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Study Evaluating Inotuzumab Ozogamicin [CMC-544] Administered In Combination With Rituximab In Subjects With Non-Hodgkin's Lymphoma (NHL)

Last updated on July 31, 2018

FOR MORE INFORMATION
Study Location
University of Alabama at Birmingham-
Birmingham, Alabama, 35249 - 3300 United States
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
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects with CD20 and CD22-positive, follicular or diffuse large B-cell NHL who have
not responded or progressed after 1 or 2 prior therapies; or subjects with CD20 and
CD22-positive intermediate/aggressive NHL (diffuse large B-cell, mantle cell,
transformed follicular or follicular grade 3b NHL) who have not responded or
progressed after 1 or more prior therapies and are refractory to a previous rituximab
containing therapy.

- Prior therapy must contain at least one course of rituximab therapy, as single agent
or in combination.

- Measurable disease.

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

- Subjects who are candidates for other potentially curative therapies.

- Subjects must not have received previous radioimmunotherapy.

- Subjects who have undergone a prior bone marrow transplantation within the last 6
months.

NCT00299494
Pfizer
Completed
Study Evaluating Inotuzumab Ozogamicin [CMC-544] Administered In Combination With Rituximab In Subjects With Non-Hodgkin's Lymphoma (NHL)

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Study Evaluating Inotuzumab Ozogamicin [CMC-544] Administered In Combination With Rituximab In Subjects With Non-Hodgkin's Lymphoma (NHL)
A Phase 1/2 Study Of CMC-544 Administered In Combination With Rituximab In Subjects With Follicular Or Diffuse Large B-Cell Non-Hodgkin's Lymphoma
The purpose of the study is to determine the tolerability, the initial safety profile and maximum tolerated dose, and to obtain preliminary information on the antitumor activity of inotuzumab ozogamicin [CMC-544] in combination with rituximab in subjects with follicular, diffuse large B-Cell, or mantle cell NHL.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
B-Cell Lymphoma
  • Drug: inotuzumab ozogamicin
    IV, 1.8 mg/m2, q4w
    Other Name: CMC-544
  • Drug: Rituximab
    rituximab 375 mg/m^2 via IV infusion on Day 1
  • Experimental: 1
    Follicular
    Interventions:
    • Drug: inotuzumab ozogamicin
    • Drug: Rituximab
  • Experimental: 2
    Diffuse Large B-cell Lymphoma
    Interventions:
    • Drug: inotuzumab ozogamicin
    • Drug: Rituximab
  • Experimental: 3
    Refractory Aggressive NHL
    Interventions:
    • Drug: inotuzumab ozogamicin
    • Drug: Rituximab
Fayad L, Offner F, Smith MR, Verhoef G, Johnson P, Kaufman JL, Rohatiner A, Advani A, Foran J, Hess G, Coiffier B, Czuczman M, Giné E, Durrant S, Kneissl M, Luu KT, Hua SY, Boni J, Vandendries E, Dang NH. Safety and clinical activity of a combination therapy comprising two antibody-based targeting agents for the treatment of non-Hodgkin lymphoma: results of a phase I/II study evaluating the immunoconjugate inotuzumab ozogamicin with rituximab. J Clin Oncol. 2013 Feb 10;31(5):573-83. doi: 10.1200/JCO.2012.42.7211. Epub 2013 Jan 7.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
119
June 2014
May 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects with CD20 and CD22-positive, follicular or diffuse large B-cell NHL who have not responded or progressed after 1 or 2 prior therapies; or subjects with CD20 and CD22-positive intermediate/aggressive NHL (diffuse large B-cell, mantle cell, transformed follicular or follicular grade 3b NHL) who have not responded or progressed after 1 or more prior therapies and are refractory to a previous rituximab containing therapy.
  • Prior therapy must contain at least one course of rituximab therapy, as single agent or in combination.
  • Measurable disease.

Exclusion Criteria:

  • Subjects who are candidates for other potentially curative therapies.
  • Subjects must not have received previous radioimmunotherapy.
  • Subjects who have undergone a prior bone marrow transplantation within the last 6 months.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   France,   Germany,   Hong Kong,   Italy,   Korea, Republic of,   Netherlands,   Poland,   Spain,   Switzerland,   United Kingdom,   United States
Singapore
 
NCT00299494
3129K3-101
B1931004 ( Other Identifier: Alias Study Number )
2005-005436-27 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
UCB Pharma
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2015

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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