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VomitingPhase 4NCT02576327

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

A Phase 4 study testing Tropisetron, Dexamethasone and Aprepitant in people with Vomiting, run by Jun Zhu.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Vomiting
What is being tested?
Tropisetron, Dexamethasone and Aprepitant
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
No sites listed yet
Study dates
Oct 2015to Dec 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

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

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.

Read the 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.

Conditions
Vomiting
Being tested
Tropisetron, Dexamethasone, Aprepitant
Keywords
Lymphoma, Aprepitant, Chemotherapy-induced nausea and vomiting (CINV), Autologous Hematopoietic Stem Cell Transplantation, Hematological Malignancies
Medical subject headings
Vomiting, Lymphoma, Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TropisetronDrug

    Also called Tropisetron Hydrochloride Injection

    Tropisetron Hydrochloride Injection 5mg (Day 1-6)

  • DexamethasoneDrug

    Also called Dexamethasone Sodium Phosphate Injection

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

  • AprepitantDrug

    Also called Emend

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

Study groups in NCT02576327
Study groupRoleWhat they receive
Aprepitant ArmExperimentalTropisetron 5mg（Day1-6）+ Dexamethasone 10mg（Day1-6）+ Aprepitant125mg（Day1-2）、80mg（Day3-6）
Receives: Drug: Tropisetron; Drug: Dexamethasone; Drug: Aprepitant
Control ArmActive comparatorTropisetron 5mg（Day1-6）+ Dexamethasone 10mg（Day1-6）
Receives: Drug: Tropisetron; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall complete response (no emesis and no rescue therapy)

    Measured: During and post chemotherapy (0-120 h)

Secondary outcomes (4)

  1. 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

    Measured: 30 days post-transplantation

  2. 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.

    Measured: 30 days post-transplantation

  3. Quality of Life

    Measured: During and post chemotherapy (0-120 h)

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

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionOct 2017 (estimated)
  4. Study completionDec 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
130 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02576327
Sponsor's protocol ID
PKU-2015YJZ25
Status last verified
Dec 2016
First submitted
13 Oct 2015
Last updated
30 Dec 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tropisetron, Dexamethasone and Aprepitant in people with Vomiting, run by Jun Zhu.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall complete response (no emesis and no rescue therapy) (time frame: During and post chemotherapy (0-120 h)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02576327.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2016.

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