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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:
ClinicalTrials.gov Identifier:
NCT00496132
First Posted: July 4, 2007
Last Update Posted: July 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Genentech, Inc.
  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: None (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 ]

Secondary Outcome Measures:
  • Pharmacokinetic parameters; CD19-positive B-cell counts [ Time Frame: Length of study ]
  • Overall response rate and progression-free survival (Phase II only) [ Time Frame: Length of study ]

Enrollment: 16
Actual Study Start Date: August 27, 2007
Study Completion Date: June 17, 2009
Primary Completion Date: June 17, 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: PRO131921
Escalating doses by IV infusion

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00496132


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

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00496132     History of Changes
Other Study ID Numbers: ACO4198g
First Submitted: July 3, 2007
First Posted: July 4, 2007
Last Update Posted: July 2, 2017
Last Verified: June 2017

Keywords provided by Genentech, Inc.:
CLL
Leukemia
Lymph

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs