RecruitingPhase 2NCT05881265

Treatment of Chidamide and Venetoclax for Retinoic Acid and Arsenic Resistant Acute Promyelocytic Leukemia

Multi-center Phase II Prospective Study for the Treatment of Chidamide and Venetoclax in Patients With All-trans Retinoic Acid (ATRA) and Arsenic (As) Resistant Acute Promyelocytic Leukemia (APL)


Sponsor

Shanghai Jiao Tong University School of Medicine

Enrollment

30 participants

Start Date

May 15, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Based on the current treatment with retinoic acid (ATRA) and arsenic (As), most patients with APL achieved long-term survival. There are few patients relapsed and became refractory to the RA and As treatment. In our pre-clinical study, we found that targeting histone deacetylase inhibitor 3 (HDAC3)degraded PML-RARa oncoprotein and induced differentiation and apoptosis of RA and As resistant APL in vitro and in vivo. In this study, we evaluate the efficacy and feasibility of combination therapy for HDAC3 inhibitor and venetoclax in patients with refractory APL.


Eligibility

Min Age: 16 YearsMax Age: 70 Years

Inclusion Criteria4

  • Patients with PML-RARα+ APL
  • Patients in non-remission status after treatment of RA combined with As
  • Patients with life expectance \>=3 months
  • Inform consent provided

Exclusion Criteria3

  • Patients with incontrollable infection
  • Patients with life-expectancy less than 2 months
  • Patients with abnormal liver (\>3XN) and renal function (\>3XN)

Interventions

DRUGChidamide+venetoclax

Chidamide 30mg BIW x 4 weeks; Venetoclax 100mg D1, 200mg D2 and 400mg D3-28


Locations(5)

The Affiliated Huai An No 1 Perople's Hospital of NanJing University

Huai'an, Jiangsu, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Jiong HU

Shanghai, Shanghai Municipality, China

Zhaxin Hospital, Go Broad Health Care

Shanghai, Shanghai Municipality, China

NanFang Hospital

Guangzhou, China

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NCT05881265