Clinical trial · Interventional
Bevacizumab + CHOP-Rituximab in Untreated Mantle Cell Lymphoma
Phase II Study of Bevacizumab Plus CHOP-Rituximab in Patients With Untreated Mantle Cell Lymphoma (NHL)
- 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)
Primary Objective 1\. To evaluate the safety profile of Bevacizumab (Bevacizumab™)- Rituximab (Rituxan®)-CHOP (RA-CHOP) in patients with newly diagnosed mantle cell lymphoma (MCL). Secondary Objectives 1. To evaluate the response rate and time to disease progression of the RA-CHOP regimen in patients with newly diagnosed MCL. 2. To prospectively characterize the angiogenic profiles of MCL patients during RA-CHOP treatment.
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 |
|---|---|---|---|
| Untreated Mantle Cell Lymphoma | Mantle Cell Lymphoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| CHOP | Drug | — | UNRESOLVED |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Study Treatment Arm
- description
- Bevacizumab-R-CHOP therapy included bevacizumab administered at 15 mg/kg on day 1, and standard dose R-CHOP on day 3, for six 21-day cycles
- interventionNames
- Drug: Bevacizumab
- Drug: Rituximab
- Drug: CHOP
Primary outcomes (1)
- measure
- Number of Participants With Toxicity
- timeFrame
- 38 months
- description
- Number of patients with reversible myelosuppression (Primary toxicity was reversible myelosuppression) Toxicities were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0.
Secondary outcomes (3)
- measure
- Overall Response Rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed diagnosis of mantle cell Non-Hodgkin's Lymphoma with characteristic immunophenotypic profile: CD5(+), CD19(+) or CD20(+), cyclin D1(+), CD23(-) and CD10(-) * Patient has not received any prior anti-cancer therapy for lymphoma * Laboratory parameters (unless considered by investigator to be due to lymphoma): Absolute neutrophil count \> 1000 cells/mm3 Platelet count \> 50,000 cells/mm3 Hemoglobin \> 7 gm/dL Creatinine \< 2.0 x ULN Total bilirubin \< 2.0 x ULN * Patient has at least one tumor mass \> 1.5 cm in one dimension * Available tumor tissue for correlative studies (rebiopsy to be performed if needed) * Patient is \> 18 years old * Patient has KPS \> 50% * Patient has signed IRB-approved informed consent * Patient agrees to use birth control for duration of study Exclusion Criteria: * Known central nervous system (CNS) involvement by lymphoma * Known hepatitis infection * Known HIV positivity * Known history of renal disease with proteinuria; urine protein:creatinine ratio ³1.0 at screening * Uncontrolled hypertension: blood pressure of \>150/100 mmHg at screening * Unstable angina * History of myocardial infarction within 6 months * History of stroke within 6 months * Clinically significant peripheral vascular disease * New York Heart Association (NYHA) Grade II or greater congestive heart failure * Patient has ejection fraction \< 50% * Patient is taking coumadin, or has known history of thrombosis within last 6 months * Evidence of bleeding diathesis or coagulopathy * Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1, anticipation of need for major surgical procedure during the course of the study * Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to Day 1 * History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 1 * Serious, non-healing wound, ulcer, or bone fracture * Concomitant malignancies or previous malignancies within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix. * Patient is pregnant or nursing * Patient is receiving other investigational drugs
References
Publications (0)
Data not yet available