Overview

Study Evaluating Chemotherapy in Combination With Inotuzumab Ozogamicin In Subjects With Non-Hodgkin's Lymphoma

Status:
Completed
Trial end date:
2014-03-01
Target enrollment:
0
Participant gender:
All
Summary
This is a phase 1 trial designed to evaluate safety and tolerability of chemotherapy in combination with inotuzumab ozogamicin, an investigational product, in adults with CD22-positive non-Hodgkin's lymphoma. The trial will involve two arms. In one arm, subjects will receive chemotherapy regimen R-CVP (rituximab, cyclophosphamide, vincristine and prednisone). In the other arm, subjects will receive R-GDP (rituximab, gemcitabine, cisplatinum and dexamethasone). Subjects in both arms will also receive inotuzumab ozogamicin.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Collaborator:
UCB Pharma
Treatments:
BB 1101
Cisplatin
Cyclophosphamide
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Gemcitabine
Inotuzumab Ozogamicin
Prednisone
Rituximab
Vincristine
Criteria
Inclusion Criteria:

- Dose escalation cohorts: subjects with diagnosis of CD22-positive Non-Hodgkin's
Lymphoma (NHL) who have had at least 1 prior anticancer treatment, including prior
treatment with rituximab and chemotherapy.

- Expanded maximum tolerated dose (MTD) confirmation and preliminary efficacy cohorts:
subjects with diagnosis of CD22-positive NHL who have had at least 1 prior anticancer
treatment, including prior treatment with rituximab and chemotherapy or newly
diagnosed subjects who are not candidates for anthracycline-based therapy.

- At least 1 measurable disease lesion that is > 1 cm in the longest transverse
diameter, with a product of the diameters > 2.25 cm2 by CT or magnetic resonance
imaging (MRI).

Exclusion Criteria:

- Candidate for potentially curative therapy such as stem cell transplantation.

- Prior allogeneic hematopoietic stem cell transplantation (HSCT).

- Prior autologous transplantation, radioimmunotherapy, or other anti CD22 immunotherapy
<= 6 months before the first dose of investigational product.

- More than 3 previous combination chemotherapy (2 or more cytotoxics) anticancer
regimens.