MedTrace Logo

Reduced-Intensity Regimen Before Donor Bone Marrow Transplant in Treating Patients With Myelodysplastic Syndromes

NCT00045305 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2023-06-28

Study results available
· View outcomes & findings →

Summary

RATIONALE: Photopheresis treats the patient's blood with drugs and ultraviolet light outside the body and kills the white blood cells. Giving photopheresis, pentostatin, and radiation therapy before a donor bone marrow or stem cell transplant helps stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer 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 pentostatin before transplant and cyclosporine or mycophenolate mofetil after transplant may stop this from happening.

PURPOSE: This phase II trial is studying how well giving pentostatin together with photopheresis and total-body irradiation work before donor bone marrow transplant in treating patients with myelodysplastic syndromes.

Conditions

Interventions

DRUG

Cyclosporine

Immunosuppressant

DRUG

Methotrexate

Antimetabolite

DRUG

Photopheresis

Psoralens

DRUG

Mycofenolate mofetil

an antibiotic with immunosuppressamt properties isolated from Penicillium spp

DRUG

Pentostatin

Purine analogue

PROCEDURE

allogeneic bone marrow

Unmanipulated allogeneic bone marrow

PROCEDURE

peripheral blood stem cell

G-CSF mobilized peripheral blood stem cell

RADIATION

Total body irradiation

a total of 600 cGy given in 3 200 cGy fractionated doses

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Eastern Cooperative Oncology Group

    lead NETWORK

Principal Investigators

  • Selina M. Luger, MD · Abramson Cancer Center at Penn Medicine

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
2006-10-24
Primary Completion
2014-02-28
Completion
2014-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT00045305 on ClinicalTrials.gov