Status:
TERMINATED
Non-Myeloablative HLA-Mismatched Ex-Vivo T-cell Depleted Stem Cell Transplantation for Hematologic Malignancies
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Dana-Farber Cancer Institute
Conditions:
Lymphoma
Leukemia
Eligibility:
All Genders
Up to 65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine if recipients of non-myeloablative ex-vivo T-cell depleted peripheral blood (PBSC) stem cell transplantation using a mismatched related donor will have less s...
Detailed Description
One major obstacle to further advancement in the role of bone marrow transplant (BMT) in hematological malignancies is graft-versus-host-disease (GVHD), which can best be prevented by removing T-cells...
Eligibility Criteria
Inclusion
- Disease Status: NHL, HD, MM that are chemorefractory or relapsed; CLL that is Rai stage III or IV, or lymphocyte doubling time of 6 months, or stage I/II resistant to \> 2 cycles of chemotherapy regimens; CML in accelerated or blast phase; MDS with life-threatening cytopenias; patients who have had a previous autologous or allogeneic bone marrow or stem cell transplant; other hematological disorders where allogeneic transplant is appropriate and the risk of conventional transplantation is considered to be unacceptably high.
- estimated disease free survival of less than one year
- ECOG performance status of 0, 1, or 2
- HLA 1 to 3 mismatched (at A, B, DR loci) related donor
Exclusion
- Cardiac disease: symptomatic congestive heart failure, ejection fraction of \< 45%, active angina pectoris or uncontrolled hypertension.
- Pulmonary disease: severe chronic obstructive lung disease, or symptomatic restrictive lung disease, or corrected DLCO of \< 50%
- Renal disease: serum creatinine \> 2.0 mg/dl or creatinine clearance \< 50 ml/min
- Hepatic disease: serum bilirubin \> 2.0 mg/dl or alkaline phosphate, SGPT or SGOT \> 3 x normal
- Neurologic disease: symptomatic leukoencephalopathy, active CNS malignancy or other neuropsychiatric abnormalities believed to preclude transplantation
- HIV antibody or Hepatitis B surface antigen positivity
- Uncontrolled infection
- Presence of HAMA or HAHA in patient previously treated with monoclonal antibody therapy or who have received a product in which the preparation involved a monoclonal antibody affinity step
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00113646
Start Date
November 1 2002
End Date
December 1 2007
Last Update
March 16 2018
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02116