Official Title: Autologous Versus Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation HSCT for Patients With Chemosensitive Follicular Non-Hodgkins Lymphoma Beyond First Complete Response or First Partial Response BMT CTN 0202
Status: TERMINATED
Status Verified Date: 2022-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: lower than anticipated accrual
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This study is designed as a Phase IIIII 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
Detailed Description: BACKGROUND
Although patients with follicular non-Hodgkins lymphoma NHL typically experience a relatively indolent course the disease is rarely curable with conventional chemotherapy Patients with follicular NHL are usually treated only when symptoms require palliation or if bulky disease exists since no survival advantage has been shown as compared to administering conventional treatment at initial diagnosis While most patients achieve a remission with initial chemotherapy a continuous pattern of relapse occurs resulting in progressively shorter remission durations Additionally the increased response rates conferred by anthracycline-containing regimens have not translated into improved survival and thus the median survival time of 6 to 10 years has not been significantly impacted over the last decade
DESIGN NARRATIVE
The overall study design is a comparison of two treatment arms determined by biologic assignment based on the availability of an HLA-matched sibling in patients diagnosed with relapsed follicular non-Hodgkins lymphoma Patients without an HLA-matched sibling will receive an autologous HSCT Patients with an HLA-matched sibling will receive a non-myeloablative allogeneic HSCT
The overall study design is that of biologic assignment based on the availability of an HLA-matched sibling to one of two strategies to improve the outcome for follicular lymphoma patients with chemosensitive disease All patients will undergo cytoreduction with cyclophosphamide 4 gmm2 and rituximab 375 mgm2 x 2 doses Rituximab will be given in two doses approximately 1 week apart with the cyclophosphamide administered the day after the first dose of rituximab Patients assigned to the autologous arm will have their hematopoietic stem cells mobilized from this cytoreductive regimen Patients with an HLA-matched sibling will undergo a non-myeloablative allogeneic HSCT Pre-transplant conditioning will consist of fludarabine 30 mgm2day and cyclophosphamide 750 mgm2day x 3 days with rituximab 375 mgm2day on Days -13 and -6 pre-HSCT and on Days 1 and 8 post-HSCT The immunosuppressive regimen will consist of tacrolimus and methotrexate MTX to control graft-versus-host and host-versus-graft reactions Patients without an HLA-matched sibling who have collected an adequate autologous hematopoietic cell graft defined as at least 20 106 CD34 cellskg will receive a preparative regimen of total body irradiation TBI 1200 cGy or Carmustine BCNU 15 mgkg In addition VP-16 60 mgkg and cyclophosphamide 100 mgkg will be given for both autologous preparative regimens Post-autologous HSCT therapy with rituximab 375 mgm2 weekly x 4 doses will commence between Days 42-75 post-HSCT
Study Oversight
Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID
Type
Domain
Link
5U24CA076518
NIH
Blood and Marrow Transplant Clinical Trials Network