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A Phase 2 Study in Poor Risk Diffuse Large B-cell Lymphoma of Total Lymphoid Irradiation & Antithymocyte Globulin Followed by Matched Allogeneic Hematopoietic Transplantation as Consolidation to Autologous Hematopoietic Cell Transplantation
The purpose of this study is to determine if double autologous then allogeneic hematopoietic cell transplant may offer an improved treatment option for patients with relapsed diffuse large B-cell lymphoma (DLBCL) who are not likely to be cured by the conventional transplantation regimen.
This study tests a tandem transplant approach that starts with transplantation of the participant's own hematopoietic (blood) cells, eg, autologous hematopoietic cell transplant (auto-HCT) as preparation for an subsequent matched-donor allogeneic HCT (allo-HCT). Participants will be have progenitor cells (stem cells) mobilized into the peripheral blood with rituximab, chemotherapy (cyclophosphamide or etoposide), and filgrastim (G-CSF); undergo apheresis to collect autologous peripheral blood stem cells (PBSC, aka hematopoietic cells); and be re-infused with ≥ 3 x 10e6 CD34+ cells/kg (auto-HCT). Subsequently, participants will receive therapeutic, non-myeloablative chemotherapy (carmustine + cyclophosphamide + etoposide), then transplant conditioning \[total lymphoid irradiation (TLI) + anti-thymocyte globulin (ATG)\] followed by ≥ 2 x 10e6 CD34+ cells/kg allogeneic PBSC obtained from a human leukocyte antigen (HLA)-matched or HLA single allele / antigen-mismatched donor (allo-HCT). Donors will be mobilized with 16 µg/kg filgrastim. Participant allo-HCT transplant is to occur within 150 days of auto-HCT. Post-allo-HCT infusion treatment includes cyclosporine and mycophenolate mofetil (MMF) Subject's participation ends if a suitable matched donor is not identified within the 150 days. Pre-medication treatments administered during this study may include acetaminophen; diphenhydramine; hydrocortisone; and methylprednisolone.
Age
18 - 70 years
Sex
ALL
Healthy Volunteers
No
Stanford University School of Medicine
Stanford, California, United States
Start Date
October 1, 2006
Primary Completion Date
May 1, 2010
Completion Date
May 1, 2010
Last Updated
May 14, 2018
3
ACTUAL participants
Autologous hematopoietic stem cell transplantation (auto-HSCT)
PROCEDURE
Allogeneic hematopoietic stem cell transplantation (allo-HSCT)
PROCEDURE
Total lymphoid irradiation (TLI)
PROCEDURE
Rituximab
DRUG
Carmustine
DRUG
Etoposide
DRUG
Filgrastim
DRUG
Anti-thymocyte globulin (ATG)
DRUG
Cyclosporine
DRUG
Mycophenolate mofetil (MMF)
DRUG
Cyclophosphamide
DRUG
Acetaminophen
DRUG
Diphenhydramine
DRUG
Hydrocortisone
DRUG
Methylprednisolone
DRUG
Lead Sponsor
Stanford University
NCT06510361
NCT05442515
Data Source & Attribution
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