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

Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02576327
• Other study ID #: PKU-2015YJZ25
• Status: Active, not recruiting
• Phase: Phase 4
• First received: October 13, 2015
• Last updated: December 28, 2016
• Start date: October 2015
• Est. completion date: December 2017

Study information

• Verified date: December 2016
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 130
• Est. completion date: December 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vomiting

Intervention

Drug:
• Tropisetron
Tropisetron Hydrochloride Injection 5mg (Day 1-6)
• Dexamethasone
Dexamethasone Sodium Phosphate Injection 10mg (Day 1-6)
• Aprepitant
Aprepitant 125mg (Day1-2), 80mg (Day 3-6)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jun Zhu

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall complete response (no emesis and no rescue therapy)		During and post chemotherapy (0-120 h)	No
Secondary	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	No
Secondary	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	No
Secondary	Quality of Life		During and post chemotherapy (0-120 h)	No
Secondary	Safety and Tolerability assessed by possible side effects, and all AE will be reported during 30 days after the chemotherapy.		30 days	Yes