Clinical trial · Interventional
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Aggressive Non-Hodgkin's Lymphoma
Standard Chemotherapy (CHOP Regimen) Versus Sequential High-Dose Chemotherapy With Autologous Stem Cell Transplantation in Patients With Newly Diagnosed Aggressive Non-Hodgkin's Lymphomas and Poor Prognostic Factors: A Randomized Phase III Study (MISTRAL)
- 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 tumor cells from dividing so they stop growing or die. Combining peripheral stem cell transplantation with more than one drug regimen may kill more tumor cells. It is not known whether receiving standard combination chemotherapy alone is more effective than receiving multiple combination chemotherapy plus peripheral stem cell transplantation for aggressive non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is comparing giving different combination chemotherapy regimens together with peripheral stem cell transplantation to see how well they work in treating patients with newly diagnosed aggressive non-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 (17)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bone marrow ablation with stem cell support | Procedure | — | UNRESOLVED |
| CHOP regimen | Drug | CHOP Regimen | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| cytarabine | Drug | Cytarabine | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed aggressive non-Hodgkin's lymphoma (NHL) * Diffuse large B-cell lymphoma * Primary mediastinal large B-cell lymphoma * Anaplastic large cell lymphoma (B-cell, T-cell, or null-cell type) * At least two of the following risk factors: * Stage III or IV * LDH greater than upper limit of normal (ULN) * ECOG 2, 3, or 4 * No CNS involvement PATIENT CHARACTERISTICS: Age: * 18 to 60 Performance status: * See Disease Characteristics * ECOG 0-4 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * No hepatitis B or C * AST or ALT no greater than 2 times ULN\* * Bilirubin no greater than 2.34 mg/dL\* NOTE: \*Unless due to tumor involvement Renal: * Creatinine clearance at least 60 mL/min (unless due to tumor involvement) Cardiovascular: * No significant heart failure * LVEF normal * No active angina pectoris * No myocardial infarction within the past 6 months * No major ventricular arrhythmia Pulmonary: * No significant lung disorder Other: * HIV negative * No severe active acute or chronic infection * No severe psychoses * No prior or concurrent malignancy except adequately treated carcinoma in situ of the cervix or nonmelanomatous skin cancer * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy for NHL (except emergency therapy, but no more than 1 course of standard chemotherapy) Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy for NHL (except emergency therapy of no greater than 600 cGy radiation) * No concurrent prophylactic radiotherapy to the brain Surgery: * Not specified
References
Publications (1)
- RESULTBetticher DC, Martinelli G, Radford JA, Kaufmann M, Dyer MJ, Kaiser U, Aulitzky WE, Beck J, von Rohr A, Kovascovics T, Cogliatti SB, Cina S, Maibach R, Cerny T, Linch DC. Sequential high dose chemotherapy as initial treatment for aggressive sub-types of non-Hodgkin lymphoma: results of the international randomized phase III trial (MISTRAL). Ann Oncol. 2006 Oct;17(10):1546-52. doi: 10.1093/annonc/mdl153. Epub 2006 Aug 3. PMID 16888080