A Study Evaluating the Efficacy and Safety of Aprepitant in Autologous Hematopoietic Stem Cell Transplantation

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of additional aprepitant to standard antiemetic regimen in Autologous Hematopoietic Stem Cell Transplantation.

Detailed Description
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Chemotherapy-induced nausea and vomiting (CINV) is a serious complication of treatments of hematological malignancies. Although aprepitant has been shown to control CINV in highly emetogenic therapies for solid tumors, the antiemetic effect of aprepitant in hematological chemotherapies is still not clear. In this multi-central perspective randomized controlled study, the investigators are trying to evaluate the efficacy and safety of additional aprepitant to standard antiemetic regimen in Autologous Hematopoietic Stem Cell Transplantation.

Official Title
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A Multi-central Perspective Randomized Controlled Study Evaluating the Efficacy and Safety of Aprepitant in Autologous Hematopoietic Stem Cell Transplantation

Conditions
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Vomiting

Intervention / Treatment
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* Drug: Tropisetron
* Drug: Dexamethasone
* Drug: Aprepitant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women >/= 18 years, <65 years Patients with lymphoma receiving autologous hematopoietic stem cell transplantation for the first time ECOG 0-2 TBIL,AST and ALT < 2.5-fold upper normal range Female and male subjects of childbearing potential must agree to use a medically accepted method of adequate contraception. Signed informed consent Exclusion Criteria: Prior autologous/ allogeneic hematopoietic stem cell transplantation for lymphoma Women who are pregnant or breast feeding. Serious or uncontroled infection Serious complications Severe renal or hepatic disease Severe mental or nervous system diseases

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aprepitant Arm<br>Tropisetron 5mg（Day1-6）+ Dexamethasone 10mg（Day1-6）+ Aprepitant125mg（Day1-2）、80mg（Day3-6） | Drug: Tropisetron<br>* Tropisetron Hydrochloride Injection 5mg (Day 1-6)<br>* Other names: Tropisetron Hydrochloride Injection;Drug: Dexamethasone<br>* Dexamethasone Sodium Phosphate Injection 10mg (Day 1-6)<br>* Other names: Dexamethasone Sodium Phosphate Injection;Drug: Aprepitant<br>* Aprepitant 125mg （Day1-2）, 80mg (Day 3-6)<br>* Other names: Emend;|
| Active Comparator: Control Arm<br>Tropisetron 5mg（Day1-6）+ Dexamethasone 10mg（Day1-6） | Drug: Tropisetron<br>* Tropisetron Hydrochloride Injection 5mg (Day 1-6)<br>* Other names: Tropisetron Hydrochloride Injection;Drug: Dexamethasone<br>* Dexamethasone Sodium Phosphate Injection 10mg (Day 1-6)<br>* Other names: Dexamethasone Sodium Phosphate Injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall complete response (no emesis and no rescue therapy) |  | During and post chemotherapy (0-120 h) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to initial neutrophil engraftment | Time to initial neutrophil engraftment is defined as 1st of 3 consecutive days of an ANC ≥0.5 × 10^9/L | 30 days post-transplantation | 
| Time to initial platelet recovery | Time to initial platelet recovery is defined as 1st of 3 consecutive platelet count measurements tested on different days with a count ≥20 × 10^9/L with no platelet transfusion in the prior 7 days. | 30 days post-transplantation | 
| Quality of Life |  | During and post chemotherapy (0-120 h) | 
| Safety and Tolerability assessed by possible side effects, and all AE will be reported during 30 days after the chemotherapy. |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lymphoma, Aprepitant, Chemotherapy-induced nausea and vomiting (CINV), Autologous Hematopoietic Stem Cell Transplantation, Hematological Malignancies