Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02576327
Recruitment Status : Unknown
Verified December 2016 by Jun Zhu, Peking University.
Recruitment status was:  Active, not recruiting
First Posted : October 15, 2015
Last Update Posted : December 30, 2016
Sponsor:
Information provided by (Responsible Party):
Jun Zhu, Peking University

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.

Condition or disease Intervention/treatment Phase
Vomiting Drug: Tropisetron Drug: Dexamethasone Drug: Aprepitant Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-central Perspective Randomized Controlled Study Evaluating the Efficacy and Safety of Aprepitant in Autologous Hematopoietic Stem Cell Transplantation
Study Start Date : October 2015
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : December 2017


Arm Intervention/treatment
Experimental: Aprepitant Arm
Tropisetron 5mg(Day1-6)+ Dexamethasone 10mg(Day1-6)+ Aprepitant125mg(Day1-2)、80mg(Day3-6)
Drug: Tropisetron
Tropisetron Hydrochloride Injection 5mg (Day 1-6)
Other Name: Tropisetron Hydrochloride Injection

Drug: Dexamethasone
Dexamethasone Sodium Phosphate Injection 10mg (Day 1-6)
Other Name: Dexamethasone Sodium Phosphate Injection

Drug: Aprepitant
Aprepitant 125mg (Day1-2), 80mg (Day 3-6)
Other Name: Emend

Active Comparator: Control Arm
Tropisetron 5mg(Day1-6)+ Dexamethasone 10mg(Day1-6)
Drug: Tropisetron
Tropisetron Hydrochloride Injection 5mg (Day 1-6)
Other Name: Tropisetron Hydrochloride Injection

Drug: Dexamethasone
Dexamethasone Sodium Phosphate Injection 10mg (Day 1-6)
Other Name: Dexamethasone Sodium Phosphate Injection




Primary Outcome Measures :
  1. Overall complete response (no emesis and no rescue therapy) [ Time Frame: During and post chemotherapy (0-120 h) ]

Secondary Outcome Measures :
  1. Time to initial neutrophil engraftment [ Time Frame: 30 days post-transplantation ]
    Time to initial neutrophil engraftment is defined as 1st of 3 consecutive days of an ANC ≥0.5 × 10^9/L

  2. Time to initial platelet recovery [ Time Frame: 30 days post-transplantation ]
    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.

  3. Quality of Life [ Time Frame: 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. [ Time Frame: 30 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02576327


Sponsors and Collaborators
Jun Zhu
Investigators
Layout table for investigator information
Principal Investigator: Jun Zhu, MD Beijing Cancer Hospital

Layout table for additonal information
Responsible Party: Jun Zhu, Department of Hematology Oncology, clinical oncology college, Director of department, Party Secretary, Peking University
ClinicalTrials.gov Identifier: NCT02576327     History of Changes
Other Study ID Numbers: PKU-2015YJZ25
First Posted: October 15, 2015    Key Record Dates
Last Update Posted: December 30, 2016
Last Verified: December 2016
Keywords provided by Jun Zhu, Peking University:
Lymphoma
Aprepitant
Chemotherapy-induced nausea and vomiting (CINV)
Autologous Hematopoietic Stem Cell Transplantation
Hematological Malignancies
Additional relevant MeSH terms:
Layout table for MeSH terms
Dexamethasone 21-phosphate
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Dexamethasone
Dexamethasone acetate
Aprepitant
Fosaprepitant
Tropisetron
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Serotonin 5-HT3 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents