- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00868608
Study Evaluating Inotuzumab Ozogamicin (CMC-544) In Indolent Non-Hodgkins Lymphoma
October 27, 2017 updated by: Pfizer
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
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
81
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Gent, Belgium, 9000
- Universitair Ziekenhuis Gent
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Leuven, Belgium, 3000
- Universitaire Ziekenhuizen UZ Gasthuisberg
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Wilrijk, Belgium, 2610
- Oncologisch Centrum GZA - Location St. Augustinus
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Berlin, Germany, 10117
- Charité Campus Mitte
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Berlin, Germany, 13353
- Charité Berlin-Campus Virchow-Klinikum
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Shatin, N.T., Hong Kong
- The Chinese University of Hong Kong, Prince of Wales Hospital
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Debrecen, Hungary, 4012
- Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum Belgyogyaszati Intezet,
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Kaposvar, Hungary, 7400
- Kaposi Mor Oktato Korhaz, Belgyogyaszati Osztaly
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Aichi, Japan, 466-8650
- Nagoya Daini Red Cross Hospital
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Aichi, Japan, 460-0003
- EPMint Co., Ltd
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Fukuoka, Japan, 811-1395
- National Hospital Organization Kyushu Cancer Center
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Fukuoka, Japan
- National Hp. Org. Kyushu Medical Center
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Kanagawa, Japan, 259-1193
- Tokai University Hospital
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Tokyo, Japan, 135-8550
- Cancer Inst. Hp. of Japanese Foundation for Cancer Research
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Chiba
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Kashiwa, Chiba, Japan, 277-8577
- National Cancer Center Hospital East
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Tokyo
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Chuo-ku, Tokyo, Japan, 104-0045
- National Cancer Center Hospital
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Korea
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Seoul, Korea, Korea, Republic of, 135-710
- Samsung Medical Center
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Rotterdam, Netherlands, 3015 CE
- Erasmus Medisch Centrum
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Rotterdam, Netherlands, 3015 GD
- Erasmus MC Apotheek
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Singapore, Singapore, 169 608
- Singapore General Hospital
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Alabama
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Birmingham, Alabama, United States, 35294-3300
- University of Alabama Birmingham
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Birmingham, Alabama, United States, 35294-3330
- University of Alabama at Birmingham
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Birmingham, Alabama, United States, 35294
- University of Alabama at Birmingham Comprehensive Cancer Center
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California
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Loma Linda, California, United States, 92354
- Loma Linda University Medical Center
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Loma Linda, California, United States, 92350 1700
- Loma Linda University Cancer Center
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Loma Linda, California, United States, 92354
- Loma Linda University Cancer Center #5
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Mission Hills, California, United States, 91345
- Facey Medical Group
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Mission Hills, California, United States, 91345
- Providence Holy Cross
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Illinois
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Chicago, Illinois, United States, 60612
- Rush University Medical Center
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Minnesota
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Saint Louis Park, Minnesota, United States, 55426
- Park Nicollet Frauenshuh Cancer Center
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Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
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Saint Louis, Missouri, United States, 63110
- Barnes-Jewish Hospital
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New Jersey
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Hackensack, New Jersey, United States, 07601
- Hackensack University Medical Center
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Hackensack, New Jersey, United States, 07601
- John Theurer Cancer Center
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New York
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Hawthorne, New York, United States, 10532
- New York Medical College
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Pennsylvania
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Allentown, Pennsylvania, United States, 18103-6205
- Quest Diagnostics
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Carlisle, Pennsylvania, United States, 17015
- Carlisle Regional Medical Center Lab
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Hershey, Pennsylvania, United States, 17033-0850
- Penn State Milton S. Hershey Medical Center
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Lewistown, Pennsylvania, United States, 17044
- Lewistown Hospital
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Philadelphia, Pennsylvania, United States, 19111-2497
- Fox Chase Cancer Center
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State College, Pennsylvania, United States, 16803
- CMSA Medical Lab
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Texas
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Houston, Texas, United States, 77030-4009
- University of Texas, MD Anderson Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: inotuzumab ozogamicin
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Administered intravenously at 1.8 mg/m2 every 4 weeks for a planned 4 - 8 cycles
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Participants With Indolent NHL Achieving CR or Partial Response (PR) According to International Response Criteria for NHL
Time Frame: 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.
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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.
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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.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Participants With Follicular NHL Achieving CR or PR According to International Response Criteria for NHL
Time Frame: 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.
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CR was defined as complete disappearance of all target lesions and disease-related symptoms; all nodes must have decreased to normal (≤1.5 cm in their greatest transverse diameter for nodes >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 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 ≥50% in the SPD or greatest transverse diameter (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.
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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.
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Percentage of Participants With Indolent NHL Achieving a CR According to International Response Criteria for NHL
Time Frame: 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.
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CR was defined as complete disappearance of all target lesions and disease-related symptoms; all nodes must have decreased to normal (≤1.5 cm in their greatest transverse diameter for nodes >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.
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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.
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Percentage of Participants With Follicular NHL Achieving a CR According to International Response Criteria for NHL
Time Frame: 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.
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CR was defined as complete disappearance of all target lesions and disease-related symptoms; all nodes must have decreased to normal (≤1.5 cm in their greatest transverse diameter for nodes >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.
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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.
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Duration of Response in Participants With Indolent NHL
Time Frame: 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.
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Duration of response was measured from the first date of response until the first date that the objective progression of disease (PD) or symptomatic deterioration or initiation of new anticancer therapy for the lymphoma or death from any cause is documented.
Participants without an event were censored at the date of the last valid tumor assessment.
A valid tumor assessment visit was defined as the tumor assessment visit with overall response of CR, PR, stable disease (SD), or PD, but not 'Not Done' or 'Unknown'.
PD was defined according to the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.
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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.
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Probability of Maintaining a Response at 6, 12 and 24 Months in Participants With Indolent NHL
Time Frame: 6, 12 and 24 months
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Duration of response was measured from the first date of response until the first date that the objective PD or symptomatic deterioration or initiation of new anticancer therapy for the lymphoma or death from any cause is documented.
Participants without an event were censored at the date of the last valid tumor assessment.
A valid tumor assessment visit was defined as the tumor assessment visit with overall response of CR, PR, stable disease (SD), or PD, but not 'Not Done' or 'Unknown'.
PD was defined according to the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.
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6, 12 and 24 months
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Duration of Response in Participants With Follicular NHL
Time Frame: 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.
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Duration of response was measured from the first date of response until the first date that the objective PD or symptomatic deterioration or initiation of new anticancer therapy for the lymphoma or death from any cause is documented.
Participants without an event were censored at the date of the last valid tumor assessment.
A valid tumor assessment visit was defined as the tumor assessment visit with overall response of CR, PR, stable disease (SD), or PD, but not 'Not Done' or 'Unknown'.
PD was defined according to the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.
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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.
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Probability of Maintaining a Response at 6, 12 and 24 Months in Participants With Follicular NHL
Time Frame: 6, 12 and 24 months
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Duration of response was measured from the first date of response until the first date that the objective PD or symptomatic deterioration or initiation of new anticancer therapy for the lymphoma or death from any cause is documented.
Participants without an event were censored at the date of the last valid tumor assessment.
A valid tumor assessment visit was defined as the tumor assessment visit with overall response of CR, PR, stable disease (SD), or PD, but not 'Not Done' or 'Unknown'.
PD was defined according to the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.
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6, 12 and 24 months
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Kaplan-Meier Estimate of the Progression-Free Survival (PFS) in Participants With Indolent NHL
Time Frame: 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.
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Kaplan-Meier: a rule for calculating an estimate of survival.
PFS was defined as time from enrollment to death from any cause without progression, progression during and after treatment, and initiation of all new anti-cancer treatments for the lymphoma.
For participants with no event, censorship occurred at the date of last valid disease assessment.
PD was defined in accordance with the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.
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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.
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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
Time Frame: 6, 12 and 24 months
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Kaplan-Meier: a rule for calculating an estimate of survival.
PFS was defined as time from enrollment to death from any cause without progression, progression during and after treatment, and initiation of all new anti-cancer treatments for the lymphoma.
For participants with no event, censorship occurred at the date of last valid disease assessment.
PD was defined in accordance with the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.
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6, 12 and 24 months
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Kaplan-Meier Estimate of the PFS in Participants With Follicular NHL
Time Frame: 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.
|
Kaplan-Meier: a rule for calculating an estimate of survival.
PFS was defined as time from enrollment to progression of disease or death from any cause.
Events were defined as death from any cause without progression, progression during and after treatment, and initiation of all new anti-cancer treatments for the lymphoma.
For participants with no event, censorship occurred at the date of last valid disease assessment.
PD was defined in accordance with the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.
|
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.
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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
Time Frame: 6, 12 and 24 months
|
Kaplan-Meier: a rule for calculating an estimate of survival.
PFS was defined as time from enrollment to progression of disease or death from any cause.
Events were defined as death from any cause without progression, progression during and after treatment, and initiation of all new anti-cancer treatments for the lymphoma.
For participants with no event, censorship occurred at the date of last valid disease assessment.
PD was defined in accordance with the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.
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6, 12 and 24 months
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Kaplan-Meier Estimate of the Overall Survival (OS) in Participants With Indolent NHL
Time Frame: 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.
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Kaplan-Meier: a rule for calculating an estimate of survival.
OS was defined as the time from enrollment to death from any cause.
For participants without death, censorship occurred at the date of last contact.
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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.
|
Kaplan-Meier Estimates of the Probability of Survival at 6, 12 and 24 Months in Participants With Indolent NHL
Time Frame: 6, 12 and 24 months
|
Kaplan-Meier: a rule for calculating an estimate of survival.
OS was defined as the time from enrollment to death from any cause.
For participants without death, censorship occurred at the date of last contact.
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6, 12 and 24 months
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Kaplan-Meier Estimate of the OS in Participants With Follicular NHL
Time Frame: 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.
|
Kaplan-Meier: a rule for calculating an estimate of survival.
OS was defined as the time from enrollment to death from any cause.
For participants without death, censorship occurred at the date of last contact.
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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.
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Kaplan-Meier Esitmates of the Probability of Survival at 6, 12 and 24 Months in Participants With Follicular NHL
Time Frame: 6, 12 and 24 months
|
Kaplan-Meier: a rule for calculating an estimate of survival.
OS was defined as the time from enrollment to death from any cause.
For participants without death, censorship occurred at the date of last contact.
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6, 12 and 24 months
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Median Induced Change From Baseline of QT Study Specific Correction (QTcS) by Cycle Based on Median Maximum Calicheamicin Concentration (Cmax)
Time Frame: 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
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Triplicate 12-lead electrocardiogram (ECG) measurements were performed approximately 2 minutes apart.
ECG assessments were pre-specified in the protocol to be time-matched with selected pharmacokinetic (PK) samples in order to conduct a concentration-QTc analysis.
A study-specific QT correction factor was estimated using the un-averaged triplicate data and was used to calculate the study-specific corrected QT (QTcS).
QTcS interval versus serum concentrations were modeled using a population analysis approach to identify potential effects of total calicheamicin exposure.
Results for drug effects were based on the median Cmax for total calicheamicin across all participants: median Cmax was 61.3 ng/mL
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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
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Percentage of Participants With a Treatment Emergent Adverse Event (TEAE) (Safety Population)
Time Frame: Protocol reporting period: from informed consent to at least 28 days after the last dose.
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Includes all TEAEs: any event that emerged after the first dose of the study treatment during the treatment period that was absent before administration of any study treatment, or worsened during the treatment period relative to the pre-treatment state.
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Protocol reporting period: from informed consent to at least 28 days after the last dose.
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Percentage of Participants With QTc Interval Corrected Using Fridericia's Formula (QTcF) by Category (Safety Population)
Time Frame: 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.
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Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.
The time corresponding to the beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR).
Maximum QTcF was categorized as less than or equal to (≤) 450 msec, >450 msec to ≤480 msec, >480 msec to ≤500 msec and >500 msec.
Participants are reported only once under the maximum QTcF interval observed at any of the time-points.
Maximum increase from baseline was categorized as <30 msec, ≥30 to <60 msec (borderline) and ≥60 msec (prolonged) were summarized.
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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.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 30, 2009
Primary Completion (Actual)
January 10, 2012
Study Completion (Actual)
June 27, 2013
Study Registration Dates
First Submitted
March 24, 2009
First Submitted That Met QC Criteria
March 24, 2009
First Posted (Estimate)
March 25, 2009
Study Record Updates
Last Update Posted (Actual)
October 31, 2017
Last Update Submitted That Met QC Criteria
October 27, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3129K7-2001
- B1931007 (Other Identifier: Alias Study Number)
- 2008-001635-34 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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PfizerUCB PharmaCompletedB-Cell LymphomaUnited States, Belgium, Korea, Republic of, Switzerland, France, Poland, Spain, Hong Kong, Australia, Germany, Italy, Netherlands, United Kingdom
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PfizerCompleted
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)TerminatedRecurrent Acute Lymphoblastic Leukemia | Refractory Acute Lymphoblastic Leukemia | CD22 PositiveUnited States
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M.D. Anderson Cancer CenterWyeth is now a wholly owned subsidiary of PfizerCompletedAcute Lymphoblastic LeukemiaUnited States