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Conditioning Treatment With Umbilical Cord Blood Transplant for Hematologic Malignancies

NCT01622556 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2014-02-11

No results posted yet for this study

Summary

This is a phase II study to assess the day 180 event free and overall survival after administration of a specified combination of fludarabine, busulfan, Total Body Irradiation (TBI), and thymoglobulin reduced intensity conditioning and 2 unit UCB stem cell transplant in a single institution setting in patients with hematologic malignancies for whom allogeneic transplantation is indicated.

Conditions

Interventions

DRUG

Fludarabine

35 mg/m2 IV/day x 5 days

DRUG

Busulfan

.8 mg/kg IV Q6h x 8 doses

DRUG

Thymoglobulin

1.5 mg/kg/day x 3 days

RADIATION

Total Body Irradiation

150 cGy for 2 days

BIOLOGICAL

Umbilical Cord Blood

Two partially HLA-matched UCB units. Each unit must match at a minimum of 4 of 6 at HLA-A, -B, -DRB1 loci with the recipient.

Sponsors & Collaborators

  • University of Virginia

    lead OTHER

Principal Investigators

  • Amer M Beitinjaneh, MD · University of Virginia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2014-02-28
Completion
2017-01-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT01622556 on ClinicalTrials.gov