SWOG clinical trial number
S0410

Tandem Autologous Stem Cell Transplantation For Patients With Primary Progressive or Recurrent Hodgkin's Disease (A BMT Study), Phase II

Closed
Phase
Accrual
100%
Abbreviated Title
HODGKIN'S: Tandem Autologous Stem Cell Transplant Study
Activated
10/15/2005
Closed
02/01/2009
Participants
Limited Institutions: SWOG Approved Autologous BMT Facilities, Limited Institutions: BMT CTN Approved Autologous BMT Facilities

Research committees

Lymphoma

Treatment

Cyclophosphamide BCNU Melphalan VP-16 RT

Eligibility Criteria Expand/Collapse

Histologically or cytologically confirmed relapsed or refractory Hodgkin's disease; all patients must have received systemic chemotherapy as all or part of their initial treatment for Hodgkin's disease; bilateral or unilateral BM aspirate and biopsy that meets one of the following criteria: a) w/in 42 days prior to stem cell collection, b) w/in 28 days prior to initating salvage chemotherapy, provided the BM asp/biopsy is negative for HD and the patient has a response of PR, CRU, or CR to salvage therapy, c) after stem cell collection and w/in 28 days prior to starting the transplant procedure, provided the patient DID NOT have a marrow exam before salvage chemotherapy and stem cells were collected on the rebound after one of the salveage chemotherapy cycles; must have had a minimum of 3.5 X 10(6) CD34+ cells/kg collected; must not have any clonal abnormalities detected in the pre-stem cell collection marrow; patients with bulk disease > 5 cm must agree to receive involved field radiation therapy; patients who relapse after achieving a complete remission must complete a minimum of two courses of salvage chemotherapy or a minimum of 2,500 cGy of radiation to determine if they have "sensitive" or "resistant" recurrent disease; adequate sections from the original diagnostic specimen must be made available for submission to be reviewed by the SWOG Lymphoma Repository; PS=0-2; >=age 15 and <=age 70; chest x-ray w/in 28 days prior to registration; CT scan or thorax, abdomen and pelvis within 28 days prior to registration; no clinical evidence of CNS involvement by Hodgkin's disease; must be in good general medical condition that will permit agressive HDT; ANC >= 1,500 cells/mcL; measured or calculated creatinine clearance >= 60 mL/min and serum creatinine <= 2 X IULN; serum bilirubin <= 1.5 x IULN; must be free of active bacterial, fungal, or viral infection; must not be requiring therapy for coronary artery disease, cardiomyopathy, congestive heart failure, or arrhythmias; must have adequate pulmonary function as measured by a corrected DLCO >= 60% OR FEV1>= 60% of predicted within 42 days prior to registration; must not have known HIV or AIDS; must not be pregnant or nursing; no prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, or other cancer for which the patient has been disease free for 5 years; must not have a prior history of lymphoma, myelodysplastic syndrome, or leukemia.

Publication Information Expand/Collapse

2018

Tandem autologous hematopoietic cell transplantation for patients with primary progressive or recurrent hodgkin lymphoma: a SWOG and Blood & Marrow Transplant Clinical Trials Network phase II Trial (SWOG S0410/BMT CTN 0703)

EP Smith;H Li;J Friedberg;L Constine;L Rimsza;G Laport;L Popplewell;L Holmberg;SM Smith;SM Smith;M Leblanc;SJ Forman;RI Fisher;PJ Stiff Biology of Blood and Marrow Transplantation Apr;24(4):700-707

PMid: PMID29289757 | PMC number: PMC5965270

2014

SWOG S0410/CTN 0703: A phase II trial of tandem autologous stem cell transplantation (AHCT) for patients with primary progressive or recurrent Hodgkin lymphoma (HL) (ClinicalTrials.gov Identifier: NCT00233987)

E Smith;H Li;JW Friedberg;LS Constine;LM Rimsza;GG Laport;LL Popewell;DG Maloney;M Leblanc;SJ Forman;RI Fisher;P Stiff Blood 124(21):676; American Society for Hematology (December 6-9, 2014, San Francisco, CA), oral;