A Phase 1/2 interventional study of Bortezomib, CHOP, Rituximab in Non-Hodgkin's Lymphoma, sponsored by Weill Medical College of Cornell University. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-06-19.
Sponsored by Weill Medical College of Cornell University · Phase 1/2, Interventional, and Treatment
Primary Objective:
To determine the toxicity profile and maximum tolerated dose (MTD) of VELCADE when administered in combination with CHOP + Rituximab to patients with previously untreated diffuse large B cell or mantle cell non-Hodgkin's lymphoma (NHL)
Secondary Objectives:
To assess the response rate (overall and complete), event-free survival and overall survival with VELCADE and CHOP-R in patients with previously untreated diffuse large B cell or mantle cell lymphoma (phase II component)
Treatment:
Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles
Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications)
VELCADE is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of VELCADE will be determined by the following dose escalation schedule:
Level Dose/Schedule (-2) 0.7 mg/m2 on day 1 of each cycle (-1) 0.7 mg/m2 on days 1 and 8 (0) 0.7 mg/m2 on days 1 and 4 (+1) 1.0 mg/m2 on days 1 and 4 (+2) 1.3 mg/m2 on days 1 and 4
Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles
Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications)
VELCADE is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of VELCADE will be determined by the following dose escalation schedule:
Once completed six cycles of therapy (\~18 weeks), patients will be evaluated every 3 months for the first year post treatment, then every 6 months until disease progression or death for years 2 through 5 post treatment. Patients who have disease progression will be contacted every 6 months until death to assess for survival status.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 76 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Weill Medical College of Cornell University is the lead sponsor of 867 studies on the registry; 160 are open to participants now.
Of its 119 completed or terminated interventional studies of FDA-regulated products, 91 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications) VELCADE (Bortezomib) is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of VELCADE will be determined by a dose escalation schedule.
Drug: Bortezomib, CHOP, Rituximab
Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications) VELCADE (Bortezomib) is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of VELCADE will be determined by the following dose escalation schedule: Level Dose/Schedule (-2) 0.7 mg/m2 on day 1 of each cycle (-1) 0.7 mg/m2 on days 1 and 8 (0) 0.7 mg/m2 on days 1 and 4 (+1) 1.0 mg/m2 on days 1 and 4 (+2) 1.3 mg/m2 on days 1 and 4
Also known as: VELCADE
ORR
Overall Response Rate
Time frame: 6 cycles (18 weeks)
| Milestone | Arm 1 |
|---|---|
| Started | 76 |
| Completed | 76 |
| Not completed | 0 |
Overall Response Rate
| percentage of patients | Untreated DLBCL | Untreated MCL |
|---|---|---|
| ORR | 88 | 81 |
Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm 1 | — | 1/76 (1.3%) | 76/76 (100%) |
| Event | Arm 1 |
|---|---|
| Uroepithelial carcinomaRenal and urinary disorders | 1/76 |
| Event | Arm 1 |
|---|---|
| AnemiaBlood and lymphatic system disorders | 60/76 |
| ThrombocytopeniaBlood and lymphatic system disorders | 59/76 |
| NeuropathyNervous system disorders | 49/76 |
| NeutropeniaBlood and lymphatic system disorders | 42/76 |
| ConstipationGastrointestinal disorders | 37/76 |
| NauseaGeneral disorders | 33/76 |
| AnorexiaGastrointestinal disorders | 31/76 |
| DiarrheaGastrointestinal disorders | 25/76 |
| EdemaGeneral disorders | 18/76 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 18/76 |
| Age, Continuous(years) | Untreated DLBCL | Untreated MCL | Total |
|---|---|---|---|
| Median | 56 (20 to 87) | 66 (45 to 80) | 63 (20 to 87) |
| Sex: Female, Male(Participants) | Untreated DLBCL | Untreated MCL | Total |
|---|---|---|---|
| Female | 13 | 6 | 19 |
| Male | 27 | 30 | 57 |
Plan to share: Undecided
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Weill Medical College of Cornell University