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

NCT00144703 | Completed Phase 2

• 1 other identifier: 02-090
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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 a related donor.

Conditions

Hematologic Malignancies; Myelogenous Leukemia; Acute Lymphoblastic Leukemia; Myelodysplastic Syndrome; Non-Hodgkin's Lymphoma; Hodgkin's Disease

Keywords

Graft versus host disease; GVHD; Stem cell transplantation; sirolimus; tacrolimus

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

• To compare the rates of grade II-IV and III-IV acute GVHD with historical controls

• to determine the incidence of 100 day mortality after stem cell transplant using this regimen

• to determine the overall survival at 1 year after transplantation in this patient population.

Interventions

Sirolimus DRUG

Tacrolimus DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Brigham and Women's Hospital: collaborator

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms; Leukemia, Myeloid; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic Syndromes; Lymphoma, Non-Hodgkin; Hodgkin Disease; Graft vs Host Disease

Interventions

Sirolimus; Tacrolimus

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia; Neoplasms by Histologic Type; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Bone Marrow Diseases; Lymphoma

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Corey Cutler, MD, MPH

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 1, 2005
• First Posted: September 5, 2005
• Study Start: July 1, 2002
• Primary Completion: November 1, 2006
• Study Completion: November 1, 2006
• Last Updated: January 26, 2012

Record last verified: 2009-01

Locations

US (1)