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Optimized Donor Selection, Nonmyeloablative BMT for B-cell Lymphomas With Post-transplantation Cy and Rituximab

NCT00946023 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2018-08-27

Study results available
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Summary

This phase II trial is studying how well giving fludarabine and cyclophosphamide together with total-body irradiation and rituximab works in treating patients with B-cell lymphoma or chronic lymphocytic leukemia who are undergoing an allogeneic (donor) bone marrow transplant. The type of bone marrow transplant is a less intensive or "mini" transplant using a relative as the bone marrow donor. The donated bone marrow stem cells may replace the patient's immune system cells and help destroy any remaining cancer (graft-versus-tumor effect). Patients undergoing this type of transplant often have more than one relative who could be a donor. The trial is also studying a new way of choosing amongst possible donors which might improve how the rituximab works.

Conditions

Interventions

DRUG

Fludarabine

Days -6 through -2: 30 mg/m\^2 IV daily

DRUG

Cyclophosphamide

Days -6 and -5: 14.5 mg/kg IV daily; Days 3 and 4: 50 mg/kg IV daily

RADIATION

Total body irradiation

Day -1: 200 centigray (cGy) in a single fraction

DRUG

Tacrolimus

Start on Day 5 through Day 180

DRUG

Mycophenolate Mofetil

Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day)

DRUG

Rituximab

Day 30 and every week after for 8 total doses: 375 mg/m\^2 IV

BIOLOGICAL

Allogeneic Bone Marrow Transplant (BMT)

Day 0: Donor bone marrow infusion

Sponsors & Collaborators

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Yvette L Kasamon, MD · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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
2009-07-31
Primary Completion
2013-07-31
Completion
2013-07-17

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 NCT00946023 on ClinicalTrials.gov