Clinical trial · Interventional
Combination Chemotherapy in Treating Patients With Aggressive Non-Hodgkin's Lymphoma
Phase III Trial Comparing CHOP ot PMitCEBO in Good Risk Patients With Histologically Aggresive Non Hodgkin's Lymphoma
- 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. It is not yet known which regimen of combination chemotherapy is most effective for non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying two regimens of combination chemotherapy and comparing how well they work in treating patients with 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 (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bleomycin sulfate | Biological | Bleomycin | ALIAS |
| CHOP regimen | Drug | CHOP Regimen | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| mitoxantrone hydrochloride | Drug | Mitoxantrone | ALIAS |
| prednisolone | Drug | Prednisolone | ALIAS |
| vincristine sulfate | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall survival in patients treated with mitoxantrone, cyclophosphamide, etoposide, vincristine, bleomycin, and prednisolone (PMitCEBO) versus cyclophosphamide, doxorubicin, vincristine, and prednisolone (CHOP)
Secondary outcomes (1)
- measure
- Failure-free survival, disease specific survival, relapse-free survival, death due to toxicity, response rate, and toxicity at 4 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 59 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically proven previously untreated bulky stage IA or stage IB-IV aggressive non-Hodgkin's lymphoma of 1 of the following types:
* Working formulation:
* Follicular large cell
* Diffuse mixed cell
* Diffuse large cell
* Diffuse immunoblastic OR
* REAL classification:
* Diffuse large B-cell
* Peripheral T-cell
* Measurable or evaluable disease
* Good prognosis defined as no more than one of the following:
* Stage III/IV disease
* LDH greater than upper limit of normal
* ECOG/WHO 2-4
* No lymphoblastic or Burkitt's lymphoma
* No CNS involvement
PATIENT CHARACTERISTICS:
Age:
* 18 to 59
Performance status:
* See Disease Characteristics
Life expectancy:
* Not specified
Hematopoietic:
* Hemoglobin at least 10 g/dL
* Neutrophil count at least 2,000/mm3
* Platelet count at least 100,000/mm3
Hepatic:
* Bilirubin, AST, and ALT no greater than 1.5 times upper limit of normal
Renal:
* Creatinine no greater than 1.7 mg/dL
Cardiovascular:
* Ejection fraction at least 50% unless dysfunction attributable to lymphoma
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No other concurrent serious uncontrolled medical conditions
* No other prior malignancy except adequately treated nonmelanoma skin cancer or cervical intraepithelial neoplasia
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior radiotherapy to more than 35% of hematopoietic sites
* Concurrent consolidation radiotherapy allowed
Surgery:
* Not specifiedReferences
Publications (0)
Data not yet available