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

This study has been completed.
Sponsor:
Collaborator:
UCB, Inc.
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00299494
First received: March 2, 2006
Last updated: August 8, 2014
Last verified: August 2014

March 2, 2006
August 8, 2014
May 2006
June 2014   (final data collection date for primary outcome measure)
Determination of MTD and safety as measured by the incidence of AEs [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
Safety and Efficacy
Complete list of historical versions of study NCT00299494 on ClinicalTrials.gov Archive Site
  • Objective response rate [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
  • Progression free survival at 6 months [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
  • Overall survival data [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic and pharmacodynamic measures of inotuzumab ozogamicin given in combination with rituximab [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
  • Objective response rate
  • Progression free survival at 6 months
  • Overall survival data
Not Provided
Not Provided
 
Study Evaluating 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 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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoma, B-Cell
Drug: inotuzumab ozogamicin
iv, 1.8 mg/m2, q4w
  • Experimental: 1
    Follicular
    Intervention: Drug: inotuzumab ozogamicin
  • Experimental: 2
    Diffuse Large B-cell Lymphoma
    Intervention: Drug: inotuzumab ozogamicin
  • Experimental: 3
    Refractory Aggressive NHL
    Intervention: Drug: inotuzumab ozogamicin
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
118
June 2014
June 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   France,   Germany,   Hong Kong,   Italy,   Korea, Republic of,   Netherlands,   Poland,   Spain,   Switzerland,   United Kingdom
 
NCT00299494
3129K3-101, B1931004
No
Pfizer
Pfizer
UCB, Inc.
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2014

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