- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03236220
Effect of NAC on the Hematopoietic Reconstitution After Haploidentical Hematopoietic Stem Cell Transplantation
Effect of the Prophylactic Intervention of N-acetyl-L-cysteine (NAC) on the Incidence of Poor Graft Function and Prolonged Isolated Thrombocytopenia in Acute Leukemia Patients After Haploidentical Hematopoietic Stem Cell Transplantation
Study Overview
Status
Intervention / Treatment
Detailed Description
Acute leukemia patients with complete remission, whose bone marrow endothelial cells were less than 0.1% detected before haploidentical hematopoietic stem cell transplantation, receive NAC (orally at dosages of 400mg 3 times per day). NAC treatment begins from 14 days pre-allotransplant to 2 months after-allotransplant continuously in the absence of disease progression or unacceptable toxicity. The effect of NAC on hematopoietic stem cells, megakaryocytes, immunologic subsets, and the elements of bone marrow microenvironment will be monitored pre- and post-allotransplant.
Drug:N-acetyl-L-cysteine (NAC) is orally administrated at dosages of 400mg 3 times per day. NAC treatment begins from 14 days pre-allotransplant to 2 months after-allotransplant continuously in the absence of disease progression or unacceptable toxicity.
Participant:Acute leukemia patients with CR, whose bone marrow endothelial cells were less than 0.1% detected before haploidentical hematopoietic stem cell transplantation.
Eligibility Ages Eligible for Study: 15-60 Years Genders Eligible for Study: Both Accepts The trial will be terminated in following situation
- Severe toxicity occurrence
- Cumulative incidence of relapse increased) (≥ 30%)
- Cumulative incidence of mortality increased (≥ 30%)
- Cumulative incidence of severe graft-versus-host disease increased (≥ 30%)
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Beijng, China
- Peking University People's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Acute leukemia patients with complete remission, whose bone marrow endothelial cells were less than 0.1% detected before haploidentical hematopoietic stem cell transplantation;
Exclusion Criteria:
- Bronchial asthma;
- Allergic to N-acetyl-L-cystein
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: N-acetyl-L-cysteine group
Acute leukemia patients with complete remission, whose bone marrow endothelial cells were less than 0.1% detected before haploidentical hematopoietic stem cell transplantation, receive N-acetyl-L-cysteine.
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Acute leukemia patients with complete remission, whose bone marrow endothelial cells were less than 0.1% detected before haploidentical hematopoietic stem cell transplantation, receive N-acetyl-L-cysteine (NAC) (orally at dosages of 400mg 3 times per day).
NAC treatment begins from 14 days pre-allotransplant to 2 months after-allotransplant continuously in the absence of disease progression or unacceptable toxicity.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of poor graft function and prolonged isolated thrombocytopenia
Time Frame: Participants will be followed for 2 months post-HSCT.
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Number of participants with poor graft function and prolonged isolated thrombocytopenia will be calculated at 2-month post-HSCT.
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Participants will be followed for 2 months post-HSCT.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with treatment-related adverse events will be assessed by CTCAE v4.0 during oral administration of NAC.
Time Frame: From 14 days pre-HSCT to 2 months post-HSCT.
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Participants will be closely observed for NAC-related toxicities during the NAC administration until 2-month post-HSCT.
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From 14 days pre-HSCT to 2 months post-HSCT.
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Effect of NAC on hematopoietic stem cells, megakaryocytes and the elements of bone marrow microenvironment.
Time Frame: Participants will be followed for 100 days post-HSCT.
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Examine hematopoietic stem cells, megakaryocytes and the elements of bone marrow microenvironment by flow cytometry and bone marrow histological examination. |
Participants will be followed for 100 days post-HSCT.
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Incidence of GVHD
Time Frame: Participants will be followed for 100 days post-HSCT.
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Number of participants with I-IV aGVHD will be observed for 100 days post-HSCT.
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Participants will be followed for 100 days post-HSCT.
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Incidence of relapse
Time Frame: Participants will be followed for 1 year post-HSCT.
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Number of participants with morphologic relapse will be calculated at one year post-HSCT.
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Participants will be followed for 1 year post-HSCT.
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Incidence of viral infection
Time Frame: Participants will be followed for 100 days post-HSCT.
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Number of participants with viral infection(CMV,EBV,et al) will be observed for 100 days post-HSCT.
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Participants will be followed for 100 days post-HSCT.
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Non-relapse mortality
Time Frame: Participants will be followed for 1 year post-HSCT.
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Number of participants with non-relapse mortality will be observed for 1 year post-HSCT.
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Participants will be followed for 1 year post-HSCT.
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Progression-free survival
Time Frame: Participants will be followed for 1 year post-HSCT.
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Number of participants survived with progression-free will be observed for 1 year post-HSCT.
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Participants will be followed for 1 year post-HSCT.
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Overall survival
Time Frame: Participants will be followed for 1 year post-HSCT.
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Number of participants survived for 1 year post-HSCT will be calculated.
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Participants will be followed for 1 year post-HSCT.
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Collaborators and Investigators
Investigators
- Principal Investigator: Xiao-Jun Huang, MD, Peking University People's Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Hematologic Diseases
- Blood Platelet Disorders
- Thrombocytopenia
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Protective Agents
- Respiratory System Agents
- Antioxidants
- Antidotes
- Free Radical Scavengers
- Expectorants
- Acetylcysteine
- N-monoacetylcystine
Other Study ID Numbers
- 2015PHB220
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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