Aprepitant's Effect on Drug Metabolism in Multi-Day Combination (CHOP/R-CHOP) Chemotherapy Regimen in Lymphoma Patients
Summary
The goal of this clinical research study is to learn the effect of combining aprepitant with CHOP or R-CHOP in patients with Non-Hodgkin's Lymphoma (NHL) that is either newly diagnosed or has come back. Researchers also want to see if aprepitant can help to prevent nausea and/or vomiting that may be caused by chemotherapy treatment with CHOP or R-CHOP, in these patients. CHOP consists of four drugs - Cyclophosphamide (also called Cytoxan/Neosar), Doxorubicin (or Adriamycin), Vincristine (Oncovin) and Prednisolone while R-CHOP includes Rituximab and CHOP.
Timeline
- Start
- 2008-03
- Primary completion
- 2011-09
- Completion
- 2011-09
Outcome
Mixed primary results
registry analysis (non-inferiority or equivalence test); Aprepitant vs Control Group; Ratio Geometric Mean AUC 1.20 (90% CI 1.08 to 1.33); 90% CI NCT00651755 ↗
registry analysis (non-inferiority or equivalence test); Aprepitant vs Control; ratio Geometric mean AUC 0.75 (95% CI 0.65 to 0.86); equivalence analysis NCT00651755 ↗
registry analysis (non-inferiority or equivalence test); Aprepitant vs Control; Ratio Geometric mean AUC 0.97 (90% CI 0.83 to 1.13); equivalence analysis NCT00651755 ↗
registry analysis (non-inferiority or equivalence test); Aprepitant vs Control; Ratio Geometric Mean AUC 1.04 (90% CI 0.82 to 1.33); equivalence analysis NCT00651755 ↗
registry analysis (non-inferiority or equivalence test); Aprepitant vs Control; Ratio Geometric Mean AUC 1.08 (90% CI 1.02 to 1.15); equivalence analysis NCT00651755 ↗
registry analysis (non-inferiority or equivalence test); Aprepitant vs Control; Ratio Geometric Mean AUC 1.16 (90% CI 1.01 to 1.32); equivalence analysis NCT00651755 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aprepitant | Other / unclassified | 80 mg | Oral |
| Subject | Cyclophosphamide | Other / unclassified | 750 mg/m2 | Intravenous |
| Subject | Prednisone | Other / unclassified | 100 mg | Oral |
| Subject | Vincristine | Small molecule | 2 mg | Intravenous |
| Background | Doxorubicin | Other / unclassified | 25 mg/m2 | Intravenous |
| Background | Ondansetron | Other / unclassified | 8 mg | — |
| Background | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |