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


Phase 2
18 Years
N/A
Not Enrolling
Both
Hematologic Malignancies, Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome, 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 Matched, Related Allogeneic Hematopoietic Stem Cell Transplantation


- Therapy to prevent GVHD will consist of an infusion of tacrolimus intravenously and
sirolimus orally once per day 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 9 weeks at at stable dose, then will be tapered by 1/3 on
week 9 and 1/3 on week 17. It will be stopped on week 26 if there is no significant
evidence of GVHD. These dose modifications will occur at home and patients will be
seen weekly for the first 2 months after discharge.

- If GVHD is present, the tapering schedule wil be slower and based upon the patient's
clinical condition.

- Tacrolimus will be given orally once the patient is discharged from the hospital and
will be tapered at the same schedule as sirolimus. Blood levels of both tacrolimus and
sirolimus will be monitored and the dose adjusted accordingly.

- During the year following stem cell transplant, blood work will be performed to
evaluate the immune system and GVHD.


Inclusion Criteria:



- Patients with hematologic malignancies who will undergo allogeneic HSCT from matched
family-members.

- Age greater than 18

- ECOG performance status 0-2

- Total bilirubin < 2.0 mg/dl

- AST < 90 IU

- Serum creatinine < 2.0 mg/dl

Exclusion Criteria:

- Active, uncontrolled infection

- Ejection fraction < 45% by echocardiogram or MUGA scan

- Forced vital capacity < 60%

- Uncontrolled hypertension

- Second transplantation

- Evidence of HIV 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 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:

02-090

NCT ID:

NCT00144703

Start Date:

July 2002

Completion Date:

November 2006

Related Keywords:

  • Hematologic Malignancies
  • Myelogenous Leukemia
  • Acute Lymphoblastic Leukemia
  • Myelodysplastic Syndrome
  • Non-Hodgkin's Lymphoma
  • Hodgkin's Disease
  • Graft versus host disease
  • GVHD
  • Stem cell transplantation
  • sirolimus
  • tacrolimus
  • Neoplasms
  • Graft vs Host Disease
  • Hodgkin Disease
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Myelodysplastic Syndromes
  • Preleukemia
  • Hematologic Neoplasms

Name

Location

Dana-Farber Cancer InstituteBoston, Massachusetts  02115