Clinical trial NCT00151320: Phase I/II Trial of VELCADE + CHOP-Rituximab in Untreated DLCBL or Mantle Cell NHL
Official title: Phase I/II Trial of VELCADE+ CHOP-Rituximab in Patients With Previously Untreated Diffuse Large B Cell or Mantle Cell Non-Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Non-Hodgkin's Lymphoma
Keywords: diffuse large B cell
mantle cell lymphoma
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Millennium Pharmaceuticals, Inc.
First posted: 2005-09-08
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model 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 dose escalation schedule.
Primary purpose: TREATMENT

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

Detailed 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.

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 \< 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

Primary outcomes:
measure: ORR
timeFrame: 6 cycles (18 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Omaha
country: United States
facility: Nebraska Medical Center
state: Nebraska
city: New York
country: United States
facility: Weill Medical College of Cornell University
state: New York
city: New York
country: United States
facility: Columbia University College of Physicians and Surgeons
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: John P Leonard, MD
role: PRINCIPAL_INVESTIGATOR
References: