Status:
TERMINATED
Non-Myeloablative HLA-Matched 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
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this trial is to determine if patients with hematologic diseases who have a HLA 6/6 matched related donor and are not eligible for a standard myeloablative stem cell transplant will hav...
Detailed Description
Our prior experience in the lab and in clinical trials with non-myeloablative HLA-matched and mismatched transplant strategies have been remarkable for a low transplant related mortality rate, but a s...
Eligibility Criteria
Inclusion
- Disease statue: NHL, HD, or MM that are chemorefractory or relapsed; CLL that is Rai Stage III/IV, or lymphocyte doubling time of 6 months, or stage I/II that is resistant to \> 2 chemotherapy regimens; AML or ALL in 1st or subsequent remission with poor prognostic features; CML in accelerated or blast phae; MDS with life-threatening cytopenias; patients who have had a previous autologous or allogeneic bone marrow or stem cell transplant; other hematologic disorders which allogeneic stem cell transplantation is appropriate where 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-genotypically or phenotypically matched (at A, B, DR loci) related donor
Exclusion
- Patients who life expectancy is limited by diseases other than their hematologic malignancy.
- Cardiac Disease: symptomatic congestive hearth failure, or RVG, or ejection fraction of \< 45%, active angina pectoris, or uncontrolled hypertension.
- Pulmonary Disease: severe chronic obstructive lung disease, or symptomatic restrictive lung disease, or 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 phosphatase, SGOT or SGPT \> 3 times normal.
- Neurologic Disease: symptomatic leukoencephalopathy, active CNS malignancy or other neuropsychiatric abnormalities believed to preclude transplantation
- HIV or HTLV I antibody or Hepatitis B surface antigen positivity
- Uncontrolled infection
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00113828
Start Date
December 1 2004
End Date
March 1 2007
Last Update
March 15 2018
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114