Study Evaluating Chemotherapy in Combination With Inotuzumab Ozogamicin In Subjects With Non-Hodgkin's Lymphoma
| Status: | Completed |
|---|---|
| Conditions: | Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/14/2017 |
| Start Date: | March 2010 |
| End Date: | March 2014 |
An Open-Label, Phase 1 Study Of R-CVP Or R-GDP In Combination With Inotuzumab Ozogamicin In Subjects With CD22-Positive Non-Hodgkin's Lymphoma
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.
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.
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.
We found this trial at
8
sites
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