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

Primary Purpose

Chronic Lymphocytic Leukemia

Status

Terminated

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

PRO131921

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia focused on measuring CLL, Leukemia, Lymph

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Dose-limiting toxicities and adverse events

Secondary Outcome Measures

Pharmacokinetic parameters; CD19-positive B-cell counts

Overall response rate and progression-free survival (Phase II only)

Full Information

NCT ID

NCT00496132

First Posted

July 3, 2007

Last Updated

June 26, 2017

Sponsor

Genentech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00496132

Brief Title

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

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Terminated

Study Start Date

August 27, 2007 (Actual)

Primary Completion Date

June 17, 2009 (Actual)

Study Completion Date

June 17, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Genentech, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Lymphocytic Leukemia

Keywords

CLL, Leukemia, Lymph

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

PRO131921

Intervention Description

Escalating doses by IV infusion

Primary Outcome Measure Information:

Title

Dose-limiting toxicities and adverse events

Time Frame

Length of study

Secondary Outcome Measure Information:

Title

Pharmacokinetic parameters; CD19-positive B-cell counts

Time Frame

Length of study

Title

Overall response rate and progression-free survival (Phase II only)

Time Frame

Length of study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bill Ho, M.D.

Organizational Affiliation

Genentech, Inc.

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

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