Clinical trial · Interventional
Aprepitant, Granisetron, & Dexamethasone in Preventing Nausea & Vomiting in Pts. Receiving Cyclophosphamide Before a Stem Cell Transplant
Pilot Study Evaluating Aprepitant (MK-869) for Prevention of Nausea & Vomiting Secondary to High Dose Cyclophosphamide Administered to Patients Underging Undergoing Peripheral Hematopoietic Progenitor Cell Mobilization Prior to Autologous Transplantation
- 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)
RATIONALE: Antiemetic drugs, such as aprepitant, granisetron, and dexamethasone, may help lessen or prevent nausea and vomiting in patients treated with chemotherapy. PURPOSE: This clinical trial is studying how well giving aprepitant together with granisetron and dexamethasone works in preventing nausea and vomiting in patients receiving cyclophosphamide before undergoing an autologous stem cell transplant.
Conditions
Conditions (12)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Chronic Myeloproliferative Disorders | Myeloproliferative Neoplasm | ALIAS | 0.90 |
| Gestational Trophoblastic Tumor | Gestational Trophoblastic Tumor | ONTOLOGY_EXACT | 0.98 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma and Plasma Cell Neoplasm | — | UNRESOLVED | — |
| Myelodysplastic/Myeloproliferative Neoplasms | Myelodysplastic/Myeloproliferative Neoplasm | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndromes |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aprepitant | Drug | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Granisetron hydrochloride | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Aprepitant, Dexamethasone, Cytoxan & Kytril
- description
- Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration. Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes. Days 2 \& 3: Aprepitant 80 mg once daily in the morning.
- interventionNames
- Drug: Aprepitant
- Drug: Cyclophosphamide
- Drug: Dexamethasone
- Drug: Granisetron hydrochloride
Primary outcomes (1)
- measure
- Proportion of Participants With Controlled Acute Vomiting
- timeFrame
- at 0-24 hours
- description
- No episodes of vomiting and no rescue medication during first 24 hours after cyclophosphamide administration.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Undergoing autologous peripheral blood stem cell transplantation and stem cell mobilization using cyclophosphamide * Candidate (per institutional requirements) for autologous peripheral blood stem cell transplantation * No psychiatric illness or multi-system organ failure * No nausea at baseline PATIENT CHARACTERISTICS: * SWOG performance status 0-2 * Fewer than 5 alcoholic drinks per day within the past year * No current illness requiring chronic systemic steroids or requirement for chronic use of anti-emetics * No gastrointestinal obstruction or active peptic ulcer disease * AST and ALT ≤ 3 times upper limit of normal (ULN) * Bilirubin ≤ 3 times ULN * Alkaline phosphatase ≤ 3 times ULN * Creatinine ≤ 2 mg/dL * No known hypersensitivity to any component of the study regimen * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception * No unrelenting hiccups PRIOR CONCURRENT THERAPY: * No chronic therapeutic warfarin \> 1 mg dose per day * No other concurrent investigational agents * No concurrent oral contraceptives (except for stopping menses), tolbutamide, phenytoin, midazolam, ketoconazole, rifampin, paroxetine hydrochloride, or diltiazem hydrochloride * No concurrent illegal drugs
References
Publications (0)
Data not yet available