Phase 1
Completed N=10
Study Evaluating The Safety And Tolerability Of Combination Therapy Inotuzumab Ozogamicin (CMC-544) And Rituximab
Source: ClinicalTrials.gov NCT00724971 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcomePrimary: Number of Participants With Dose-limiting Toxicities (DLT) — 2 Participants
Summary
To assess the tolerability and the initial safety profile of Inotuzumab Ozogamicin (CMC-544) in combination with Rituximab in patients with B-Cell Non-Hodgkin's lymphoma (NHL).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose-limiting Toxicities (DLT) |
2 | — |
| SECONDARY Number of Participants With Objective Response: Evaluable Population |
6; 1; 0; 7 | — |
| SECONDARY Number of Participants With Objective Response: Intent-to-treat (ITT) Population |
6; 1; 1; 8 | — |
| SECONDARY Progression-Free Survival (PFS) |
NA | — |
Eligibility Criteria
Inclusion Criteria
- CD20 and CD22-positive, B-cell NHL which has progressed after 1 or 2 prior therapies.
- Prior therapy must have contained at least one dose of Rituximab therapy. Patients can not be refractory to Rituximab (refractory = PD under treatment or within 6 month
- Eastern Cooperative Oncology Group (ECOG) performance status: 0/ 1.
- Patients must not have received previous radioimmunotherapy.
- Patients tolerant to Rituximab.
- Patients must not have received chemotherapy, cancer immunosuppressive therapy, growth factors (except erythropoietin), or investigational agents within 28 days before first dose of test article.
Exclusion Criteria
- Candidate for potentially curative therapies
- Subjects must not have received previous radioimmunotherapy.
- Subjects with autologous hematopoietic stem cell transplant within the last 6 months
Data sourced from ClinicalTrials.gov (NCT00724971). 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.