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
1 other identifier
interventional
130
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2015
Typical duration for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 13, 2015
CompletedFirst Posted
Study publicly available on registry
October 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedDecember 30, 2016
December 1, 2016
2 years
October 13, 2015
December 28, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall complete response (no emesis and no rescue therapy)
During and post chemotherapy (0-120 h)
Secondary Outcomes (4)
Time to initial neutrophil engraftment
30 days post-transplantation
Time to initial platelet recovery
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
Study Arms (2)
Aprepitant Arm
EXPERIMENTALTropisetron 5mg（Day1-6）+ Dexamethasone 10mg（Day1-6）+ Aprepitant125mg（Day1-2）、80mg（Day3-6）
Control Arm
ACTIVE COMPARATORTropisetron 5mg（Day1-6）+ Dexamethasone 10mg（Day1-6）
Interventions
Tropisetron Hydrochloride Injection 5mg (Day 1-6)
Dexamethasone Sodium Phosphate Injection 10mg (Day 1-6)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jun Zhulead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jun Zhu, MD
Peking University Cancer Hospital & Institute
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Department of Hematology Oncology, clinical oncology college, Director of department, Party Secretary
Study Record Dates
First Submitted
October 13, 2015
First Posted
October 15, 2015
Study Start
October 1, 2015
Primary Completion
October 1, 2017
Study Completion
December 1, 2017
Last Updated
December 30, 2016
Record last verified: 2016-12