Clinical trial NCT00868608: Study Evaluating Inotuzumab Ozogamicin (CMC-544) In Indolent Non-Hodgkins Lymphoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma
Keywords: Refractory Indolent NHL
lymphoma
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: UCB Pharma
First posted: 2009-03-25
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Percentage of Participants With Indolent NHL Achieving CR or Partial Response (PR) According to International Response Criteria for NHL
timeFrame: 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:
measure: Percentage of Participants With Follicular NHL Achieving CR or PR According to International Response Criteria for NHL
timeFrame: 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.
measure: Percentage of Participants With Indolent NHL Achieving a CR According to International Response Criteria for NHL
timeFrame: 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.
measure: Percentage of Participants With Follicular NHL Achieving a CR According to International Response Criteria for NHL
timeFrame: 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.
measure: Duration of Response in Participants With Indolent NHL
timeFrame: 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.
measure: Probability of Maintaining a Response at 6, 12 and 24 Months in Participants With Indolent NHL
timeFrame: 6, 12 and 24 months
measure: Duration of Response in Participants With Follicular NHL
timeFrame: 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.
measure: Probability of Maintaining a Response at 6, 12 and 24 Months in Participants With Follicular NHL
timeFrame: 6, 12 and 24 months
measure: Kaplan-Meier Estimate of the Progression-Free Survival (PFS) in Participants With Indolent NHL
timeFrame: 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.
measure: Kaplan-Meier Estimates of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12 and 24 Months in Participants With Indolent NHL
timeFrame: 6, 12 and 24 months
measure: Kaplan-Meier Estimate of the PFS in Participants With Follicular NHL
timeFrame: 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.
measure: Kaplan-Meier Estimate of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12 and 24 Months in Participants With Follicular NHL
timeFrame: 6, 12 and 24 months
measure: Kaplan-Meier Estimate of the Overall Survival (OS) in Participants With Indolent NHL
timeFrame: Any time up to 2 years after enrollment. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
measure: Kaplan-Meier Estimates of the Probability of Survival at 6, 12 and 24 Months in Participants With Indolent NHL
timeFrame: 6, 12 and 24 months
measure: Kaplan-Meier Estimate of the OS in Participants With Follicular NHL
timeFrame: Any time up to 2 years after enrollment. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
measure: Kaplan-Meier Esitmates of the Probability of Survival at 6, 12 and 24 Months in Participants With Follicular NHL
timeFrame: 6, 12 and 24 months
measure: Median Induced Change From Baseline of QT Study Specific Correction (QTcS) by Cycle Based on Median Maximum Calicheamicin Concentration (Cmax)
timeFrame: Cycle 1: pre-dose, 1 hour; Cycle 3 & 4: pre-dose, 1, 3, 48, 168 hours; Cycle 6 (if applicable): pre-dose; end of treatment: during clinic visit
measure: Percentage of Participants With a Treatment Emergent Adverse Event (TEAE) (Safety Population)
timeFrame: Protocol reporting period: from informed consent to at least 28 days after the last dose.
measure: Percentage of Participants With QTc Interval Corrected Using Fridericia's Formula (QTcF) by Category (Safety Population)
timeFrame: Screening; Cycle 1: pre-dose & 1 hour; Cycles 3 and 4: pre-dose, 1, 3, 48, and 168 hours; Cycle 6: pre-dose; end of treatment: 28 to 56 days post-last dose.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Comprehensive Cancer Center
state: Alabama
city: Loma Linda
country: United States
facility: Loma Linda University Cancer Center
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Cancer Center #5
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: Mission Hills
country: United States
facility: Facey Medical Group
state: California
city: Mission Hills
country: United States
facility: Providence Holy Cross
state: California
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Saint Louis Park
country: United States
facility: Park Nicollet Frauenshuh Cancer Center
state: Minnesota
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Hackensack
country: United States
facility: John Theurer Cancer Center
state: New Jersey
city: Hawthorne
country: United States
facility: New York Medical College
state: New York
city: Allentown
country: United States
facility: Quest Diagnostics
state: Pennsylvania
city: Carlisle
country: United States
facility: Carlisle Regional Medical Center Lab
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Milton S. Hershey medical Center
state: Pennsylvania
city: Lewistown
country: United States
facility: Lewistown Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: State College
country: United States
facility: CMSA Medical Lab
state: Pennsylvania
city: Houston
country: United States
facility: University of Texas, MD Anderson Cancer Center
state: Texas
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen UZ Gasthuisberg
city: Wilrijk
country: Belgium
facility: Oncologisch Centrum GZA - Location St. Augustinus
city: Berlin
country: Germany
facility: Charite Campus Mitte
city: Berlin
country: Germany
facility: Charite Berlin-Campus Virchow-Klinikum
city: Shatin, N.T.
country: Hong Kong
facility: The Chinese University of Hong Kong, Prince of Wales Hospital
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum Belgyogyaszati Intezet,
city: Kaposvar
country: Hungary
facility: Kaposi Mor Oktato Korhaz, Belgyogyaszati Osztaly
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Aichi
country: Japan
facility: EPMint Co., Ltd
city: Aichi
country: Japan
facility: Nagoya Daini Red Cross Hospital
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
city: Fukuoka
country: Japan
facility: National Hp. Org. Kyushu Medical Center
city: Kanagawa
country: Japan
facility: Tokai University Hospital
city: Tokyo
country: Japan
facility: Cancer Inst. Hp. of Japanese Foundation for Cancer Research
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Korea
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
city: Rotterdam
country: Netherlands
facility: Erasmus MC Apotheek
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: