ClinicalTrials.Veeva

Menu

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

Dana-Farber Cancer Institute logo

Dana-Farber Cancer Institute

Status and phase

Completed
Phase 2

Conditions

Graft Versus Host Disease
Acute Myelogenous Leukemia
Non-Hodgkin's Lymphoma
Hodgkin's Disease
Chronic Myelogenous Leukemia
Acute Lymphoblastic Leukemia
Myelodysplastic Syndromes

Treatments

Drug: tacrolimus
Drug: sirolimus

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full description

  • 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.

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems