INST Phase II Trial of Gemcitabine and Irinotecan in Patients With Relapsed or Refractory Lymphoma.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00276003

Enrollment

Registered

2006-01-12

Start date

2002-08-31

Completion date

2005-08-31

Last updated

2010-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Non-Hodgkin's Lymphoma

Keywords

Lymphoma-Non Hodgkins, Phase II, Gemcitabine, Irinotecan

Brief summary

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.

Detailed description

The purpose of the study is to see how well patients with relapsed or refractory lymphoma respond to treatment with Gemcitabine and Irinotecan. Patients on this study take part because they have relapsed or refractory lymphoma. Additionally, the study will assess treatment-related side effects and time until disease progression or recurrence.

Interventions

DRUGGemcitabine, Irinotecan, Allopurinol.

Gemcitabine - 1000mg/m2; IV; d1, 8; q 21 days Irinotecan - 100mg/m2; IV; d1, 8; q 21 days Allopurinol - 300 mg; PO; day 1-5; 1st cycle

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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.	3 years

Secondary

Measure	Time frame
Assess progression free survival in these patients with this regimen.	3 years
Assess toxicity of this regimen in this group of patients.	3 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026