Clinical trial · Interventional
A Trial of the Safety of Escalating Doses of PRO131921 in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
An Open-Label, Multicenter, Phase I/II Trial of the Safety of Escalating Doses of PRO131921 in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia Who Have Been Treated With a Purine Nucleoside Analogue-Containing Regimen
- 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 is an open-label, multicenter, Phase I/II study of the safety of escalating doses of single-agent PRO131921 in patients with chronic lymphocytic leukemia (CLL) who have relapsed after or were refractory to treatment with a purine nucleoside analogue-containing regimen. The trial will enroll in two phases: a Phase I dose-escalation portion and a Phase II expanded treatment cohort, with enrollment of additional patients in order to expand safety experience and collect preliminary anti-leukemia activity data.
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 |
|---|---|---|---|
| PRO131921 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: PRO131921
Primary outcomes (1)
- measure
- Dose-limiting toxicities and adverse events
- timeFrame
- Length of study
Secondary outcomes (2)
- measure
- Pharmacokinetic parameters; CD19-positive B-cell counts
- timeFrame
- Length of study
- measure
- Overall response rate and progression-free survival (Phase II only)
- timeFrame
- Length of study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Documented history of histologically confirmed B-cell CLL * Relapsed or refractory CLL with history of prior treatment with purine nucleoside analogue-containing regimen * Eligible for treatment of their CLL based on criteria adapted from the National Cancer Institute-Working Group (NCI-WG) Response Criteria for CLL * For patients of reproductive potential (males and females), use of a reliable means of contraception * For females of childbearing potential, a negative serum pregnancy test Exclusion Criteria: * Prior use of anti-CD20 monoclonal antibody therapy (other than rituximab) * Prior use of any non-CD20 targeted monoclonal antibody therapy within 6 months of enrollment * Current or recent CLL treatment * History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies * Evidence of acute/active autoimmune hemolytic anemia or other autoimmune complications of CLL * Use of hematopoietic growth factors or RBC and/or platelet transfusions * Evidence of significant uncontrolled concomitant diseases, such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders * Evidence of myelodysplasia or myelodysplastic changes on bone marrow examination * History of cancer other than CLL) * Known active bacterial, viral, fungal, mycobacterial, or other infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics or oral antibiotics * A major episode of infection requiring hospitalization or treatment with IV antimicrobials within 4 weeks of screening or oral antimicrobials within 2 weeks of screening * Positive hepatitis B or C serology * Positive human immunodeficiency virus (HIV) serology * Active cytomegalovirus (CMV) disease by antigen or polymerase chain reaction testing * Pregnancy or lactation * CNS leukemia * Recent major surgery, other than diagnostic surgery
References
Publications (0)
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