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An Open-Label, Phase 1 Study Of R-CVP Or R-GDP In Combination With Inotuzumab Ozogamicin In Subjects With CD22-Positive Non-Hodgkin's Lymphoma


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

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Trial Information

An Open-Label, Phase 1 Study Of R-CVP Or R-GDP In Combination With Inotuzumab Ozogamicin In Subjects With CD22-Positive Non-Hodgkin's Lymphoma


Inclusion Criteria:



- Dose escalation cohorts: subjects with diagnosis of CD22-positive Non-Hodgkin's
Lymphoma (NHL) who have had at least 1 prior anticancer treatment, including prior
treatment with rituximab and chemotherapy.

- Expanded maximum tolerated dose (MTD) confirmation and preliminary efficacy cohorts:
subjects with diagnosis of CD22-positive NHL who have had at least 1 prior anticancer
treatment, including prior treatment with rituximab and chemotherapy or newly
diagnosed subjects who are not candidates for anthracycline-based therapy.

- At least 1 measurable disease lesion that is > 1 cm in the longest transverse
diameter, with a product of the diameters > 2.25 cm2 by CT or magnetic resonance
imaging (MRI).

Exclusion Criteria:

- Candidate for potentially curative therapy such as stem cell transplantation.

- Prior allogeneic hematopoietic stem cell transplantation (HSCT).

- Prior autologous transplantation, radioimmunotherapy, or other anti CD22
immunotherapy <= 6 months before the first dose of investigational product.

- More than 3 previous combination chemotherapy (2 or more cytotoxics) anticancer
regimens.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the tolerability, the initial safety profile, as evaluated by an analysis of laboratory results and adverse event (AE) reporting.

Outcome Time Frame:

2 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:

3129K2-1105

NCT ID:

NCT01055496

Start Date:

March 2010

Completion Date:

February 2015

Related Keywords:

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

Name

Location

Pfizer Investigational SiteSpringfield, Illinois  62701-1014
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteFederal Way, Washington  98003
Pfizer Investigational SiteClearwater, Florida  33761
Pfizer Investigational SiteKingston, Pennsylvania  18704-5535
Pfizer Investigational SiteLivingston, New Jersey  07039