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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00496132
First received: July 3, 2007
Last updated: January 18, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Chronic Lymphocytic Leukemia
Drug: PRO131921
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Dose-limiting toxicities and adverse events [ Time Frame: Length of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetic parameters; CD19-positive B-cell counts [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • Overall response rate and progression-free survival (Phase II only) [ Time Frame: Length of study ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: September 2007
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: PRO131921
Escalating doses by IV infusion

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00496132

Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Bill Ho, M.D. Genentech, Inc.
  More Information

No publications provided

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00496132     History of Changes
Other Study ID Numbers: ACO4198g
Study First Received: July 3, 2007
Last Updated: January 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech, Inc.:
CLL
Leukemia
Lymph

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell

ClinicalTrials.gov processed this record on October 19, 2014