Study of Unrelated Cord Blood Transplantation Using Tacrolimus and Sirolimus

Completed · Phase 2

Conditions studied: Multiple Myeloma, Non-Hodgkin's Lymphoma, Hodgkin's Disease, Myelogenous Leukemia, Lymphoblastic Leukemia

In brief

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 blood transplantation.

Key facts

Study ID

NCT00133367

Run by

Massachusetts General Hospital

People needed

32

Starts

2005-08-01

Expected to finish

2011-11-01

Last updated by the study team

2016-07-25

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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