Study Evaluating Inotuzumab Ozogamicin (CMC-544) Plus Rituximab In Diffuse Large B-Cell Non-Hodgkin's Lymphoma

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-08

Study Completion Date

2012-10-31

Brief Summary

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The purpose of this study is to evaluate inotuzumab ozogamicin in combination with rituximab prior to an autologous stem cell transplant (aSCT) in patients with relapsed/refractory diffuse large B-cell Non-Hodgkin's lymphoma.

Detailed Description

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Conditions

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Lymphoma, B-Cell

Keywords

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Diffuse large b-cell lymphoma inotuzumab ozogamicin autologous stem cell transplant

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2

Inotuzumab ozogamicin, in combination with rituximab, will be administered to patients with relapsed/refractory diffuse large B-cell Non-Hodgkin's lymphoma prior to an autologous stem cell transplant (aSCT).

Group Type EXPERIMENTAL

inotuzumab ozogamicin (CMC-544)

Intervention Type DRUG

1.8 mg/m\^2 every 21 days by intravenous infusion, 3 to 6 doses

rituximab

Intervention Type DRUG

375 mg/m\^2 two days before cycle 1 by intravenous infusion; 375 mg/m\^2 every 21 days by intravenous infusion, 3 to 6 doses

Interventions

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inotuzumab ozogamicin (CMC-544)

1.8 mg/m\^2 every 21 days by intravenous infusion, 3 to 6 doses

Intervention Type DRUG

rituximab

375 mg/m\^2 two days before cycle 1 by intravenous infusion; 375 mg/m\^2 every 21 days by intravenous infusion, 3 to 6 doses

Intervention Type DRUG

Other Intervention Names

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cmc-544

Eligibility Criteria

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Inclusion Criteria

* CD20/CD22-positive diffuse large B-cell NHL that has relapsed after 1 or 2 prior therapies; one prior therapy must include anthracyclines and one must include rituximab in combination with chemotherapy
* Relapsed/disease progression within 12 months after start of prior therapy and/or secondary International Prognostic Index (sIPI) score greater than 1
* Eligible for autologous stem cell transplant (aSCT)

Exclusion Criteria

* Prior allogeneic hematopoietic stem cell transplant
* Within 6 months prior to test article: autologous transplant, treatment with anti-CD22 antibodies, radio-immunotherapy
* Veno-occlusive disease or sinusoidal obstruction syndrome, chronic liver disease, systemic vasculitides, current or chronic hepatitis B or C infection

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Loyola University Medical Center, Foster G. McGraw Hospital and Satellites

Maywood, Illinois, United States

Site Status

Tufts Medical Center

Boston, Massachusetts, United States

Site Status

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Site Status

Siteman Cancer Center

City of Saint Peters, Missouri, United States

Site Status

Barnes-Jewish Hospital

St Louis, Missouri, United States

Site Status