MedTrace Logo

Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other Disease

NCT00423826 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2016-02-29

No results posted yet for this study

Summary

RATIONALE: Giving low doses of chemotherapy and total-body irradiation before a donor umbilical cord blood stem cell transplant helps stop the growth of cancer or abnormal cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer or abnormal cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus and mycophenolate mofetil before the transplant may stop this from happening.

PURPOSE: This clinical trial is studying how well umbilical cord blood stem cell transplant works in treating patients with hematologic cancer or other disease.

Conditions

Interventions

DRUG

Busulfan

3 mg/kg intravenously over 3 hours

DRUG

Cytarabine

Patients with previous history of CNS involvement will receive pre-transplant intrathecal Cytarabine (Ara-C) (30 mg/M2) therapy.

DRUG

Fludarabine phosphate

25 mg/M2/day IV

DRUG

mycophenolate mofetil

Orally at the dose of 1 gm every 8 hours.

DRUG

tacrolimus

0.015 mg/kg IV every 12 hours by continuous infusion.

PROCEDURE

allogeneic hematopoietic stem cell transplantation

10 days post drug intervention

PROCEDURE

umbilical cord blood transplantation

10 days post drug intervention

RADIATION

total-body irradiation

10 days post drug intervention

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Barbara Ann Karmanos Cancer Institute

    lead OTHER

Principal Investigators

  • Voravit Ratanatharathorn, MD · Barbara Ann Karmanos Cancer Institute

Eligibility

Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00423826 on ClinicalTrials.gov