Autologous Transplantation for Chronic Myelogenous Leukemia
Busulfan, Cyclophosphamide, Imatinib Mesylate and Autologous Stem Cell Transplantation in Patients With Chronic Myelogenous Leukemia
1 other identifier
interventional
24
1 country
1
Brief Summary
The goal of this clinical research is to learn if treatment with high-dose busulfan and cyclophosphamide plus autologous bone marrow transplantation followed by treatment with Gleevec (imatinib mesylate) is effective in treating chronic myelogenous leukemia (CML). Objectives:
- 1.To assess the efficacy of high dose busulfan-cyclophosphamide and autologous hematopoietic transplantation with post transplant Imatinib mesylate for the treatment of CML. The primary endpoint of the study is to determine the proportion of patients with CML alive in cytogenetic remission at one year following this treatment.
- 2.Secondary endpoints are time to progression and survival.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2005
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 26, 2009
CompletedFirst Posted
Study publicly available on registry
October 28, 2009
CompletedNovember 2, 2011
October 1, 2011
2.8 years
October 26, 2009
October 31, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants with CML alive in cytogenetic remission at one year following treatment
Cytogenetic complete remission confirmed via bone marrow examination for morphology, cytogenetics or Fluorescence in situ hybridization (FISH).
Baseline to 1 Year post treatment, up to 18 months
Study Arms (1)
Autologous Transplantation
EXPERIMENTALBusulfan 130 mg/m\^2 intravenous (IV) every 24 hours Days -7 to -4; Cyclophosphamide 60 mg/kg over 4 hours Day -3 and -2; Imatinib Mesylate Starting dose 100 mg/day, and Autologous Stem Cell Transplantation on Day 0.
Interventions
130 mg/m\^2 in normal saline over three (3) hours IV every twenty-four (24) hours for four (4) consecutive days (days -7 to -4)
60 mg/kg in 500 ml of normal saline over 4 hours on each of 2 consecutive days (day -3, -2)
Starting dose 100 mg/day (mg/d), escalated to maximal dose of 400 mg/d as tolerated, after day 28 when Absolute neutrophil count (ANC) is \>1500/mcl and platelets \>50,000 /mcl, may be titrated to maintain ANC \>1.0 and platelets \>50,000 /mcl.
Stem Cell Infusion: Unpurged hematopoietic stem cells administered intravenously on day 0.
Eligibility Criteria
You may qualify if:
- Criteria for hematopoietic stem cell collection and cryopreservation: a- Patients with Philadelphia chromosome positive CML \< age 70 who achieve a cytogenetic remission (no Ph+ cells on bone marrow cytogenetics, at least twenty metaphases counted) are eligible for hematopoietic stem cell collection and cryopreservation. b- Patients must have a Zubrod PS \<2. c.Creatinine \< 1.8 mg/dl d.Serum bilirubin \< 1.5 mg/dl e. SGPT \< 3 x normal values f. Patients with an HLA identical sibling are eligible if they refuse allogeneic transplantation.
- Patients are eligible for high dose therapy and autologous transplantation if they meet the following criteria (numbered 2-13): - Cytogenetic relapse characterized by \> 10% Ph+ metaphases (by FISH analysis or \> 2 of 20 Ph+ metaphases on 2 consecutive cytogenetic studies at least 1 month apart).
- Cytogenetic relapse (as above) with hematologic remission or chronic phase disease, or
- Accelerated phase or second or subsequent chronic phase.
- Availability of stored autologous hematopoietic stem cells collected when the patient was in cytogenetic complete remission (0 of \>= 20 metaphases positive for Ph+ cells).A minimum of 0.5 x 10 6 CD34 positive cells/kg or 1 x 10 8 total nucleated cells/Kg must be available.
- Age \< 70 years.
- Zubrod PS \<=2.
- Creatinine \< 1.8 mg/dL.
- Cardiac ejection fraction \> 40%.
- DLCO \> 50% of the predicted value.
- Serum bilirubin \< 1.5 mg/dL.
- SGPT \< 3 x normal values.
- Patients with an HLA identical sibling are eligible if they refuse allogeneic transplantation.
You may not qualify if:
- Uncontrolled life-threatening infections or comorbid condition that could impair tolerance to the regimen.
- HIV positivity.
- Pregnant or lactating women.
- Blast crisis (\>30% blasts in blood or marrow)
- Hepatitis B or C positivity.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UT MD Anderson Cancer Center
Houston, Texas, 77070, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Marcos de Lima, MD
UT MD Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2009
First Posted
October 28, 2009
Study Start
March 1, 2005
Primary Completion
December 1, 2007
Study Completion
October 1, 2009
Last Updated
November 2, 2011
Record last verified: 2011-10