Clinical trial · Interventional
The Humanized Monoclonal Antibody Milatuzumab for Refractory Chronic Lymphocytic Leukemia (CLL)
Phase I-II Trial of the Anti CD74 Monoclonal Antibody-Milatuzumab as a Single Agent in Refractory Chronic Lymphocytic Leukemia
NCT00868478CI-TRIAL-00003499unknownPhase 1 / Phase 2ClinicalTrials.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)
The purpose of this study is to determine whether Milatuzumab is effective in patients with refractory chronic lymphocytic leukemia, and also to find out in which range of doses is a response seen.
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 |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Milatuzumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Response to treatment
- timeFrame
- 12 weeks, 24 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * B-CLL confirmed according to NCI criteria * CLL relapsed or refractory to prior antineoplastic therapy * Signs of progressive disease; at least one: * B symptoms * lymphocyte doubling time of \< 6 months * symptomatic lymphadenopathy or splenomegaly * cytopenias due to bone marrow failure) * Age \> 18 years, and less then 80 * Serum ALAT, ASAT, bilirubin, creatinine \< 2x upper limit of normal * Life expectancy \> 6 months * Patient's written informed consent Exclusion Criteria: * Active bacterial or viral infection * Hypersensitivity to humanized monoclonal antibodies * Concurrent antineoplastic treatment for CLL or other malignant disease * Absolute neutrophil count \< 1.5 K/
References
Publications (1)
- BACKGROUNDBinsky I, Haran M, Starlets D, Gore Y, Lantner F, Harpaz N, Leng L, Goldenberg DM, Shvidel L, Berrebi A, Bucala R, Shachar I. IL-8 secreted in a macrophage migration-inhibitory factor- and CD74-dependent manner regulates B cell chronic lymphocytic leukemia survival. Proc Natl Acad Sci U S A. 2007 Aug 14;104(33):13408-13. doi: 10.1073/pnas.0701553104. Epub 2007 Aug 8. PMID 17686984