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An Open-Label, Single-Arm, Phase 2 Study Of Inotuzumab Ozogamicin Plus Rituximab In Subjects With Relapsed/Refractory CD22-Positive Diffuse Large B-Cell Lymphoma, Eligible For Autologous Stem Cell Transplantation


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma, B-Cell

Thank you

Trial Information

An Open-Label, Single-Arm, Phase 2 Study Of Inotuzumab Ozogamicin Plus Rituximab In Subjects With Relapsed/Refractory CD22-Positive Diffuse Large B-Cell Lymphoma, Eligible For Autologous Stem Cell Transplantation


Inclusion Criteria:



- CD20/CD22-positive diffuse large B-cell NHL that has relapsed after 1 or 2 prior
therapies; one prior therapy must include anthracyclines and one must include
rituximab in combination with chemotherapy

- Relapsed/disease progression within 12 months after start of prior therapy and/or
secondary International Prognostic Index (sIPI) score greater than 1

- Eligible for autologous stem cell transplant (aSCT)

Exclusion Criteria:

- Prior allogeneic hematopoietic stem cell transplant

- Within 6 months prior to test article: autologous transplant, treatment with
anti-CD22 antibodies, radio-immunotherapy

- Veno-occlusive disease or sinusoidal obstruction syndrome, chronic liver disease,
systemic vasculitides, current or chronic hepatitis B or C infection

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:

Overall response rate after 3 cycles of inotuzumab ozogamicin plus rituximab therapy.

Outcome Time Frame:

~3 months

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:

3129K5-2005

NCT ID:

NCT00867087

Start Date:

June 2009

Completion Date:

October 2012

Related Keywords:

  • Lymphoma, B-Cell
  • Diffuse large b-cell lymphoma
  • inotuzumab ozogamicin
  • autologous stem cell transplant
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse

Name

Location
Pfizer Investigational Site Detroit, Michigan  48201
Pfizer Investigational Site Springfield, Illinois  62701-1014
Pfizer Investigational Site Bronx, New York  10461
Pfizer Investigational Site Houston, Texas  77030
Pfizer Investigational Site North Adams, Massachusetts  01247
Pfizer Investigational Site Columbia, Missouri  65201
Pfizer Investigational Site Kingston, Pennsylvania  18704-5535
Pfizer Investigational Site Milwaukee, Wisconsin  53215
Pfizer Investigational Site Livingston, New Jersey  07039