Status:
COMPLETED
Phase I Study of Sequential Cord Blood Transplants
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Dana-Farber Cancer Institute
Conditions:
Lymphoma
Leukemia
Eligibility:
All Genders
Up to 65 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the safety of sequential cord blood transplantation (2 cord blood units) for patients who have diseases that are capable of being cured by allogeneic stem cel...
Detailed Description
Eligible patients will receive conditioning therapy with fludarabine 30 mg/m2/day x 6 days, melphalan 100 mg/m2/day x 1 day, rabbit antithymocyte globulin 1.5 mg/kg/day x 4 days. GVHD prophylaxis will...
Eligibility Criteria
Inclusion
- Disease Status: NHL, HD, or MM refractory to chemotherapy or relapsed; CLL Rai Stage III/IV, or lymphocyte doubling time of 6 months, or Stage I/II resistant to 2 chemotherapy regimens; AML or ALL in second or subsequent remission or in first remission with adverse cytogenetics or antecedent hematologic disorder
- Estimated disease-free survival of less than one year
- ECOG performance status of 0, 1, 2
- Lack of 6/6 or 5/6 HLA matched related or 6/6 matched unrelated donor, or a donor is not available within the time frame necessary to perform a potentially curative stem cell transplant
- 4/6 or greater HLA A, B, CRB1 cord blood units with a combined nucleated cell dose from of \> 3.7 x 10(7) NC/kg
Exclusion
- Cardiac disease: symptomatic congestive hearth failure or RVG or echocardiogram determined left ventricular 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
- Hepatic disease: serum bilirubin \> 2.0 mg/dl (except in the case of Gilbert's syndrome), SGPT or SGOT \> 3 x normal
- Neurologic disease: symptomatic leukoencephalopathy, active DNS malignancy or other neuropsychiatric abnormalities believed to preclude transplantation
- HIV antibody or Hepatitis B surface antigen positivity
- Uncontrolled infection
- Pregnancy or breast-feeding mother
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00299767
Start Date
May 1 2003
End Date
May 1 2009
Last Update
May 11 2016
Active Locations (2)
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1
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02116