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

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 I Phase II

MedlinePlus related topics:

Leukemia, Adult Acute Leukemia, Adult Chronic

ChemIDplus related topics:

Proline

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment

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

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 ]

Estimated Enrollment:	72
Study Start Date:	September 2007
Estimated Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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:

Signed informed consent
Ability and willingness to comply with the requirements of the study protocol
Age ≥ 18 years
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
ECOG performance status of 0 or 1
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

Contacts


Contact: Morgan Lam		lam.morgan@gene.com

Locations


United States, District of Columbia
	Georgetown University	Recruiting
	Washington, District of Columbia, United States, 20007
	Contact: Pari Ramzi 202-784-0038 ramzip1@georgetown.edu

United States, Tennessee
	Sarah Cannon Research Inst	Recruiting
	Nashville, Tennessee, United States, 37203
	Contact: Mihaela Neculcea 615-986-7628 Mihaela.Neculcea@scresearch.net

United States, Wisconsin
	University of Wisconsin	Recruiting
	Madison, Wisconsin, United States, 53792
	Contact: Connie Sparks 608-263-4511 cs5@medicine.wisc.edu

Sponsors and Collaborators

Genentech

Investigators


Study Director:	Bill Ho, M.D.	Genentech

More Information

Responsible Party:	Genentech, Inc. ( Bill Ho, M.D., Study Director )
Study ID Numbers:	ACO4198g
First Received:	July 3, 2007
Last Updated:	September 29, 2008
ClinicalTrials.gov Identifier:	NCT00496132
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genentech:

CLL

Leukemia

Lymph

Study placed in the following topic categories:

Chronic lymphocytic leukemia

Lymphatic Diseases

Leukemia

Leukemia, Lymphoid

Immunoproliferative Disorders

Leukemia, Lymphocytic, Chronic, B-Cell

Lymphoproliferative Disorders

Leukemia, B-Cell

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Immune System Diseases

ClinicalTrials.gov processed this record on October 06, 2008

Sponsored by:	Genentech
Information provided by:	Genentech
ClinicalTrials.gov Identifier:	NCT00496132