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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


Phase 2
18 Years
55 Years
Not Enrolling
Both
Acute Myelogenous Leukemia, Graft Versus Host Disease, Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, Myelodysplastic Syndromes, Non-Hodgkin's Lymphoma, Hodgkin's Disease

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Trial Information

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


- 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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

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

Principal Investigator

Corey Cutler, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

03-290

NCT ID:

NCT00144677

Start Date:

November 2003

Completion Date:

June 2006

Related Keywords:

  • Acute Myelogenous Leukemia
  • Graft Versus Host Disease
  • Acute Lymphoblastic Leukemia
  • Chronic Myelogenous Leukemia
  • Myelodysplastic Syndromes
  • Non-Hodgkin's Lymphoma
  • Hodgkin's Disease
  • Graft versus Host Disease
  • GVHD
  • sirolimus
  • tacrolimus
  • Stem cell transplant
  • Graft vs Host Disease
  • Hodgkin Disease
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Dana-Farber Cancer CenterBoston, Massachusetts  02115