Clinical trial · Interventional
Combination Chemotherapy and Peripheral Stem Cell Transplant in Treating Patients With Relapsed Hodgkin's Lymphoma
A Randomized Trial Of BEAM Plus PBSCT Versus Single Agent High-Dose Therapy Followed By BEAM Plus PBSCT In Patients With Relapsed Hodgkin's Disease
- 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: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplant may allow the doctors to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known which combination chemotherapy regimen given before peripheral stem cell transplant is more effective in treating relapsed Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is comparing different regimens of combination chemotherapy followed by peripheral stem cell transplant to see how well they work in treating patients with relapsed 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 (12)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bone marrow ablation with stem cell support | Procedure | — | UNRESOLVED |
| carmustine | Drug | Carmustine | ALIAS |
| cisplatin | Drug | Cisplatin | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| cytarabine | Drug | Cytarabine | ALIAS |
| dexamethasone | Drug | Dexamethasone | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Efficacy at 3 months
- measure
- Toxicity at 3 months
Secondary outcomes (3)
- measure
- Complete remission at 3 months
- measure
- Relapse-free survival at 3 months
- measure
- Overall survival at 3 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed Hodgkin's lymphoma * Early or late first relapse * Complete or partial remission for at least 3 months after completion of prior COPP/ABVD, COPP/ABV/IMEP, MOPP/ABV, ABVD, BEACOPP, or other polychemotherapy regimen with or without radiotherapy * No prior salvage therapy OR * Second relapse * Any prior salvage therapy * No prior high-dose chemotherapy PATIENT CHARACTERISTICS: Age: * 18 to 60 Performance status: * Karnofsky 70-100% OR * ECOG 0-2 Life expectancy: * More than 3 months with treatment Hematopoietic: * Absolute neutrophil count at least 2,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Not specified Renal: * Creatinine clearance at least 60 mL/min Cardiovascular: * No uncontrolled hypertension (diastolic blood pressure greater than 115 mm Hg) * No unstable angina * No New York Heart Association class III or IV heart disease (congestive heart failure) * No myocardial infarction within the past 6 months * No uncontrolled atrial or ventricular cardiac arrhythmias Pulmonary: * No chronic pulmonary disease Other: * Not pregnant or nursing * Fertile patients must use effective contraception * HIV negative * No active infection * No poorly controlled diabetes * No cerebral disorder * No other concurrent malignancy except adequately treated basal cell skin cancer or cervical intraepithelial neoplasia * No significant non-malignant disease * No psychiatric, addictive, or other disorder that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * No other concurrent chemotherapy Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics Surgery: * Not specified Other: * At least 6 months since prior coronary angioplasty * No other concurrent investigational drugs * No concurrent non-steroidal anti-inflammatory drugs, salicylate, sulfonamide, trimethoprim, allopurinol, aminoglycoside, amoxicillin, or probenecid during high-dose methotrexate administration
References
Publications (1)
- DERIVEDBrockelmann PJ, Muller H, Casasnovas O, Hutchings M, von Tresckow B, Jurgens M, McCall SJ, Morschhauser F, Fuchs M, Borchmann P, Moskowitz CH, Engert A. Risk factors and a prognostic score for survival after autologous stem-cell transplantation for relapsed or refractory Hodgkin lymphoma. Ann Oncol. 2017 Jun 1;28(6):1352-1358. doi: 10.1093/annonc/mdx072. PMID 28327958