Clinical trial · Interventional
Bortezomib, Combination Chemotherapy, and Rituximab as First-Line Therapy in Treating Patients With Stage III or Stage IV Follicular Non-Hodgkin's Lymphoma
A Multi-Centre Phase II Trial Investigating the Efficacy and Tolerability of Bortezomib Added to Cyclophosphamide, Vincristine, Prednisone, and Rituximab (BCVP-R) for Patients With Advanced Stage Follicular Non-Hodgkin's Lymphoma Requiring Systemic First-Line Treatment
- 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: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. 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. Giving bortezomib together with combination chemotherapy and rituximab may kill more cancer cells. PURPOSE: This phase II trial is studying the side effects and how well giving bortezomib together with combination chemotherapy and rituximab works when given as first-line therapy in treating patients with stage III or stage IV follicular 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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bortezomib | Drug | Bortezomib | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| prednisone | Drug | Prednisone | ALIAS |
| rituximab | Biological | Rituximab | ALIAS |
| vincristine sulfate | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bortezomib + BCVP-R
- description
- BCVP-R - q 21 days x 4 cycles Bortezomib: 1.3 mg/m2 Days 1 \& 8 Cyclophosphamide: 750 mg/m2 IV Day 1 Vincristine: 1.4 mg/m2 IV Day 1 (dose capped at 2 mg) Prednisone: 40 mg/m2 po Days 1-5 Rituximab: 375 mg/m2 IV Day 1
- interventionNames
- Biological: rituximab
- Drug: bortezomib
- Drug: cyclophosphamide
- Drug: prednisone
- Drug: vincristine sulfate
Primary outcomes (2)
- measure
- Complete response rate
- timeFrame
- 5 years
- measure
- Incidence of severe grade 3 or 4 neurotoxicity or neuropathic pain during the first 4 courses of treatment
- timeFrame
- 5 years
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed follicular non-Hodgkin's lymphoma meeting the following criteria: * Stage III or IV disease * Grade 1, 2, or 3 disease requiring systemic first-line treatment * No transformation to diffuse large cell lymphoma * At least 1 bidimensionally measurable lesion meeting 1 of the following criteria: * Lymph nodes \> 1.5 cm x 1.0 cm by physical exam or CT scan * Other non-nodal lesion ≥ 1.0 cm x 1.0 cm by MRI or CT scan OR ≥ 1.0 cm x 1.0 cm (e.g., skin lesions or nodules) by physical exam * Must have a medical indication for treatment, as indicated by 1 of the following: * Presence of constitutional symptoms that are attributed to lymphoma (e.g., B symptoms, including night sweats, fever, weight loss, fatigue, or pain) * Lymphadenopathy that requires treatment based on presence of associated symptoms, potential threat to organ function (e.g., ureteric compromise from retroperitoneal disease), or degree of enlargement (i.e., \> 5 cm) * Impairment of normal organ function (e.g., impaired hematopoiesis due to marrow involvement by lymphoma or from splenomegaly and hypersplenism) * Immune-related complications of lymphoma that require therapy * Rate of disease progression for which observation is deemed inappropriate * No history of any other lymphoproliferative disorder or evidence of transformation to an aggressive histology lymphoma * No known CNS involvement by lymphoma PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy ≥ 12 weeks * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Platelet count ≥ 75,000/mm\^3\* * Absolute neutrophil count ≥ 1,000/mm\^3\* * Creatinine ≤ 1.5 times upper limit of normal (ULN) * Bilirubin ≤ 1.5 times ULN * AST or ALT ≤ 2.5 times ULN (5 times ULN if liver involvement with lymphoma) * Able (i.e., sufficiently fluent) and willing to complete the quality of life questionnaires in either English or French * Inability (illiteracy in English or French, loss of sight, or other equivalent reason) to complete the questionnaires will not make the patient ineligible for the study * No history of other malignancies, except for the following: * Adequately treated nonmelanoma skin cancer * Curatively treated in situ cancer of the cervix * Ductal carcinoma in situ of the breast (as long as radiation limitation is not exceeded) * Other solid tumors curatively treated with no evidence of disease for \> 5 years * No history of allergic reactions attributed to compounds containing boron or mannitol * No history of an unusual or severe allergic reaction to rituximab or similar agent * No pre-existing neuropathy ≥ grade 2 * No known HIV infection * No other serious illness or medical condition that would preclude study participation, including any of the following: * Active, uncontrolled bacterial, fungal, or viral infection * Significant cardiac dysfunction * Cardiovascular disease NOTE: \*Exceptions will be allowed for values below these thresholds in patients with marrow involvement by lymphoma or lymphoma-related hypersplenism PRIOR CONCURRENT THERAPY: * No prior systemic therapy for lymphoma * No prior bortezomib, cyclophosphamide, or vincristine * At least 4 weeks since prior radiotherapy that involved ≤ 25% of functioning bone marrow and recovered * Exceptions may be made for low-dose, nonmyelosuppressive radiotherapy or if the irradiated field is not a significant marrow-bearing area * At least 2 weeks since prior major surgery * No other concurrent anticancer therapy, investigational agents, corticosteroids (except for physiologic replacement or antiemesis), cytotoxic chemotherapy, or immunotherapy
References
Publications (2)
- RESULTSehn LH, Macdonald DA, Rubin SH, et al.: Tolerability and efficacy of bortezomib added to CVP-R for previously untreated advanced stage follicular fymphoma: interim analysis of a phase II study by the NCIC Clinical Trials Group. [Abstract] Blood 112 (11): A-1576, 2008.
- RESULTSehn LH, MacDonald D, Rubin S, Cantin G, Rubinger M, Lemieux B, Basi S, Imrie K, Gascoyne RD, Sussman J, Chen BE, Djurfeldt M, Shepherd L, Couban S, Crump M. Bortezomib ADDED to R-CVP is safe and effective for previously untreated advanced-stage follicular lymphoma: a phase II study by the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 2011 Sep 1;29(25):3396-401. doi: 10.1200/JCO.2010.33.6594. Epub 2011 Aug 1. PMID 21810681