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

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Aichi, , Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
B-Cell Lymphoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-74 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Candidate for potentially curative therapies

- Subjects must not have received previous radioimmunotherapy.

- Subjects with autologous hematopoietic stem cell transplant within the last 6 months

NCT00724971
Pfizer
Completed
Study Evaluating The Safety And Tolerability Of Combination Therapy Inotuzumab Ozogamicin (CMC-544) And Rituximab

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Study Evaluating The Safety And Tolerability Of Combination Therapy Inotuzumab Ozogamicin (CMC-544) And Rituximab
A Phase 1 Study Of Inotuzumab Ozogamicin (CMC-544) Administered In Combination With Rituximab In Subjects With B-Cell Non-Hodgkin's Lymphoma
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).
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Lymphoma, B-Cell
  • 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.
Experimental: 1
Interventions:
  • Drug: Inotuzumab Ozogamicin (CMC-544)
  • Drug: Rituximab (Rituxan)
Ogura M, Hatake K, Ando K, Tobinai K, Tokushige K, Ono C, Ishibashi T, Vandendries E. Phase I study of anti-CD22 immunoconjugate inotuzumab ozogamicin plus rituximab in relapsed/refractory B-cell non-Hodgkin lymphoma. Cancer Sci. 2012 May;103(5):933-8. doi: 10.1111/j.1349-7006.2012.02241.x. Epub 2012 Mar 20.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
March 2010
March 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years to 74 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00724971
3129K3-1104
B1931005
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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