Aggressive Non-Hodgkin Lymphoma (NHL) MedDRA version: 14.1 Level: PT Classification code 10029547 Term: Non-Hodgkin's lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Inotuzumab Ozogamicin
Product Code: PF-05208773
Pharmaceutical Form: Powder for injection
INN or Proposed INN: Inotuzumab ozogamicin
CAS Number: N/A
Current Sponsor code: PF-05208773
Ot
Sponsors
Pfizer Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects with a diagnosis of CD20 and CD22-positive aggressive NHL (based on local immunophenotyping and histopathology) who have: a. Refractory disease: defined as disease progression while receiving their most recent prior cytotoxic chemotherapy (single-agent immunotherapy as maintenance is not considered cytotoxic therapy); b. Persistent disease: defined as stable disease or partial response at the completion of their most recent prior cytotoxic chemotherapy; c. Relapsed/recurrent disease: defined as complete response at the end of their most recent prior cytotoxic chemotherapy with subsequent relapse or disease recurrence. Eligible aggressive subtypes identified per the 2008 World Health Organization classification include: a) DLBCL (including DLBCL with follicular elements), b) transformed indolent lymphoma with DLBCL, and c) primary mediastinal large B-cell lymphomas. 2. Subjects must have received prior rituximab and may have received up to 3 prior regimens containing cytotoxic chemotherapies for aggressive NHL. In order to ensure consistency in the application of the inclusion criterion: •Only count regimens that contain 1 or more cytotoxic drug. Do not count palliation with steroids alone, vaccines, non-systemic therapy such as radiation, or maintenance therapies such as rituximab. •Only count INDUCTION regimens. Do not count maintenance or consolidation therapy. •If a patient had progression of disease between 2 cytotoxic regimens, they always count as 2 separate regimens. Note: If a regimen was changed (e.g. because the patient did not tolerate it or for financial reasons) and the patient did not progress before the regimen was changed, it is not counted as a separate regimen. •If a patient has transformed indolent lymphoma with DLBCL, only count the regimens received for aggressive lymphoma. 3. Subjects must not be candidates for intensive high-dose chemotherapy, with or without an autologous stem cell transplant (aSCT), due to one or more of the following factors: age, comorbid disease, performance status, prior high-dose chemotherapy, or persisting toxicities from prior chemotherapy. (*transplant preparatory regimen, eg, BEAM, BEAC). 4. Age 18 years or older (For Japan: Age 20 years or older). 5. Absolute neutrophil count (ANC) =1.0 x 109/L (1000/µL) and platelets =75 x 10to the power of 9/L (75,000/µL), unless related to bone marrow infiltration. 6. Serum creatinine =1.5 x the upper limit of normal (ULN) (or any serum creatinine level associated with a measured or calculated creatinine clearance of =40 mL/min). 7. Total bilirubin =1.5 mg/dL (25.65 µmol/L) unless Gilbert’s syndrome, aspartate and alanine aminotransferase (AST, ALT) =2.5 x ULN. 8. At least 1 measurable disease lesion that is =1.0 cm in 2 perpendicular dimensions, with the product diameter =2.25 cm2 by computed tomography (CT) or magnetic resonance imaging (MRI). Tumor lesions that are located in a previously irradiated area will be considered measurable only if progression is documented following completion of radiation therapy. 9. Negative serum pregnancy test within 1 week before first treatment if the subject is a woman of childbearing potential. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant. This includes women who are using contraceptives or whose sexual partners are either sterile or using contraceptives. 10. All female and male subjects who are biologically capable of hav
Exclusion criteria
Exclusion criteria: 1. Prior allogeneic hematopoietic stem cell transplant (HSCT). 2. Within =6 months before first dose of investigational product: a. Prior treatment with anti-CD22 antibodies; b. Prior radioimmunotherapy. 3. Prior autologous stem cell transplant within =4 months before first dose of investigational product. 4. Contraindication to rituximab. 5. Contraindication to both investigator’s choice immuno-chemotherapy regimens. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 4 and/or a life expectancy 470 msec (based on the average of 3 consecutive ECGs). 22. History of chronic liver disease (eg, cirrhosis) or suspected history of alcohol abuse. 23. Administration of a live vaccine =6 weeks before first dose of investigational product. 24. Any major illness/condition or abnormal laboratory finding that, in the investigator’s judgment, will substantially increase the risk associated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: ? To evaluate efficacy as measured by overall survival (OS), with a goal of demonstrating the superiority of inotuzumab ozogamicin when administered in combination with rituximab, compared with an active comparator arm.;Secondary Objective: ? To evaluate the safety and tolerability of inotuzumab ozogamicin in combination with rituximab compared to the active comparator arm; ? To evaluate the efficacy of inotuzumab ozogamicin in combination with rituximab, as measured by overall (objective) response rate (ORR), progression free survival (PFS), and duration of response (DoR) compared to the active comparator arm; ? To compare patient-reported health-related quality of life (HRQOL), lymphoma specific symptoms, and health status between the treatment arms.;Primary end point(s): Overall survival (OS).;Timepoint(s) of evaluation of this end point: 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Progression free survival (PFS); • Overall (objective) response rate (ORR); • Duration of response (DoR); • Patient-reported health-related quality of life, lymphoma specific symptoms, and health status for subjects in each treatment arm as measured by the Functional Assessment of Cancer Therapy for Lymphoma (FACT-Lym) and EuroQol-5D (EQ 5D) questionnaires.;Timepoint(s) of evaluation of this end point: Approximately every 3 to 6 months | — |
Countries
Belgium, Brazil, Bulgaria, Canada, Croatia, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Lithuania, Mexico, Netherlands, Poland, Portugal, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom
Contacts
Public ContactClinical Trials.gov Call Centre
Pfizer Inc
Outcome results
None listed