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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 Pharma
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00299494
First received: March 2, 2006
Last updated: August 8, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Lymphoma, B-Cell
Drug: inotuzumab ozogamicin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Determination of MTD and safety as measured by the incidence of AEs [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 118
Study Start Date: May 2006
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Follicular
Drug: inotuzumab ozogamicin
iv, 1.8 mg/m2, q4w
Experimental: 2
Diffuse Large B-cell Lymphoma
Drug: inotuzumab ozogamicin
iv, 1.8 mg/m2, q4w
Experimental: 3
Refractory Aggressive NHL
Drug: inotuzumab ozogamicin
iv, 1.8 mg/m2, q4w

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00299494

  Show 37 Study Locations
Sponsors and Collaborators
Pfizer
UCB Pharma
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00299494     History of Changes
Other Study ID Numbers: 3129K3-101, B1931004
Study First Received: March 2, 2006
Last Updated: August 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Lymphoma
NHL

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 25, 2014