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An Open-Label, Randomized, Phase 3 Study Of Inotuzumab Ozogamicin (CMC-544) Administered In Combination With Rituximab Compared To A Defined Investigator's Choice Therapy In Subjects With Relapsed Or Refractory, CD22-Positive, Follicular B-Cell Non-Hodgkin's Lymphoma


Phase 3
18 Years
N/A
Not Enrolling
Both
Lymphoma, Follicular

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Trial Information

An Open-Label, Randomized, Phase 3 Study Of Inotuzumab Ozogamicin (CMC-544) Administered In Combination With Rituximab Compared To A Defined Investigator's Choice Therapy In Subjects With Relapsed Or Refractory, CD22-Positive, Follicular B-Cell Non-Hodgkin's Lymphoma


On January 14th 2009, enrollment in the study was discontinued because of poor enrollment
and because it was unlikely that the study would meet the estimated enrollment of
approximately 978 subjects. The decision was not prompted by the identification of any
safety signals in this or other studies. Active treatment and follow-up of the already
enrolled subjects was continued. On July, 22th 2010 , the study was amended to shorten the
long-term follow-up to one year after active treatment.


Inclusion Criteria:



- Subjects with a diagnosis of CD20 and CD22-positive, follicular lymphoma, who have
received 1 or 2 prior regimens, at least 1 of which should have contained
administration of rituximab (either as a single agent or in combination).

- Age 18 years or older.

- ECOG performance status <= 2.

- ANC >= 1.5 x 10^9/L (1500/mL) and platelets >= 75 x 10^9/L (75,000/mL), serum
creatinine <= 1.5 x ULN and urine protein to creatinine ratio of <= 0.5, total
bilirubin <= 1.5 x ULN, AST and ALT <= 2.5 x ULN.

- At least 1 measurable disease lesion that is >= 1.5 cm x 1.5 cm by CT or MRI, in an
area of no prior radiation therapy, or documented progression in an area that was
previously irradiated.

Exclusion Criteria:

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

- Subjects whose disease is rituximab refractory, meaning that they did not have a CR
or PR, or that they experienced disease progression within 6 months from the
initiation of the rituximab or rituximab containing treatment regimen administered
immediately preceding study enrollment.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Outcome Measure:

To assess efficacy as measured by progression free survival (PFS), with a goal of demonstrating the superiority of inotuzumab ozogamicin when administered in combination with rituximab, compared with an active comparator arm.

Outcome Time Frame:

4 years

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

3129K4-3301

NCT ID:

NCT00562965

Start Date:

November 2007

Completion Date:

April 2011

Related Keywords:

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

Name

Location

Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteDetroit, Michigan  48201
Pfizer Investigational SiteRochester, Minnesota  55905
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteFederal Way, Washington  98003
Pfizer Investigational SiteCarmel, Indiana  46032
Pfizer Investigational SiteWestminster, Maryland  21157
Pfizer Investigational SiteOlive Branch, Mississippi  38654
Pfizer Investigational SiteLivingston, New Jersey  07039