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

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

Inotuzumab Ozogamicin (CMC-544)

Rituximab (Rituxan)

About this trial

This is an interventional treatment trial for Lymphoma, B-Cell focused on measuring B-cell Non-Hodgkin's Lymphoma, NHL

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Nagoya Daini Red Cross Hospital
Tokai University Hospital
National Cancer Center Hospital
Cancer Inst. Hp. of Japanese Foundation for Cancer Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Inotuzumab Ozogamicin + Rituximab

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of Participants With Objective Response: Evaluable Population

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

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.

Progression-Free Survival (PFS)

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.

Full Information

NCT ID

NCT00724971

First Posted

July 25, 2008

Last Updated

December 4, 2018

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00724971

Brief Title

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

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

July 4, 2008 (Actual)

Primary Completion Date

March 10, 2010 (Actual)

Study Completion Date

March 10, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoma, B-Cell

Keywords

B-cell Non-Hodgkin's Lymphoma, NHL

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Inotuzumab Ozogamicin + Rituximab

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Inotuzumab Ozogamicin (CMC-544)

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Rituximab (Rituxan)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of Participants With Dose-limiting Toxicities (DLT)

Description

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

Time Frame

Up to 28 days

Secondary Outcome Measure Information:

Title

Number of Participants With Objective Response: Evaluable Population

Description

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.

Time Frame

Up to 8 cycles (1 cycle = 28 days)

Title

Number of Participants With Objective Response: Intent-to-treat (ITT) Population

Description

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.

Time Frame

Up to 8 cycles (1 cycle = 28 days)

Title

Progression-Free Survival (PFS)

Description

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.

Time Frame

Up to 591 days

Other Pre-specified Outcome Measures:

Title

Maximum Observed Serum Concentration (Cmax) of CMC-544, Total Calicheamicin, and Anti-human CD22 Antibody (G544)

Description

CMC-544 is composed of G544, an anti-human CD22 antibody, linked to a potent cytotoxic antitumor antibiotic called calicheamicin. CD22 is expressed on the malignant cells of the majority of B-lymphocyte malignancies.

Time Frame