MedTrace Logo

Chemotherapy, Total-Body Irradiation, Rituximab, and Donor Stem Cell Transplant in Treating Patients With B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia

NCT00425802 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2017-10-31

Study results available
· View outcomes & findings →

Summary

RATIONALE: Giving low doses of chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. Also, monoclonal antibodies, such as rituximab, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. The donated stem cells may replace the patient's immune 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 rituximab before transplant and cyclosporine and mycophenolate mofetil after transplant may stop this from happening.

PURPOSE: This phase II trial is studying the side effects and how well giving chemotherapy and radiation therapy together with rituximab and donor stem cell transplant works in treating patients with B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia.

Conditions

Interventions

BIOLOGICAL

anti-thymocyte globulin

BIOLOGICAL

filgrastim

BIOLOGICAL

graft-versus-tumor induction therapy

BIOLOGICAL

rituximab

DRUG

cyclophosphamide

DRUG

cyclosporine

DRUG

fludarabine phosphate

DRUG

mycophenolate mofetil

PROCEDURE

nonmyeloablative allogeneic hematopoietic stem cell transplantation

RADIATION

total-body irradiation

Sponsors & Collaborators

Principal Investigators

  • Hugo R. Castro-Malaspina, MD · Memorial Sloan Kettering Cancer Center

  • Juliet Barker, MBBS · Memorial Sloan Kettering Cancer Center

  • Craig Moskowitz, MD · Memorial Sloan Kettering Cancer Center

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
2006-11-28
Primary Completion
2016-10-28
Completion
2016-10-28

Countries

  • United States

Study Locations

More Related Trials

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 NCT00425802 on ClinicalTrials.gov