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Study of Unrelated Cord Blood Transplantation Using Tacrolimus and Sirolimus

NCT00133367 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2016-07-25

No results posted yet for this study

Summary

The purpose of this study is to measure the effectiveness of 2 drugs, tacrolimus and sirolimus, in preventing graft versus host disease (GVHD) after treatment with chemotherapy followed by donor cord blood transplantation.

Conditions

  • Multiple Myeloma
  • Non-Hodgkin's Lymphoma
  • Hodgkin's Disease
  • Myelogenous Leukemia
  • Lymphoblastic Leukemia

Interventions

DRUG

Tacrolimus

Given three days before transplant and every day for 3-6 months after transplant. After first 100 days post-transplant, the dose will be reduced.

DRUG

Sirolimus

Given three days before transplant and every day for 3-6 months after transplant. After first 100 days post-transplant, the dose will be reduced.

DRUG

G-CSF

Given starting on day 5 after transplant until the subjects white blood cell count recovers.

DRUG

Antithymocyte globulin

Given intravenously for 4 days before transplant (days 7, 5, 3, 1).

DRUG

Thymoglobulin

Given intravenously for 4 days before transplant (days 7, 5, 3, 1).

DRUG

Fludarabine

Given intravenously for six days prior to transplant (days 8,7,6,5,4,3).

DRUG

Melphalan

Given intravenously on day 2 before transplant.

Sponsors & Collaborators

Principal Investigators

  • Karen K Ballen, MD · Massachusetts General Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2007-11-30
Completion
2011-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00133367 on ClinicalTrials.gov