A Multicenter Randomized Open-label Study of Chidamide Plus HD-DEX Versus HD-DEX in ITP

NCT05411874 | Unknown Phase 2 DMC

• 1 other identifier: ITP-Chidamide plus DEX
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Recently, histone deacetylase inhibitors (HDACi) has been used for their anti-inflammatory and immunomodulatory activities. It has been shown that HDACi can alleviate graft-versus-host disease by enhancing the number and function of Foxp3+ Tregs. Our group found that low-dose HDACi alleviated thrombocytopenia in both passive and active murine models of ITP. Furthermore, low-dose HDACi attenuated macrophage phagocytosis of antibody-coated platelets, stimulated production of natural Foxp3+ Tregs, promoted peripheral conversion of T cells into Tregs, and restored Treg suppressive function in vivo and in vitro. The project was undertaking by Qilu Hospital of Shandong University and other 10 well-known hospitals in China. In order to report the efficacy and safety of the low dose chidamide combined with high-dose dexamethasone versus high-dose dexamethasone in the management of ITP.

Conditions

Thrombocytopenia

Keywords

HD-DEX; Chidamide

Outcome Measures

Primary Outcomes (1)

• Sustained response

  The maintenance of platelet count ≥ 30 x 10\^9/L, at least 2-fold increase of the baseline count, the absence of bleeding, and no need for rescue medication at the 6-month follow-up.

  6 month

Secondary Outcomes (6)

• Initial response

  day 14

• Number of patients with bleeding

  6 month

• Number of patients with adverse events

  6 month

• Time to response

  6 month

• Duration of response (DOR)

  6 month

Study Arms (2)

Chidamide plus HD-DXM

EXPERIMENTAL

Chidamide (orally at 5 mg biw for 24 weeks) HD-DXM (orally at 40 mg daily for 4 days)

Drug: Chidamide; Drug: HD-DXM

HD-DXM

ACTIVE COMPARATOR

HD-DXM (orally at 40 mg daily for 4 days )

Drug: HD-DXM

Interventions

Chidamide DRUG

5mg po biw for 24 weeks

Chidamide plus HD-DXM

HD-DXM DRUG

40mg po qd for 4days

Chidamide plus HD-DXM; HD-DXM

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• newly diagnosed ITP patients need of treatment(s) to minimize the risk of clinically significant bleeding primary ITP confirmed by excluding other supervened causes of thrombocytopenia

You may not qualify if:

• pregnancy hypertension cardiovascular disease diabetes liver and kidney function impairment HCV, HIV, HBsAg seropositive status patients with systemic lupus erythematosus and/or antiphospholipid syndrome

Sponsors & Collaborators

• Shandong University: lead

Related Publications (2)

• Provan D, Stasi R, Newland AC, Blanchette VS, Bolton-Maggs P, Bussel JB, Chong BH, Cines DB, Gernsheimer TB, Godeau B, Grainger J, Greer I, Hunt BJ, Imbach PA, Lyons G, McMillan R, Rodeghiero F, Sanz MA, Tarantino M, Watson S, Young J, Kuter DJ. International consensus report on the investigation and management of primary immune thrombocytopenia. Blood. 2010 Jan 14;115(2):168-86. doi: 10.1182/blood-2009-06-225565. Epub 2009 Oct 21.

  PMID: 19846889 BACKGROUND

• Rodeghiero F, Stasi R, Gernsheimer T, Michel M, Provan D, Arnold DM, Bussel JB, Cines DB, Chong BH, Cooper N, Godeau B, Lechner K, Mazzucconi MG, McMillan R, Sanz MA, Imbach P, Blanchette V, Kuhne T, Ruggeri M, George JN. Standardization of terminology, definitions and outcome criteria in immune thrombocytopenic purpura of adults and children: report from an international working group. Blood. 2009 Mar 12;113(11):2386-93. doi: 10.1182/blood-2008-07-162503. Epub 2008 Nov 12.

  PMID: 19005182 BACKGROUND

MeSH Terms

Conditions

Thrombocytopenia

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Central Study Contacts

Ming Hou, Doctor

CONTACT

houming@medmail.com.cn

Ming Hou, Doctor

CONTACT

82169896; houming@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director

Study Record Dates

• First Submitted: June 6, 2022
• First Posted: June 9, 2022
• Study Start: October 1, 2022
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2024
• Last Updated: June 9, 2022

Record last verified: 2022-06