Autologous Followed by Non-myeloablative Allogeneic Transplantation for Non-Hodgkin's Lymphoma
Trial ID or NCT#
NCT00481832
Status
NOT RECRUITING
Purpose
The purpose of this trial is to develop an alternative treatment for patients with poor risk non-Hodgkin's lymphoma. This trial uses a combination of high dose chemotherapy with stem cell transplant using the patient's own cells. This is followed with non-myeloablative transplant using stem cells from a related or unrelated donor to try and generate an anti-lymphoma response from the new immune system.
Official Title
Autologous Followed by Non-myeloablative Allogeneic Transplantation for Non-Hodgkin's Lymphoma
Eligibility Criteria
Ages Eligible for Study: 18 Years to 70 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
- - Age 18 to 70 years. - Histologically proven non-Hodgkin's lymphoma - Relapse after achieving initial remission or failure to achieve initial remission. - KPS > 70% - Matched related or unrelated donor identified and available. Donor must be a complete match or have only a single allele mismatch. - Recent Bone marrow biopsy and cytogenetic analysis - 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 > 50 cc/min by the following formula (all tests must be performed within 28 days prior to mobilization ): Estimated Creatinine Clearance = (140 age) X WT(kg) X 0.85 if female 72 X 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 must have an echocardiogram or MUGA scan within 42 days of registration. If the ejection fraction is < 40%, the patient will not be eligible. If the ejection fraction is 40-50%, patients must have an exercise echocardiogram or dobutamine-echo with a normal response to exercise. - Patients must have a corrected diffusion capacity > 50% prior to the autologous transplant and > 40% prior to the allogeneic transplant. - Patients with known allergy to etoposide or a history of Grade 3 hemorrhagic cystitis with cyclophosphamide 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.
Exclusion Criteria:
- - Pregnant or breast-feeding women are ineligible due to the known birth defects association with the treatments used in this study. - Patients known to be human immunodeficiency virus (HIV)-positive are ineligible because the concern for opportunistic infection and hematologic reserve are considered to be significantly greater in this population. - Patients with prior maligancies diagnosed > 5 years ago without evidence of disease are eligible. Patients with a prior malignancy treated < 5 years ago but have a life expectancy of > 5 years for that malignancy are eligible. - Patients with uncontrolled infection. - No prior autologous or allogeneic hematopoietic cell transplantation. Donor Selection/Evaluation: - Related or unrelated HLA identical donors who are in good health and have no contra-indication to donation. - No contra-indication for the donor to collection by apheresis of mononuclear cells mobilized by G-CSF at a dose of 16 µg/kg of body weight. - Virology testing including CMV, HIV, EBV, HTLV, RPR, Hepatitis A, B and C will be performed within 30 days of donation. - No prior malignancy is allowed except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or other cancer for which the donor has been disease-free for five years
Investigator(s)
Wen-Kai Weng, MD, PhD
Blood and marrow transplant specialist,
Blood and marrow transplant specialist,
Lymphoma specialist,
Medical oncologist,
Multiple myeloma specialist
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and, by courtesy, of Dermatology
Robert Lowsky
Blood and marrow transplant specialist,
Hematologist,
Blood and marrow transplant specialist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Laura Johnston
Blood and marrow transplant specialist,
Blood and marrow transplant specialist,
Medical oncologist,
Hematologist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Robert Negrin
Blood and marrow transplant specialist,
Hematologist,
Blood and marrow transplant specialist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Sandra Horning
Sally Arai
Blood and marrow transplant specialist,
Hematologist,
Blood and marrow transplant specialist
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Judith Shizuru
Blood and marrow transplant specialist,
Hematologist,
Blood and marrow transplant specialist,
Hematologist-Oncologist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and of Pediatrics (Stem Cell Transplantation)
Contact us to find out if this trial is right for you.
Contact
Physician Referrals
650-723-0822
View on ClinicalTrials.gov
