Blood and Marrow Clinical Trials Network (BMT CTN) A Phase II Trial of Non-Myeloablative Allogeneic Hematopoietic Cell Transplantation for Patients With Relapsed Follicular Non-Hodgkin's Lymphoma Beyond First Complete Response (0701)
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April 2009 – August 2016
August 8, 2018
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To determine the effectiveness of reduced intensity conditioning (RIC) in the procedure called non-myeloablative allogeneic blood stem cell transplant for people with relapsed follicular non-Hodgkin’s lymphoma (NHL).
Follicular non-Hodgkin’s Lymphoma or simply, follicular lymphoma (FL) is a type of blood cancer which is often classified as low grade because it is typically slow to progress. Approximately 15,000 new cases are diagnosed each year in the U.S. with initial symptoms presenting as painless swelling in lymph nodes of the neck, armpit, or groin. Radiation is often the initial and only treatment needed if few nodes are affected in the same region. When diffuse nodes are affected, chemotherapy is recommended but relapse is common. For advanced FL, another treatment option is to receive a blood stem cell transplant in a procedure called allogeneic hematopoietic cell transplantation (alloHCT). To prepare for the transplant, individuals receive high doses of chemotherapy in order to destroy cancerous cells and reduce the likelihood of transplant rejection. High doses of chemotherapy though are associated with several risks, some of which are life threatening. In this study, participants received lower doses of chemotherapy in an effort to reduce the severity of side effects and rate of mortality.
Sixty-five participants met the eligibility requirements of this study: age 75 years or younger, diagnosis of follicular lymphoma, a Karnofsky performance status greater than or equal to 70%, and a histologically confirmed diagnosis of lymphoma (grade I or II REAL or WHO grades 1, 2, or 3a FL in first or subsequent partial remission (PR) or second or subsequent complete remission (CR). If not in CR, response criteria compared to the most recent regimen required either:
- stable disease if all lymph node masses were ≤ 3 cm and unchanged (or smaller); or
- chemotherapy sensitivity defined as reduction of all lymph node masses to ≤ 3 cm in axial diameter or, if larger than 3 cm, a minimum of 50% reduction in estimated nodal diameters.
Patients with uncontrolled hypertension were excluded from the study as were those who were seropositive for HIV ab, hepatitis B sAg or polymerase chain reaction (PCR)+, or hepatitis C ab or PCR+. Three out of the 65 enrolled participants were excluded from the primary analysis since they did not receive a transplant (n=1), withdrew consent (n=1) or were found ineligible due to transformed disease (n=1) leaving 62 participants in the study.
The study was a Phase II, single arm, multicenter trial led by the NHLBI Blood and Marrow Transplant Clinical Trials Network in collaboration with the Eastern Cooperative Oncology Group and the Southwest Oncology Group. Prior to transplant administration, all eligible participants received a preconditioning regimen of high dose Rituxan of 375 mg/m2 on Day – 13 and 1000mg/m2 on Day –6, day +1, and day +8. Fludarabine was administered intravenously at 30mg/m2 and Cyclophosphamide 750mg/m2 on days –5, –4, and –3. On day 0, participants received matched related or matched unrelated donor transplants of peripheral blood progenitor cells (PBPC).
Oral tacrolimus and methotrexate were given on days +1, +3, and +6 to all patients receiving a related donor transplant. Unrelated donor recipients received an additional dose of methotrexate of 5 on day +11. Participants also received antimicrobial prophylaxis, blood product support, and possibly hematopoietic growth factors and immunizations depending on institutional guidelines.
The primary endpoint for this study was 2 year progression-free survival (PFS).
The primary endpoint was 74%. This and other findings demonstrate that alloHCT with fludarabine, cyclophosphamide, RTX (FCR) provides excellent PFS for high risk FL patients. This study also agrees with prior findings that alloHCT with FCR conditioning offers high CR rates and a low incidence of relapse/progression.
Laport GG, Wu J, Logan B, et al. Reduced Intensity Conditioning with Fludarabine, Cyclophosphamide, and High Dose Rituxan for allogeneic hematopoietic cell transplantation for follicular lymphoma: A phase II multicenter trial from the Blood and Marrow Transplant Network (BMT CTN). Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation. 2016;22(8):1440-1448. doi:10.1016/j.bbmt.2016.04.014.
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Resources AvailableStudy Datasets Only
- Data Dictionary (PDF - 649.5 KB)
- Case Report Forms (PDF - 797.7 KB)
- Data Submission Documentation (PDF - 312.0 KB)
- Documentation for Outcomes Dataset (PDF - 515.2 KB)
- Protocol (PDF - 4.8 MB)
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