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

J

Jun Zhu

Status and phase

Unknown
Phase 4

Conditions

Vomiting

Treatments

Drug: Tropisetron
Drug: Dexamethasone
Drug: Aprepitant

Study type

Interventional

Funder types

Other

Identifiers

NCT02576327
PKU-2015YJZ25

Details and patient eligibility

About

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.

Full 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.

Enrollment

130 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

130 participants in 2 patient groups

Aprepitant Arm
Experimental group
Description:
Tropisetron 5mg(Day1-6)+ Dexamethasone 10mg(Day1-6)+ Aprepitant125mg(Day1-2)、80mg(Day3-6)
Treatment:
Drug: Aprepitant
Drug: Dexamethasone
Drug: Tropisetron
Control Arm
Active Comparator group
Description:
Tropisetron 5mg(Day1-6)+ Dexamethasone 10mg(Day1-6)
Treatment:
Drug: Dexamethasone
Drug: Tropisetron

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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