Clinical trial · Interventional
Aprepitant's Effect on Drug Metabolism in Multi-Day Combination (CHOP/R-CHOP) Chemotherapy Regimen in Lymphoma Patients
Evaluation of Aprepitant's Effect on Drug Metabolism in Multi-Day Combination (CHOP/R-CHOP) Chemotherapy Regimen in Patients With Non-Hodgkin's Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aprepitant | Drug | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Ondansetron | Drug | — | UNRESOLVED |
| Prednisone | Drug | Prednisone | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
| Vincristine | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Aprepitant + CHOP/R-CHOP
- description
- Aprepitant 125 mg oral (PO) Day 1 of Cycle 1 followed by 80 mg PO Daily Days 2-3 with CHOP (steroid in CHOP) or R-CHOP plus Rituximab 375 mg/m\^2 intravenous Day 1. CHOP or R-CHOP chemotherapy: (1) bolus or 48-hour infusion CHOP \[cyclophosphamide 750 mg/m\^2 IV Day 1, doxorubicin 25 mg/m\^2/day IV given bolus or over 48 hours continuous infusion Days 1-2, vincristine 2 mg IV Day 1, prednisone PO 100 mg \* 5 days\]; or (2) Bolus or 48-hour infusion R-CHOP \[Rituximab 375 mg/m\^2 on Day 1 + CHOP as above\]. \[For patients receiving R-CHOP, CHOP may be administered starting on Day 2 at the discretion of the treating physician\]
- interventionNames
- Drug: Aprepitant
- Drug: Cyclophosphamide
- Drug: Doxorubicin
- Drug: Vincristine
- Drug: Prednisone
- Drug: Rituximab
- type
- EXPERIMENTAL
- label
- Standard of Care (Control) + CHOP/R-CHOP
- description
- Anti-emetics, Ondansetron 8 mg daily for 2 days, plus steroids in CHOP or R-CHOP regimen.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Newly diagnosed or relapsed lymphoid malignancy. 2. Patients receiving either:(1) Bolus or 48-hr infusion CHOP (cyclophosphamide 750 mg/m\^2 IV Day 1, doxorubicin 25 mg/m\^2/day IV given as bolus infusion or over 48 hours continuous infusion Days 1-2, vincristine 2 mg IV Day 1, prednisone PO 100 mg \* 5 days) OR (2) Bolus or 48-hr infusion R-CHOP (Rituximab 375mg/m\^2 on Day 1+ CHOP as above). (For patients receiving R-CHOP, CHOP may be administered starting on Day 2 at the discretion of the treating physician 3. Age \>/= to 18 years 4. Adequate organ function defined as serum total bilirubin \</= 1.2 mg/dL, serum aspartate aminotransferase or serum glutamate oxaloacetate transaminase (SGOT) \</= 60 IU/L, creatinine \< 1.5 mg/dL. Exclusion Criteria: 1. Evidence of neoplastic central nervous system disease 2. Patients who are unable to take oral medication (e.g. due to tumor obstruction) 3. History of Diabetes Mellitus (Diabetes as defined by established diagnosis of diabetes currently receiving medications for the diabetes management and/or a fasting blood glucose of \>/= 126 mg/dL.)
References
Publications (0)
Data not yet available