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| Name | Class |
|---|---|
| Peking University People's Hospital | OTHER |
| Henan Cancer Hospital | OTHER_GOV |
| Nanfang Hospital, Southern Medical University | OTHER |
| The First Affiliated Hospital of Soochow University |
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A Phase II study evaluating the safety and efficacy of TGRX-678 in Chronic Myelogenous Leukemia (CML) patients in Accelerated phase (AP) and are relapsed or refractory from third-generation Tyrosine Kinase Inhibitor (TKI) treatment
This Phase II study is of single-arm, open-label and multi-center designs to study safety and efficacy profiles of TGRX-678 in CML-AP patients. Patients need to have medical history of failing treatment(s) from third-generation TKI drugs. Patients with or without T315I mutation is enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: TGRX-678 | Experimental | All patients with CML-AP to be treated with TGRX-678. Patients with T315I mutation or without T315I mutation will be assigned into separate cohorts for evaluation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TGRX-678 | Drug | All patients will be given TGRX-678 240 mg once daily. TGRX-678 is to be taken orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Major Hematologic Response (MaHR) | Number of patients who reached, and rate of occurence of major hematologic response, including those who reached complete hematologic response (CHR) or no evidence of leukemia (NEL). CHR and NEL are defined per China national treatment guideline for CML (ver. 2022). Indicators for hematologic responses will be obtained via peripheral blood tests. | At screening, on Day 1 of every treatment cycle (each cycle is 28 days) and at end of treatment; average of study duration is 3.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Cytogenetic Response | Number of patients who reached, and rate of occurence of cytogenetic response, including those with major cytogenetic response (MCyR) or complete cytogenetic response (CCyR). Cytogenetic responses are defined per China national treatment guideline for CML (ver. 2022). Indicators for cytogenetic responses will be obtained via bone marrow biopsy. | At screening, on Day 1 of cycle 2, cycle 4 and every 3 cycles afterwards of the treatment cycle (each cycle is 28 days) and at the end of treatment; average of study duration is 3.5 years |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yingkun Lu | Contact | 18602219981 | yingkun.lv@tjrbiosciences.com |
| Name | Affiliation | Role |
|---|---|---|
| Qian Jiang, MD | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | China |
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| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D015465 | Leukemia, Myeloid, Accelerated Phase |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| OTHER |
| Chinese Academy of Medical Sciences | OTHER |
| First Affiliated Hospital of Zhejiang University | OTHER |
| Shenzhen Second People's Hospital | OTHER |
| Ruijin Hospital | OTHER |
| Shengjing Hospital | OTHER |
| Huazhong University of Science and Technology | OTHER |
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| Major Molecular Response (MMR) | Number of patients who reached, and rate of occurence of MMR. Cytogenetic response is defined per China national treatment guideline for CML (ver. 2022). Indicators for molecular responses will be obtained via genetic testing on transcript levels of BCR-ABL gene. | At screening, on Day 1 of cycle 2, cycle 4 and every 3 cycles afterwards of the treatment cycle (each cycle is 28 days) and at the end of treatment; average of study duration is 3.5 years |
| Time to Response (TTR) | TTR defined by the time from the start of treatment to the first efficacy response; TTR as evaluated by investigator | At screening, on Day 1 of cycle 2, cycle 4 and every 3 cycles afterwards of the treatment cycle (each cycle is 28 days) and at the end of treatment; average of study duration is 3.5 years |
| Duration of Response (DOR) | DOR defined as the duration from first occurence of treatment response to progressive disease/relapse; DOR as evaluated by investigator | At screening, on Day 1 of cycle 2, cycle 4 and every 3 cycles afterwards of the treatment cycle (each cycle is 28 days) and at the end of treatment; average of study duration is 3.5 years |
| Progression Free Survival (PFS) | PFS defined as the time from enrollment to progressive disease or death of any cause; PFS as evaluated by investigator. | At screening, on Day 1 of cycle 2, cycle 4 and every 3 cycles afterwards of the treatment cycle (each cycle is 28 days) and at the end of treatment; average of study duration is 3.5 years |
| Overall Survival (OS) | OS defined as the time from enrollment to death of any cause; OS as evaluated by investigator | At screening, on Day 1 of cycle 2, cycle 4 and every 3 cycles afterwards of the treatment cycle (each cycle is 28 days) and at the end of treatment; average of study duration is 3.5 years |
| Treatment Emergent Adverse Event (TEAE) | To record and analyse the occurence and frequency of adverse events during the study | Through completion of the study, an average of 3.5 years |
| D009196 |
| Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |