Clinical trial · Interventional
Chemotherapy Followed by Radiation Therapy and Peripheral Stem Cell Transplant Compared With Chemotherapy Plus Interferon Alfa in Treating Patients With Stage III or Stage IV Mantle Cell Lymphoma
Treatment of Mantle Cell Lymphomas at Advanced Stages: Prospective Randomized Comparison of Myeloablative Radiochemotherapy Followed by Blood Stem Cell Transplantation Versus Maintenance With Interferon Alpha in First Remission After Initial Cytoreductive Chemotherapy With an Anthracycline Containing Combination
- 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 work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. Peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Interferon alfa may interfere with the growth of cancer cells. It is not yet known whether giving more than one drug (combination chemotherapy) with radiation therapy and peripheral stem cell transplant is more effective than chemotherapy followed by interferon alfa in treating mantle cell lymphoma. PURPOSE: This randomized phase III trial compares how well chemotherapy followed by radiation therapy, chemotherapy, and peripheral stem cell transplant works compared to chemotherapy plus interferon alfa in treating patients who have stage III or stage IV mantle cell 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 (11)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bone marrow ablation with stem cell support | Procedure | — | UNRESOLVED |
| carmustine | Drug | Carmustine | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| cytarabine | Drug | Cytarabine | ALIAS |
| dexamethasone | Drug | Dexamethasone | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| melphalan | Drug | Melphalan | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed stage III or IV mantle cell lymphoma * Previously untreated * Not qualified for primary potentially curative radiotherapy PATIENT CHARACTERISTICS: Age: * 18 to 65 years Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * No impairment of liver function (unless due to lymphoma) * Transaminases no greater than 3 times normal * Bilirubin no greater than 2.0 mg/dL Renal: * No renal insufficiency * Creatinine no greater than 2.0 mg/dL Cardiovascular: * No manifest heart failure or coronary heart disease * No severe uncontrolled hypertension Pulmonary: * No chronic lung disease with hypoxemia Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No severe uncontrolled diabetes mellitus PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior interferon * No prior organ, bone marrow, or peripheral blood stem cell transplantation Chemotherapy: * No prior cytostatic chemotherapy Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy Surgery: * Not specified
References
Publications (1)
- DERIVEDDetermann O, Hoster E, Ott G, Wolfram Bernd H, Loddenkemper C, Leo Hansmann M, Barth TE, Unterhalt M, Hiddemann W, Dreyling M, Klapper W; European Mantle Cell Lymphoma Network and the German Low Grade Lymphoma Study Group. Ki-67 predicts outcome in advanced-stage mantle cell lymphoma patients treated with anti-CD20 immunochemotherapy: results from randomized trials of the European MCL Network and the German Low Grade Lymphoma Study Group. Blood. 2008 Feb 15;111(4):2385-7. doi: 10.1182/blood-2007-10-117010. Epub 2007 Dec 12. PMID 18077791