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

Weill Cornell Medicine (WCM) logo

Weill Cornell Medicine (WCM)

Status and phase

Completed
Phase 2
Phase 1

Conditions

Non-Hodgkin's Lymphoma

Treatments

Drug: Bortezomib, CHOP, Rituximab

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00151320
0309006313

Details and patient eligibility

About

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

Full description

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.

Enrollment

76 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 \< 2.0 x ULN * Total bilirubin \< 2.0 x ULN

Exclusion criteria

* Known central nervous system (CNS) involvement by lymphoma * Known HIV disease * Patient is pregnant or nursing * Patient has had major surgery within the last 3 weeks * Patient is receiving other investigational drugs * Known peripheral neuropathy \> Grade 2

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

76 participants in 1 patient group

Arm 1
Experimental group
Description:
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.
Treatment:
Drug: Bortezomib, CHOP, Rituximab

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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