NCT00124189

Brief Summary

The purpose of this study is to determine the safety and maximum tolerated dose of GRN163L in treating patients with refractory or relapsed chronic lymphoproliferative disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2005

Longer than P75 for phase_1

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

July 25, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 27, 2005

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

December 24, 2015

Status Verified

December 1, 2015

Enrollment Period

7.7 years

First QC Date

July 25, 2005

Last Update Submit

December 22, 2015

Conditions

Chronic Lymphoproliferative Diseases

Keywords

Chronic lymphocytic leukemiaT-cell prolymphocytic leukemiaChronic lymphoproliferative diseasesTelomeraseTelomerase Inhibition

Outcome Measures

Primary Outcomes (1)

  • Safety, tolerability, dose-limiting toxicities (DLT), and maximum tolerated dose (MTD) or recommended phase II dose of GRN163L in patients with relapsed or refractory chronic lymphoproliferative disease

    First 3 weeks

Secondary Outcomes (1)

  • PK and PD

    Measured in the first 6 weeks

Study Arms (1)

open label

OTHER

Sequential dose cohort, open label, escalation trial evaluating one infusion duration of 2 hours

Drug: GRN163L

Interventions

GRN163LDRUG

Weekly intravenous infusion

open label

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • Male or female
  • Chronic lymphoproliferative disease with related biology or similar clinical pattern to B-Cell Leukemia (CLL)including: small lymphocytic lymphoma (SLL), T cell prolymophocytic leukemia (T-PLL), B cell prolymphocytic leukemia (B-PLL), mantle cell lymphoma or other non-Hodgkins lymphoma in leukemic phase (peripheral blood circulating malignant cells present), Waldenstrom's macroglobulinemia
  • Must have relapsed from or be refractory to prior therapeutic regimens
  • Patients with CLL or SLL must have received at least one prior purine analogue-based chemotherapy regimen (eg, fludarabine, pentostatin or cladribine)
  • If previously treated with an anthracycline, anthracenedione, or trastuzumab, must have left ventricular ejection fraction \> 50%
  • ECOG performance status 0-2
  • Life expectancy 3 months or greater

You may not qualify if:

  • Pregnant or lactating women
  • Active 2nd malignancy or history of another malignancy within 2 years, except:treated, non-melanoma skin cancer,treated breast or cervical carcinoma in situ,or resected T1a or b prostate cancer
  • Chemotherapeutic agents within 4 weeks prior to study
  • High dose CTX with stem cell support within 6 months prior to study
  • Signal transduction inhibitors,or monoclonal antibodies within 4 weeks prior to study
  • Immunotherapy or biological response modifiers within 4 weeks prior to study
  • Systemic hormonal therapy within 4 weeks prior to study
  • Anticoagulant therapy, antiplatelet therapy within 2 weeks prior to study
  • Radiotherapy within 4 weeks prior to study
  • Active autoimmune disorder
  • Central nervous system or leptomeningeal involvement
  • Clinically significant cardiovascular disease
  • Known HIV infection
  • Serious/active infection
  • Surgical procedure within 2 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Rocky Mountain Cancer Center

Denver, Colorado, 80218, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Roswell Park Cancer Center

Buffalo, New York, 14263, United States

Location

Long Island Jewish Medical Center

New Hyde Park, New York, 11040, United States

Location

Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

The Ohio State University James Cancer Hospital

Columbus, Ohio, 43210, United States

Location

UT Southwestern

Dallas, Texas, 75390, United States

Location

University of Texas Health Science Center

San Antonio, Texas, 78229, United States

Location

Related Links

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-CellLeukemia, Prolymphocytic, T-Cell

Interventions

GRN163L peptide

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, ProlymphocyticLeukemia, T-Cell

Study Officials

  • Stephen Kelsey, MD

    Geron Corporation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2005

First Posted

July 27, 2005

Study Start

July 1, 2005

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

December 24, 2015

Record last verified: 2015-12

Locations

US(8)