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A Study to Assess Safety and Preliminary Efficacy of LP-108 Combined With Azacitidine In Subjects With AML, MDS, CMML

Primary Purpose

Acute Myeloid Leukemia, Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
LP-108
Azacitidine
Sponsored by
Guangzhou Lupeng Pharmaceutical Company LTD.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subject must has a diagnosis of one of the following: relapsed or refractory (R/R) or untreated ineligible for treatment with a standard induction chemotherapy acute myeloid leukemia (AML) ; R/R myelodysplastic syndrome(MDS) or untreated MDS with excess blasts defined as ≥ 5% blasts in either bone marrow or blood or with high risk (high and very high-risk groups according to IPSS-R) ;CMML-1 or 2 by WHO, no requirements for prior therapy. ECOG performance status ≤ 2. Estimated survival ≥ 12 weeks. Baseline white blood cell count (WBC) ≤ 25 x 109/L. Subject must has adequate organ function as defined below: Aspartate transaminase (AST) and alanine transaminase (ALT)≤3 x ULN; Bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin); adequate renal function as demonstrated by a creatinine clearance ≤1.5 x ULN ; calculated by the Cockcroft Gault formula; APTT ≤ 1.5 x ULN, INR ≤ 1.5 x ULN. Prior treatment-related toxicities must be grade 1 or baseline except for alopecia. If subject is sexually active, he/she must agree to carry out birth control throughout the study and 90 days after the last dose of LP-108. Subject must agree to have a negative serum β-HCG test result within 7 days prior to study drug. Subject must voluntarily sign and date an informed consent. Exclusion Criteria: Subject is allergic to LP-108, Azacitidine or excipients, or with poor tolerance to Azacitidine. Subject has received prior therapy with a BH3 mimetic. Subject has acute promyelocytic leukemia. Subject has t(9;22) karyotype abnormality or positive BCR/ABL1 fusion gene. Subject has known and active CNS involvement. Subject has myeloid sarcoma but no bone marrow involvement. Subject has Acute unidentified leukemia. Subject has treatment related MDS or AML. Subject has AML/MDS/CMML with myelofibrosis ≥ grade 2. Subject has received allogeneic Hematopoietic Stem Cell Transplantation (HSCT) or autologous HSCT within 3 months prior to the first dose of study drug. Subject must be at least 4 weeks from antitumor therapy, major surgery, radiation therapy, or participation in other investigational trials. Subject has received a strong and/or moderate CYP3A inhibitor or inducer, P-gp inhibitor or CYP2C8 substrate within 14 days prior to the initiation of study treatment. Subject has received drugs with a potential to cause prolonged QT intervals or torsade de pointes. Administration or consumption of any of the following within 3 days prior to the first dose of study drug: Grapefruit or grapefruit products; Seville oranges (including marmalade containing Seville oranges); Star fruit. Subject has known malignancy within 3 years prior to the first dose of study drug, with the exception of: Adequately treated basal skin cancers, in situ carcinoma of the cervix uteri or breast, localized squamous cell carcinoma. Subject has serious and/or uncontrolled systemic diseases, in the opinion of the investigator, the subject is inappropriate for enrollment into this study (serious active infection with grade ≥ 2(based on CTCAE), high blood pressure that cannot be controlled by medication, diabetes, unstable angina, congestive heart failure, Respiratory diseases requiring continuous oxygen intake, severe vascular embolism, uncontrolled massive bleeding or bleeding from vital organs, severe liver, kidney or metabolic diseases, such as cirrhosis, kidney failure, etc.). Subject has myocardial infarction or stroke within 6 months prior to the first dose of study drug. Subject has a cardiac history including the following: History of CHF requiring treatment or Ejection Fraction <50% or a cardiovascular disability status of New York Heart Association. Subject has uncontrolled and/or active systemic infection (viral, bacterial or fungal). Subject has difficulty to swallow pills or has conditions that affect drug absorption or pharmacokinetics. Strong and/or moderate CYP3A inhibitor or inducer and CYP2C8 substrate cannot be discontinued during the study. Vaccination with live, attenuated vaccines ≤4 weeks prior to initiation of study treatment or anticipation of need for such a vaccine during the study or 4 weeks after the last dose of study drug. Subject has an autoimmune disease that requires immunosuppressive therapy In the opinion of the investigator, the subject is inappropriate for enrollment into this study.

Sites / Locations

  • The First Affiliated Hospital of Nanchang UniversityRecruiting
  • First Affiliated Hospital of Soochow UniversityRecruiting
  • Affiliated Tumor Hospital of Zhengzhou University, Henan Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Dose Escalation

Safety Expansion

Efficacy Expansion [AML]

Efficacy Expansion [MDS&CMML]

Arm Description

LP-108: Cycle 0: ramp-up from Day 1, Cycle 1+: at escalating dose levels in participants with AML, MDS or CMML. Azacitidine: beginning on Day 1 through Day 7 of each Cycle (expect for Cycle 0). Strong/moderate CYP3A inhibitor and inducer are prohibited. Participants are treated indefinitely until disease progression, unacceptable toxicity or withdrawal for other reasons.

LP-108: Cycle 0: ramp-up from Day 1, Cycle 1+: Participants with AML, MDS or CMML will be treated with LP-108 to enable selection of the recommended Phase 2 dose (RP2D). Azacitidine: beginning on Day 1 through Day 7 of each Cycle (expect for Cycle 0). Strong/moderate CYP3A inhibitor and inducer are prohibited. Participants are treated indefinitely until disease progression, unacceptable toxicity or withdrawal for other reasons.

LP-108: Cycle 0: ramp-up from Day 1, Cycle 1+: at RP2D level in participants with AML . Azacitidine: beginning on Day 1 through Day 7 of each Cycle (expect for Cycle 0). After the completion of Part 1, the Part 2 dose expansion phase will begin. Strong/moderate CYP3A inhibitor and inducer are prohibited. Participants are treated indefinitely until disease progression, unacceptable toxicity or withdrawal for other reasons.

LP-108: Cycle 0: ramp-up, Cycle 1+: at RP2D level in participants with MDS or CMML. Azacitidine: beginning on Day 1 through Day 7 of each Cycle (expect for Cycle 0). Strong/moderate CYP3A inhibitor and inducer are prohibited. Participants are treated indefinitely until disease progression, unacceptable toxicity or withdrawal for other reasons.

Outcomes

Primary Outcome Measures

Maximum Tolerated Dose(MTD)
Standard phase I 3+3 design. The first 3 subjects will be assigned to dose level 1 cohort. If none of the first three subjects experiences DLT, escalation to dose level 2 cohort is permitted. If one of the first three subjects' experiences DLT, a total of six subjects will be required in that dose cohort, and escalation will only be permitted if five of six subjects do not experience DLT. If more than one DLT is observed in the dose level 2 cohort, this will be determined to be the maximally administered dose, and three more subjects will be enrolled in the dose level 1 cohort if only three were previously treated at that dose. Escalation from dose level 2 to level 3 cohort will be with the same method as before. The MTD will be the cohort in which ≤1/6 subjects have dose limiting toxicity at the dose prior to the maximally administered dose. If the dose level 3 cohort has ≤1/6 subjects with a DLT, the MTD will not have been reached.
Recommended Phase 2 Dose(RP2D)
RP2D will be determined using available safety and pharmacokinetics data upon completion of the dose escalation phase.
Incidence of AEs
Type, frequency and severity of AEs, relationship of AEs to study treatment
Incidence of clinically significant changes in clinical laboratory results
Clinically significant changes in hematology, chemistry, coagulation and urinalysis tests results.
Cmax of LP-108
Maximum plasma concentration (Cmax) of LP-108.
Tmax of LP-108
Time to maximum plasma concentration (Tmax) of LP-108.
t1/2 of LP-108
The terminal elimination half-life (t1/2).
AUC0-t of LP-108
Area under the plasma concentration-time curve (AUC) from 0 to the time of the last measurable concentration of LP-108.
CL/F of LP-108
Apparent clearance (CL/F) of LP-108.
Vd/F of LP-108
Apparent volume of distribution of LP-108.

Secondary Outcome Measures

Objective Response Rate (ORR)
Response criteria follows the 2017 European Leukemia Net (ELN) recommendations for AML( CR, CRi, PR) , the International Working Group (IWG) response criteria for MDS(CR, PR, marrow CR, HI), the international consortium proposal of uniform response criteria for myelodysplastic/myeloproliferative neoplasms (MDS/MPN) in adults(CR, PR, Marrow response, Clinical benefit).
Progression-Free Survival(PFS) (only for MDS or CMML)
PFS is defined as the number of days from the date of the first dose of study drug to the date of earliest disease progression or death.
Time to Response(TTR)
TTR is defined as the number of days from the date of the first dose of study drug to the date of earliest response.
Duration of Response(DOR)
DOR is defined as the number of days from the date of the first remission to the date of earliest disease progression or death.
DOCR (only for CR/CRi participants)
DOCR is defined as the number of days from the date of the first CR/CRi to the date of earliest disease progression or death.
Event-free Survival (EFS)
EFS is defined as the number of days from the date of first dose to the date of earliest evidence of disease progression/relapse, or initiation of new non-protocol-specified antitumor therapy without documented progression, or death.
OS
OS is defined as the number of days from the date of first dose to the date of death.

Full Information

First Posted
November 17, 2022
Last Updated
February 16, 2023
Sponsor
Guangzhou Lupeng Pharmaceutical Company LTD.
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1. Study Identification

Unique Protocol Identification Number
NCT05641259
Brief Title
A Study to Assess Safety and Preliminary Efficacy of LP-108 Combined With Azacitidine In Subjects With AML, MDS, CMML
Official Title
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of LP-108, a BCL-2 Inhibitor, Combined With Azacitidine In Subjects With AML, MDS, CMML
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 14, 2023 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangzhou Lupeng Pharmaceutical Company LTD.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a Phase 1, open-label, multicenter, dose-escalation & expansion study to evaluate the safety,tolerability and pharmacokinetics (PK) of LP-108, a BCL-2 inhibitor, combined with azacitidine, to determine the dose limiting toxicity (DLT) and the recommended Phase 2 dose (RP2D), and to assess the preliminary efficacy of this combination.
Detailed Description
This Phase 1 study will look at different doses and different treatment schedules in order to better understand the effects of the combined regimens on the newly diagnosed or refractory/relapsed adult participants with AML ,MDS or CMML. The procedures include screening for eligibility, study treatments, and blood & bone marrow tests. All the safety events will be record, pharmacokinetic parameters (Tmax, Cmax,T1/2, AUC et al.) will be calculated, response and survival will be assess during the study. Participants will be treated indefinitely until disease progression, unacceptable toxicity or withdrawal for other reasons.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia, Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
This is a Phase 1 study with a dose escalation design and an expansion cohort.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
198 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose Escalation
Arm Type
Experimental
Arm Description
LP-108: Cycle 0: ramp-up from Day 1, Cycle 1+: at escalating dose levels in participants with AML, MDS or CMML. Azacitidine: beginning on Day 1 through Day 7 of each Cycle (expect for Cycle 0). Strong/moderate CYP3A inhibitor and inducer are prohibited. Participants are treated indefinitely until disease progression, unacceptable toxicity or withdrawal for other reasons.
Arm Title
Safety Expansion
Arm Type
Experimental
Arm Description
LP-108: Cycle 0: ramp-up from Day 1, Cycle 1+: Participants with AML, MDS or CMML will be treated with LP-108 to enable selection of the recommended Phase 2 dose (RP2D). Azacitidine: beginning on Day 1 through Day 7 of each Cycle (expect for Cycle 0). Strong/moderate CYP3A inhibitor and inducer are prohibited. Participants are treated indefinitely until disease progression, unacceptable toxicity or withdrawal for other reasons.
Arm Title
Efficacy Expansion [AML]
Arm Type
Experimental
Arm Description
LP-108: Cycle 0: ramp-up from Day 1, Cycle 1+: at RP2D level in participants with AML . Azacitidine: beginning on Day 1 through Day 7 of each Cycle (expect for Cycle 0). After the completion of Part 1, the Part 2 dose expansion phase will begin. Strong/moderate CYP3A inhibitor and inducer are prohibited. Participants are treated indefinitely until disease progression, unacceptable toxicity or withdrawal for other reasons.
Arm Title
Efficacy Expansion [MDS&CMML]
Arm Type
Experimental
Arm Description
LP-108: Cycle 0: ramp-up, Cycle 1+: at RP2D level in participants with MDS or CMML. Azacitidine: beginning on Day 1 through Day 7 of each Cycle (expect for Cycle 0). Strong/moderate CYP3A inhibitor and inducer are prohibited. Participants are treated indefinitely until disease progression, unacceptable toxicity or withdrawal for other reasons.
Intervention Type
Drug
Intervention Name(s)
LP-108
Intervention Description
Oral administration for 21 or 28 days on a 28-day cycle
Intervention Type
Drug
Intervention Name(s)
Azacitidine
Intervention Description
Subcutaneous administration for 7 days on a 28-day cycle at the dose of 75mg/m2 2-2.5h hours after LP-108.
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose(MTD)
Description
Standard phase I 3+3 design. The first 3 subjects will be assigned to dose level 1 cohort. If none of the first three subjects experiences DLT, escalation to dose level 2 cohort is permitted. If one of the first three subjects' experiences DLT, a total of six subjects will be required in that dose cohort, and escalation will only be permitted if five of six subjects do not experience DLT. If more than one DLT is observed in the dose level 2 cohort, this will be determined to be the maximally administered dose, and three more subjects will be enrolled in the dose level 1 cohort if only three were previously treated at that dose. Escalation from dose level 2 to level 3 cohort will be with the same method as before. The MTD will be the cohort in which ≤1/6 subjects have dose limiting toxicity at the dose prior to the maximally administered dose. If the dose level 3 cohort has ≤1/6 subjects with a DLT, the MTD will not have been reached.
Time Frame
Up to 42 days after initial dose of study drug at the designated cohort dose.
Title
Recommended Phase 2 Dose(RP2D)
Description
RP2D will be determined using available safety and pharmacokinetics data upon completion of the dose escalation phase.
Time Frame
Up to 1.5 years
Title
Incidence of AEs
Description
Type, frequency and severity of AEs, relationship of AEs to study treatment
Time Frame
From first dose of study drug to 28 days after last dose of study drug
Title
Incidence of clinically significant changes in clinical laboratory results
Description
Clinically significant changes in hematology, chemistry, coagulation and urinalysis tests results.
Time Frame
From first dose of study drug to 28 days after last dose of study drug
Title
Cmax of LP-108
Description
Maximum plasma concentration (Cmax) of LP-108.
Time Frame
Up to 24 hours post dose
Title
Tmax of LP-108
Description
Time to maximum plasma concentration (Tmax) of LP-108.
Time Frame
Up to 24 hours post dose
Title
t1/2 of LP-108
Description
The terminal elimination half-life (t1/2).
Time Frame
Up to 24 hours post dose
Title
AUC0-t of LP-108
Description
Area under the plasma concentration-time curve (AUC) from 0 to the time of the last measurable concentration of LP-108.
Time Frame
Up to 24 hours post dose
Title
CL/F of LP-108
Description
Apparent clearance (CL/F) of LP-108.
Time Frame
Up to 24 hours post dose
Title
Vd/F of LP-108
Description
Apparent volume of distribution of LP-108.
Time Frame
Up to 24 hours post dose
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
Response criteria follows the 2017 European Leukemia Net (ELN) recommendations for AML( CR, CRi, PR) , the International Working Group (IWG) response criteria for MDS(CR, PR, marrow CR, HI), the international consortium proposal of uniform response criteria for myelodysplastic/myeloproliferative neoplasms (MDS/MPN) in adults(CR, PR, Marrow response, Clinical benefit).
Time Frame
Measured from Cycle 1 Day 1 to 28 days after last dose of study drug, and assessed up to 24 months.
Title
Progression-Free Survival(PFS) (only for MDS or CMML)
Description
PFS is defined as the number of days from the date of the first dose of study drug to the date of earliest disease progression or death.
Time Frame
Measured from the date of first dose of study drug to the date of earliest disease progression or death or last visit, and assessed up to 24 months.
Title
Time to Response(TTR)
Description
TTR is defined as the number of days from the date of the first dose of study drug to the date of earliest response.
Time Frame
Measured from the date of the first dose of study drug to the date of earliest response, and assessed up to 6 months.
Title
Duration of Response(DOR)
Description
DOR is defined as the number of days from the date of the first remission to the date of earliest disease progression or death.
Time Frame
Measured from the date of the first remission to the date of earliest disease progression or death, and assessed up to 24 months.
Title
DOCR (only for CR/CRi participants)
Description
DOCR is defined as the number of days from the date of the first CR/CRi to the date of earliest disease progression or death.
Time Frame
Measured from the date of the first CR/CRi to the date of earliest disease progression or death, and assessed up to 24 months.
Title
Event-free Survival (EFS)
Description
EFS is defined as the number of days from the date of first dose to the date of earliest evidence of disease progression/relapse, or initiation of new non-protocol-specified antitumor therapy without documented progression, or death.
Time Frame
Measured from the date of first dose to the date of earliest evidence of disease progression, initiation of new non-protocol-specified antitumor therapy without documented progression, death, and for up to 5 years after the last subject is enrolled.
Title
OS
Description
OS is defined as the number of days from the date of first dose to the date of death.
Time Frame
Measured from the date of date of first dose to the date of death or last visit, and for up to 5 years after the last subject is enrolled.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject must has a diagnosis of one of the following: relapsed or refractory (R/R) or untreated ineligible for treatment with a standard induction chemotherapy acute myeloid leukemia (AML) ; R/R myelodysplastic syndrome(MDS) or untreated MDS with excess blasts defined as ≥ 5% blasts in either bone marrow or blood or with high risk (high and very high-risk groups according to IPSS-R) ;CMML-1 or 2 by WHO, no requirements for prior therapy. ECOG performance status ≤ 2. Estimated survival ≥ 12 weeks. Baseline white blood cell count (WBC) ≤ 25 x 109/L. Subject must has adequate organ function as defined below: Aspartate transaminase (AST) and alanine transaminase (ALT)≤3 x ULN; Bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin); adequate renal function as demonstrated by a creatinine clearance ≤1.5 x ULN ; calculated by the Cockcroft Gault formula; APTT ≤ 1.5 x ULN, INR ≤ 1.5 x ULN. Prior treatment-related toxicities must be grade 1 or baseline except for alopecia. If subject is sexually active, he/she must agree to carry out birth control throughout the study and 90 days after the last dose of LP-108. Subject must agree to have a negative serum β-HCG test result within 7 days prior to study drug. Subject must voluntarily sign and date an informed consent. Exclusion Criteria: Subject is allergic to LP-108, Azacitidine or excipients, or with poor tolerance to Azacitidine. Subject has received prior therapy with a BH3 mimetic. Subject has acute promyelocytic leukemia. Subject has t(9;22) karyotype abnormality or positive BCR/ABL1 fusion gene. Subject has known and active CNS involvement. Subject has myeloid sarcoma but no bone marrow involvement. Subject has Acute unidentified leukemia. Subject has treatment related MDS or AML. Subject has AML/MDS/CMML with myelofibrosis ≥ grade 2. Subject has received allogeneic Hematopoietic Stem Cell Transplantation (HSCT) or autologous HSCT within 3 months prior to the first dose of study drug. Subject must be at least 4 weeks from antitumor therapy, major surgery, radiation therapy, or participation in other investigational trials. Subject has received a strong and/or moderate CYP3A inhibitor or inducer, P-gp inhibitor or CYP2C8 substrate within 14 days prior to the initiation of study treatment. Subject has received drugs with a potential to cause prolonged QT intervals or torsade de pointes. Administration or consumption of any of the following within 3 days prior to the first dose of study drug: Grapefruit or grapefruit products; Seville oranges (including marmalade containing Seville oranges); Star fruit. Subject has known malignancy within 3 years prior to the first dose of study drug, with the exception of: Adequately treated basal skin cancers, in situ carcinoma of the cervix uteri or breast, localized squamous cell carcinoma. Subject has serious and/or uncontrolled systemic diseases, in the opinion of the investigator, the subject is inappropriate for enrollment into this study (serious active infection with grade ≥ 2(based on CTCAE), high blood pressure that cannot be controlled by medication, diabetes, unstable angina, congestive heart failure, Respiratory diseases requiring continuous oxygen intake, severe vascular embolism, uncontrolled massive bleeding or bleeding from vital organs, severe liver, kidney or metabolic diseases, such as cirrhosis, kidney failure, etc.). Subject has myocardial infarction or stroke within 6 months prior to the first dose of study drug. Subject has a cardiac history including the following: History of CHF requiring treatment or Ejection Fraction <50% or a cardiovascular disability status of New York Heart Association. Subject has uncontrolled and/or active systemic infection (viral, bacterial or fungal). Subject has difficulty to swallow pills or has conditions that affect drug absorption or pharmacokinetics. Strong and/or moderate CYP3A inhibitor or inducer and CYP2C8 substrate cannot be discontinued during the study. Vaccination with live, attenuated vaccines ≤4 weeks prior to initiation of study treatment or anticipation of need for such a vaccine during the study or 4 weeks after the last dose of study drug. Subject has an autoimmune disease that requires immunosuppressive therapy In the opinion of the investigator, the subject is inappropriate for enrollment into this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yue Shen, PhD
Phone
86-020-31605119
Email
yshen@lupengbio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Depei Wu, PhD
Organizational Affiliation
First Affiliated Hospital of Soochow University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Xudong Wei, PhD
Organizational Affiliation
Affiliated Tumor Hospital of Zhengzhou University, Henan Cancer Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Qiubai Li, PhD
Organizational Affiliation
Wuhan Union Hospital, China
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Li Wang, PhD
Organizational Affiliation
First Affiliated Hospital of Chongqing Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fei Li, PhD
Organizational Affiliation
The First Affiliated Hospital of Nanchang University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiaojing Yan, PhD
Organizational Affiliation
First Hospital of China Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fei Li
Facility Name
First Affiliated Hospital of Soochow University
City
Suzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Depei Wu
Facility Name
Affiliated Tumor Hospital of Zhengzhou University, Henan Cancer Hospital
City
Zhengzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fei Li

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27895058
Citation
Dohner H, Estey E, Grimwade D, Amadori S, Appelbaum FR, Buchner T, Dombret H, Ebert BL, Fenaux P, Larson RA, Levine RL, Lo-Coco F, Naoe T, Niederwieser D, Ossenkoppele GJ, Sanz M, Sierra J, Tallman MS, Tien HF, Wei AH, Lowenberg B, Bloomfield CD. Diagnosis and management of AML in adults: 2017 ELN recommendations from an international expert panel. Blood. 2017 Jan 26;129(4):424-447. doi: 10.1182/blood-2016-08-733196. Epub 2016 Nov 28.
Results Reference
result
PubMed Identifier
16609072
Citation
Cheson BD, Greenberg PL, Bennett JM, Lowenberg B, Wijermans PW, Nimer SD, Pinto A, Beran M, de Witte TM, Stone RM, Mittelman M, Sanz GF, Gore SD, Schiffer CA, Kantarjian H. Clinical application and proposal for modification of the International Working Group (IWG) response criteria in myelodysplasia. Blood. 2006 Jul 15;108(2):419-25. doi: 10.1182/blood-2005-10-4149. Epub 2006 Apr 11.
Results Reference
result
PubMed Identifier
25624319
Citation
Savona MR, Malcovati L, Komrokji R, Tiu RV, Mughal TI, Orazi A, Kiladjian JJ, Padron E, Solary E, Tibes R, Itzykson R, Cazzola M, Mesa R, Maciejewski J, Fenaux P, Garcia-Manero G, Gerds A, Sanz G, Niemeyer CM, Cervantes F, Germing U, Cross NC, List AF; MDS/MPN International Working Group. An international consortium proposal of uniform response criteria for myelodysplastic/myeloproliferative neoplasms (MDS/MPN) in adults. Blood. 2015 Mar 19;125(12):1857-65. doi: 10.1182/blood-2014-10-607341. Epub 2015 Jan 26.
Results Reference
result

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A Study to Assess Safety and Preliminary Efficacy of LP-108 Combined With Azacitidine In Subjects With AML, MDS, CMML

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