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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Lymphoma, B-Cell

Treatments: Drug: inotuzumab ozogamicin+rituximab +cyclophosphamide+vincristine+prednisone; Drug: inotuzumab ozogamicin+rituximab+gemcitabine+cisplatinum+dexamethasone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01055496

3129K2-1105

2009-015497-35 (EudraCT Number)

B1931003 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 103 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

103 participants in 2 patient groups

Arm 1 (R-CVP)

Experimental group

Description:

Subjects in arm 1 will be enrolled in dose escalation cohorts that will initially evaluate an escalating dose of cyclophosphamide in combination with set doses of inotuzumab ozogamicin, vincristine, prednisone, and rituximab.

Treatment:

Drug: inotuzumab ozogamicin+rituximab +cyclophosphamide+vincristine+prednisone

Arm 2 (R-GDP)

Experimental group

Description:

Subjects in arm 2 will be enrolled in dose escalation cohorts that will initially evaluate escalating doses of gemcitabine and/or cisplatinum in combination with set doses of inotuzumab ozogamicin, dexamethasone, and rituximab.

Treatment:

Drug: inotuzumab ozogamicin+rituximab+gemcitabine+cisplatinum+dexamethasone