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

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NCT00299494

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Study Location
University of Alabama at Birmingham-
Birmingham, Alabama, 35249 - 3300, United States
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Contact
1-800-718-1021
[email protected]
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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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating Inotuzumab Ozogamicin [CMC-544] Administered In Combination With Rituximab In Subjects With Non-Hodgkin's Lymphoma (NHL)
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE B-Cell Lymphoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB (FOLLICULAR)
    Follicular
    Interventions:
    • Drug: inotuzumab ozogamicin
    • Drug: Rituximab
  • Experimental: INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB (DLBCL)
    Diffuse Large B-cell Lymphoma
    Interventions:
    • Drug: inotuzumab ozogamicin
    • Drug: Rituximab
  • Experimental: INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB (REFRACTORY)
    Refractory Aggressive NHL
    Interventions:
    • Drug: inotuzumab ozogamicin
    • Drug: Rituximab
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 10, 2015)		119
Original Enrollment  ICMJE
 (submitted: March 2, 2006)		100
Actual Study Completion Date  ICMJE June 2, 2014
Actual Primary Completion Date May 19, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   France,   Germany,   Hong Kong,   Italy,   Korea, Republic of,   Netherlands,   Poland,   Spain,   Switzerland,   United Kingdom,   United States
Removed Location Countries Singapore
 
Administrative Information
NCT Number  ICMJE NCT00299494
Other Study ID Numbers  ICMJE 3129K3-101
B1931004 ( Other Identifier: Alias Study Number )
2005-005436-27 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE UCB Pharma
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP