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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
ClinicalTrials.gov Identifier:
NCT00496132
First received: July 3, 2007
Last updated: January 18, 2013
Last verified: January 2013
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Genentech:

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

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

No publications provided

Responsible Party: Genentech
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:
CLL
Leukemia
Lymph

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

ClinicalTrials.gov processed this record on May 19, 2013