Clinical trial · Interventional
Rituximab and Combination Chemotherapy in Treating Older Patients With Diffuse Large B-Cell Lymphoma
A Phase II Study Of Rituximab-CHOP With Pegylated Liposomal Doxorubicin In Patients Older Than 60 Years Of Age With Untreated Aggressive B-Cell 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: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. 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. Giving rituximab together with combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating older patients with diffuse large B-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 (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Filgrastim | Biological | Filgrastim | ALIAS |
| Pegfilgrastim | Biological | Pegfilgrastim | ALIAS |
| Pegylated liposomal doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| Prednisone | Drug | Prednisone | ALIAS |
| Rituximab | Biological | Rituximab | ALIAS |
| Vincristine Sulfate | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Rituximab - Combination Chemotherapy
- description
- Rituximab 375 mg/m\^2 intravenous (IV), Cyclophosphamide IV over 1-1½ hours, Pegylated doxorubicin HCl liposome 40 mg/m\^2 IV over 1 hour, Vincristine 2 mg IV, day 1, \& oral Prednisone 40 mg/m\^2 days 1 - 5; Filgrastim (G-CSF) 5 mcg/kg subcutaneously (SC) once daily beginning day 6 continuing until blood counts recover OR Pegfilgrastim 6 mg SC once on day 6 (24 hours after chemotherapy). Treatment repeats every 21 days for up to 8 courses.
- interventionNames
- Biological: Filgrastim
- Biological: Pegfilgrastim
- Biological: Rituximab
- Drug: Cyclophosphamide
- Drug: Pegylated liposomal doxorubicin hydrochloride
- Drug: Prednisone
- Drug: Vincristine Sulfate
Primary outcomes (2)
- measure
- Disease Response (Complete, Complete Unconfirmed, and Partial Responses) After 4 Courses
- timeFrame
- Evaluation after 12 weeks (4 cycles of 21 days)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 61 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed diffuse large B-cell lymphoma * Stage II, III, or IV disease * Previously untreated disease * Measurable or evaluable disease * No primary central nervous system (CNS) lymphoma or follicular B-cell lymphoma PATIENT CHARACTERISTICS: Age * 61 and over Performance status * Zubrod 0-2 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count \> 1,000/mm\^3\* * Platelet count \> 100,000/mm\^3\* NOTE: \* Unless due to lymphoma-related hypersplenism or bone marrow infiltration Hepatic * Bilirubin \< 2 mg/dL * Hepatitis B surface antigen negative * Hepatitis B core antibody negative * Hepatitis C Virus antibody negative Renal * Creatinine \< 2 mg/dL Cardiovascular * left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram or ple gated acquisition (MUGA) scan * No uncontrolled hypertension or cardiac symptoms * Cardiologist consultation required for patients with stage A cardiac failure or any of the following known heart diseases: * Diastolic dysfunction * Prior coronary artery bypass graft * Prior percutaneous transluminal coronary angioplasty * Prior stent insertion * Prior radiotherapy to the chest * No myocardial infarction within the past 6 months * No New York Heart Association class II-IV heart failure * No uncontrolled angina * No severe uncontrolled ventricular arrhythmias * No clinically significant pericardial disease * No acute ischemic or active conduction system abnormality by electrocardiogram (EKG) Other * Not pregnant or nursing * Fertile patients must use effective contraception * No psychiatric illness that would preclude study compliance or giving informed consent * No other major life-threatening illness that would preclude study treatment PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * See Cardiovascular Surgery * See Cardiovascular
References
Publications (0)
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