MedTrace Logo

Total-Body Irradiation With or Without Fludarabine Phosphate Followed By Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer

NCT00075478 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2017-05-15

Study results available
· View outcomes & findings →

Summary

This randomized phase III trial is studying total-body irradiation (TBI) and fludarabine phosphate to see how it works compared with TBI alone followed by donor stem cell transplant in treating patients with hematologic cancer. Giving low doses of chemotherapy, such as fludarabine phosphate, and radiation therapy before a donor stem cell transplant helps stop the growth of cancer 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 system cells 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 cyclosporine and mycophenolate mofetil after transplant may stop this from happening. It is not yet known whether TBI followed by donor stem cell transplant is more effective with or without fludarabine phosphate in treating hematologic cancer.

Conditions

  • Acute Lymphoblastic Leukemia in Remission
  • Acute Myeloid Leukemia in Remission
  • Aggressive Non-Hodgkin Lymphoma
  • Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Diffuse Large B-Cell Lymphoma
  • Hematopoietic and Lymphoid Cell Neoplasm
  • Indolent Non-Hodgkin Lymphoma
  • Mantle Cell Lymphoma
  • Myelodysplastic/Myeloproliferative Neoplasm
  • Plasma Cell Myeloma
  • Refractory Chronic Lymphocytic Leukemia
  • Refractory Hodgkin Lymphoma
  • Waldenstrom Macroglobulinemia

Interventions

PROCEDURE

Total-Body Irradiation

Undergo TBI

DRUG

Fludarabine Phosphate

Given IV

DRUG

Mycophenolate Mofetil

Given PO

DRUG

Cyclosporine

Given PO

PROCEDURE

Peripheral Blood Stem Cell Transplantation

Undergo transplantation

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • National Cancer Institute (NCI)

    collaborator NIH

  • Fred Hutchinson Cancer Center

    lead OTHER

Principal Investigators

  • Brenda Sandmaier · Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-10-31
Primary Completion
2014-02-28
Completion
2014-02-02

Countries

  • United States
  • Germany
  • Italy

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 NCT00075478 on ClinicalTrials.gov