Clinical trial · Interventional
Phase I/II Study of Different Doses and Dose Schedules of Milatuzumab (hLL1) in CLL
A Phase I/II Study of Immunotherapy With Milatuzumab (hLL1) in Patients With Chronic Lymphocytic Leukemia (CLL)
NCT00603668CI-TRIAL-00053290completedPhase 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)
This study will test different doses of anti-CD74 antibody in patients with NHL and/or CLL.
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 Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| milatuzumab | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- milatuzumab
- description
- different doses of hLL1
- interventionNames
- Biological: milatuzumab
Primary outcomes (1)
- measure
- Safety of the anti-CD74 antibody will be evaluated based upon physical examinations, hematology and chemistry laboratory evaluations and toxicity events
- timeFrame
- over first 12 weeks
Secondary outcomes (5)
- measure
- Efficacy (to see if the study drug works) in patients with NHL and CLL
- timeFrame
- over the first 12 weeks, then over up to 2 years
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed diagnosis of recurrent chronic lymphocytic leukemia (by NCI criteria) * Received at least one prior treatment with standard therapy (previous antibody therapy is acceptable) * Measurable disease (WBC \> 5,000 for CLL) * See protocol for full list Exclusion Criteria: * Pregnant or lactating women. Women of childbearing potential must have a negative pregnancy test Pregnancy testing is not required for post-menopausal or surgically sterilized women * Women of childbearing potential and fertile men who are not practicing or who are unwilling to practice birth control while enrolled in the study until at least 12 weeks after the last milatuzumab infusion * Prior therapy with other human or humanized monoclonal antibodies, unless HAHA tested and negative; * Bulky disease by CT, defined as any single mass \>10 cm in its greatest diameter * Known HIV positive or active hepatitis B or C, or presence of hepatitis B surface antigens or presence of hepatitis C antibody * Known autoimmune disease or presence of autoimmune phenomena * At least 7 days beyond any infection requiring antibiotic use. * Systemic corticosteroids within 2 weeks, except low dose regimens (prednisone, \<20 mg/day, or equivalent) which may continue if unchanged. * Substance abuse or other concurrent medical or psychiatric conditions that, in the Investigator's opinion, could confound study interpretation or affect the patient's ability to tolerate or complete the study.
References
Publications (2)
- BACKGROUNDStein R, Mattes MJ, Cardillo TM, Hansen HJ, Chang CH, Burton J, Govindan S, Goldenberg DM. CD74: a new candidate target for the immunotherapy of B-cell neoplasms. Clin Cancer Res. 2007 Sep 15;13(18 Pt 2):5556s-5563s. doi: 10.1158/1078-0432.CCR-07-1167. PMID 17875789
- BACKGROUNDStein R, Qu Z, Cardillo TM, Chen S, Rosario A, Horak ID, Hansen HJ, Goldenberg DM. Antiproliferative activity of a humanized anti-CD74 monoclonal antibody, hLL1, on B-cell malignancies. Blood. 2004 Dec 1;104(12):3705-11. doi: 10.1182/blood-2004-03-0890. Epub 2004 Aug 5. PMID 15297317