Chronic Lymphoproliferative Diseases Clinical Trial
Official title:
A Phase I, Sequential Cohort, Dose Escalation Trial to Determine the Safety, Tolerability, and Maximum Tolerated Dose of GRN163L in Patients With Chronic Lymphoproliferative Disease
| Verified date | December 2015 |
| Source | Geron Corporation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 48 |
| Est. completion date | March 2013 |
| Est. primary completion date | March 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 18 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 Exclusion Criteria: - 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 |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Roswell Park Cancer Center | Buffalo | New York |
| United States | The Ohio State University James Cancer Hospital | Columbus | Ohio |
| United States | UT Southwestern | Dallas | Texas |
| United States | Rocky Mountain Cancer Center | Denver | Colorado |
| United States | Hackensack University Medical Center | Hackensack | New Jersey |
| United States | Long Island Jewish Medical Center | New Hyde Park | New York |
| United States | Weill Medical College of Cornell University | New York | New York |
| United States | University of Texas Health Science Center | San Antonio | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Geron Corporation |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes | |
| Secondary | PK and PD | Measured in the first 6 weeks | No |