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A Phase 1 Study Of CMC-544 Administered As A Single Agent In Subjects With B-Cell Non-Hodgkin's Lymphoma


Phase 1
18 Years
N/A
Not Enrolling
Both
Lymphoma, B-Cell

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Trial Information

A Phase 1 Study Of CMC-544 Administered As A Single Agent In Subjects With B-Cell Non-Hodgkin's Lymphoma


Inclusion Criteria:



- Subjects who have been previously diagnosed with CD22-positive, B-cell NHL, according
to WHO classification, which has progressed after at least 2 prior therapies of
probable clinical benefit

- At the expanded cohort, part 2 of the study, subjects must have one of the following:

- Follicular lymphoma previously treated with at least one dose of rituximab, but have
not received radioimmunotherapy

- Diffuse large B-cell lymphoma

- Age 18 years or older

Exclusion Criteria:

- Candidate for potentially curative therapies in the opinion of the investigator

- Chronic lymphocytic leukemia

- Burkitt's lymphoma, primary effusion lymphoma, and precursor B-cell lymphoblastic
lymphoma

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety profile

Outcome Time Frame:

5 years

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

3129K1-100

NCT ID:

NCT00073749

Start Date:

August 2003

Completion Date:

December 2010

Related Keywords:

  • Lymphoma, B-Cell
  • B-Cell
  • Non-Hodgkin's
  • Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

Name

Location

Pfizer Investigational SiteBirmingham, Alabama  35205
Pfizer Investigational SiteCincinnait, Ohio  45236
Pfizer Investigational SiteSpringfield, Illinois  62701-1014
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteKingston, Pennsylvania  18704-5535