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

Primary Purpose

Vomiting

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Tropisetron
Dexamethasone
Aprepitant
Sponsored by
Jun Zhu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vomiting focused on measuring Lymphoma, Aprepitant, Chemotherapy-induced nausea and vomiting (CINV), Autologous Hematopoietic Stem Cell Transplantation, Hematological Malignancies

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Aprepitant Arm

    Control Arm

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Overall complete response (no emesis and no rescue therapy)

    Secondary Outcome Measures

    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
    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.
    Quality of Life
    Safety and Tolerability assessed by possible side effects, and all AE will be reported during 30 days after the chemotherapy.

    Full Information

    First Posted
    October 13, 2015
    Last Updated
    December 28, 2016
    Sponsor
    Jun Zhu
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02576327
    Brief Title
    A Study Evaluating the Efficacy and Safety of Aprepitant in Autologous Hematopoietic Stem Cell Transplantation
    Official Title
    A Multi-central Perspective Randomized Controlled Study Evaluating the Efficacy and Safety of Aprepitant in Autologous Hematopoietic Stem Cell Transplantation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2015 (undefined)
    Primary Completion Date
    October 2017 (Anticipated)
    Study Completion Date
    December 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Jun Zhu

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vomiting
    Keywords
    Lymphoma, Aprepitant, Chemotherapy-induced nausea and vomiting (CINV), Autologous Hematopoietic Stem Cell Transplantation, Hematological Malignancies

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    130 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Aprepitant Arm
    Arm Type
    Experimental
    Arm Description
    Tropisetron 5mg（Day1-6）+ Dexamethasone 10mg（Day1-6）+ Aprepitant125mg（Day1-2）、80mg（Day3-6）
    Arm Title
    Control Arm
    Arm Type
    Active Comparator
    Arm Description
    Tropisetron 5mg（Day1-6）+ Dexamethasone 10mg（Day1-6）
    Intervention Type
    Drug
    Intervention Name(s)
    Tropisetron
    Other Intervention Name(s)
    Tropisetron Hydrochloride Injection
    Intervention Description
    Tropisetron Hydrochloride Injection 5mg (Day 1-6)
    Intervention Type
    Drug
    Intervention Name(s)
    Dexamethasone
    Other Intervention Name(s)
    Dexamethasone Sodium Phosphate Injection
    Intervention Description
    Dexamethasone Sodium Phosphate Injection 10mg (Day 1-6)
    Intervention Type
    Drug
    Intervention Name(s)
    Aprepitant
    Other Intervention Name(s)
    Emend
    Intervention Description
    Aprepitant 125mg （Day1-2）, 80mg (Day 3-6)
    Primary Outcome Measure Information:
    Title
    Overall complete response (no emesis and no rescue therapy)
    Time Frame
    During and post chemotherapy (0-120 h)
    Secondary Outcome Measure Information:
    Title
    Time to initial neutrophil engraftment
    Description
    Time to initial neutrophil engraftment is defined as 1st of 3 consecutive days of an ANC ≥0.5 × 10^9/L
    Time Frame
    30 days post-transplantation
    Title
    Time to initial platelet recovery
    Description
    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.
    Time Frame
    30 days post-transplantation
    Title
    Quality of Life
    Time Frame
    During and post chemotherapy (0-120 h)
    Title
    Safety and Tolerability assessed by possible side effects, and all AE will be reported during 30 days after the chemotherapy.
    Time Frame
    30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jun Zhu, MD
    Organizational Affiliation
    Peking University Cancer Hospital & Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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