Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prolonged Isolated Thrombocytopenia After Allo-SCT : N-acetyl-L-cysteine (NAC) Versus Supportive Therapy

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03391856
Recruitment Status : Recruiting
First Posted : January 5, 2018
Last Update Posted : April 30, 2018
Sponsor:
Collaborators:
The First Affiliated Hospital of Soochow University
Nanfang Hospital of Southern Medical University
Information provided by (Responsible Party):
Xiaojun Huang, Peking University People's Hospital

Brief Summary:
Isolated prolonged thrombocytopenia (PT) is a common complication after allogeneic stem cell transplantation with significant poor prognosis. No standard treatment is available. The current study assigned PT randomly to 2 arms: intervention arm with N-acetyl-L-cysteine (NAC) and control arm with supportive therapy.This is a prospective randomized controlled study.

Condition or disease Intervention/treatment Phase
Thrombocytopenia Stem Cell Transplant Complications Drug: N-acetyl-L-cysteine (NAC) Other: supportive therapy Phase 2 Phase 3

Detailed Description:
  1. patients diagnosed with PT at day 60 post transplant will be randomized assigned to intervention arm (NAC) or controlled arm (supportive therapy: prophylactic platelet transfusion was given when platelet count <20000/ul.)
  2. Response will be evaluated at day 90. Response was defined as platelet recovery to >= 20000/ul for 7 consecutive days without transfusion support during the enrollment period. All the other patients not achieved above criteria was defined as no response.
  3. For those without response in both arms, patients will received NAC plus recombinant human thrombopoietin (rhTPO) for an additional 30 days. rhTPO was given at 300IU/kg/d for 28 consecutive days or platelet > 50000/ul independent of platelet transfusion.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Controlled Study for Intervention of Prolonged Isolated Thrombocytopenia After Allogeneic Hematopoietic Stem Cell Transplantation: N-acetyl-L-cysteine (NAC) Versus Supportive Therapy
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: intervention arm
NAC 400mg p.o tid from day 60 to day 90 post transplant
Drug: N-acetyl-L-cysteine (NAC)
NAC treatment for PT: 400mg p.o tid from day 60 to 90 post transplant

controlled arm
Supportive therapy including platelet infusion:prophylactic platelet transfusion was given when platelet count <20000/ul
Other: supportive therapy
prophylactic platelet transfusion was given when platelet count <20000/ul




Primary Outcome Measures :
  1. response rate [ Time Frame: 30 days after the start of enrollement ]
    rate of response after 30 days of treatment


Secondary Outcome Measures :
  1. overall survival [ Time Frame: the day of last follow-up ]
    survival proportion at the last followup after transplantation

  2. non-relapse mortality [ Time Frame: the day of last follow-up ]
    non-relapse mortality at the last followup after transplantation

  3. grade 2-4 acute graft versus host disease [ Time Frame: day 100 after transplant ]
    grade 2-4 aGVHD at day 100 after transplant

  4. chronic graft versus host disease [ Time Frame: the day of last follow-up ]
    chronic graft versus host disease at the day of last follow-up



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:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age>= 14 years
  • diagnosed as PT (defined as platelet count in peripheral blood never achieve 20000/miro-liter for 7 consecutive days without transfusion at day 60 post transplantation)
  • serum creatine level < ULN (upper limit of normal), serum ALT/AST /TBil<=2 ULN
  • without active CMV/EBV/ADV reactivation, active GVHD, without relapse or minimal residual disease at enrollment

Exclusion Criteria:

  • history of asthma
  • allergy to NAC
  • refuse to participate

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): NCT03391856


Contacts
Layout table for location contacts
Contact: Yu-Qian Sun, MD 86-10-88324577 sunyuqian83@hotmail.com

Locations
Layout table for location information
China, Beijing
Peking University People's Hospital Recruiting
Beijing, Beijing, China, 100044
Contact: Yuqian Sun, M.D         
Sponsors and Collaborators
Peking University People's Hospital
The First Affiliated Hospital of Soochow University
Nanfang Hospital of Southern Medical University
Investigators
Layout table for investigator information
Principal Investigator: Xiao-Jun Huang, MD Peiking University

Layout table for additonal information
Responsible Party: Xiaojun Huang, Head of Peking University Institute of Hematology, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT03391856     History of Changes
Other Study ID Numbers: 2017PHB220
First Posted: January 5, 2018    Key Record Dates
Last Update Posted: April 30, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Acetylcysteine
N-monoacetylcystine
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes