A Trial of the Safety of Escalating Doses of PRO131921 in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Chronic Lymphocytic Leukemia

Intervention / Treatment
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* Drug: PRO131921


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: PRO131921<br>* Escalating doses by IV infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose-limiting toxicities and adverse events |  | Length of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters; CD19-positive B-cell counts |  | Length of study | 
| Overall response rate and progression-free survival (Phase II only) |  | Length of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CLL, Leukemia, Lymph