Study Evaluating The Safety And Tolerability Of Combination Therapy Inotuzumab Ozogamicin (CMC-544) And Rituximab
A Phase 1 Study Of Cmc-544 Administered In Combination With Rituximab In Subjects With B-cell Non-hodgkin's Lymphoma
2 other identifiers
interventional
10
1 country
4
Brief Summary
To assess the tolerability and the initial safety profile of Inotuzumab Ozogamicin (CMC-544) in combination with Rituximab in patients with B-Cell Non-Hodgkin's lymphoma (NHL).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jul 2008
4 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
Study Start
First participant enrolled
July 4, 2008
CompletedFirst Submitted
Initial submission to the registry
July 25, 2008
CompletedFirst Posted
Study publicly available on registry
July 30, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 10, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 10, 2010
CompletedResults Posted
Study results publicly available
March 15, 2019
CompletedMarch 15, 2019
November 1, 2018
1.7 years
July 25, 2008
July 24, 2017
December 4, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Dose-limiting Toxicities (DLT)
A DLT was defined as the following drug-related adverse event which occurred during the first 28 days: 1) Any National Cancer Institute (NCI) Grade 3 or 4 nonhematologic toxicity (except Grade 3 nausea or vomiting without optimal treatment), 2) Febrile neutropenia, 3) Grade 4 absolute neutrophil count lasting \>=7 days, 4) Grade 4 thrombocytopenia lasting \>=3 days, 5) Grade 3 or 4 thrombocytopenia associated with a bleeding episode requiring platelet transfusion, 6)Delayed recovery (to grade \<=1 or baseline, except alopecia) from a drug-related toxicity that delayed the next dose \>2 weeks
Up to 28 days
Secondary Outcomes (3)
Number of Participants With Objective Response: Evaluable Population
Up to 8 cycles (1 cycle = 28 days)
Number of Participants With Objective Response: Intent-to-treat (ITT) Population
Up to 8 cycles (1 cycle = 28 days)
Progression-Free Survival (PFS)
Up to 591 days
Other Outcomes (8)
Maximum Observed Serum Concentration (Cmax) of CMC-544, Total Calicheamicin, and Anti-human CD22 Antibody (G544)
Cycle 1, Cycle 2 and Cycle 3 at hour 0 (predose) and at hours 1 (before the end of infusion), 4, 48, 144,192, 312, 480, and 648 relative to the start of infusion of CMC-544
Serum Decay Half-Life (t1/2) of CMC-544, Total Calicheamicin, and G544
Cycle 1, Cycle 2 and Cycle 3 at hour 0 (predose) and at hours 1 (before the end of infusion), 4, 48, 144,192, 312, 480, and 648 relative to the start of infusion of CMC-544
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CMC-544, Total Calicheamicin, and G544
Cycle 1, Cycle 2 and Cycle 3 at hour 0 (predose) and at hours 1 (before the end of infusion), 4, 48, 144,192, 312, 480, and 648 relative to the start of infusion of CMC-544
- +5 more other outcomes
Study Arms (1)
Inotuzumab Ozogamicin + Rituximab
EXPERIMENTALInterventions
1.8 mg/m2, IV on day 2 of each 28 day cycle; up to 8 cycles unless PD, unacceptable toxicity, or subject's refusal occurs.
375 mg/m2, IV on day 1 of each 28 day cycle; up to 8 cycles unless PD, unacceptable toxicity, or subject's refusal occurs.
Eligibility Criteria
You may qualify if:
- CD20 and CD22-positive, B-cell NHL which has progressed after 1 or 2 prior therapies.
- Prior therapy must have contained at least one dose of Rituximab therapy. Patients can not be refractory to Rituximab (refractory = PD under treatment or within 6 month
- Eastern Cooperative Oncology Group (ECOG) performance status: 0/ 1.
- Patients must not have received previous radioimmunotherapy.
- Patients tolerant to Rituximab.
- Patients must not have received chemotherapy, cancer immunosuppressive therapy, growth factors (except erythropoietin), or investigational agents within 28 days before first dose of test article.
You may not qualify if:
- Candidate for potentially curative therapies
- Subjects must not have received previous radioimmunotherapy.
- Subjects with autologous hematopoietic stem cell transplant within the last 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (4)
Nagoya Daini Red Cross Hospital
Aichi, 466-8650, Japan
Tokai University Hospital
Kanagawa, 259-1193, Japan
National Cancer Center Hospital
Tokyo, 104-0045, Japan
Cancer Inst. Hp. of Japanese Foundation for Cancer Research
Tokyo, 135-8550, Japan
Related Publications (1)
Ogura M, Hatake K, Ando K, Tobinai K, Tokushige K, Ono C, Ishibashi T, Vandendries E. Phase I study of anti-CD22 immunoconjugate inotuzumab ozogamicin plus rituximab in relapsed/refractory B-cell non-Hodgkin lymphoma. Cancer Sci. 2012 May;103(5):933-8. doi: 10.1111/j.1349-7006.2012.02241.x. Epub 2012 Mar 20.
PMID: 22335424DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2008
First Posted
July 30, 2008
Study Start
July 4, 2008
Primary Completion
March 10, 2010
Study Completion
March 10, 2010
Last Updated
March 15, 2019
Results First Posted
March 15, 2019
Record last verified: 2018-11