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

Phase 4

• Conditions: Vomiting
• Interventions: Drug: Tropisetron; Drug: Dexamethasone; Drug: Aprepitant

• Registration Number: NCT02576327
• Lead Sponsor: Jun Zhu

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-13
• Study First Submitted QC: 2015-10-14
• Study First Posted: 2015-10-15
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-28
• Last Update Posted: 2016-12-30
• Primary Completion: 2017-10
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aprepitant Arm	Tropisetron	Tropisetron 5mg（Day1-6）+ Dexamethasone 10mg（Day1-6）+ Aprepitant125mg（Day1-2）、80mg（Day3-6）
Aprepitant Arm	Dexamethasone	Tropisetron 5mg（Day1-6）+ Dexamethasone 10mg（Day1-6）+ Aprepitant125mg（Day1-2）、80mg（Day3-6）
Aprepitant Arm	Aprepitant	Tropisetron 5mg（Day1-6）+ Dexamethasone 10mg（Day1-6）+ Aprepitant125mg（Day1-2）、80mg（Day3-6）
Control Arm	Dexamethasone	Tropisetron 5mg（Day1-6）+ Dexamethasone 10mg（Day1-6）
Control Arm	Tropisetron	Tropisetron 5mg（Day1-6）+ Dexamethasone 10mg（Day1-6）

Primary Outcome Measures

Name	Time	Method
Overall complete response (no emesis and no rescue therapy)	During and post chemotherapy (0-120 h)

Secondary Outcome Measures

Name	Time	Method
Time to initial platelet recovery	30 days post-transplantation	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.
Quality of Life	During and post chemotherapy (0-120 h)
Time to initial neutrophil engraftment	30 days post-transplantation	Time to initial neutrophil engraftment is defined as 1st of 3 consecutive days of an ANC ≥0.5 × 10\^9/L
Safety and Tolerability assessed by possible side effects, and all AE will be reported during 30 days after the chemotherapy.	30 days