Clinical trial NCT00724971: Study Evaluating The Safety And Tolerability Of Combination Therapy Inotuzumab Ozogamicin (CMC-544) And Rituximab
Official title: A Phase 1 Study Of Cmc-544 Administered In Combination With Rituximab In Subjects With B-cell Non-hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lymphoma, B-Cell
Keywords: B-cell Non-Hodgkin's Lymphoma
NHL
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-07-30
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Candidate for potentially curative therapies
* Subjects must not have received previous radioimmunotherapy.
* Subjects with autologous hematopoietic stem cell transplant within the last 6 months

Primary outcomes:
measure: Number of Participants With Dose-limiting Toxicities (DLT)
timeFrame: Up to 28 days
Secondary outcomes:
measure: Number of Participants With Objective Response: Evaluable Population
timeFrame: Up to 8 cycles (1 cycle = 28 days)
measure: Number of Participants With Objective Response: Intent-to-treat (ITT) Population
timeFrame: Up to 8 cycles (1 cycle = 28 days)
measure: Progression-Free Survival (PFS)
timeFrame: Up to 591 days
Other outcomes:
measure: Maximum Observed Serum Concentration (Cmax) of CMC-544, Total Calicheamicin, and Anti-human CD22 Antibody (G544)
timeFrame: 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
measure: Serum Decay Half-Life (t1/2) of CMC-544, Total Calicheamicin, and G544
timeFrame: 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
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CMC-544, Total Calicheamicin, and G544
timeFrame: 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
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC∞) of CMC-544, Total Calicheamicin, and G544
timeFrame: 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
measure: Clearance (CL) of CMC-544, Total Calicheamicin, and G544
timeFrame: 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
measure: Volume of Distribution (Vss) of CMC-544, Total Calicheamicin, and G544
timeFrame: 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
measure: Number of Participants With Positive Serum Antibody to Inotuzumab Ozogamicin (CMC-544)
timeFrame: Up to 8 Cycles (1 cycle = 28 days)
measure: Number of Participants With Positive Serum Antibody to Rituximab
timeFrame: Up to 8 Cycles (1 cycle = 28 days)
Locations:
city: Aichi
country: Japan
facility: Nagoya Daini Red Cross Hospital
city: Kanagawa
country: Japan
facility: Tokai University Hospital
city: Tokyo
country: Japan
facility: National Cancer Center Hospital
city: Tokyo
country: Japan
facility: Cancer Inst. Hp. of Japanese Foundation for Cancer Research
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.