Status:
COMPLETED
Study of Unrelated Cord Blood Transplantation Using Tacrolimus and Sirolimus
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Dana-Farber Cancer Institute
Conditions:
Multiple Myeloma
Non-Hodgkin's Lymphoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to measure the effectiveness of 2 drugs, tacrolimus and sirolimus, in preventing graft versus host disease (GVHD) after treatment with chemotherapy followed by donor cord ...
Detailed Description
* The chemotherapy portion of the study involves the intravenous administration of fludarabine, for six days (Days 8, 7, 6, 5,4, and 3) before transplant, melphalan, for one day (Day 2) before transpl...
Eligibility Criteria
Inclusion
- Patients with hematologic malignancies for whom allogeneic stem cell transplantation is deemed clinically appropriate
- Non-Hodgkin's lymphoma, or Hodgkin's lymphoma: in Complete Remission \>2 (second complete remission, third complete remission, etc) or in partial remission
- Multiple myeloma: relapsed
- Chronic lymphocytic leukemia, Rai stage III or IV, or lymphocyte doubling time of 6 months, or stage I-II, having progressed after \> 2 chemotherapy regimens, in partial remission.
- Acute myelogenous or lymphoblastic leukemia in second or subsequent remission or in first remission with adverse cytogenetic or antecedent hematologic disorder
- Chronic myelogenous leukemia in accelerated or second stable phase, or imatinib resistant and not eligible for an ablative transplant
- Myelodysplasia, previously treated or not eligible for ablative transplant
- Age 18-65 years.
- ECOG performance status of 0, 1, or 2.
- Lack of 6/6 or 5/6 HLA-matched related, 10/10 matched unrelated donor, or unrelated donor not available within the time frame necessary to perform a potentially curative stem cell transplant.
Exclusion
- Cardiac disease:
- symptomatic congestive heart failure or
- radionuclide ventriculogram (RVG) or echocardiogram determined left ventricular ejection fraction of \< 40%,
- active angina pectoris, or
- uncontrolled hypertension.
- Pulmonary disease:
- severe chronic obstructive lung disease, or
- symptomatic restrictive lung disease, or
- corrected DLCO of \< 50% of predicted.
- Renal disease:
- serum creatinine \> 2.0 mg/dl.
- Hepatic disease:
- serum bilirubin \> 2.0 mg/dl (except in the case of Gilbert's syndrome or hemolytic anemia in which the bilirubin can be elevated greater than 2.0mg/dl),
- SGOT or SGPT \> 3 x normal.
- Neurologic disease:
- symptomatic leukoencephalopathy,
- active central nervous system (CNS) malignancy or other neuropsychiatric abnormalities believed to preclude transplantation (previous CNS malignancy, presently in complete remission \[CR\] is not exclusion).
- HIV antibody.
- Uncontrolled infection.
- Pregnancy or breast feeding mother.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2011
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00133367
Start Date
August 1 2005
End Date
November 1 2011
Last Update
July 25 2016
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115