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A Phase 2 Study Of Inotuzumab Ozogamicin (CMC-544) In Subjects With Indolent Non-Hodgkin's Lymphoma (NHL) That Is Refractory To Or Has Relapsed After Rituximab And Chemotherapy Or Radioimmunotherapy


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

Thank you

Trial Information

A Phase 2 Study Of Inotuzumab Ozogamicin (CMC-544) In Subjects With Indolent Non-Hodgkin's Lymphoma (NHL) That Is Refractory To Or Has Relapsed After Rituximab And Chemotherapy Or Radioimmunotherapy


Inclusion Criteria:



- Subjects who have been previously diagnosed with CD22-positive, indolent NHL (defined
as follicular, marginal zone, or small lymphocytic lymphoma) that has progressed
after 2 or more prior systemic therapies.

- Previous anticancer treatment given must have contained rituximab and chemotherapy,
or anti CD20 Radio Immuno Therapy. Subjects must have exhibited no response or have
progressed within 6 months from the completion of the most recent rituximab or
rituximab containing therapy or within 12 months of the completion of Radio Immuno
Therapy.

- Measurable disease with adequate bone marrow function, renal and hepatic function

Exclusion Criteria:

- History of, or suggestive of, veno-occlusive disease (VOD) or sinusoidal obstruction
syndrome (SOS) or history of chronic liver disease (eg, cirrhosis) or suspected
alcohol abuse.

- Prior allogeneic hematopoietic stem cell transplant (HSCT).

- Clinical evidence of transformation to a more aggressive subtype of lymphoma or grade
3b follicular lymphoma.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Response rate of subjects with indolent NHL treated with inotuzumab ozogamicin as measured by CT/MRI scans at regular intervals.

Outcome Time Frame:

12 months

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:

3129K7-2001

NCT ID:

NCT00868608

Start Date:

July 2009

Completion Date:

July 2013

Related Keywords:

  • Lymphoma
  • Refractory Indolent NHL
  • lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Pfizer Investigational SiteBirmingham, Alabama  35205
Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteRochester, Minnesota  55905
Pfizer Investigational SiteSpringfield, Illinois  62701-1014
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteColumbia, Missouri  65201
Pfizer Investigational SiteKingston, Pennsylvania  18704-5535
Pfizer Investigational SiteLivingston, New Jersey  07039