Prolonged Isolated Thrombocytopenia After Allo-SCT : N-ac... | NCT03391856

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

NCT03391856

Sponsor

Peking University People's Hospital

Status

Terminated

Last Update Posted

Sep 25, 2020Actual

Enrollment

15Actual

Phase

Phase 2Phase 3

Conditions

Thrombocytopenia
Stem Cell Transplant Complications

Interventions

N-acetyl-L-cysteine (NAC)
supportive therapy

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

protocol changed

Expanded Access Info

Start Date

Mar 1, 2018Actual

Primary Completion Date

Dec 30, 2018Actual

Completion Date

Dec 30, 2018Actual

First Submitted Date

Jan 2, 2018

First Submission Date that Met QC Criteria

Jan 4, 2018

First Posted Date

Jan 5, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 23, 2020

Last Update Posted Date

Sep 25, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xiaojun Huang,MD, Head of Peking University Institute of Hematology, Peking University People's HospitalPrincipal Investigator

Lead Sponsor

Peking University People's HospitalOTHER

Collaborators

Name	Class
The First Affiliated Hospital of Soochow University	OTHER
Nanfang Hospital, Southern Medical University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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.)
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.
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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
intervention arm	Experimental	NAC 400mg p.o tid from day 60 to day 90 post transplant	Drug: N-acetyl-L-cysteine (NAC)
controlled arm	Other	Supportive therapy including platelet infusion:prophylactic platelet transfusion was given when platelet count <20000/ul	Other: supportive therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
N-acetyl-L-cysteine (NAC)	Drug	NAC treatment for PT: 400mg p.o tid from day 60 to 90 post transplant	intervention arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
response rate	rate of response after 30 days of treatment	30 days after the start of enrollement

Secondary Outcomes

Measure	Description	Time Frame
overall survival	survival proportion at the last followup after transplantation	the day of last follow-up
non-relapse mortality	non-relapse mortality at the last followup after transplantation

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Xiao-Jun Huang, MD	Peiking University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University People's Hospital		Beijing	Beijing Municipality	100044	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013921	Thrombocytopenia

Ancestor Terms

ID	Term
D001791	Blood Platelet Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D000095542	Cytopenia

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000111	Acetylcysteine
D010166	Palliative Care

Ancestor Terms

ID	Term
D003545	Cysteine
D000603	Amino Acids, Sulfur
D013457	Sulfur Compounds
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided