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

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

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.

Study Overview

• Status: Unknown
• Conditions: Vomiting
• Intervention / Treatment: Drug: Tropisetron; Drug: Dexamethasone; Drug: Aprepitant

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 Type: Interventional
• Enrollment (Anticipated): 130
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Jun Zhu

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Anticipated): October 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: October 13, 2015
• First Submitted That Met QC Criteria: October 14, 2015
• First Posted (Estimate): October 15, 2015

Study Record Updates

• Last Update Posted (Estimate): December 30, 2016
• Last Update Submitted That Met QC Criteria: December 28, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Lymphoma; Autologous Hematopoietic Stem Cell Transplantation; Aprepitant; Chemotherapy-induced nausea and vomiting (CINV); Hematological Malignancies
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Serotonin Agents; Serotonin Antagonists; Serotonin 5-HT3 Receptor Antagonists; Neurokinin-1 Receptor Antagonists; Dexamethasone; Dexamethasone acetate; BB 1101; Dexamethasone 21-phosphate; Aprepitant; Tropisetron
• Other Study ID Numbers: PKU-2015YJZ25