Clinical trial · Interventional
Combination Chemotherapy Plus Filgrastim With or Without Rituximab in Treating Older Patients With Non-Hodgkin's Lymphoma
A Randomized Phase III Study Of Chimeric Anti-CD20 Monoclonal Antibody (Rituximab) With 2-Weekly CHOP Chemotherapy In Elderly Patients With Intermediate Or High-Risk 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. Monoclonal antibodies such as rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells. It is not yet known if combination chemotherapy plus filgrastim is more effective with or without rituximab in treating non-Hodgkin's lymphoma. PURPOSE: Randomized phase III trial to determine the effectiveness of combination chemotherapy plus filgrastim with or without rituximab in treating older patients who have 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 (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| prednisone | Drug | Prednisone | ALIAS |
| rituximab | Biological | Rituximab | ALIAS |
| vincristine sulfate | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Event-free survival
Secondary outcomes (4)
- measure
- Complete response
- measure
- Overall survival
- measure
- Disease-free interval
- measure
- Toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed non-Hodgkin's lymphoma (NHL)
* Low- or high-intermediate or high-risk lymphoma of any of the following subtypes:
* Mantle cell lymphoma
* Follicular lymphoma (grade III)
* Diffuse large B-cell lymphoma
* CD20-positive
* No suspected or documented CNS involvement by NHL NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age:
* 65 and over
Performance status:
* WHO 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Bilirubin less than 1.75 mg/dL\*
* Transaminases less than 2.5 times normal\* NOTE: \* Unless due to NHL
Renal:
* Creatinine less than 1.7 mg/dL (unless due to NHL)
Cardiovascular:
* No severe cardiac dysfunction
* No New York Heart Association class II-IV heart disease
* LVEF at least 45%
Pulmonary:
* No uncontrolled asthma requiring steroid treatment
Other:
* HIV negative
* No intolerance to exogenous protein administration
* No active, uncontrolled infection
* No uncontrolled allergy requiring steroid treatment
* No other malignancy within the past 5 years except basal cell skin cancer or stage 0 cervical cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior immunotherapy for NHL
Chemotherapy:
* No prior chemotherapy for NHL
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior radiotherapy for NHL except local radiotherapy for potential organ dysfunction by localized lymphoma mass or infiltration
* Concurrent local radiotherapy for potential or actual organ dysfunction by localized lymphoma mass or infiltration allowed
Surgery:
* Not specifiedReferences
Publications (0)
Data not yet available