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

This study has been completed.
Sponsor:
Collaborator:
UCB, Inc.
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00867087
First received: March 20, 2009
Last updated: December 4, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Lymphoma, B-Cell
Drug: inotuzumab ozogamicin (CMC-544)
Drug: rituximab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Overall response rate after 3 cycles of inotuzumab ozogamicin plus rituximab therapy. [ Time Frame: ~3 months ] [ Designated as safety issue: No ]
  • Safety as measured by the incidence of adverse events and laboratory abnormalities. [ Time Frame: every ~3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics: concentration of inotuzumab ozogamicin in serum [ Time Frame: 2-3 months ] [ Designated as safety issue: No ]
  • Efficacy: progression free survival, complete response, overall survival, event free survival [ Time Frame: at ~3 months, ~6 months, and ~2 years ] [ Designated as safety issue: No ]
  • Successful Peripheral Blood Stem Cell Collection: mobilization-adjusted overall response rate; rate of successful peripheral blood stem cell collections [ Time Frame: ~3 months ] [ Designated as safety issue: No ]
  • Transplantation rate [ Time Frame: ~3 months ] [ Designated as safety issue: No ]

Enrollment: 65
Study Start Date: June 2009
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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)
1.8 mg/m2 every 21 days by intravenous infusion, 3 to 6 doses
Other Name: cmc-544
Drug: rituximab
375 mg/m2 two days before cycle 1 by intravenous infusion; 375 mg/m2 every 21 days by intravenous infusion, 3 to 6 doses

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00867087

  Show 33 Study Locations
Sponsors and Collaborators
Pfizer
UCB, Inc.
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00867087     History of Changes
Other Study ID Numbers: 3129K5-2005, B1931001
Study First Received: March 20, 2009
Last Updated: December 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Diffuse large b-cell lymphoma
inotuzumab ozogamicin
autologous stem cell transplant

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 29, 2014