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Safety and Efficacy of ProHema Modulated Umbilical Cord Blood Units in Subjects With Hematologic Malignancies.

NCT00890500 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2013-10-08

No results posted yet for this study

Summary

The purpose of this research study is to determine the safety and efficacy of a reduced intensity conditioning regimen during a double umbilical cord blood unit transplant with one of the cord blood units modulated with ProHema.

Conditions

Interventions

DRUG

Fludarabine

30mg/m2/day IV x 6 days

DRUG

Melphalan

100 mg/m2/day IV x 1 day

DRUG

Antithymocyte Globulin

1mg/kg/day x 4 days

DRUG

Sirolimus

GVHD Prophylaxis: Target range 3-12 ng/ml

DRUG

Tacrolimus

GVHD Prophylaxis: Target range 5-10 ng/ml

Sponsors & Collaborators

Principal Investigators

  • Corey Cutler, MD, MPH, FRCP(C) · Dana-Farber Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

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

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2013-05-31
Completion
2013-10-31

Countries

  • United States

Study Locations

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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 NCT00890500 on ClinicalTrials.gov