Clinical trial · Interventional
S0410 Tandem Stem Cell Transplantation in Treating Patients With Progressive or Recurrent Hodgkin's Lymphoma
Tandem Autologous Stem Cell Transplantation for Patients With Primary Progressive or Recurrent Hodgkin's Disease (A BMT Study), Phase II
NCT00233987CI-TRIAL-00031877completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Radiation therapy uses high-energy x-rays to kill cancer cells. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy with a peripheral stem cell transplant may allow more chemotherapy to be given so that more cancer cells are killed. Tandem (two) autologous stem cell transplants may be an effective treatment for Hodgkin's lymphoma. PURPOSE: This phase II trial is studying how well tandem stem cell transplantation works in treating patients with progressive or recurrent Hodgkin's lymphoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous-autologous tandem hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| carmustine | Drug | Carmustine | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| melphalan | Drug | Melphalan | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- High-dose therapy plus tandem transplant
- description
- Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million cluster of differentiation 34 positive (CD34+) cells. Cycle 2 consists of either TBI-based or 1,3-bis(2-chloroethyl)-1-nitrosourea (BCNU)-based high-dose therapy followed by infusion of at least 2 million CD34+ cells.
- interventionNames
- Drug: carmustine
- Drug: cyclophosphamide
- Drug: etoposide
- Drug: melphalan
- Procedure: autologous-autologous tandem hematopoietic stem cell transplantation
- Radiation: radiation therapy
Primary outcomes (1)
- measure
- 2-year Progression-free Survival
- timeFrame
- At day 60, then every 6 months for 2 years
- description
- Measured from date of randomization to date of first observation of progressive disease, or death due to any cause
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 70 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed Hodgkin's lymphoma * Relapsed or refractory disease * Biopsy or radiological evidence of disease at time of recurrence/progression required * Has received ≥ 1 prior systemic chemotherapy regimen * No clonal abnormalities in marrow collection * Must undergo involved-field radiotherapy if bulky disease \> 5 cm * Must have adequate sections of original diagnostic specimen available for review * Needle aspirations or cytologies are not adequate * No prior lymphoma, myelodysplastic syndromes, or leukemia (even if disease free \> 5 years) * Patients who relapse after achieving a complete remission must complete a minimum of 2 courses of salvage chemotherapy or radiation therapy to determine if sensitive or resistant recurrent disease is present * No central nervous system (CNS) involvement PATIENT CHARACTERISTICS: Age * 15 to 70 Performance status * Zubrod 0-2 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 Hepatic * Bilirubin ≤ 1.5 times upper limit of normal (ULN) (unless due to Hodgkin's disease) Renal * Creatinine clearance ≥ 60 mL/min * Creatinine ≤ 2 times upper limit of normal Cardiovascular * None of the following conditions requiring therapy: * Coronary artery disease * Cardiomyopathy * Congestive heart failure * Arrhythmias * Ejection fraction ≥ 45% by Multi Gated Acquisition Scan (MUGA) or 2-D echocardiogram Pulmonary * Adequate pulmonary function * Corrected diffusing capacity of lung for carbon monoxide (DLCO) ≥ 60% OR * Forced Expiratory Volume in One Side (FEV\_1) ≥ 60% of predicted Other * Not pregnant or nursing * Fertile patients must use effective contraception * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer * No known HIV or AIDS infection * No active bacterial, fungal, or viral infection * No medical condition that would preclude study treatment PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics Surgery * Not specified
References
Publications (1)
- DERIVEDSmith EP, Li H, Friedberg JW, Constine LS, Rimsza LM, Cook JR, Laport GG, Popplewell LL, Holmberg LA, Smith SM, LeBlanc M, Forman SJ, Fisher RI, Stiff PJ. Tandem Autologous Hematopoietic Cell Transplantation for Patients with Primary Progressive or Recurrent Hodgkin Lymphoma: A SWOG and Blood and Marrow Transplant Clinical Trials Network Phase II Trial (SWOG S0410/BMT CTN 0703). Biol Blood Marrow Transplant. 2018 Apr;24(4):700-707. doi: 10.1016/j.bbmt.2017.12.798. Epub 2017 Dec 28. PMID 29289757