Study Evaluating Inotuzumab Ozogamicin (CMC-544) In Indolent Non-Hodgkins Lymphoma

This study has been completed.
Sponsor:
Collaborator:
UCB Pharma
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00868608
First received: March 24, 2009
Last updated: July 17, 2013
Last verified: July 2013
  Purpose

The purpose of this study is to evaluate the efficacy of inotuzumab ozogamicin (CMC-544) in subjects with indolent Non-Hodgkins lymphoma (NHL) that is refractory or has relapsed after multiple therapies including rituximab or radioimmunotherapy. The investigational drug will be given to subjects with indolent NHL by intravenous infusion at a dose of 1.8 mg/m2, every 4 weeks.


Condition Intervention Phase
Lymphoma
Drug: Inotuzumab Ozogamicin (CMC-544)
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: A Phase 2 Study Of Inotuzumab Ozogamicin (CMC-544) In Subjects With Indolent Non-Hodgkin's Lymphoma (NHL) That Is Refractory To Or Has Relapsed After Rituximab And Chemotherapy Or Radioimmunotherapy

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Response rate of subjects with indolent NHL treated with inotuzumab ozogamicin as measured by CT/MRI scans at regular intervals. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety and tolerability of inotuzumab ozogamicin in the treatment of subjects with indolent NHL. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Further assess the response rate of subjects with indolent NHL treated with inotuzumab ozogamicin by evaluating the complete response (CR) rate, duration of response (DR), progression free survival (PFS) and overall survival (OS). [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Determine the ORR, CR, DR, PFS and OS in subjects with follicular NHL treated with inotuzumab ozogamicin. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Evaluate the population pharmacokinetic (PK) profile of inotuzumab ozogamicin. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Evaluate the concentration-effect relationship of cardiac QT measures. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 81
Study Start Date: July 2009
Study Completion Date: June 2013
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: inotuzumab ozogamicin
inotuzumab ozogamicin
Drug: Inotuzumab Ozogamicin (CMC-544)
Administered intravenously at 1.8 mg/m2 every 4 weeks for a planned 4 - 8 cycles
Other Name: inotuzumab ozogamicin

  Eligibility

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

Inclusion Criteria:

  • Subjects who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone, or small lymphocytic lymphoma) that has progressed after 2 or more prior systemic therapies.
  • Previous anticancer treatment given must have contained rituximab and chemotherapy, or anti CD20 Radio Immuno Therapy. Subjects must have exhibited no response or have progressed within 6 months from the completion of the most recent rituximab or rituximab containing therapy or within 12 months of the completion of Radio Immuno Therapy.
  • Measurable disease with adequate bone marrow function, renal and hepatic function

Exclusion Criteria:

  • History of, or suggestive of, veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS) or history of chronic liver disease (eg, cirrhosis) or suspected alcohol abuse.
  • Prior allogeneic hematopoietic stem cell transplant (HSCT).
  • Clinical evidence of transformation to a more aggressive subtype of lymphoma or grade 3b follicular lymphoma.
  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: NCT00868608

  Show 29 Study Locations
Sponsors and Collaborators
Pfizer
UCB Pharma
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00868608     History of Changes
Other Study ID Numbers: 3129K7-2001, B1931007
Study First Received: March 24, 2009
Last Updated: July 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Refractory Indolent NHL
lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 21, 2014