Autologous or Donor Stem Cell Transplantation in Treating Patients With Recurrent Non-Hodgkin's Lymphoma (BMT CTN 0202)

Stopped early · Phase 2/Phase 3

Conditions studied: Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Follicular Lymphoma

In brief

This study is designed as a Phase II/III, multi-center trial, comparing two transplant strategies to determine whether non-myeloablative allogeneic Hematopoietic Stem Cell Transplantation (HSCT) will improve long-term progression-free survival compared to autologous HSCT. Recipients will be biologically assigned to the appropriate treatment arm depending on the availability of a Human Leukocyte Antigen (HLA) matched sibling.

Key facts

Study ID

NCT00096460

Run by

Medical College of Wisconsin

People needed

30

Starts

2004-08-01

Expected to finish

2009-03-01

Last updated by the study team

2023-01-05

Who can join

Age: any, up to 75. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Karnofsky performance score less than 70%
• Follicular lymphoma that show histologic evidence of transformation
• Uncontrolled hypertension
• Patients with uncontrolled bacterial, viral or fungal infection (currently taking medication and progression without clinical improvement).
• Prior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ; cancer treated with curative intent more than 5 years previously will be reviewed on a case-by-case basis by a Protocol Chair or Medical Monitor.
• Pregnant (positive Beta Human chorionic gonadotropin (β-HCG)) or breastfeeding
• Seropositive for Human immunodeficiency virus (HIV)
• Unwilling to use contraceptive techniques during treatment
• Prior autologous or allogeneic HSCT
• Known anaphylactic reaction to rituximab

Where it is running

• City of Hope National Medical Center — Duarte, California, United States
• Scripps Clinic — La Jolla, California, United States
• UCSD Medical Center — La Jolla, California, United States
• Stanford Hospital and Clinics — Stanford, California, United States
• University of Florida College of Medicine (Shands) — Gainesville, Florida, United States
• H. Lee Moffitt Cancer Center — Tampa, Florida, United States
• Emory University — Atlanta, Georgia, United States
• BMT Group of Georgia — Atlanta, Georgia, United States
• Loyola University — Atlanta, Georgia, United States
• Indiana BMT at Beech Grove — Beech Grove, Indiana, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• University of Michigan Medical Center — Ann Arbor, Michigan, United States
• Karmanos Cancer Institute/BMT — Detroit, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Kansas City Cancer Centers — Kansas City, Missouri, United States
• Washington University/Barnes Jewish Hospital — St Louis, Missouri, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University Hospitals of Cleveland/Case Western — Cleveland, Ohio, United States
• Providence Portland Medical Center — Portland, Oregon, United States
• Oregon Health Sciences University — Portland, Oregon, United States
• University of Pennsylvania Cancer Center — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Cancer Institute — Pittsburgh, Pennsylvania, United States
• Vanderbilt University — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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