Clinical trial · Interventional
Safety and Dose Study of GRN163L to Treat Patients With Chronic Lymphoproliferative Disease(CLD)
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
NCT00124189CI-TRIAL-00020335completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphoproliferative Diseases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GRN163L | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- open label
- description
- Sequential dose cohort, open label, escalation trial evaluating one infusion duration of 2 hours
- interventionNames
- Drug: GRN163L
Primary outcomes (1)
- measure
- 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
- timeFrame
- First 3 weeks
Secondary outcomes (1)
- measure
- PK and PD
- timeFrame
- Measured in the first 6 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.