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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00724971
First Posted: July 30, 2008
Last Update Posted: February 15, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]

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 ]
  • 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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00724971


Locations
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:
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
First Submitted: July 25, 2008
First Posted: July 30, 2008
Last Update Posted: February 15, 2013
Last Verified: February 2013

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

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