成大醫院血液科臨床試驗

NCKUH Hematology Trial Dashboard

Showing 13 trials

CLL
Recruiting

BELLWAVE-010

NCT05947851•Merck Sharp & Dohme LLC (MSD)
CLLSLLR/r>1Lnon-covalent_BTKi2L3L

Nemtabrutinib (MK-1026) + venetoclax
Phase III, randomized, open-label, two-part (Part 1: dose-finding safety run-in; Part 2: randomized active-controlled), multicenter; comparator VR (venetoclax + rituximab)
Key Inclusion

Adults ≥18 with R/R CLL/SLL (not refractory to venetoclax), ≥1 prior therapy, active disease, ECOG 0–2, measurable disease burden, adequate organ function.

PI: 李欣學曾睦捷 (4620)
Enrolled/ Expected:0 / 0
Lymphoma
Recruiting

DR-01-ONC-001

NCT05475925•Dren Bio, Inc.
LGLLNKTCLPTCLCD94

DR-01
Multicenter, open-label, FIH Phase 1/2 study.
Key Inclusion

Adults >=18 with LGLL or eligible cytotoxic lymphoma, ECOG and disease-specific prior-therapy requirements, adequate organ/coagulation function, and reproductive precautions; disease must be evaluable per protocol response frameworks.

PI: 陳彩雲李佳玲 (4620)
Enrolled/ Expected:2 / 2
AML-MDS
Recruiting

DSP-5336-101

NCT04988555•Sumitomo Pharma America, Inc.
AMLALLRRMLLrKMT2A_fusionNPM1_mutationMenin_Inhibiitor

Enzomenib (DSP-5336)
Phase 1/2, multicohort, open-label study
Key Inclusion

R/R AML/ALL (± MLLr or NPM1m) with required disease/genomic confirmation; age >=18 (site exceptions), ECOG <=2, WBC below protocol threshold, adequate renal/hepatic function, life expectancy >=3 months, contraception/pregnancy requirements met.

PI: 陳彩雲賴文睿 (3041)
Enrolled/ Expected:0 / 3
Lymphoma
Recruiting

DZ2022J0004

NCT07234162•Dizal (Jiangsu) Pharmaceutical Co., Ltd.
RRPTCLAITLALCL-ALK+ALCL-ALK-FTCLPTCL-TFHEATLMEITLNKTCLHSTCLSPTCL

Golidicitinib
Phase 3, open-label, randomized, multinational study
Key Inclusion

Adults (>=18) with histologically confirmed r/r PTCL subtype, ECOG 0–2, prior systemic therapy failure/intolerance (with subtype-specific prior-therapy requirements), transplant-ineligible

PI: 陳彩雲李佳玲 (4620)
Enrolled/ Expected:3 / 4
AML-MDS
Recruiting

ELRISE MDS

NCT07422480•Takeda Pharmaceuticals
MDSIPSS-R-VLRIPSS-R-LRIPSS-R-IR1LESA-naïvetransfusion-dependent

Elritercept (TAK-226, formerly KER-050)
Phase 3, multicenter, randomized, open-label, active-controlled, two-arm, parallel-group
Key Inclusion

Adults ≥18 with WHO 2016 MDS, IPSS-R very low/low/intermediate risk, BM blasts <5%, sEPO <500 U/L, RBC transfusion-dependent (2–6 units/8 wks), Hgb <11 g/dL, ECOG 0–2.

PI: 陳彩雲李佳玲 (4620)
Enrolled/ Expected:0 / 0
MPN
Recruiting

KRT-232-115

NCT06479135•Kartos Therapeutics, Inc.
PMF1LPost-ET-MFPost-PV-MFTP53WTMDM2

Navtemadlin (KRT-232) + Ruxolitinib
Global, multicenter Phase 3 randomized double-blind placebo-controlled add-on trial.
Key Inclusion

Adults with PMF/post-PV MF/post-ET MF, ECOG 0–2, TP53WT at randomization, ruxolitinib run-in response in suboptimal range, stable ruxolitinib dosing, protocol-defined hematologic/hepatic/renal function, and strict contraception requirements.

PI: 許雅婷鄭琍文 (4620)
Enrolled/ Expected:0 / 0
MPN
Recruiting

MANIFEST-3

NCT07357727•Novartis Pharma AG
JAKi-naive MF (PMFpost-PV/ET MF)1LBET inhibitor + JAKiPhase IIIRCTdouble-blind

pelabresib (DAK539) + ruxolitinib (Jakavi)
Phase 3, randomized 1:1, double-blind, placebo-controlled combination, two-arm, multicenter, ~460 patients (~280 with TSS ≥25), stratified by DIPSS, platelet count, and baseline TSS; no crossover; primary endpoints at Week 24 (spleen volume, MFSAF v4.0 symptoms)
Key Inclusion

Adults ≥18 with PMF or post-PV/ET MF (ICC 2022), DIPSS int-1 to high risk, JAKi-naive, spleen ≥450 cm3, TSS ≥15, platelets ≥100, ANC ≥1, blood blasts <5%, ECOG 0–2, adequate liver function.

PI: 陳彩雲鄭琍文 (4620)
Enrolled/ Expected:0 / 0
CLL
Recruiting

MK1026-010

NCT05947851•Merck Sharp & Dohme LLC (MSD)
Relapsed/Refractory CLL/SLL2L+BTK inhibitor (non-covalent)BCL2 inhibitorPhase 3open-labelrandomized controlled trial

Nemtabrutinib + Venetoclax
Phase 3, randomized 1:1, open-label, two-arm, multicenter
PI: 李欣學曾睦捷 (27-1284)
Enrolled/ Expected:0 / 4
ALL
Recruiting

POLARIS-1

NCT06051409 (EU CT Number / EUCTN: 2024-511496-14)•Ascentage Pharma Group Inc.
Ph+ALLALL1LBCR-ABL-TKIT315

Olverembatinib (HQP1351)
Phase 3, randomized 2:1 (Part 2), open-label, multicenter, two-arm; two-part study (Part 1 safety/efficacy up to 50 pts; Part 2 registrational ~300 pts)
Key Inclusion

Adults ≥18 with newly diagnosed Ph+/BCR-ABL1+ ALL (2016 WHO), essentially treatment-naïve, ECOG ≤2, life expectancy ≥3 mo, adequate hepatic/renal/cardiac/coagulation function, agree to contraception.

PI: 陳彩雲李佳玲
Enrolled/ Expected:0 / 0
CML
Recruiting

POLARIS-2

NCT06423911 •Ascentage Pharma Group Inc.
CML-CPTKIOlverrembatinibHQP1351T315IT315

Olverembatinib (HQP1351)
Phase 3, two parts; Part A: randomized 2:1, open-label, olverembatinib 30 mg QOD vs bosutinib 500 mg QD in CML-CP after ≥2 TKIs (N=285), stratified by BCR::ABL1 (IS) ratio, crossover permitted on treatment failure; Part B: single-arm, olverembatinib 40 mg QOD in T315I+ CML-CP after ≥1 TKI (N=48); primary endpoint MMR rate at 24 weeks
Key Inclusion

Adults ≥18 with CML-CP after ≥2 TKIs (Part A) or T315I+ after ≥1 TKI with no other options (Part B), TKI failure/intolerance per ELN 2025, ECOG ≤2, adequate organ function and electrolytes.

PI: 陳彩雲李佳玲 (4620)
Enrolled/ Expected:0 / 0
Lymphoma
Recruiting

R1979-ONC-2210 (OLYMPIA-5)

NCT06149286•Regeneron Pharmaceuticals, Inc.
FLMZL2L3L

Odronextamab (REGN1979) in combination with lenalidomide
Phase 3, open-label, randomized comparative study
Key Inclusion

Adult (>=18) R/R FL1-3a or MZL after >=1 prior systemic line incl anti-CD20; measurable disease; ECOG 0-2; adequate marrow/organ function; informed consent; questionnaire/visit compliance; lenalidomide precautions.

PI: 陳彩雲溫上容 (3998)
Enrolled/ Expected:0 / 3
AML-MDS
Recruiting

RENEW (KER-050-D301)

NCT06499285•Takeda Pharmaceuticals
MDSIPSS-R-VLRIPSS-R-LRIPSS-R-IR1LESA-naïvetransfusion-dependent

Elritercept (TAK-226, formerly KER-050)
III
Key Inclusion

Adults ≥18; MDS by WHO 2016, IPSS-R very-low/low/intermediate risk; transfusion-dependent (≥4 RBC units/16 wks); refractory/intolerant or unlikely to respond to ESAs; <5% marrow blasts; ECOG 0–2.

PI: 陳彩雲曾睦捷 (4620)
Enrolled/ Expected:0 / 2
MM
Recruiting

TRIlogy-5

NCT07518186 •Janssen Research & Development, LLC (Johnson & Johnson)
RRMMMM2L3L4LCD38_Lena_Exposed

JNJ-79635322 (INN: ramantamig)
Phase 3, randomized 1:1, open-label, parallel-group, two-arm, multicenter
Key Inclusion

Adults ≥18 with measurable R/R multiple myeloma, 1–3 prior lines including an anti-CD38 antibody and lenalidomide, ECOG 0–2, adequate organ/marrow function, no prior BCMA/GPRC5D T-cell redirection.

PI: 陳彩雲曾睦捷 (815271284)
Enrolled/ Expected:0 / 0
臨床試驗資訊以最新版本計畫書為準 Clinical trial information is subject to the latest version of the Protocol.