Study of Unrelated Cord Blood Transplantation Using Tacrolimus and Sirolimus

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

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 blood transplantation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: Dana-Farber Cancer Institute
• Treatments: Antilymphocyte Serum; Everolimus; Fludarabine; Melphalan; Sirolimus; Tacrolimus; Thymoglobulin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.