Phase 2 N=76 Treatment

Phase I/II Trial of VELCADE + CHOP-Rituximab in Untreated DLCBL or Mantle Cell NHL

Non-Hodgkin's Lymphoma

Bottom Line

View on ClinicalTrials.gov: NCT00151320 ↗

Enrolled (actual)

Serious AEs

1.3%

Results posted

Apr 2017

Primary outcome: Primary: ORR — 88; 81 percentage of patients

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Bortezomib, CHOP, Rituximab (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Weill Medical College of Cornell University
Primary completion: Apr 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY ORR	88; 81	—

Summary

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

Eligibility Criteria

Inclusion Criteria

Histologically confirmed diagnosis of diffuse large B cell or mantle cell Non-Hodgkin's Lymphoma with characteristic immunophenotypic profiles. For mantle cell: CD5(+), CD19(+) or CD20(+), cyclin D1(+), CD23(-) and CD10(-).
Patient has not received any prior anti-cancer therapy for lymphoma
Tumor tissue confirmed to express the CD20 antigen
Available frozen tumor tissue(rebiopsy if needed)
Patient has measurable disease as defined by a tumor mass > 1.5 cm
Patient has Stage II, III, or IV disease
Age > 18 years
Absolute granulocyte count > 1000 cells/mm3
Platelet count > 50,000 cells/mm3
Creatinine Grade 2

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00151320). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.