Autologous Stem Cell Transplants for Chronic Myelogenous Leukemia
This study has been terminated.
(Terminated due to low accrual.)
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Information provided by:
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00446173
First received: March 9, 2007
Last updated: October 5, 2009
Last verified: September 2009
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Purpose
Primary Objective:
1. To study ex-vivo purging of autologous hematopoietic stem cells that will be used to support high-dose chemotherapy in patients with chronic myelogenous leukemia (CML). Major endpoints are neutrophil engraftment and survival.
Secondary Objectives:
- To evaluate the toxicity of ex-vivo purged autologous cells when used to support high-dose chemotherapy.
- To evaluate the rate and duration of cytogenetic remissions achieved with this strategy.
- To determine the time to platelet recovery to 20,000/mm3.
- To determine the one-year survival rate.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Drug: Busulfan Drug: Cyclophosphamide Drug: G-CSF Drug: GM-CSF |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Autologous Purged Hematopoietic Stem Cell Transplantation for Chronic Myelogenous Leukemia (CML) |
Resource links provided by NLM:
Drug Information available for:
Cyclophosphamide
Busulfan
Filgrastim
Sargramostim
Granulocyte colony-stimulating factor
U.S. FDA Resources
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Time to Absolute Neutrophil Count (ANC) Recovery to 500 [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
- Survival Time [ Time Frame: 30 Days (Success Rate + ANC Recovery to 500) ] [ Designated as safety issue: No ]
| Enrollment: | 0 |
| Study Start Date: | March 2007 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Busulfan + Cyclophosphamide + G-CSF + GM-CSF |
Drug: Busulfan
130 mg/m^2 IV Daily Over 3 Hours x 4 Days
Other Names:
Drug: Cyclophosphamide
60 mg/kg IV Daily Over 4 Hours x 2 Days
Other Names:
Drug: G-CSF
10 mcg/kg Subcutaneously Once Daily
Other Names:
Drug: GM-CSF
250 mcg/kg Subcutaneously Once Daily
Other Names:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 21 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with Philadelphia (Ph) chromosome positive CML < age 65 and older than 21 years.
- Ph positive CML that is either in: 1. late 1st chronic phase (> 2 years from diagnosis) 2. early chronic phase who did not achieve complete cytogenetic remission after one year on imatinib 3. beyond first chronic phase 4. accelerated phase 5. blastic phase that has responded to therapy (characterized by the presence of < 10% bone marrow and/or circulating blasts at consent signing) 6. chronic phase, developing imatinib resistance (loss of molecular remission defined as at least a 1 log increase in the BCR-ABL/ABL ratio, in 2 time points at least 1 month apart, or loss of cytogenetic remission)
- Patients must have a Zubrod PS < 3. Creatinine < 1.8 mg/dl
- Serum bilirubin </= 1.5 mg/dl
- SGPT < 3 x normal values
- Patients with an HLA identical sibling are eligible if they refuse allogeneic transplantation, or if they are ineligible for allogeneic transplantation due to age.
- DLCO >/= 50% of predicted
- Cardiac Ejection fraction >/= 40%
Exclusion Criteria:
- Uncontrolled life-threatening infections or comorbid condition that could impair tolerance to the regimen.
- HIV positivity.
- Pregnant or lactating women.
- CML in blastic phase that has not responded to therapy given prior to enrollment in this study (characterized by the presence of more than 9% bone marrow and/or peripheral blood blasts at the time of consent signing)
- Hepatitis B or C virus infection. Hepatitis B infection defined by positive DNA test, positive E and / or surface antigen.
- CML in first molecular remission.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00446173
Locations
| United States, Texas | |
| U.T. M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Principal Investigator: | Marcos de Lima, MD | M.D. Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Marcos de Lima, MD/Associate Professor, U.T.M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00446173 History of Changes |
| Other Study ID Numbers: | 2003-0710 |
| Study First Received: | March 9, 2007 |
| Results First Received: | September 1, 2009 |
| Last Updated: | October 5, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by M.D. Anderson Cancer Center:
|
Chronic Myelogenous Leukemia Leukemia Philadelphia (Ph) chromosome positive CML Busulfan Busulfex Myleran Cyclophosphamide Cytoxan |
Neosar G-CSF Filgrastim Neupogen GM-CSF Sargramostim Leukine |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Neoplasms by Histologic Type Neoplasms Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases Busulfan Cyclophosphamide Immunosuppressive Agents |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Myeloablative Agonists Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 22, 2013