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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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma, B-Cell

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Trial Information

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


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.

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:

Determination of MTD and safety as measured by the incidence of AEs

Outcome Time Frame:

Up to 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:

3129K3-101

NCT ID:

NCT00299494

Start Date:

May 2006

Completion Date:

May 2014

Related Keywords:

  • Lymphoma, B-Cell
  • Lymphoma
  • NHL
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

Name

Location

Pfizer Investigational SiteBirmingham, Alabama  35205
Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteAtlanta, Georgia  30342
Pfizer Investigational SiteCincinnait, Ohio  45236
Pfizer Investigational SiteSpringfield, Illinois  62701-1014
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteLas Vegas, Nevada  89128
Pfizer Investigational SiteKingston, Pennsylvania  18704-5535