18 and older, any sex, with Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Response Rate in Patients With Relapsed or Refractory B- and T-cell NHL With Gemcitabine and Bortezomib Combination Treatment.Primary· At screening and after completing cycle 3, cycle 6 and 30 days after Cycle 8
Response rate in patients with relapsed or refractory B- and T-cell NHL with Gemcitabine and Bortezomib combination treatment will be defined as the number of patients with Complete Remission \[CR\] and Partial Remission \[PR\]. CT scans at screening and after completing cycle 3, cycle 6 and 30 days after Cycle 8 assessed by the Response Criteria for Non-hodgkins Lymphoma will be used to determine response where:
CR=Complete disappearance of all detectable clinical and radiographic evidence of disease PR=\> 50% decrease in SPD of the six largest dominant nodes or nodal masses
Group
Value
95% CI
Phase II Gemcitabine 800 mg/m2 + Bortezomib 1.6 mg/m2 D1+D8
1
Phase II Gemcitabine 800 mg/m2 + Bortezomib 1.6 mg/m2 D1+D15
2
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected from the start of treatment through 30 days post treatment. The study was designed for a maximum of 8 Cycles of treatment (1 Cycle = 28 days) and the range of cycles attemted by any patient was 1 - 8..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine together with bortezomib may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of bortezomib when given together with gemcitabine and to see how well they work in treating patients with relapsed or refractory B-cell or T-cell non-Hodgkin's lymphoma.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Northwestern University
Last refreshed: 28 May 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00290706.