Status:
UNKNOWN
Allogeneic Stem Cell Transplantation in CML With Partial T Cell Depletion
Lead Sponsor:
Rambam Health Care Campus
Collaborating Sponsors:
Miltenyi Biomedicine GmbH
Conditions:
Philadelphia Chromosome-positive Chronic Myelocytic Leukemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
Allogeneic stem cell transplantation, the only known curative modality for CML, was abandoned in recent years for a very effective and much less toxic targeted therapy with the tyrosine kinase inhibit...
Detailed Description
Patients were conditioned with oral busulfan 12mg/kg (days -6 to -4), cyclophosphamide 120mg/kg (days -3,-2), rabbit antithymocytic globulin, (Fresenius, Bad Hamburg, Germany) 25mg/kg (days -5 to -1) ...
Eligibility Criteria
Inclusion
- Diagnosis of chronic phase CML by hematological, cytogenetic and molecular studies.
- Age \>18
- Candidates for allogeneic stem cell transplantation
- Available matched related donor
Exclusion
- Age\< 18 years
- Other malignancy
- Decreased cardiac function (by echo), reduced pulmonary function (decreased DLCO, FEV1), abnormal kidney function (creatinine \> 1.5 N), abnormal liver function (AST, ALT \>2N)
Key Trial Info
Start Date :
December 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00966810
Start Date
December 1 1999
End Date
January 1 2011
Last Update
August 27 2009
Active Locations (1)
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1
Rambam Health Care Campus
Haifa, Israel, 31096