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

NCT00151320 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 0309006313
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 4

Brief 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

Conditions

Non-Hodgkin's Lymphoma

Keywords

diffuse large B cell; mantle cell lymphoma

Outcome Measures

Primary Outcomes (1)

• ORR

  Overall Response Rate

  6 cycles (18 weeks)

Study Arms (1)

Arm 1

EXPERIMENTAL

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

Interventions

Bortezomib, CHOP, Rituximab DRUG

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

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Millennium Pharmaceuticals, Inc.: collaborator

Study Sites (4)

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

Columbia University College of Physicians and Surgeons

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma, Mantle-Cell

Interventions

Bortezomib; Rituximab

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: John Leonard, MD
• Organization: Weill Cornell Medicine

amr2017@med.cornell.edu

646.962.2064

Study Officials

• John P Leonard, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 dose escalation schedule.

Study Record Dates

• First Submitted: September 6, 2005
• First Posted: September 8, 2005
• Study Start: January 1, 2004
• Primary Completion: April 1, 2010
• Study Completion: April 24, 2013
• Last Updated: June 19, 2018
• Results First Posted: April 7, 2017

Record last verified: 2018-05

Locations

US (4)