Kronik Miyeloid Lösemi (CML) Hastalarında TGRX-678 Çin Faz II Çalışması

Sade dilde özet

Bu çalışma, kronik miyeloid lösemi (chronic myeloid leukemia, CML) hastalarında TGRX-678 ilacının kullanımını incelemektedir. Çalışmaya, üçüncü kuşak tirozin kinaz inhibitörü tedavisine dirençli veya bu tedaviden sonra nükseden, 18 yaş ve üzeri CML hastaları alınmaktadır. Çalışma Faz 2 aşamasında yürütülmekte ve halen katılımcı almaktadır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 2 (Phase 2)

Durum

Katılımcı alıyor

Sponsor

Shenzhen TargetRx Co., Ltd.

Müdahale

TGRX-678

Başlangıç

15.07.2024

Tahmini bitiş

30.04.2028

Ülkeler

China

İlgili genler

Merkezler

• Beijing, China

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria:

* Willing to consent
* 18 years of age or above at time of screening; both sexes eligible
* Relapsed or refactory from 3rd-generation Tyrosine kinase inhibitor (TKI) treatment
* For patients without T315I mutation, the patients must received 1st, 2nd and 3rd generation TKI
* For patients with T315I mutation, the patients much received Olverembatinib or Ponatinib treatment
* Diagnosis of CML-AP by bone marrow morphological test, molecular biology test or cytogenetic tests
* ECOG score \</=2
* Minimum life expectancy of at least 3 months
* Adequate hematological indicators
* Adequate kidney function
* Adequate liver function
* Adequate coagulation function
* Adequate pancreatic function
* Adequate QTc interval as confirmed by electrocardiogram (ECG) test
* Negative pregnancy result at screening for female patients of child-bearing potential
* Willing to take contraceptive measure during the study (For male and female patients of child-bearing potential)

Exclusion Criteria:

* Reception of TKI treatment or presence of unrecovered TKI treatment related non-hematological adverse events within 7 days of first dose
* Reception of other anti-tumor treatments
* In need for immune suppressive treatment
* Usage of drugs associated with Torsades de Pointes within 1 months before screening
* Presence of other medical conditions that require using treatment that may have drug-drug interaction with the investigational drug
* History of hemapoietic stem cell transplant
* Presence of active central nervous system conditions
* CML-AP patients who already reached major hematological response
* CML-AP patients who used to progress to Blast Phase (BP)
* Presence or having uncontrolled condition for cardiovascular diseases
* History of any heart or cardiovascular conditions (except for patients with hypertension which is controlled by anti-hypertensive drugs, and blood pressure is controlled at no higher than 160/100 mmHg for 1 months before screening)
* Usage of any Traditional Chinese Medicine indicated for anti-tumor purpose 2 weeks before first dose
* Severe hemorrhagic disease unrelated to CML
* History of severe cardiovascular condition during past TKI treatment for CML
* History of pancreatic inflammation or alcohol abuse within 3 years before first dose
* Uncontrolled Hypertriglyceridemia
* Presence of malabsorption or other conditions that may affect drug absorption
* Diagnosis of other primary malignant tumor within 5 years
* Reception of major surgery 14 days before first dose
* Presence of continuous or active infection (including HIV, hepatitis B, hepatitis C)
* Presence of other conditions that the investigators or medical monitor deem unfit for the study