Clinical trial · Interventional
Study Evaluating Safety and Tolerability of Inotuzumab Ozogamicin (CMC-544) in Japanese Patients With B-cell Non-Hodgkin's Lymphoma (NHL)
A Phase 1 Study Of CMC-544 Administered As A Single Agent In Subjects With B-Cell Non-Hodgkin's Lymphoma
NCT00717925CI-TRIAL-00020128completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To assess the tolerability and the initial safety profile of Inotuzumab Ozogamicin (CMC-544) in patients with B-Cell Non-Hodgkin's Lymphoma (NHL).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, B-Cell | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Inotuzumab Ozogamicin (CMC-544) | Drug | Inotuzumab Ozogamicin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: Inotuzumab Ozogamicin (CMC-544)
Primary outcomes (1)
- measure
- Incidence and severity of adverse events, dose-limiting toxicities, and changes in laboratory test results.
- timeFrame
- 4 months
Secondary outcomes (1)
- measure
- Tumor response (according to the International Response Criteria for Non-Hodgkin's Lymphomas).
- timeFrame
- 4 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria: * CD22-positive, B-cell NHL which has progressed after 1 or 2 prior therapies. * Patients who have progressed after at least 1 prior chemotherapy regimen for indolent lymphoma, or 1/ 2 chemotherapy regimens, which include anthracylin or anthraquinon for aggressive lymphoma. * Eastern Cooperative Oncology Group (ECOG) performance status: 0/ 1. Exclusion Criteria: * Patients must not have received monoclonal antibodies or radioimmunoconjugates within 3 months before first dose of test article. * Patients must not have received bilateral pelvic irradiation. * Patients must not have received chemotherapy, cancer immunosuppressive therapy, growth factors (except erythropoietin), or investigational agents within 4 weeks before first dose of test article.
References
Publications (1)
- DERIVEDOgura M, Tobinai K, Hatake K, Uchida T, Kasai M, Oyama T, Suzuki T, Kobayashi Y, Watanabe T, Azuma T, Mori M, Terui Y, Yokoyama M, Mishima Y, Takahashi S, Ono C, Ohata J. Phase I study of inotuzumab ozogamicin (CMC-544) in Japanese patients with follicular lymphoma pretreated with rituximab-based therapy. Cancer Sci. 2010 Aug;101(8):1840-5. doi: 10.1111/j.1349-7006.2010.01601.x. Epub 2010 Apr 23. PMID 20491780