Clinical trial · Interventional
Rituximab Augmentation Following R-CHOP Induction Chemotherapy in Extremely Elderly Patients With Diffuse Large B Cell Lymphoma
Phase II Trial of Rituximab (R) Augmentation Following R-CHOP (Cyclophosphamide, Doxorubicin, Vincristine, and Prednisolone) Induction Chemotherapy in Extremely Elderly Patients With Diffuse Large B Cell Lymphoma (DLBCL)
- 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)
Rituximab (R) plus CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone) combination is considered as the new gold standard for the first-line treatment of elderly patients with diffuse large B-cell lymphoma (DLBCL). The study is aimed to evaluate the overall response rate and the safety of four cycles of R-CHOP chemotherapy and followed by rituximab augmentation (weekly four times infusion) in newly diagnosed DLBCL patients with aged more than 70 years.
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, Large B-cell, Diffuse | Lymphoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- rituximab
- interventionNames
- Drug: rituximab
Primary outcomes (2)
- measure
- the overall response rate
- timeFrame
- three years after the completion of rituximab augmentation
- description
- To evaluate the objective overall response rate of four cycles of R-CHOP and followed by four times weekly rituximab augmentation in exteremely elderly patients with DLBCL.
- measure
- Number of patients with adverse events
- timeFrame
- three years
- description
- All patients will be evaluated for the toxicity during the treatment. Toxicity is graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC v3.0).
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria:
1. Histologically confirmed CD20 positive DLBCL
2. Age ≥ 70
3. Ann Arbor stage II, III and IV
4. No prior chemotherapy or radiotherapy for DLBCL
5. Performance status (Eastern Cooperative Oncology Group) ≤ 2
6. At least one or more bidimensionally measurable lesion(s)
* ≥ 2 cm by conventional computerized tomography (CT)
* ≥ 1 cm by spiral CT
* skin lesion (photographs should be taken) ≥ 2 cm
* measurable lesion by physical examination ≥ 2 cm
7. Cardiac ejection fraction ≥ 50% as measured by echocardiogram without clinically significant abnormalities
8. Adequate renal function: serum creatinine level \< 2 mg/dL (177 μmol/L)
9. Adequate liver functions:
10. Adequate bone marrow functions:
hemoglobin ≥ 9 g/dL absolute neutrophil count ≥ 1,500/μL and platelet count ≥ 75,000/μL, unless abnormalities are due to bone marrow involvement by lymphoma
11. Life expectancy more than 6 months
12. Informed consent
Exclusion Criteria:
1. Other subtypes of non-Hodgkin's lymphoma
2. Patients who transformed follicular lymphoma or other indolent lymphoma
3. Primary Central Nervous System (CNS) DLBCL
4. CNS involvement by lymphoma or any evidence of spinal cord compression.
5. Patients with a known history of human immunodeficiency virus (HIV) seropositivity or hepatitis C virus (+).
6. Any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri
7. Pregnant or lactating women, women of childbearing potential not employing adequate contraception
8. Other serious illness or medical conditionsReferences
Publications (0)
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