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Leukemia, Promyelocytic, Acute clinical trials

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NCT ID: NCT05881265 Recruiting - APL Clinical Trials

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

Start date: May 15, 2023
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT05832320 Recruiting - Clinical trials for Acute Promyelocytic Leukemia

Optimum Induction Therapy of Low-risk APL

Start date: January 1, 2023
Phase: N/A
Study type: Interventional

Despite the high cure probability for acute promyelocytic leukemia (APL), a minority of patients will relapse and the risk factors for relapse are unclear. The goal of this clinical trial is to compare the effectiveness and safety of induction of oral all-trans retinoic acid (ATRA) and realgar-indigo naturalis formula (RIF) combined with oral etoposide or daunorubicin as cytoreductive therapies in low-risk APL. The present study was to explored a cytoreduction of an oral etoposide for low-risk APL with dual induction of ATRA and RIF as a high efficacy, low recurrence, and more convenient all-oral regimen.

NCT ID: NCT05497310 Recruiting - Clinical trials for Promyelocytic Leukemia

Effectiveness and Safety of Therapy Based on Attenuated ATO Plus Low-Dose ATRA in Patients With APL

Start date: July 1, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

ATRA is the standard of care for all patients with APL. The use of lower doses of ATRA has been shown since the 1990s to achieve therapeutic efficacy with doses of 25mg/m2/day. ATO demonstrated considerable effectiveness in this disease. More recently, an attenuated regimen has been proven to be effective. In this study we intent to demonstrate the effectiveness of combined therapy of low-dose ATRA plus attenuated dose ATO.

NCT ID: NCT04996030 Suspended - Clinical trials for Acute Promyelocytic Leukemia

A Study for Oral SY-2101 for Participants With Acute Promyelocytic Leukemia

Start date: September 17, 2021
Phase: Phase 1
Study type: Interventional

SY-2101 is being studied as a treatment for participants with a type of leukemia called acute promyelocytic leukemia (APL). SY-2101 is an oral formulation of a drug called arsenic trioxide (ATO). ATO is already used to treat APL in a formulation that is given as an intravenous (IV) infusion (through a needle in the arm). SY-2101 is a formulation of ATO that is taken orally (by mouth). This trial will include participants with APL in remission, who are receiving standard of care (SOC) treatment with all-trans-retinoic acid (ATRA) and IV ATO, during the consolidation phase of chemotherapy or within the past 6 months. The participants in this trial will receive continued treatment with ATO and ATRA to help keep their cancer from coming back. There will be some weeks when participants receive IV ATO and others when they receive SY-2101 (ATO taken orally). Participants with high-risk APL may be eligible for part 1 or 4 of the study for the 6 months following completion of their standard of care ATRA and ATO treatment.

NCT ID: NCT04897490 Recruiting - Clinical trials for Promyelocytic Leukemia, Adult Acute

RWE of 1st Line Treatment With ATO/ATRA for Adult APL

Start date: March 1, 2021
Phase:
Study type: Observational

This is a multicenter, observational real world clinical trial with prospective follow up that will evaluate the treatment outcome of acute promyelocytic leukemia (APL) patients in the first line with arsenic trioxide and all trans retinoic acid (ATO/ATRA) based regimens in Argentina.

NCT ID: NCT04793919 Recruiting - Clinical trials for Acute Promyelocytic Leukemia

Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia

Start date: October 9, 2019
Phase: Phase 2
Study type: Interventional

The trial is open to all patients with a diagnosis of acute promyelocytic leukemia (APL) who are PCR-positive for the PML-RARα transcript and less than 18 years of age.

NCT ID: NCT04687176 Recruiting - Clinical trials for Acute Promyelocytic Leukemia

Frontline Oral Arsenic Trioxide for APL

Start date: January 1, 2021
Phase: Phase 2
Study type: Interventional

The investigators have formulated an oral preparation of arsenic trioxide (oral-ATO), and shown that it is efficacious for APL in R1, inducing CR2 in more than 90% of patients [8,9]. Furthermore, in an effort to prevent relapse, the investigators have moved oral-ATO forward to the maintenance of CR1. This strategy results in favorable overall-survival (OS) and leukemia-free-survival (LFS) [10], implying that prolonged treatment with oral-ATO may prevent relapses. Current protocols have incorporated i.v.-ATO in the treatment of newly-diagnosed APL [11-15]. For regimens comprising oral-ATO, ATRA and chemotherapy, 5-year OS in excess of 90% is achieved [11-15]. The investigators have also published long-term data showing the use of oral-ATO is highly effective and safe in the relapsed and frontline settings [16,17]. In this study, the investigators evaluate the use of oral-ATO and ATRA based induction regimens in newly diagnosed patients with APL with no of minimal chemotherapy in a prospective multicentre phase 2 study.

NCT ID: NCT04562818 Completed - Clinical trials for Promyelocytic Leukemia, Acute

Results From a Mexican Acute Promyelocytic Leukemia.

Mexico APL
Start date: January 1, 2007
Phase:
Study type: Observational

Retrospective, observational study, comparing treatments of acute promyelocytic leukemia in different centers in México. There is no sufficient information about acute promyelocytic leukemia in America Latina, particularly in Mexico. For these reason the investigators started a study adding all promyelocityc patients from the main Hospital in Mexico in order to put together a group of patient and analyze the response, overall survival and what are the characteristics of the population. The investigators included 5 Hospital in Mexico City and states as Monterrey, Guadalajara, San Luis Potosi, Puebla, Veracruz, Yucatán, Oaxaca, Guanajuato, Estado de México. Even do, the investigators didn´t have arsenic trioxide they are treating patients with standard chemotherapy. These paper will help to show the authorities that the cost of treating patient with standard chemotherapy is much more higher than ATO-ATRA. The investigators are now doing a cost benefit analysis so the investigators, can soon have ATO treatment as standard of care in Mexico for the treatment of acute promyelocytic leukemia.

NCT ID: NCT04446806 Recruiting - Safety and Efficacy Clinical Trials

Prevention and Treatment of Differentiation Syndrome in Patients With Acute Promyelocytic Leukemia

Start date: June 1, 2019
Phase: Phase 4
Study type: Interventional

With the introduction of all-trans-retinoic acid (ATRA) and arsenic,the outcome of patients with acute promyelocytic leukemia (APL)has been improved considerably over the last decades.However,early deaths (EDs), mainly due to APL-specific coagulopathy, differentiation syndrome (DS)emerge as a major threat to APL patients.We observe and evaluate the effectivity of induction therapy in patients with APL. Administrate intravenous dexamethasone to prevent or preemptive treat DS. Assess the efficacy and safety of ruxolitinib as second treatment in patients with severe DS with no respond to dexamethasone.Furthermore,the changes of spectrum of cytokines are monitered to find the relationship between the cytokines and the severity of DS.

NCT ID: NCT04251754 Recruiting - Clinical trials for Acute Promyelocytic Leukemia

The Acute Promyelocytic Leukaemia Asian Consortium (APL-AC) Project

Start date: February 2, 2020
Phase:
Study type: Observational

There is currently lack of collaborative data on the epidemiology, clinicopathologic features and treatment outcome of newly diagnosed and relapsed APL in Asia. In addition, there is lack of data comparing oral- As2O3-based regimens with other treatment approaches, including intravenous As2O3,in the frontline or relapsed setting. With the long-term data of oral-As2O3 based regimen for APL available from Hong Kong, retrospective and prospective comparison with other treatment approaches in other Asian countries will generate important information to pave the way for widespread application of oral-As2O3 outside Hong Kong.