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

Status

Terminated

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00496132

Enrollment

Registered

2007-07-04

Start date

2007-08-27

Completion date

2009-06-17

Last updated

2017-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Lymphocytic Leukemia

Keywords

CLL, Leukemia, Lymph

Brief summary

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.

Interventions

DRUGPRO131921

Escalating doses by IV infusion

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Dose-limiting toxicities and adverse events	Length of study

Secondary

Measure	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026