A Phase II Study in Poor Risk Diffuse Large B-cell Lymphoma (DLBCL) of Total Lymphoid Irradiation (TLI) and Antithymocyte Globulin (ATG) Followed by Matched Allogeneic Hematopoietic Transplantation as a Consolidation to Autologous Hematopoietic Cell Transplantation (AHCT)
The purpose of this study is to develop an alternative treatment for patients with relapsed diffuse large B cell lymphoma who are not likely to be cured by the conventional transplantation regimen.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- Laura Johnston, MD
- Robert Negrin, M.D.
- Wen-Kai Weng, MD, PhD
- Robert Lowsky, MD
- Sandra Horning
- Sally Arai, MD
- Ginna G. Laport
- Judith Shizuru, Ph.D., M.D.
- drug : Anti-thymocyte globulin (ATG)
- procedure : Autologous hematopoietic cell transplantation (AHCT)
- procedure : Allogeneic hematopoietic cell transplantation
- procedure : Total lymphoid irradiation (TLI)
Phase: Phase 2
Ages Eligible For Study:
- Age 18 to 70 years. - Histologically proven diffuse large B-cell lymphoma (DLBCL) by the WHO classification. - Relapse after achieving initial remission or failure to achieve initial remission. Patients with residual radiographic abnormalities after primary therapy are eligible if abnormalities are FDG-PET positive. - Receipt of 2 cycles of second-line therapy and FDG-PET positive per Stanford (central) review. FDG-PET to be done 2 weeks after cycle 2 of second line chemotherapy. - ECOG performance status < 2 - Matched related or unrelated donor identified and available - Bone marrow biopsy and cytogenetic analysis within 8 weeks of registration - Women of child-bearing potential and sexually active males are strongly advised to use an accepted and effective method of birth control. - Patients must have a pretreatment serum bilirubin < 2 x the institutional ULN, a serum creatinine < 2 x the institutional ULN and measured or estimated creatinine clearance > 60 cc/min by the following formula (all tests must be performed within 28 days prior to registration): - Estimated Creatinine Clearance = (140 age)X WT(kg) X 0.85 if female 72X serum creatinine(mg/dl). - Patients must have an EKG within 42 days prior to registration that shows no significant abnormalities that are suggestive of active cardiac disease. - Patients requiring therapy for coronary artery disease, cardiomyopathy, dysrhythmia, or congestive heart failure are not eligible. - Patients must have a radionuclide ejection fraction within 42 days of registration. If the ejection fraction is <40%, the patient will not be eligible. If the ejection fraction is 40-50%, the patient will have a cardiology consult. - Patients must have a corrected diffusion capacity >55%. - Patients with known allergy to etoposide or a history of Grade 3 hemorrhagic cystitis with cyclophosphamide are not eligible. - Patients with > grade 2 sensory or motor peripheral neuropathy from prior vinca alkaloid use are not eligible. - Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.