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

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ClinicalTrials.gov Identifier: NCT00724971
Recruitment Status : Completed
First Posted : July 30, 2008
Last Update Posted : February 15, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
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 or disease Intervention/treatment Phase
Lymphoma, B-Cell Drug: Inotuzumab Ozogamicin (CMC-544) Drug: Rituximab (Rituxan) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
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
Study Start Date : July 2008
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Safety: physical examinations (with vital signs) and laboratory test measurements. [ Time Frame: A maximum of 16 months ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]


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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

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

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 Posted: July 30, 2008    Key Record Dates
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