Study Evaluating The Safety And Tolerability Of Combination Therapy Inotuzumab Ozogamicin (CMC-544) And Rituximab

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00724971
First received: July 25, 2008
Last updated: February 14, 2013
Last verified: February 2013
  Purpose

To assess the tolerability and the initial safety profile of Inotuzumab Ozogamicin (CMC-544) in combination with Rituximab in patients with B-Cell Non-Hodgkin's lymphoma (NHL).


Condition Intervention Phase
Lymphoma, B-Cell
Drug: Inotuzumab Ozogamicin (CMC-544)
Drug: Rituximab (Rituxan)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Study Of Inotuzumab Ozogamicin (CMC-544) Administered In Combination With Rituximab In Subjects With B-Cell Non-Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Safety: physical examinations (with vital signs) and laboratory test measurements. [ Time Frame: A maximum of 16 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy: tumor response, best overall response and progression status (according to the International Response Criteria for Non-Hodgkin's Lymphomas). [ Time Frame: A maximum of 16 months ] [ Designated as safety issue: No ]
  • Pharmacokinetics: serum concentration of Inotuzumab Ozogamicin (CMC-544), G544, total and free (unconjugated) calicheamicin, anti-Inotuzumab Ozogamicin (CMC-544) antibody and anti-Rituximab antibody. [ Time Frame: A maximum of 8 months ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: July 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Inotuzumab Ozogamicin (CMC-544)
1.8 mg/m2, IV on day 2 of each 28 day cycle; up to 8 cycles unless PD, unacceptable toxicity, or subject's refusal occurs.
Drug: Rituximab (Rituxan)
375 mg/m2, IV on day 1 of each 28 day cycle; up to 8 cycles unless PD, unacceptable toxicity, or subject's refusal occurs.

  Eligibility

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • CD20 and CD22-positive, B-cell NHL which has progressed after 1 or 2 prior therapies.
  • Prior therapy must have contained at least one dose of Rituximab therapy. Patients can not be refractory to Rituximab (refractory = PD under treatment or within 6 month
  • Eastern Cooperative Oncology Group (ECOG) performance status: 0/ 1.
  • Patients must not have received previous radioimmunotherapy.
  • Patients tolerant to Rituximab.
  • Patients must not have received chemotherapy, cancer immunosuppressive therapy, growth factors (except erythropoietin), or investigational agents within 28 days before first dose of test article.

Exclusion Criteria:

  • Candidate for potentially curative therapies
  • Subjects must not have received previous radioimmunotherapy.
  • Subjects with autologous hematopoietic stem cell transplant within the last 6 months
  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: NCT00724971

Locations
Japan
Pfizer Investigational Site
Unknown, Tokyo, Japan
Pfizer Investigational Site
Aichi, Japan
Pfizer Investigational Site
Kanagawa, Japan
Pfizer Investigational Site
Tokyo, Japan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00724971     History of Changes
Other Study ID Numbers: 3129K3-1104, B1931005
Study First Received: July 25, 2008
Last Updated: February 14, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Pfizer:
B-cell Non-Hodgkin's Lymphoma
NHL

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

ClinicalTrials.gov processed this record on July 31, 2014