Featured Clinical Trial:

Non-Hodgkins lymphoma; B-cell lymphoma; Diffuse B-cell lymphoma (product/compound: Inotuzumab; ozogamicin; Rituximab; gemcitabine; bendamustine)

ClinicAid Locations: Southern California – Fountain Valley, Corona, Riverside

Status:
Open for enrollment (accepting patients). Please contact us and mention Trial ID NCT01232556.

Condition: Lymphoma, Non-Hodgkin ; Lymphoma, B-cell ; Lymphoma, B-cell, Diffuse

Product Name/Compound: Inotuzumab ozogamicin ; Rituximab ; rituximab + gemcitabine ; rituximab + bendamustine

Full Study Title: An Open-Label, Randomized, Phase 3 Study Of Inotuzumab Ozogamicin Administered In Combination With Rituximab Compared To Defined Investigator's Choice Therapy In Subjects With Relapsed Or Refractory CD22-Positive Aggressive Non-Hodgkin Lymphoma Who Are Not Candidates For Intensive High-Dose Chemotherapy

Study Summary: The purpose of this study is to evaluate the efficacy of inotuzumab ozogamicin plus rituximab in relapsed/refractory aggressive Non-Hodgkin lymphoma patients who are not candidates for intensive high-dose chemotherapy. Specifically, the goal is to demonstrate the superiority of this combination compared with an active comparator arm (investigator's choice of rituximab+bendamustine or rituximab+gemcitabine) using the primary endpoint of overall survival.

Eligible Participants:

Inclusion (Eligible):

Men and women >= 18 years of age
relapsed/refractory/persistent CD20+/CD22+ aggressive NHL (DLBCL, transformed indolent lymphoma with DLBCL, primary mediastinal large B-cell lymphomas)
up to 3 prior regimens containing cytotoxic chemotherapies
not candidates for intensive high-dose chemotherapy, with or without an autologous stem cell transplant

Exclusion (Not Eligible):

Any prior allogeneic hematopoietic stem cell transplant; autotransplant within prior 4 months
anti-CD22 treatment or radioimmunotherapy within prior 6 months
contraindication to both investigator choice regimens
chronic liver disease, history of veno-occlusive disease

Study Phase: Phase III (What are Phases?)

To receive information and updates for this trial:
Please contact us and mention the Trial ID below.

Trial ID (ClinicalTrials.gov): NCT01232556

<< Back to all ClinicAid clinical trials