Study Stopped
lower than anticipated accrual
Autologous or Donor Stem Cell Transplantation in Treating Patients With Recurrent Non-Hodgkin's Lymphoma (BMT CTN 0202)
Autologous Versus Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) for Patients With Chemosensitive Follicular Non-Hodgkin's Lymphoma Beyond First Complete Response or First Partial Response (BMT CTN #0202)
4 other identifiers
interventional
30
1 country
30
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2004
Typical duration for phase_2
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
November 9, 2004
CompletedFirst Posted
Study publicly available on registry
November 10, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedResults Posted
Study results publicly available
September 17, 2012
CompletedJanuary 5, 2023
December 1, 2022
1.6 years
November 9, 2004
August 16, 2011
December 7, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Lymphoma Progression-free Survival
Three years post-Hematopoietic Stem Cell Transplant (HSCT)
Study Arms (2)
Autologous Transplant
ACTIVE COMPARATORCyclophosphamide and Rituximab with Filgrastim conditioning and chemotherapy or radiation therapy prior to autologous Hematopoietic Stem Cell Transplant (HSCT). Rituximab maintenance therapy following HSCT.
Allogeneic Transplant
ACTIVE COMPARATORNon-myeloablative conditioning regimen followed by allogeneic Hematopoietic Stem Cell Transplant (HSCT). Graft-versus-Host Disease (GVHD) Prophylaxis therapy following HSCT.
Interventions
Prior to undergoing HSCT, all patients will receive Cyclophosphamide 4 gm/m2 with Rituximab 375 mg/m2 x 2 doses and G-CSF support.
Autologous HSCT patients will receive 10 mcg/kg/day and allogeneic HSCT patients will receive 5 mcg/kg/day subcutaneous (SQ) or intravenous (IV) starting 2 days after the initiation of Cyclophosphamide.
Chemotherapy - BCNU 15 mg/kg IV x 1 dose to be administered over 2 hours on Day -6 pre-HSCT. VP-16 60 mg/kg IV x 1 dose to be administered over 4 hours on Day -4. Radiation - administered at a rate of \< 20 cGy/min in one of the following doses; 120 cGy/fraction are administered at no less than 4-hour intervals three times/day or 2 times/day for a total of 10 doses (1200 cGy) over 4 days (Day -8, -7, -6 and -5), or doses of 150 cGy/fraction twice daily for a total of 8 doses (1200 cGy) over 4 days (Day -8, -7, -6 and -5). VP-16 60 mg/kg IV x 1 dose to be administered over 4 hours on Day -4 pre-HSCT. Cyclophosphamide 100 mg/kg IV x 1 dose to be administered over 2 hours on Day -2 pre-HSCT. G-CSF 5 mcg/kg SQ or IV to start on Day +5 post-HSCT and continue until ANC \> 500/mm3 x 3 days.
Fludarabine 30 mg/m2 IV x 3 doses total to be administered daily over 30 minutes on Days -6, -5 and -4 pre-HSCT. Cyclophosphamide 750 mg/m IV x 3 doses total to be administered daily over 1 hour on Days -6, -5 and -4 pre-HSCT. Administer cyclophosphamide approximately 4 hours after start of fludarabine infusion. Rituximab 375 mg/m2 IV x 4 doses total to be administered on Days -13 and -6 pre HSCT and Days +1 and +8 post HSCT.
Infusion of G-CSF mobilized allogeneic hematopoietic stem cells
Infusion of G-CSF mobilized autologous hematopoietic stem cells
Patients must have sufficiently recovered from autologous HSCT in order to receive rituximab maintenance therapy as specified below: Dose #1: Day +42 post-autologous HSCT Dose #2: Day +49 post-autologous HSCT Dose #3: Day +56 post-autologous HSCT Dose #4: Day +63 post-autologous HSCT
Tacrolimus 0.09 mg/kg/day PO, based on body weight formulas will start on Day -2 and continue until Day +90 post-HSCT. Tacrolimus (or cyclosporine, if applicable) will be given orally in a twice-daily divided dose. Methotrexate 5 mg/m2 Intravenous Pyelogram (IVP) will be administered on Days +1, +3 and +6 post-HSCT.
Eligibility Criteria
You may qualify if:
- Histologically confirmed recurrent Revised European American Lymphoma (REAL) classification follicle center lymphoma, follicular grades I and II, OR histologically confirmed World Health Organization (WHO) classification follicular lymphoma grades 1, 2, 3a or 3b; for either classification, the diffuse component or presence of large cleaved cells (if present) cannot be more than 50% of high power field; patients do not have to express t(14;18) to be eligible
- Received three or fewer prior regimens of chemotherapy; monoclonal antibody therapy and involved field radiation therapy will not be counted as a prior therapy
- Beyond first Complete Remission (CR) or first Partial Remission (PR) AND demonstrate chemosensitive disease; chemosensitive disease will be defined as less than 20% bone marrow involvement in the aspirate or core biopsy with follicular lymphoma AND lymph node size in axial diameter of less than 3 cm or a greater than 50% reduction in estimated lymph node volume to be measured as product of bi-dimensional measurements; Positron Emission Tomography (PET) scanning will not be used for staging or response purposes
- Patients with adequate organ function as measured by:
- Cardiac: left ventricular ejection fraction at rest at least 45%
- Hepatic: bilirubin less than 2 times the upper limit of normal and alanine transaminase (ALT) and aspartate aminotransferase (AST) less than 3 times the upper limit of normal
- Renal: creatinine clearance greater than 40 mL/min
- Pulmonary: Diffusing capacity of the lung for carbon monoxide (DLCO), Forced expiratory volume in one second (FEV1), and Forced vital capacity (FVC) greater than 50% of predicted (corrected for hemoglobin)
- If the patient is younger than 18 years of age and they have reached the age of assent, then they must have completed the local Institutional Review Board (IRB) assent process.
- Able to receive cyclophosphamide and rituximab mobilization chemotherapy no earlier than 3 weeks from the beginning of the most recent cycle of salvage chemotherapy and no later than 6 weeks from enrollment
- Collection of an autologous or allogeneic graft of at least 2.0 \* 10\^6 CD34+ cells/kg
- Blood count recovery defined as Absolute Neutrophil Count (ANC) greater than 1000/mm3 and platelets greater than 100 \* 10\^9/L
- Off intravenous antibiotics and off amphotericin B formulations for proven, probable or possible fungal infections
- No active Cytomegalovirus (CMV) infections or for patients with CMV infection post-autograft, treated with ganciclovir, valganciclovir, or foscarnet per institutional guidelines and CMV antigenemia negative
- Mucositis resolved and off hyperalimentation
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medical College of Wisconsinlead
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- Blood and Marrow Transplant Clinical Trials Networkcollaborator
- National Cancer Institute (NCI)collaborator
- National Marrow Donor Programcollaborator
Study Sites (30)
City of Hope National Medical Center
Duarte, California, 91010-3000, United States
Scripps Clinic
La Jolla, California, 92037, United States
UCSD Medical Center
La Jolla, California, 92093, United States
Stanford Hospital and Clinics
Stanford, California, 94305, United States
University of Florida College of Medicine (Shands)
Gainesville, Florida, 32610-0277, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, 33624, United States
Emory University
Atlanta, Georgia, 30322, United States
BMT Group of Georgia
Atlanta, Georgia, 30342, United States
Loyola University
Atlanta, Georgia, 60153, United States
Indiana BMT at Beech Grove
Beech Grove, Indiana, 46107, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
University of Michigan Medical Center
Ann Arbor, Michigan, 48105-2967, United States
Karmanos Cancer Institute/BMT
Detroit, Michigan, 48201, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Kansas City Cancer Centers
Kansas City, Missouri, 64111, United States
Washington University/Barnes Jewish Hospital
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-7680, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
University Hospitals of Cleveland/Case Western
Cleveland, Ohio, 44106-5061, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Oregon Health Sciences University
Portland, Oregon, 97239-3098, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15232, United States
Vanderbilt University
Nashville, Tennessee, 37232-8210, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
University of Texas/MD Anderson CRC
Houston, Texas, 77030, United States
Virginia Commonwealth University MCV Hospitals
Richmond, Virginia, 23298, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792-5156, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53211, United States
Related Publications (1)
Tomblyn MR, Ewell M, Bredeson C, Kahl BS, Goodman SA, Horowitz MM, Vose JM, Negrin RS, Laport GG. Autologous versus reduced-intensity allogeneic hematopoietic cell transplantation for patients with chemosensitive follicular non-Hodgkin lymphoma beyond first complete response or first partial response. Biol Blood Marrow Transplant. 2011 Jul;17(7):1051-7. doi: 10.1016/j.bbmt.2010.11.004. Epub 2010 Nov 10.
PMID: 21073974RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Adam Mendizabal, PhD
- Organization
- The EMMES Corporation
Study Officials
- STUDY DIRECTOR
Mary Horowitz, MD
Center for International Blood and Marrow Transplant Research
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2004
First Posted
November 10, 2004
Study Start
August 1, 2004
Primary Completion
March 1, 2006
Study Completion
March 1, 2009
Last Updated
January 5, 2023
Results First Posted
September 17, 2012
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will share