Clinical trial NCT00073749: Study Evaluating CMC-544 In B-Cell Non-Hodgkin's Lymphoma
Official title: A Phase 1 Study Of Cmc-544 Administered As A Single Agent In Subjects With B-cell Non- Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lymphoma, B-Cell
Keywords: B-Cell
Non-Hodgkin's
Lymphoma
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2003-12-05
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: To determine the Maximum Tolerated Dose (MTD), the tolerability, and the initial safety profile of CMC-544 in subjects with B-cell Non-Hodgkin's Lymphoma (NHL).


Eligibility criteria: Inclusion Criteria:

* Subjects who have been previously diagnosed with CD22-positive, B-cell NHL, according to WHO classification, which has progressed after at least 2 prior therapies of probable clinical benefit
* At the expanded cohort, part 2 of the study, subjects must have one of the following:
* Follicular lymphoma previously treated with at least one dose of rituximab, but have not received radioimmunotherapy
* Diffuse large B-cell lymphoma
* Age 18 years or older

Exclusion Criteria:

* Candidate for potentially curative therapies in the opinion of the investigator
* Chronic lymphocytic leukemia
* Burkitt's lymphoma, primary effusion lymphoma, and precursor B-cell lymphoblastic lymphoma

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to 42 days after last dose of study drug (up to Day 225)
measure: Number of Participants With Grade 3 or Higher Grades Treatment-Emergent Adverse Events (TEAEs) Based on Severity
timeFrame: Baseline up to 42 days after last dose of study drug (up to Day 225)
measure: Maximum Tolerated Dose (MTD): Part 1 (Dose Escalation Cohorts)
timeFrame: Baseline up to Day 28
measure: Number of Participants With Dose-limiting Toxicity (DLT)
timeFrame: Baseline up to Day 28
Secondary outcomes:
measure: Progression-Free Survival (PFS): Evaluable Population- Part 2 (Lead-in + Expanded Cohorts)
timeFrame: Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)
measure: Progression-Free Survival (PFS): Intent-to-treat Population-Part 2 (Lead-in + Expanded Cohorts)
timeFrame: Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)
measure: Overall Survival (OS): Evaluable Population- Part 2 (Lead-in + Expanded Cohorts)
timeFrame: Baseline up to Year 5
measure: Overall Survival (OS): Intent-to-treat Population: Part 2 (Lead-in + Expanded Cohorts)
timeFrame: Baseline up to Year 5
measure: Number of Participants With Best Overall Response (BOR): Part 2 (Expanded Cohorts)
timeFrame: Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)
measure: Duration of Overall Response (DoR): Part 2 (Lead-in + Expanded Cohorts)
timeFrame: Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)
measure: Time-to-Tumor Progression: Part 2 (Expanded Cohorts)
timeFrame: Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)
Other outcomes:
measure: Percentage of Participants With Objective Response- Evaluable Population: Part 2 (Lead-in + Expanded Cohorts)
timeFrame: Baseline up to 42 days after last dose (Day 225)
measure: Percentage of Participants With Objective Response- Intent-to-treat Population: Part 2 (Lead in+ Expanded Cohorts)
timeFrame: Baseline up to 42 days after last dose of study drug (Day 225)
Locations:
city: Birmingham
country: United States
facility: UAB CCC Clinical Studies Unit
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Kirklin Clinic
state: Alabama
city: Birmingham
country: United States
facility: UAB Russell Ambulatory Pharmacy
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Chicago
country: United States
facility: Northwestern Medical Faculty Foundation
state: Illinois
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Houston
country: United States
facility: M.D. Anderson Cancer Center
state: Texas
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Gasthuisberg
city: Paris
country: France
facility: Hopital Saint Louis
city: Pierre Benite Cedex
country: France
facility: Centre Hospitalier Lyon-Sud
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
state: NRW
city: Mainz
country: Germany
facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet
city: Muenchen
country: Germany
facility: Medizinische Klinik und Poliklinik III, Klinikum der Universitat Muenchen-Grosshadern
city: Muenchen
country: Germany
facility: Universitaet Muenchen Klinikum Grosshadern
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu I Sant Pau
city: Barcelona
country: Spain
facility: Hospital Clinic I Provincial
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
city: London
country: United Kingdom
facility: St Bartholomew's Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: