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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 Site Birmingham, Alabama  35205
Pfizer Investigational Site Blendora, California  91740
Pfizer Investigational Site Atlanta, Georgia  30342
Pfizer Investigational Site Cincinnait, Ohio  45236
Pfizer Investigational Site Springfield, Illinois  62701-1014
Pfizer Investigational Site Bronx, New York  10461
Pfizer Investigational Site Houston, Texas  77030
Pfizer Investigational Site Las Vegas, Nevada  89128
Pfizer Investigational Site Kingston, Pennsylvania  18704-5535