Clinical trial NCT00496132: A Trial of the Safety of Escalating Doses of PRO131921 in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Chronic Lymphocytic Leukemia
Keywords: CLL
Leukemia
Lymph
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2007-07-04
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Dose-limiting toxicities and adverse events
timeFrame: Length of study
Secondary outcomes:
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
Other outcomes:
Locations:
Study officials:
affiliation: Genentech, Inc.
name: Bill Ho, M.D.
role: STUDY_DIRECTOR
References: