Study Evaluating Inotuzumab Ozogamicin (CMC-544) In Indolent Non-Hodgkins Lymphoma
A Phase 2 Study Of Inotuzumab Ozogamicin (Cmc-544) In Subjects With Indolent Non-hodgkin's Lymphoma (Nhl) That Is Refractory To Or Has Relapsed After Rituximab And Chemotherapy Or Radioimmunotherapy
3 other identifiers
interventional
81
9 countries
42
Brief Summary
The purpose of this study is to evaluate the efficacy of inotuzumab ozogamicin (CMC-544) in subjects with indolent Non-Hodgkins lymphoma (NHL) that is refractory or has relapsed after multiple therapies including rituximab or radioimmunotherapy. The investigational drug will be given to subjects with indolent NHL by intravenous infusion at a dose of 1.8 mg/m2, every 4 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 lymphoma
Started Jul 2009
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2009
CompletedFirst Posted
Study publicly available on registry
March 25, 2009
CompletedStudy Start
First participant enrolled
July 30, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 10, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 27, 2013
CompletedResults Posted
Study results publicly available
October 31, 2017
CompletedOctober 31, 2017
October 1, 2017
2.4 years
March 24, 2009
July 24, 2017
October 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Indolent NHL Achieving CR or Partial Response (PR) According to International Response Criteria for NHL
CR was defined as complete disappearance of all target lesions and disease-related symptoms; all nodes must have decreased to normal (less than or equal to \[≤\]1.5 cm in their greatest transverse diameter \[GTD\] for nodes more than \[\>\]1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy. PR was defined as \>50% decrease in the sum of the product diameters (SPD) of up to 6 index lesions. No increase in size of other nodes, liver or spleen. Splenic and hepatic nodules must have regressed by greater than or equal to \[≥\]50% in the SPD or GTD (for single nodules). With exception of splenic and hepatic nodules, involvement of other organs was usually assessable and no measurable disease should be present. No progression of non-target disease or new lesions.
Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
Secondary Outcomes (18)
Percentage of Participants With Follicular NHL Achieving CR or PR According to International Response Criteria for NHL
Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
Percentage of Participants With Indolent NHL Achieving a CR According to International Response Criteria for NHL
Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
Percentage of Participants With Follicular NHL Achieving a CR According to International Response Criteria for NHL
Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
Duration of Response in Participants With Indolent NHL
Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
Probability of Maintaining a Response at 6, 12 and 24 Months in Participants With Indolent NHL
6, 12 and 24 months
- +13 more secondary outcomes
Study Arms (1)
inotuzumab ozogamicin
EXPERIMENTALinotuzumab ozogamicin
Interventions
Administered intravenously at 1.8 mg/m2 every 4 weeks for a planned 4 - 8 cycles
Eligibility Criteria
You may qualify if:
- Subjects who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone, or small lymphocytic lymphoma) that has progressed after 2 or more prior systemic therapies.
- Previous anticancer treatment given must have contained rituximab and chemotherapy, or anti CD20 Radio Immuno Therapy. Subjects must have exhibited no response or have progressed within 6 months from the completion of the most recent rituximab or rituximab containing therapy or within 12 months of the completion of Radio Immuno Therapy.
- Measurable disease with adequate bone marrow function, renal and hepatic function
You may not qualify if:
- History of, or suggestive of, veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS) or history of chronic liver disease (eg, cirrhosis) or suspected alcohol abuse.
- Prior allogeneic hematopoietic stem cell transplant (HSCT).
- Clinical evidence of transformation to a more aggressive subtype of lymphoma or grade 3b follicular lymphoma.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- UCB Pharmacollaborator
Study Sites (42)
University of Alabama Birmingham
Birmingham, Alabama, 35294-3300, United States
University of Alabama at Birmingham
Birmingham, Alabama, 35294-3330, United States
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294, United States
Loma Linda University Cancer Center
Loma Linda, California, 92350 1700, United States
Loma Linda University Cancer Center #5
Loma Linda, California, 92354, United States
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
Facey Medical Group
Mission Hills, California, 91345, United States
Providence Holy Cross
Mission Hills, California, 91345, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Park Nicollet Frauenshuh Cancer Center
Saint Louis Park, Minnesota, 55426, United States
Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
John Theurer Cancer Center
Hackensack, New Jersey, 07601, United States
New York Medical College
Hawthorne, New York, 10532, United States
Quest Diagnostics
Allentown, Pennsylvania, 18103-6205, United States
Carlisle Regional Medical Center Lab
Carlisle, Pennsylvania, 17015, United States
Penn State Milton S. Hershey medical Center
Hershey, Pennsylvania, 17033-0850, United States
Lewistown Hospital
Lewistown, Pennsylvania, 17044, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111-2497, United States
CMSA Medical Lab
State College, Pennsylvania, 16803, United States
University of Texas, MD Anderson Cancer Center
Houston, Texas, 77030-4009, United States
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
Universitaire Ziekenhuizen UZ Gasthuisberg
Leuven, 3000, Belgium
Oncologisch Centrum GZA - Location St. Augustinus
Wilrijk, 2610, Belgium
Charite Campus Mitte
Berlin, 10117, Germany
Charite Berlin-Campus Virchow-Klinikum
Berlin, 13353, Germany
The Chinese University of Hong Kong, Prince of Wales Hospital
Shatin, N.T., Hong Kong
Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum Belgyogyaszati Intezet,
Debrecen, 4012, Hungary
Kaposi Mor Oktato Korhaz, Belgyogyaszati Osztaly
Kaposvár, 7400, Hungary
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045, Japan
EPMint Co., Ltd
Aichi, 460-0003, Japan
Nagoya Daini Red Cross Hospital
Aichi, 466-8650, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395, Japan
National Hp. Org. Kyushu Medical Center
Fukuoka, Japan
Tokai University Hospital
Kanagawa, 259-1193, Japan
Cancer Inst. Hp. of Japanese Foundation for Cancer Research
Tokyo, 135-8550, Japan
Erasmus Medisch Centrum
Rotterdam, 3015 CE, Netherlands
Erasmus MC Apotheek
Rotterdam, 3015 GD, Netherlands
Singapore General Hospital
Singapore, 169 608, Singapore
Samsung Medical Center
Seoul, Korea, 135-710, South Korea
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The sample size for this study was determined by clinical rather than statistical considerations.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2009
First Posted
March 25, 2009
Study Start
July 30, 2009
Primary Completion
January 10, 2012
Study Completion
June 27, 2013
Last Updated
October 31, 2017
Results First Posted
October 31, 2017
Record last verified: 2017-10