Clinical trial · Interventional
INST Phase II Trial of Gemcitabine and Irinotecan in Patients With Relapsed or Refractory Lymphoma.
NCT00276003CI-TRIAL-00002982completedPhase 2ClinicalTrials.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)
Primary objectives * Assess the response rate in patients with recurrent or refractory B-cell NHL or Hodgkins disease, treated with the combination of the gemcitabine and irinotecan. Secondary objectives * Assess progression free survival in these patients treated with this regimen. * Assess toxicity of this regimen in this group of patients.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine, Irinotecan, Allopurinol. | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Assess the response rate in patients with recurrent or refractory B-cell NHL or Hodgkins disease, treated with the combination of the gemcitabine and irinotecan.
- timeFrame
- 3 years
Secondary outcomes (2)
- measure
- Assess progression free survival in these patients with this regimen.
- timeFrame
- 3 years
- measure
- Assess toxicity of this regimen in this group of patients.
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with a histologic diagnosis of non-HIV related B-cell NHL or Hodgkins disease are eligible. 2. Patients should have documented evidence of refractory or relapsed NHL or Hodgkins disease for inclusion. 3. Patient should have received 1 or more prior chemotherapeutic regimens for relapse, and should have completed last course of treatment at least 3 weeks prior to enrollment. 4. The patient must have bidimensionally measurable or evaluable disease. 5. Age \> 18 years. 6. ECOG Performance status \< 2 7. Informed consent. 8. ANC \> 1.5, platelet count \> 100K, creatinine\< 2.0, bilirubin \< 3 9. Female patients must have a negative pregnancy test.
References
Publications (0)
Data not yet available
No reference posted for this study.