Study Evaluating CMC-544 In B-Cell Non-Hodgkin's Lymphoma

NCT00073749 | Completed Phase 1 Results

• 2 other identifiers: 3129K1-100B1931002
• Study Type: interventional
• Target: 79
• Locations: 7 countries
• Sites: 22

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).

Conditions

Lymphoma, B-Cell

Keywords

B-Cell; Non-Hodgkin's; Lymphoma

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

  An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse events (TEAE) are defined as any new event reported after first dose of study drug up to 42 days after last dose of study drug, or any event that is worse in severity than at any time during the baseline period. AEs included both SAEs and non-serious adverse events (non-SAEs).

  Baseline up to 42 days after last dose of study drug (up to Day 225)

• Number of Participants With Grade 3 or Higher Grades Treatment-Emergent Adverse Events (TEAEs) Based on Severity

  AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE severity was defined to be the maximum toxicity grade of the treatment-emergent adverse events (TEAEs) experienced by the participants during the study. AE was assessed according to severity; Grade 1 (mild AE), Grade 2 (moderate AE), Grade 3 (severe AE), Grade 4 (life-threatening or disabling AE), Grade 5 (death related to AE). Participants with Grade 3 or higher grades TEAEs were reported.

  Baseline up to 42 days after last dose of study drug (up to Day 225)

• Maximum Tolerated Dose (MTD): Part 1 (Dose Escalation Cohorts)

  MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced dose limiting toxicity (DLT). DLT was defined as any of the following events occurring during the first 21 days (or 28 days for participants treated every 4 weeks) days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 non-hematologic toxicity except grade 3 alopecia, nausea, or vomiting, any grade 4 febrile neutropenia, any grade 4 thrombocytopenia or any bleeding episode requiring platelet transfusion, any grade 4 absolute neutrophil count (for a duration of greater than or equal to \[\>=\] 7 days), delayed recovery (less than or equal to \[\<=\] grade 1 or baseline) from a toxicity that delays the initiation of the next dose by more than 2 weeks.

  Baseline up to Day 28

• Number of Participants With Dose-limiting Toxicity (DLT)

  DLT was classified as per National Cancer Institute common terminology criteria for adverse events (NCI CTCAE) version 3.0 and defined as any of the following events occurring during the first 21 days (or 28 days for participants treated every 4 weeks) days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 non-hematologic toxicity except grade 3 alopecia, nausea, or vomiting, any grade 4 febrile neutropenia, any grade 4 thrombocytopenia or any bleeding episode requiring platelet transfusion, any grade 4 absolute neutrophil count (for a duration of greater than or equal to \[\>=\] 7 days), delayed recovery (less than or equal to \[\<=\] grade 1 or baseline) from a toxicity that delays the initiation of the next dose by more than 14 days.

  Baseline up to Day 28

Secondary Outcomes (7)

• Progression-Free Survival (PFS): Evaluable Population- Part 2 (Lead-in + Expanded Cohorts)

  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)

• Progression-Free Survival (PFS): Intent-to-treat Population-Part 2 (Lead-in + Expanded Cohorts)

  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)

• Overall Survival (OS): Evaluable Population- Part 2 (Lead-in + Expanded Cohorts)

  Baseline up to Year 5

• Overall Survival (OS): Intent-to-treat Population: Part 2 (Lead-in + Expanded Cohorts)

  Baseline up to Year 5

• Number of Participants With Best Overall Response (BOR): Part 2 (Expanded Cohorts)

  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 (2)

• Percentage of Participants With Objective Response- Evaluable Population: Part 2 (Lead-in + Expanded Cohorts)

  Baseline up to 42 days after last dose (Day 225)

• Percentage of Participants With Objective Response- Intent-to-treat Population: Part 2 (Lead in+ Expanded Cohorts)

  Baseline up to 42 days after last dose of study drug (Day 225)

Study Arms (1)

Inotuzumab ozogamicin

EXPERIMENTAL

Inotuzumab ozogamicin, iv, dose escalation and expanded cohort at 1.8mg/m2

Drug: Inotuzumab ozogamicin [CMC-544]

Interventions

Inotuzumab ozogamicin [CMC-544] DRUG

CMC-544, IV, dose escalation trial

Inotuzumab ozogamicin

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (22)

UAB CCC Clinical Studies Unit

Birmingham, Alabama, 35233, United States

Location

University of Alabama at Birmingham Kirklin Clinic

Birmingham, Alabama, 35233, United States

Location

UAB Russell Ambulatory Pharmacy

Birmingham, Alabama, 35294, United States

Location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Northwestern Medical Faculty Foundation

Chicago, Illinois, 60611, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

M.D. Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Universitair Ziekenhuis Gasthuisberg

Leuven, 3000, Belgium

Location

Hopital Saint Louis

Paris, 75010, France

Location

Centre Hospitalier Lyon-Sud

Pierre-Bénite, 69495, France

Location

Universitätsklinikum Bonn

Bonn, North Rhine-Westphalia, 53105, Germany

Location

Universitaetsmedizin der Johannes Gutenberg-Universitaet

Mainz, 55131, Germany

Location

Medizinische Klinik und Poliklinik III, Klinikum der Universitat Muenchen-Grosshadern

München, 81377, Germany

Location

Universitaet Muenchen Klinikum Grosshadern

München, 81377, Germany

Location

Hospital de la Santa Creu I Sant Pau

Barcelona, 08025, Spain

Location

Hospital Clinic I Provincial

Barcelona, 08036, Spain

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, 1011, Switzerland

Location

St Bartholomew's Hospital

London, EC1A 7BE, United Kingdom

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Lymphoma, B-Cell; Lymphoma

Interventions

Inotuzumab Ozogamicin

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Calicheamicins; Aminoglycosides; Glycosides; Carbohydrates; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2003
• First Posted: December 5, 2003
• Study Start: August 1, 2003
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: December 17, 2018
• Results First Posted: October 26, 2018

Record last verified: 2018-12

Locations

BE (1); DE (4); ES (2); GB (1); US (11); FR (2); CH (1)