A Study to Evaluate the Safety and Tolerance of SYHX1903 in Patients With Relapsed/Refractory Hematologic Malignancies
NCT ID: NCT05055791
Last Updated: 2021-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1/PHASE2
312 participants
INTERVENTIONAL
2021-12-29
2026-09-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1
Cohort 1-3 dose level 1-3 in subjects with relapsed or refractory haematological malignancies including AML/ALL/CMML/CLL.
SYHX1903
SYHX1903 tablets, orally, qd
Arm 2
Cohort 1-3 dose level 1-3 in subjects with relapsed or refractory haematological malignancies including AML/ALL/CMML/CLL.
SYHX1903
SYHX1903 tablets, orally, qd
Interventions
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SYHX1903
SYHX1903 tablets, orally, qd
Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) score ≤ 1.
* Life expectancy ≥ 3 months.
Exclusion Criteria
* Proven hematologic malignancies of the central nervous system.
* Diagnosed acute promyelocytic leukemia (predominantly granulocytic promyelocytes in bone marrow, which are ≥ 30% in NEC).
* History of other malignant tumors within 5 years, except for cured skin basal cell carcinoma, skin squamous cell carcinoma or cervical carcinoma in situ.
18 Years
75 Years
ALL
No
Sponsors
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CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
INDUSTRY
Responsible Party
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Other Identifiers
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SYHX1903-CSP-001
Identifier Type: -
Identifier Source: org_study_id
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