Clinical trial · Interventional
Combination Chemotherapy With or Without Amifostine in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma or Hodgkin's Disease Undergoing Stem Cell Transplantation
A Randomized Study of Ethyol (Amifostine) With Platinum Based Salvage Chemotherapy in Patients With Lymphoma Undergoing Autologous Stem Cell Transplantation
- 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. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy. PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy with or without amifostine in treating patients with recurrent or refractory non-Hodgkin's lymphoma or Hodgkin's disease who are undergoing autologous stem cell transplantation.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Amifostine | Drug | — | UNRESOLVED |
| DHAP | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- DHAP + amifostine
- description
- Patients are randomized to receive salvage chemotherapy with intravenous dexamethasone/cisplatin/cytarabine (DHAP) with or without amifostine. Patients receive cisplatin IV over 3 hours followed by cytarabine IV for 2 doses. Patients also receive dexamethasone orally or IV. Treatment repeats every 3-4 weeks for 2-6 courses. Arm I: Patients receive amifostine IV over 15 minutes prior to all courses of DHAP, as a 15 minute infusion, beginning 30 minutes prior to cisplatin administration. Arm II: Patients do not receive amifostine. On day 3 of the last DHAP course, patients receive filgrastim (G-CSF) until the last day of progenitor stem cell (PSC) mobilization. PSC transplant continues daily for 4-10 days.
- interventionNames
- Drug: Amifostine
- Drug: DHAP
- type
- OTHER
- label
- DHAP
- description
- Patients are randomized to receive salvage chemotherapy with intravenous dexamethasone/cisplatin/cytarabine (DHAP) with or without amifostine. Patients receive cisplatin IV over 3 hours followed by cytarabine IV for 2 doses. Patients also receive dexamethasone orally or IV. Treatment repeats every 3-4 weeks for 2-6 courses. Arm I: Patients receive amifostine IV over 15 minutes prior to all courses of DHAP, as a 15 minute infusion, beginning 30 minutes prior to cisplatin administration. Arm II: Patients do not receive amifostine. On day 3 of the last DHAP course, patients receive filgrastim (G-CSF) until the last day of progenitor stem cell (PSC) mobilization. PSC transplant continues daily for 4-10 days.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Histologically proven recurrent or refractory non-Hodgkin's lymphoma or Hodgkin's disease requiring salvage chemotherapy Prior treatment with at least 3 courses of first line chemotherapy PATIENT CHARACTERISTICS: Age: Over 18 Performance Status: ECOG 0-2 Life Expectancy: Greater than 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 50,000/mm3 Hepatic: Not specified Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 40 mL/min Cardiovascular: No symptomatic congestive heart failure (class III or more as defined by American Heart Association) Electrolytes: Potassium at least 3.4 meq/L Magnesium at least 1.4 meq/L Other: Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior high dose chemotherapy with stem cell transplant At least 3 courses of first line chemotherapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
References
Publications (0)
Data not yet available