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

Phase 2

Completed

• Conditions: Non-Hodgkin's Lymphoma; Cancer

• Registration Number: NCT00276003
• Lead Sponsor: University of New Mexico

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.

Study Timeline

• Study Start: 2002-08
• Primary Completion: 2005-06
• Study Completion: 2005-08
• Study First Submitted: 2006-01-11
• Study First Submitted QC: 2006-01-11
• Study First Posted: 2006-01-12
• Status Verified: 2009-12
• Last Update Submitted: 2010-01-06
• Last Update Posted: 2010-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (2)

Lovelace Sandia Health Systems Dept of Hematology; 🇺🇸 Albuquerque, New Mexico, United States

University of New Mexico; 🇺🇸 Albuquerque, New Mexico, United States