NCT00144677

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2005

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

January 26, 2012

Status Verified

March 1, 2009

Enrollment Period

2.6 years

First QC Date

September 1, 2005

Last Update Submit

January 24, 2012

Conditions

Acute Myelogenous LeukemiaGraft Versus Host DiseaseAcute Lymphoblastic LeukemiaChronic Myelogenous LeukemiaMyelodysplastic SyndromesNon-Hodgkin's LymphomaHodgkin's Disease

Keywords

Graft versus Host DiseaseGVHDsirolimustacrolimusStem cell transplant

Outcome Measures

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 (3)

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

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

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

Interventions

sirolimusDRUG
tacrolimusDRUG

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana-Farber Cancer Center

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteGraft vs Host DiseasePrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myelogenous, Chronic, BCR-ABL PositiveMyelodysplastic SyndromesLymphoma, Non-HodgkinHodgkin Disease

Interventions

SirolimusTacrolimus

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesImmune System DiseasesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersMyeloproliferative DisordersBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic 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

November 1, 2003

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

January 26, 2012

Record last verified: 2009-03

Locations

US(1)