INST Phase II Trial of Gemcitabine and Irinotecan in Patients With Relapsed or Refractory Lymphoma.
Part of paid clinical trials in Albuquerque, New Mexico.
- Sponsor
- University of New Mexico
- Study ID
- NCT00276003
- Phase
- PHASE2
- Status
- Completed
Conditions
- Cancer
- Non-Hodgkin's Lymphoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Gemcitabine, Irinotecan, Allopurinol. — DRUGGemcitabine - 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 Details
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.
Key Dates
- Start date
- Aug 31, 2002
- Status verified
- Dec 2009
- Primary completion
- Jun 30, 2005
- Completion
- Aug 31, 2005
Study Design
- Enrollment
- 22 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Primary Outcome 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. [ Time Frame: 3 years ]
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Lovelace Sandia Health Systems Dept of Hematology | Albuquerque | New Mexico | 87108 | - |
| University of New Mexico | Albuquerque | New Mexico | 87131 | - |
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