Phase 1
Completed N=103
Study Evaluating Chemotherapy in Combination With Inotuzumab Ozogamicin In Subjects With Non-Hodgkin's Lymphoma
Source: ClinicalTrials.gov NCT01055496 ↗Enrolled (actual)
103
Serious AEs
38.8%
Results posted
Aug 2019
Primary outcomePrimary: Participants Reporting Dose Limiting Toxicity (DLT) Adverse Events (AEs) for Participants in the DE Cohort and the MTD Confirmation Cohort for Arm 1 — 0; 0; 1; 2 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants Reporting Dose Limiting Toxicity (DLT) Adverse Events (AEs) for Participants in the DE Cohort and the MTD Confirmation Cohort for Arm 1 |
0; 0; 1; 2; 2 | — |
| PRIMARY Participants Reporting DLT AEs for Participants in the DE Cohort and the MTD Confirmation Cohort for Arm 2 |
0; 2; 1; 2; 0; 3 | — |
| PRIMARY Percentage of Participants With Best Overall Response (OR) of Complete Response (CR) or Partial Response (PR) According to International Response Criteria for NHLs in the MTD and EE Cohorts |
81.3; 53.6 | — |
| PRIMARY Percentage of Participants With a Treatment Emergent AE |
100; 100; 31.3; 45.5; 89.6; 96.4 | — |
| PRIMARY Percentage of Participants With Any Grade 3/4 Chemistry Abnormality During Therapy |
21.3; 36.4 | — |
| PRIMARY Percentage of Participants With Any Grade 3/4 Hematology Abnormality During Therapy |
91.7; 96.4 | — |
| SECONDARY Percentage of Participants With a Best OR of CR or PR According to International Response Criteria for NHLs in the DE Cohorts |
81.3; 51.9 | — |
| SECONDARY Kaplan-Meier Estimate of the Progression-Free Survival (PFS) in the DE Cohorts |
16.36; 10.12 | — |
| SECONDARY Kaplan-Meier Estimates of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12, and 24 Months in the DE Cohorts |
80.00; 60.98; 66.67; 47.92; 22.22; 33.54 | — |
| SECONDARY Kaplan-Meier Estimate of the PFS in the MTD Confirmation/EE Cohorts |
14.36; 6.14 | — |
| SECONDARY Kaplan-Meier Estimates of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12, and 24 Months in the MTD Confirmation/EE Cohorts. |
61.85; 54.74; 51.54; 24.88; 44.67; NA | — |
| SECONDARY Kaplan-Meier Estimate of the Overall Survival (OS) in the DE Cohorts |
NA; NA | — |
| SECONDARY Kaplan-Meier Estimates of the Probability of Being Alive at 6, 12, and 24 Months in the DE Cohorts |
100.00; 74.07; 80.00; 62.96; 80.00; 55.09 | — |
| SECONDARY Kaplan-Meier Estimate of the OS in the MTD Confirmation/EE Cohorts |
NA; NA | — |
| SECONDARY Kaplan-Meier Estimates of the Probability of Being Alive at 6, 12, and 24 Months in the MTD Confirmation/EE Cohorts |
84.38; 88.00; 78.13; 59.11; 71.61; 53.74 | — |
| SECONDARY Mean Inotuzumab Ozogamicin Serum Concentrations |
NA; NA; NA; NA; NA; NA | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01055496). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.