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

NCT ID: NCT02576327

Last Updated: 2016-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-12-31

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.

Conditions

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Vomiting

Keywords

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Lymphoma Aprepitant Chemotherapy-induced nausea and vomiting (CINV) Autologous Hematopoietic Stem Cell Transplantation Hematological Malignancies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Aprepitant Arm

Tropisetron 5mg（Day1-6）+ Dexamethasone 10mg（Day1-6）+ Aprepitant125mg（Day1-2）、80mg（Day3-6）

Group Type EXPERIMENTAL

Tropisetron

Intervention Type DRUG

Tropisetron Hydrochloride Injection 5mg (Day 1-6)

Dexamethasone

Intervention Type DRUG

Dexamethasone Sodium Phosphate Injection 10mg (Day 1-6)

Aprepitant

Intervention Type DRUG

Aprepitant 125mg （Day1-2）, 80mg (Day 3-6)

Control Arm

Tropisetron 5mg（Day1-6）+ Dexamethasone 10mg（Day1-6）

Group Type ACTIVE_COMPARATOR

Tropisetron

Intervention Type DRUG

Tropisetron Hydrochloride Injection 5mg (Day 1-6)

Dexamethasone

Intervention Type DRUG

Dexamethasone Sodium Phosphate Injection 10mg (Day 1-6)

Interventions

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Tropisetron

Tropisetron Hydrochloride Injection 5mg (Day 1-6)

Intervention Type DRUG

Dexamethasone

Dexamethasone Sodium Phosphate Injection 10mg (Day 1-6)

Intervention Type DRUG

Aprepitant

Aprepitant 125mg （Day1-2）, 80mg (Day 3-6)

Intervention Type DRUG

Other Intervention Names

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Tropisetron Hydrochloride Injection Dexamethasone Sodium Phosphate Injection Emend

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jun Zhu

OTHER

Sponsor Role lead

Responsible Party

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Jun Zhu

Department of Hematology Oncology, clinical oncology college, Director of department, Party Secretary

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jun Zhu, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Other Identifiers

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PKU-2015YJZ25

Identifier Type: -

Identifier Source: org_study_id