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Blood Stem Cell Transplant With Low Dose Chemotherapy for Relapsed Follicular Non-Hodgkin's Lymphoma (BMT CTN 0701)

NCT00912223 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2022-12-09

Study results available
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Summary

Blood stem cell transplants are one treatment option for people with lymphoma or other types of blood cancers. For this type of treatment, family members or unrelated donors with a similar tissue type usually donate their blood stem cells to the transplant patients. This study will evaluate the effectiveness of a type of blood stem cell transplant that uses lower doses of chemotherapy in people with relapsed follicular non-Hodgkin's lymphoma (NHL).

Conditions

  • Lymphoma, Non-Hodgkin

Interventions

BIOLOGICAL

Hematopoietic Stem Cell Transplant

NOTE: The - sign is the number of days before the transplant and the + sign is the number of days after the transplant. The conditioning regimen will consist of the following: * Rituxan 375 mg/m\^2 on Day -13 * Rituxan 1000 mg/m\^2 on Days -6, +1, and +8 * Fludarabine 30 mg/m\^2 on Days -5 to -3 * Cyclophosphamide 750 mg/m\^2 on Days -5, -4, -3 Day 0 will be the day of the transplant. The GVHD prophylaxis will consist of the following: * Tacrolimus .09 mg/kg/po (Day -2 thru Day +180). Doses will be adjusted to maintain blood levels of 5-15 ng/mL. * Methotrexate 5 mg/m\^2 (Days +1, +3, and +6). Unrelated donor recipients will receive a fourth dose on Day +11.

Sponsors & Collaborators

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

    collaborator NIH

  • Blood and Marrow Transplant Clinical Trials Network

    collaborator NETWORK

  • National Cancer Institute (NCI)

    collaborator NIH

  • National Marrow Donor Program

    collaborator OTHER

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Mary Horowitz, MD, MS · Center for International Blood and Marrow Transplant Research (CIBMTR), Medical College of Wisconsin

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2014-11-30
Completion
2016-08-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00912223 on ClinicalTrials.gov