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COMPLETEDPHASE2

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

An Open-label, Single-arm, Phase 2 Study Of Inotuzumab Ozogamicin Plus Rituximab In Subjects With Relapsed/Refractory Cd22-positive Diffuse Large B-cell Lymphoma, Eligible For Autologous Stem Cell Transplantation

NCT00867087•Pfizer

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (35)

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

Maywood, Illinois, United States

Tufts Medical Center

Boston, Massachusetts, United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Siteman Cancer Center

City of Saint Peters, Missouri, United States

Barnes-Jewish Hospital

St Louis, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

John Theurer Cancer Center (JTCC) at Hackensack University Medical Center (HUMC)

Hackensack, New Jersey, United States

John Theurer Cancer Center (JTCC) at Hackensack University Medical Center (HUMC)

Hackensack, New Jersey, United States

Hackensack University Medical CenteR

Hackensack, New Jersey, United States

John Theurer Cancer Center (JTCC) at Hackensack University Medical Center (HUMC)

Hackensack, New Jersey, United States

Key Dates

Start Date

June 8, 2009

Primary Completion Date

October 31, 2012

Completion Date

October 31, 2012

Last Updated

December 5, 2017

Enrollment

ACTUAL participants

Conditions

Lymphoma, B-Cell

Interventions

inotuzumab ozogamicin (CMC-544)

DRUG

rituximab

DRUG

Phase I Master Protocol of Novel Combination Therapy for Patients With Relapsed or Refractory Aggressive B-Cell Lymphoma

NCT04161248

Lymphoma, B-Cell

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RECRUITINGPHASE1

A Phase 1 Study of UB-VV111 With and Without Rapamycin in Relapsed/Refractory CD19+ B-cell Malignancies

NCT06528301

Lymphoma, B-CellLymphoma, Non-Hodgkin (NHL)+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 5, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Phase I Master Protocol of Novel Combination Therapy for Patients With Relapsed or Refractory Aggressive B-Cell Lymphoma

A Phase 1 Study of UB-VV111 With and Without Rapamycin in Relapsed/Refractory CD19+ B-cell Malignancies

Study of a Communication Training Intervention for Large B-Cell Lymphoma Providers

MEN1703 (SEL24) to Treat Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma (JASPIS-01)

A Phase 1/2 Study of STP938 for Adult Subjects With Relapsed/Refractory B-Cell and T-Cell Lymphomas

Axicabtagene Ciloleucel for Consolidation After First-line Treatment of High-risk Large B-cell Lymphoma