Clinical trial · Interventional
GCS-100LE in Combination With Etoposide and Dexamethasone in Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Phase 1/2 Study of GCS-100 in Combination With Etoposide and Dexamethasone in Relapsed or Refractory Diffuse Large B Cell Lymphoma
NCT00776802CI-TRIAL-00011037GCS-100LEwithdrawnPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of funding
Summary
Brief summary (as posted)
Phase 1/2, open-label, dose-escalation study to assess the safety and tolerability of GCS-100 in combination with etoposide and dexamethasone in patients with relapsed or refractory diffuse large B-cell lymphoma.
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 |
|---|---|---|---|
| Diffuse Large B-cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Etoposide; Dexamethasone | Drug | — | UNRESOLVED |
| GCS-100 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GCS-10
- interventionNames
- Drug: GCS-100
- Drug: Etoposide; Dexamethasone
Primary outcomes (1)
- measure
- To determine the maximum tolerated dose of GCS-100 in combination with etoposide and dexamethasone by comprehensive lab, pharmacokinetics, physical assessments, and PET-CT imaging.
- timeFrame
- Study Day 12 for toxicity, and 21-day cycles assessed every 2 cycles by physical and imaging assessments until disease progression
Secondary outcomes (1)
- measure
- Overall response rate; correlate response to GCS-100 with the expression of galectin-3 in tumors; correlate serum galectin-3 levels with the administration of GCS-100
- timeFrame
- Baseline, Day 1, and Day 5 laboratory assessments
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female patients who are 18 years of age or older with diffuse large B-cell cell lymphoma (DLBCL) relapsed or refractory after initial therapy who: * Are not candidates for autologous stem cell transplant. * Have relapsed after autologous or allogeneic stem cell transplant. * Have relapsed or refractory disease after 3 successive chemotherapy regimens. * ECOG Performance Score 0-2 * Creatinine clearance \> 60 mL/min/1.73 m2. * Total bilirubin ≤2.0 X Institutional Upper Limit of Normal (IULN) * AST (SGOT)/ALT (SGPT) ≤2.5 X IUNL, or ≤5X IUNL in patients with liver involvement of DLBCL * Absolute neutrophil count \>1,000 /\_L; hemoglobin \>9 g/mL; platelet count \> 75,000 /\_L at screening. * Patients must be capable of understanding the purpose and risks of the study and able to provide written consent. * Patients must be willing and able to comply with the prescribed treatment protocol and evaluations Exclusion Criteria: * Treatment with experimental (unlicensed) drug within 3 weeks of treatment. * Previous chemotherapy, or major surgery within 21 days prior to first study treatment, or radiation therapy within 6 weeks. * Rapidly progressive disease or organ function threatened by disease * Serious, uncontrolled active infections. * Serologically positive for HIV, HBV, or HCV. * Clinically significant cardiac, pulmonary, and/or hepatic dysfunction * Lymphoma involving the central nervous system * Female patients who are pregnant or breast feeding. * Patients not capable of understanding the purpose and risks of the study and or unable to provide written consent. * Patients not willing and or unable to comply with the prescribed treatment protocol and evaluations
References
Publications (0)
Data not yet available
No reference posted for this study.