Study Evaluating The Safety And Tolerability Of Combination Therapy Inotuzumab Ozogamicin (CMC-544) And Rituximab

Phase 1

Completed

• Conditions: Lymphoma, B-Cell
• Interventions: Drug: Inotuzumab Ozogamicin (CMC-544); Drug: Rituximab (Rituxan)

• Registration Number: NCT00724971
• Lead Sponsor: Pfizer

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-04
• Study First Submitted: 2008-07-25
• Study First Submitted QC: 2008-07-29
• Study First Posted: 2008-07-30
• Primary Completion: 2010-03-10
• Study Completion: 2010-03-10
• Results First Submitted: 2017-07-24
• Status Verified: 2018-11
• Results First Submitted QC: 2018-12-04
• Last Update Submitted: 2018-12-04
• Results First Posted: 2019-03-15
• Last Update Posted: 2019-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Inotuzumab Ozogamicin + Rituximab	Inotuzumab Ozogamicin (CMC-544)	-
Inotuzumab Ozogamicin + Rituximab	Rituximab (Rituxan)	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Dose-limiting Toxicities (DLT)	Up to 28 days	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

Secondary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS)	Up to 591 days	The interval from the date of first administration of the test article until the first date on which relapsed disease, progressive disease (PD), or death was documented, censored at the last tumor evaluation date. Response criteria for Non-Hodgkin's Lymphoma (NHL) were based on the 1999 NCI International Workshop to standardize response criteria for NHL. Per the criteria for Lymph node masses: Relapse/PD, appearance of any new lesion or increased by \>=50% in the size.
Number of Participants With Objective Response: Evaluable Population	Up to 8 cycles (1 cycle = 28 days)	Number of participants with objective response of complete response (CR), complete response unconfirmed (CRu), or partial response (PR). Objective response included subjects with CR, CRu, and PR. Response criteria for Non-Hodgkin's Lymphoma (NHL) were based on the 1999 NCI International Workshop to standardize response criteria for NHL. Per the criteria for Lymph node masses: CR, normal size; CRu, normal or \>75% decrease in the sum of the products of the greatest diameters (SPD); PR, normal or \>=50% decrease in the SPD.
Number of Participants With Objective Response: Intent-to-treat (ITT) Population	Up to 8 cycles (1 cycle = 28 days)	Number of participants with objective response of complete response (CR), complete response unconfirmed (CRu), or partial response (PR). Objective response included subjects with CR, CRu, and PR. Response criteria for Non-Hodgkin's Lymphoma (NHL) were based on the 1999 NCI International Workshop to standardize response criteria for NHL. Per the criteria for Lymph node masses: CR, normal size; CRu, normal or \>75% decrease in the sum of the products of the greatest diameters (SPD); PR, normal or \>=50% decrease in the SPD.

Trial Locations

Locations (4)

Nagoya Daini Red Cross Hospital; 🇯🇵 Aichi, Japan

Tokai University Hospital; 🇯🇵 Kanagawa, Japan

National Cancer Center Hospital; 🇯🇵 Tokyo, Japan

Cancer Inst. Hp. of Japanese Foundation for Cancer Research; 🇯🇵 Tokyo, Japan