyruvic transaminase) or GOT (glutamic-oxaloacetic transaminase)\> 3 times normal values. Patients should not be human immunodeficiency virus (HIV) seropositive or pregnant.
- Patients should not have progressed to accelerated phase or blast crisis while receiving imatinib mesylate containing therapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Study completed early due to support issues.
Results Point of Contact
- Title
- Richard E. Champlin, MD/Professor
- Organization
- UT MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Richard E. Champlin, MD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
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 10, 2007
First Posted
July 12, 2007
Study Start
February 1, 2003
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
April 23, 2012
Results First Posted
November 7, 2011
Record last verified: 2012-04