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NCT Number: NCT00144677

Sirolimus With Tacrolimus for Graft-vs-Host Disease Prophylaxis After Un-Related Stem Cell Transplantation

The purpose of this study is to evaluate the ability of sirolimus to prevent graft versus host disease (GVHD) in patients following stem cell transplant from an unrelated donor. This trial is designed to test the hypothesis that elimination of methotrexate in the unrelated donor group would lead to less transplant-related toxicity while still preserving the effective control of GVHD.

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Key information

Conditions

Acute Myelogenous Leukemia Acute Lymphoblastic Leukemia Bone Marrow Diseases Chronic Disease Chronic Myelogenous Leukemia Disease Attributes Graft Versus Host Disease Graft vs Host Disease Hematologic Diseases Hemic and Lymphatic Diseases Hodgkin Disease Hodgkin's Disease Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Myelodysplastic Syndromes Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Non-Hodgkin's Lymphoma Pathologic Processes Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dana-Farber Cancer Center

Boston, Massachusetts, 02115, United States

About this study

  • Therapy to prevent GVHD will consist of an infusion of tacrolimus intravenously and sirolimus orally once daily starting 3 days before stem cell infusion. This will take place in the hospital where the patient will remain for the duration of the transplant.
  • Sirolimus will continue for approximately 100 days at a stable dose, then it will be tapered slowly over the course of weeks to months to prevent a flare in GVHD.
  • Patients will be seen in the clinic weekly for the first 2 months after discharge from the hospital. If GVHD is present, tapering schedule will be slower and based on the patient's clinical condition.
  • Tacrolimus will also be given orally after the patient is discharged and will be tapered on the same schedule as sirolimus.
  • During the year following stem cell transplant, blood tests will be performed to evaluate the immune system and graft versus host disease.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Acute myelogenous leukemia(AML) in first or subsequent remission, in untreated first relapse or any treated relapse.
  • Acute lymphoblastic leukemia(ALL) in first or subsequent remission, in untreated first relapse or any treated relapse.
  • Chronic myelogenous leukemia in first or second chronic stable phase or in accelerated phase.
  • Myelodysplastic syndromes or myeloproliferative diseases
  • Non-Hodgkin's lymphoma or Hodgkin's disease in second or greater complete remission, in partial remission, or induction failure.
  • Chronic lymphocytic leukemia, Rai stage 2-4, which has progressed after initial therapy.
  • Matched unrelated donor.
  • Age 18-55 years at the time of stem cell transplantation
  • ECOG performance status 0-2
  • Life expectancy of 100 days without stem cell transplantation
  • Total bilirubin < 2.0 mg/dl
  • AST < 90 IU
  • Serum creatinine < 2.0 mg/dl
  • Ejection fraction > 40% by echocardiogram or gated nuclear medicine study.

Exclusion criteria

  • Uncontrolled infection
  • Forced vital capacity or DLCO < 50% predicted for age
  • Uncontrolled hypertension
  • Prior hematopoietic stem cell transplant
  • Evidence of HIV infection or active Hepatitis B or C infection
  • Cholesterol > 300 mg/dl
  • Relapsed aggressive Burkitt's or Burkitt's-like lymphoma

Treatment and study plan

sirolimus

Drug

Tacrolimus

Drug

Primary outcomes

  1. To determine the feasibility of using a combination of sirolimus and tacrolimus without methotrexate for GVHD prophylaxis after stem cell transplantation.

Secondary outcomes

  1. To compare the rates of grade II-IV and III-IV acute GVHD with historical control

  2. to determine the incidence of 100 day mortality using this GVHD prophylaxis regimen

  3. to determine the overall survival after one year of this patient population.

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Official study title

Open Label Phase II Trial of Sirolimus in Combination With Tacrolimus for Graft-vs-Host Disease Prophylaxis After HLA-Matched, Unrelated, Allogeneic Hematopoietic Stem Cell Transplantation

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Sep 5, 2005
Registry last updated
Jan 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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