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

NCT00867087 | Completed Phase 2 Results

• 3 other identifiers: 3129K5-2005B19310012008-007802-12
• Study Type: interventional
• Target: 64
• Locations: 6 countries
• Sites: 35

Brief 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.

Conditions

Lymphoma, B-Cell

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) After 3 Cycles of Inotuzumab Ozogamicin Plus Rituximab Therapy

  Response criteria based on National Cancer Institute (NCI) International Response Criteria for non-Hodgkin's lymphoma. CR: no detectable clinical \& radiographic evidence of disease/disease-related symptoms; lymph nodes/nodal masses regressed to normal size (less than or equal to \[≤\] 1.5 cm in greatest transverse diameter for nodes greater than \[\>\] 1.5 cm pre-therapy); spleen \& other organs (if enlarged pre-therapy) regressed in size \& spleen not palpable on physical examination; repeat bone marrow infiltrate clear. PR: \> or equal to (≥) 50% decrease in sum of product diameters (SPD) of 6 largest dominant nodes/nodal masses; no increase in size of other nodes, liver, or spleen; splenic \& hepatic nodules regressed by ≥ 50% in SPD; involvement of other organs usually assessable \& no measurable disease present; no new sites of disease. Participants achieving CR, but with persistent morphologic bone marrow involvement or no bone marrow assessment after treatment were partial responders.

  Up to 2 years (9 weeks of 3 21-day cycles and every 3 to 6 months during the long-term follow-up period)

Secondary Outcomes (10)

• Kaplan-Meier Estimate of Progression Free Survival (PFS) 6 Months After Inotuzumab Ozogamicin Plus Rituximab Therapy

  6 months after the first dose of inotuzumab ozogamicin

• Kaplan-Meier Estimate of PFS 2 Years After Inotuzumab Ozogamicin Plus Rituximab Therapy

  2 years after the first dose of inotuzumab ozogamicin

• Percentage of Participants With a Response of CR or PR and Who Had Successful Granulocyte Colony Stimulating Factor (G-CSF) Mobilization of Peripheral Blood Stem Cells (PBSCs) Overall and After 3 Cycles of Inotuzumab Ozogamicin Plus Rituximab Therapy

  From the first dose to approximately 2 to 3 weeks after 3 cycles of inotuzumab ozogamicin plus rituximab (induction) therapy (up to 12 weeks) and up to approximately 2 to 3 weeks after 6 cycles (up to 21 weeks).

• Percentage of Participants With Successful G-CSF Mobilization of PBSC

  From the first dose to approximately 2 to 3 weeks after up to 6 cycles of inotuzumab ozogamicin plus rituximab (induction) therapy (up to 21 weeks).

• Percentage of Participants Who Underwent Autologous Stem Cell Transplant (aSCT)

  A minimum of 4 weeks and a maximum of 8 weeks after the last cycle of inotuzumab ozogamicin plus rituximab (induction) therapy (up to 26 weeks).

Study Arms (1)

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

EXPERIMENTAL

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).

Drug: inotuzumab ozogamicin (CMC-544); Drug: rituximab

Interventions

inotuzumab ozogamicin (CMC-544) DRUG

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

Also known as: cmc-544

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

rituximab 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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead
• UCB Pharma: collaborator

Study Sites (35)

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

Maywood, Illinois, 60153, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Siteman Cancer Center

City of Saint Peters, Missouri, 63376, United States

Location

Barnes-Jewish Hospital

St Louis, Missouri, 63110-1094, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

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

Hackensack, New Jersey, 07601-1941, United States

Location

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

Hackensack, New Jersey, 07601-2105, United States

Location

Hackensack University Medical CenteR

Hackensack, New Jersey, 07601, United States

Location

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

Hackensack, New Jersey, 07601, United States

Location

John Theurer Cancer Center, Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Memorial Sloan - Kettering Cancer Center

New York, New York, 10065, United States

Location

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

UT Southwestern University Hospital - St. Paul

Dallas, Texas, 75235, United States

Location

Zale Lipshy University Hospital

Dallas, Texas, 75235, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

The University of Texas, M. D. Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

University of Texas, MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Methodist Healthcare System of

San Antonio, Texas, 78229, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792-0001, United States

Location

Pharmaceutical Research Center

Madison, Wisconsin, 53792, United States

Location

CHRU de Lille Hopital Claude Huriez

Lille, 59037, France

Location

Institut Paoli Calmettes

Marseille, 13273, France

Location

CHU Saint-Eloi

Montpellier, 34295, France

Location

Hopital Saint Louis

Paris, 75010, France

Location

Hopital Haut-Leveque

Pessac, 33604, France

Location

CH Lyon Sud

Pierre-Bénite, 69495, France

Location

Departement d'Hematologie et d'Oncologie-

Strasbourg, 67098, France

Location

Charite Campus Virchow-Kilinikum-

Berlin, 13353, Germany

Location

Singapore General Hospital

Singapore, 169608, Singapore

Location

Samsung Medical Center

Seoul, Gangnam-gu, 135-710, South Korea

Location

Asan Medical Center

Seoul, Seoul/korea, 138-736, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 120-752, South Korea

Location

Christie Hospital

Manchester, M20 4BX, United Kingdom

Location

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse

Interventions

Inotuzumab Ozogamicin; Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Calicheamicins; Aminoglycosides; Glycosides; Carbohydrates; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Antibodies, Monoclonal, Murine-Derived

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2009
• First Posted: March 23, 2009
• Study Start: June 8, 2009
• Primary Completion: October 31, 2012
• Study Completion: October 31, 2012
• Last Updated: December 5, 2017
• Results First Posted: August 22, 2017

Record last verified: 2017-10

Locations

GB (2); US (21); DE (1); FR (7); KR (3); SG (1)