Clinical trial · Interventional
LFB-R603 Dose Finding in Patients With Advanced Stage B-Chronic Lymphocytic Leukemia
Open, Non-controlled, Multicentre, First-in-man Study Using Escalating Doses of LFB-R603 in Patients With Advanced Stage B-Chronic Lymphocytic Leukemia
NCT01098188CI-TRIAL-00006809completedPhase 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)
This study is designed to evaluate the safety, pharmacokinetics and preliminary efficacy of the anti-CD20 monoclonal antibody LFB-R603 in patients with relapsed or refractory B-cell chronic lymphocytic leukemia who have received at least one prior fludarabine-containing regimen.
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 |
|---|---|---|---|
| LFB-R603 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Safety evaluated by adverse event(s) is the primary end-point of the study. Adverse events will be reported throughout the study period using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
- timeFrame
- on going
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Signed informed consent * Relapsed or refractory B-CLL after at least one prior course of therapy with fludarabine * Circulating lymphocytes expressing CD20 * Peripheral blood lymphocyte count \> 5,000/µL * ECOG performance status ≤ 2 * Life expectancy ≥ 3 months * Negative blood pregnancy test before inclusion for women of childbearing potential * Medically acceptable method of birth control throughout the study for women of childbearing potential * Being considered as reliable and capable of adhering to the protocol and compliant with study procedures * Covered by healthcare insurance Exclusion Criteria: * Transformation of CLL into a high grade lymphoma * Allogeneic stem cell transplantation \< 6 months before enrolment * Prior treatment with anti-CD20 monoclonal antibodies \< 6 months before enrolment * Prior treatment with alemtuzumab \< 2 months before enrolment * Treatment with any IMP or participation in a clinical study within 30 days prior to enrolment * Known severe anaphylactic or other hypersensitivity reactions secondary to a prior exposure to murine antibodies or to any component of LFB-R603 * Patient with prior treatment or concomitant medication that may interfere with the interpretation of the study data * Patient with a concomitant malignancy other than basal cell carcinoma of the skin, or in situ carcinoma of the cervix or the breast * Patient with serious non-malignant disease, active infection requiring systemic antibiotic, antifungal or antiviral drug or physical examination or laboratory abnormalities, that would compromise protocol objectives * Positive serology to HIV, HCV or presence of HBs Ag * Creatinine clearance, calculated according to Cockroft -Gault formula \< 60 mL/min * ALT and /or AST level \> 1.5 times the upper limit of normal * Pregnancy or breastfeeding
References
Publications (1)
- BACKGROUNDde Romeuf C, Dutertre CA, Le Garff-Tavernier M, Fournier N, Gaucher C, Glacet A, Jorieux S, Bihoreau N, Behrens CK, Beliard R, Vieillard V, Cazin B, Bourel D, Prost JF, Teillaud JL, Merle-Beral H. Chronic lymphocytic leukaemia cells are efficiently killed by an anti-CD20 monoclonal antibody selected for improved engagement of FcgammaRIIIA/CD16. Br J Haematol. 2008 Mar;140(6):635-43. doi: 10.1111/j.1365-2141.2007.06974.x. PMID 18302712