Clinical trial · Interventional
High-Dose Chemotherapy in Treating Patients Undergoing Stem Cell Transplant for Recurrent or Refractory Hodgkin's Lymphoma
High Dose Sequential Therapy for Poor Risk Recurrent or Refractory 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: Giving high-dose chemotherapy before a peripheral blood stem cell transplant stops the growth of cancer cells by stopping them from dividing or by killing them. Giving colony-stimulating factors, such as G-CSF, helps stem cells move from the bone marrow to the blood so they can be collected and stored. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by high-dose chemotherapy and radiation therapy. PURPOSE: This clinical trial is studying the side effects and how well high-dose chemotherapy works in treating patients undergoing stem cell transplant for recurrent or refractory 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 (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| carmustine | Drug | Carmustine | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| melphalan | Drug | Melphalan | ALIAS |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Feasibility
- measure
- Toxicity as assessed by NCI CTC v2.0
Secondary outcomes (4)
- measure
- Response rate
- measure
- Progression-free survival
- measure
- Overall survival
- measure
- Percentage of patients who achieve minimal disease status after 2 courses
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 64 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed Hodgkin lymphoma * Diagnosis reviewed by the participating institution * Failed to achieve complete remission (CR) after first-line chemotherapy or chemoradiotherapy (i.e., induction failure) OR not felt to be curable by radiotherapy alone * Relapsed after standard chemotherapy regimen for Hodgkin lymphoma AND has ≥ 1 of the following poor-risk features: * Extranodal disease at relapse * Interval from first CR to relapse \< 12 months * B symptoms at relapse * Chemo-resistant relapse OR failure to achieve a second CR with conventional nontransplantation salvage chemotherapy regimen * No cytogenetic abnormality on cytogenetic analysis of bone marrow PATIENT CHARACTERISTICS: Inclusion criteria: * SWOG performance status 0-1 * LVEF \> 50% by 2D-ECHO or MUGA scan * Patients with LVEF between 45-50% and without wall motion abnormalities are assessed on an individual basis after consultation with the cardiologist * FEV\_1 or DLCO \> 45% predicted * Creatinine clearance \> 60 mL/min * HIV-negative * Hepatitis B surface antigen-negative * Hepatitis C virus-negative * ALT ≤ 5 times upper limit of normal * No inadequate vital organ function * No active infection * Fertile patients must use adequate contraception PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Concurrent, post-transplantation, consolidative radiotherapy to residual masses allowed provided the patient has engrafted with a WBC \> 4,000/μL and a platelet count \> 100,000/μL
References
Publications (0)
Data not yet available