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A Study of Tazemetostat in Combination With HMPL-689 in Patients With Relapsed/Refractory Lymphoma

Primary Purpose

Relapsed/Refractory Lymphoma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
tazemetostat
HMPL-689
Sponsored by
Hutchmed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed/Refractory Lymphoma

Eligibility Criteria

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

Criteria: Inclusion Criteria: Willing and able to give informed consent, as documented by signed ICF Age ≥ 18 years Patients with histologically confirmed R/R lymphoma: • Phase IIa (dose escalation study): patients with relapsed or refractory lymphoma who have failed standard treatment and have no standard treatment options • Phase IIb( expansion Study ): Cohort 1 (DLBCL, FL 3b) Histologically confirmed DLBCL, FL 3b (including primary mediastinal B-cell lymphoma) with relapsed/refractory disease Cohort 2 (FL) patients with histologically confirmed R/R FL (Grade 1, 2, 3a) Cohort 3 (MCL): Patients with R/R MCL who had prior therapies Cohort 4 (PTCL): Patients with histologically confirmed R/R PTCL who have failed or cannot tolerate standard therapy Patients must have at least one measurable lesion Life expectancy ≥ 12 weeks Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 Adequate bone marrow function, renal function and hepatic function: Currently human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or cytomegalovirus (CMV) is inactive Female patients of childbearing potential must agree to use a double contraception method and male patients with partners of childbearing potential must also use an effective double contraception method during the study period and for 3 months after the final dose Exclusion Criteria: Patients who have previously used EZH2 inhibitors and PI3K inhibitors, or previously could not tolerate EZH2 inhibitors or PI3K inhibitors Patients with brain metastases or leptomeningeal invasion Has thrombocytopenia, neutropenia, or anemia of Grade ≥3 (per CTCAE 5.0 criteria) and any prior history of myeloid malignancies, including myelodysplastic syndrome (MDS / AML/MPN) Has abnormalities known to be associated with MDS (e.g. del 5q, chr 7 abn) and multiple primary neoplasms (MPN) (e.g. JAK2 V617F) observed in cytogenetic testing and DNA sequencing

Sites / Locations

  • Ruijin Hospital, Shanghai Jiaotong University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

tazemetostat combined with HMP689 open-label treatment arm

Arm Description

Dose Escalation Phase (Phase IIa): patients with relapsed or refractory lymphoma who have failed standard treatment and have no standard treatment options Dose Expansion Phase (Phase IIb): Cohort 1 (DLBCL, FL 3b): Histologically confirmed DLBCL, FL 3b (including primary mediastinal B-cell lymphoma) with relapsed/refractory disease ; Cohort 2 (FL) patients with histologically confirmed R/R FL (Grade 1, 2, 3a); Cohort 3 (MCL): Patients with R/R MCL who had prior therapies ; Cohort 4 (PTCL): Patients with histologically confirmed R/R PTCL who have failed or cannot tolerate standard therapy

Outcomes

Primary Outcome Measures

Dose Escalation Phase (Phase IIa):To evaluate the safety, tolerability, and determine the maximum tolerated dose (MTD) and/or RP2D of Tazemetostat in combination with HMPL-689 in patients with R/R lymphoma
Occurrence of Dose Limiting Toxicities (DLTs) During the DLT Observation Period
Dose Expansion Phase (Phase IIb):To evaluate the ORR of Tazemetostat in combination with HMPL-689 in patients with lymphoma
Percentage of patients with Complete Response(CR) or Partial Response(PR) as the best response evaluated in accordance with Lugano2014
Dose Expansion Phase (Phase IIb):To evaluate the DCR of Tazemetostat in combination with HMPL-689 in patients with lymphoma
the proportion of patients with CR or PR or stable disease (SD) as the best response with Lugano2014
Dose Expansion Phase (Phase IIb):To evaluate the DOR of Tazemetostat in combination with HMPL-689 in patients with lymphoma
as the time from the first appearance of CR or PR to PD or death for any reason (whichever comes first), in the patients with objective response with Lugano2014)
Dose Expansion Phase (Phase IIb):To evaluate the PFS of Tazemetostat in combination with HMPL-689 in patients with lymphoma
the proportion of patients with CR or PR or stable disease (SD) as the best response with Lugano2014

Secondary Outcome Measures

Dose Escalation Phase (Phase IIa):Objective Response Rate (ORR)
Percentage of patients with Complete Response (CR) or Partial Response (PR) as the best response evaluated in accordance with Lugano 2014
Dose Escalation Phase (Phase IIa)-Complete Response Rate (CR rate)
Percentage of patients with Complete Response (CR) as the best response evaluated in accordance with Lugano 2014
Dose Escalation Phase (Phase IIa)-Disease control rate (DCR)
the proportion of patients with CR or PR or stable disease (SD) as the best response
Dose Escalation Phase (Phase IIa)-Duration of response (DoR)
as the time from the first appearance of CR or PR to PD or death for any reason (whichever comes first), in the patients with objective response
Dose Escalation Phase (Phase IIa)-Time to response (TTR)
the time from the first dose of Tazemetostat in combination with HMPL-689 to the first objective response
Dose Escalation Phase (Phase IIa)-Progression-free survival (PFS)
time from the first dose of study treatment to PD or death for any reason, whichever comes first
Dose Escalation Phase (Phase IIa)-Overall survival (OS)
time from the first dose of study treatment to death for any reason time from the first dose of study treatment to death for any reason
Dose Expansion Phase (Phase IIb)-Evaluation of Tazemetostat safety and tolerability in Combination with HMPL-689 in Patients with R/R Lymphoma
Incidence, severity, and causality to study drug of treatment-emergent adverse events (TEAEs) as determined by the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE 5.0)
Geomean maximum concentration (Cmax) of tazemetostat and its metabolite EPZ-6930 in blood
Cmax is defined as the maximum observed concentration that a drug achieves in a test area of the body after the drug has been administered. Plasma concentration-time profiles of tazemetostat and EPZ-6930 will be plotted using non-compartmental analysis and will be analyzed to determine Cmax. Cmax will be summarized as the geomean and geomean CV% for all participants.
Median time to reach maximum concentration (Tmax) of tazemetostat and its metabolite EPZ-6930 in blood
Tmax is defined as the time from dosing to reach the maximum observed concentration a drug achieves in a specified compartment or test area of the body after the drug has been administered. Plasma concentration-time profiles of tazemetostat and EPZ-6930 will be plotted using non-compartmental analysis and will be analyzed to determine Tmax. Tmax will be summarized as the median (min, max) for all participants.
Geomean area under the drug concentration-time curve (AUC) of tazemetostat and its metabolite EPZ-6930 after administration of tazemetostat
AUC represents the total drug exposure over a defined period of time. AUC will be calculated using the linear trapezoidal rule. Plasma concentrations of tazemetostat and EPZ-6930 will be analyzed using a non-compartmental analysis approach to determine individual participant estimates of AUC. AUC will be summarized as the geomean and geomean CV% for all participants
Geomean minimum observed concentration at steady-state (Cmin) of tazemetostat and its metabolite EPZ-6930 in blood
Cmin is defined as the minimum observed concentration at steady-state during one dosing interval. Cmin will be summarized as the geomean and geomean CV% for all participants.
Geomean maximum concentration (Cmax) of HMPL-689 in blood
Cmax is defined as the maximum observed concentration that a drug achieves in a test area of the body after the drug has been administered. Plasma concentration-time profiles of HMPL-689 will be plotted using non-compartmental analysis and will be analyzed to determine Cmax. Cmax will be summarized as the geomean and geomean CV% for all participants.
Median time to reach maximum concentration (Tmax) of HMPL-689 in blood
Tmax is defined as the time from dosing to reach the maximum observed concentration a drug achieves in a specified compartment or test area of the body after the drug has been administered. Plasma concentration-time profiles of HMPL-689 will be plotted using non-compartmental analysis and will be analyzed to determine Tmax. Tmax will be summarized as the median (min, max) for all participants
Geomean area under the drug concentration-time curve (AUC) of HMPL-689 after administration of HMPL-689
AUC represents the total drug exposure over a defined period of time. AUC will be calculated using the linear trapezoidal rule. Plasma concentrations of HMPL-689 will be analyzed using a non-compartmental analysis approach to determine individual participant estimates of AUC. AUC will be summarized as the geomean and geomean CV% for all participants.
Geomean minimum observed concentration at steady-state (Cmin) of HMPL-689 in blood
Cmin is defined as the minimum observed concentration at steady-state during one dosing interval. Cmin will be summarized as the geomean and geomean CV% for all participants
To investigate the preliminary efficacy and PK correlation
The efficacy of participants as assessed by Lugano2014 from different dose groups, to assess the correlation of efficacy and PK of tazemetostat and HMPL-689
To investigate the preliminary tolerability and PK relationship
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 from different dose groups, to assess the correlation of safety and PK of tazemetostat and HMPL-689

Full Information

First Posted
December 13, 2022
Last Updated
March 29, 2023
Sponsor
Hutchmed
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1. Study Identification

Unique Protocol Identification Number
NCT05713110
Brief Title
A Study of Tazemetostat in Combination With HMPL-689 in Patients With Relapsed/Refractory Lymphoma
Official Title
A Phase II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Tazemetostat in Combination With HMPL-689 in Patients With Relapsed/Refractory Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 13, 2023 (Actual)
Primary Completion Date
May 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hutchmed

4. Oversight

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

5. Study Description

Brief Summary
A phase II clinical study of tazemetostat combined with HMPL-689 in patients with R/R lymphoma. The study includes 2 phases: dose escalation phase (phase IIa) and expansion phase (phase IIb).
Detailed Description
Dose Escalation Phase (Phase IIa ):Including 10-20 patients for dose escalation, the enrollment will continue until about 10 patients in the dose group with response, as to determine Recommended Phase II dose (RP2D). Dose Expansion Phase (Phase IIb):Multiple expansion cohorts will be set up according to different tumor types, and about 15-20 patients will be enrolled in each cohort to further observe the anti-tumor effect of Tazemetostat combined with HMPL-689 in different pathological types of R/R lymphoma. This study is expected to enroll 85-140 patients total in Phase IIa and phase IIb.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed/Refractory Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tazemetostat combined with HMP689 open-label treatment arm
Arm Type
Experimental
Arm Description
Dose Escalation Phase (Phase IIa): patients with relapsed or refractory lymphoma who have failed standard treatment and have no standard treatment options Dose Expansion Phase (Phase IIb): Cohort 1 (DLBCL, FL 3b): Histologically confirmed DLBCL, FL 3b (including primary mediastinal B-cell lymphoma) with relapsed/refractory disease ; Cohort 2 (FL) patients with histologically confirmed R/R FL (Grade 1, 2, 3a); Cohort 3 (MCL): Patients with R/R MCL who had prior therapies ; Cohort 4 (PTCL): Patients with histologically confirmed R/R PTCL who have failed or cannot tolerate standard therapy
Intervention Type
Drug
Intervention Name(s)
tazemetostat
Intervention Description
Dose Escalation Phase (Phase IIa): Tazemetostat (800 mg BID orally) in a therapeutic cycle of 28 days; Dose Expansion Phase (Phase IIb): Tazemetostat (800 mg BID orally) in a therapeutic cycle of 28 days
Intervention Type
Drug
Intervention Name(s)
HMPL-689
Intervention Description
Dose Escalation Phase (Phase IIa): HMPL-689:20 mg and 30 mg, QD orally in a therapeutic cycle of 28 days. Dose Expansion Phase (Phase IIb): HMPL-689 (RP2D) in a therapeutic cycle of 28 days
Primary Outcome Measure Information:
Title
Dose Escalation Phase (Phase IIa):To evaluate the safety, tolerability, and determine the maximum tolerated dose (MTD) and/or RP2D of Tazemetostat in combination with HMPL-689 in patients with R/R lymphoma
Description
Occurrence of Dose Limiting Toxicities (DLTs) During the DLT Observation Period
Time Frame
from Cycle 1 Day 1 up to Cycle 1 Day 28 (each cycle is 28 days)
Title
Dose Expansion Phase (Phase IIb):To evaluate the ORR of Tazemetostat in combination with HMPL-689 in patients with lymphoma
Description
Percentage of patients with Complete Response(CR) or Partial Response(PR) as the best response evaluated in accordance with Lugano2014
Time Frame
from Cycle 1 Day 1 to PFS (each cycle is 28 days)
Title
Dose Expansion Phase (Phase IIb):To evaluate the DCR of Tazemetostat in combination with HMPL-689 in patients with lymphoma
Description
the proportion of patients with CR or PR or stable disease (SD) as the best response with Lugano2014
Time Frame
from Cycle 1 Day 1 to PFS (each cycle is 28 days)
Title
Dose Expansion Phase (Phase IIb):To evaluate the DOR of Tazemetostat in combination with HMPL-689 in patients with lymphoma
Description
as the time from the first appearance of CR or PR to PD or death for any reason (whichever comes first), in the patients with objective response with Lugano2014)
Time Frame
from Cycle 1 Day 1 to PFS (each cycle is 28 days)
Title
Dose Expansion Phase (Phase IIb):To evaluate the PFS of Tazemetostat in combination with HMPL-689 in patients with lymphoma
Description
the proportion of patients with CR or PR or stable disease (SD) as the best response with Lugano2014
Time Frame
from Cycle 1 Day 1 to PFS (each cycle is 28 days)
Secondary Outcome Measure Information:
Title
Dose Escalation Phase (Phase IIa):Objective Response Rate (ORR)
Description
Percentage of patients with Complete Response (CR) or Partial Response (PR) as the best response evaluated in accordance with Lugano 2014
Time Frame
From baseline to final assessment at end of safety follow-up visit(through study completion, an average of 2 years)
Title
Dose Escalation Phase (Phase IIa)-Complete Response Rate (CR rate)
Description
Percentage of patients with Complete Response (CR) as the best response evaluated in accordance with Lugano 2014
Time Frame
From baseline to final assessment at end of safety follow-up visit(through study completion, an average of 2 years)
Title
Dose Escalation Phase (Phase IIa)-Disease control rate (DCR)
Description
the proportion of patients with CR or PR or stable disease (SD) as the best response
Time Frame
From baseline to final assessment at end of safety follow-up visit(through study completion, an average of 2 years)
Title
Dose Escalation Phase (Phase IIa)-Duration of response (DoR)
Description
as the time from the first appearance of CR or PR to PD or death for any reason (whichever comes first), in the patients with objective response
Time Frame
From baseline to final assessment at end of safety follow-up visit(through study completion, an average of 2 years)
Title
Dose Escalation Phase (Phase IIa)-Time to response (TTR)
Description
the time from the first dose of Tazemetostat in combination with HMPL-689 to the first objective response
Time Frame
From baseline to final assessment at end of safety follow-up visit(through study completion, an average of 2 years)
Title
Dose Escalation Phase (Phase IIa)-Progression-free survival (PFS)
Description
time from the first dose of study treatment to PD or death for any reason, whichever comes first
Time Frame
From baseline to final assessment at end of safety follow-up visit(through study completion, an average of 2 years)
Title
Dose Escalation Phase (Phase IIa)-Overall survival (OS)
Description
time from the first dose of study treatment to death for any reason time from the first dose of study treatment to death for any reason
Time Frame
From baseline to final assessment at end of safety follow-up visit(through study completion, an average of 2 years)
Title
Dose Expansion Phase (Phase IIb)-Evaluation of Tazemetostat safety and tolerability in Combination with HMPL-689 in Patients with R/R Lymphoma
Description
Incidence, severity, and causality to study drug of treatment-emergent adverse events (TEAEs) as determined by the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE 5.0)
Time Frame
From baseline to final assessment at end of safety follow-up visit(through study completion, an average of 2 years)
Title
Geomean maximum concentration (Cmax) of tazemetostat and its metabolite EPZ-6930 in blood
Description
Cmax is defined as the maximum observed concentration that a drug achieves in a test area of the body after the drug has been administered. Plasma concentration-time profiles of tazemetostat and EPZ-6930 will be plotted using non-compartmental analysis and will be analyzed to determine Cmax. Cmax will be summarized as the geomean and geomean CV% for all participants.
Time Frame
Cycle (C) 1, Day (D) 1: predose of first administration (PoFA); 0.5, 1, 2, 4, 6, 8, and 12 hours postdose. C1D15: PoFA; 0.5, 1, 2, 4, 6, 8, and 12 hours postdose. C1D2, C1D16, C2D1, C3D1 and C4D1: PoFA
Title
Median time to reach maximum concentration (Tmax) of tazemetostat and its metabolite EPZ-6930 in blood
Description
Tmax is defined as the time from dosing to reach the maximum observed concentration a drug achieves in a specified compartment or test area of the body after the drug has been administered. Plasma concentration-time profiles of tazemetostat and EPZ-6930 will be plotted using non-compartmental analysis and will be analyzed to determine Tmax. Tmax will be summarized as the median (min, max) for all participants.
Time Frame
Cycle (C) 1, Day (D) 1: predose of first administration (PoFA); 0.5, 1, 2, 4, 6, 8, and 12 hours postdose. C1D15: PoFA; 0.5, 1, 2, 4, 6, 8, and 12 hours postdose. C1D2, C1D16, C2D1, C3D1 and C4D1: PoFA
Title
Geomean area under the drug concentration-time curve (AUC) of tazemetostat and its metabolite EPZ-6930 after administration of tazemetostat
Description
AUC represents the total drug exposure over a defined period of time. AUC will be calculated using the linear trapezoidal rule. Plasma concentrations of tazemetostat and EPZ-6930 will be analyzed using a non-compartmental analysis approach to determine individual participant estimates of AUC. AUC will be summarized as the geomean and geomean CV% for all participants
Time Frame
Cycle (C) 1, Day (D) 1: PoFA; 0.5, 1, 2, 4, 6, 8, and 12 hours postdose. C1D15: PoFA; 0.5, 1, 2, 4, 6, 8, and 12 hours postdose.
Title
Geomean minimum observed concentration at steady-state (Cmin) of tazemetostat and its metabolite EPZ-6930 in blood
Description
Cmin is defined as the minimum observed concentration at steady-state during one dosing interval. Cmin will be summarized as the geomean and geomean CV% for all participants.
Time Frame
C1D15, C1D16, C2D1, C3D1 and C4D1: PoFA
Title
Geomean maximum concentration (Cmax) of HMPL-689 in blood
Description
Cmax is defined as the maximum observed concentration that a drug achieves in a test area of the body after the drug has been administered. Plasma concentration-time profiles of HMPL-689 will be plotted using non-compartmental analysis and will be analyzed to determine Cmax. Cmax will be summarized as the geomean and geomean CV% for all participants.
Time Frame
Cycle (C) 1, Day (D) 1: predose of first administration (PoFA); 0.5, 1, 2, 4, 6, 8, 12 and 24 (C1D2, PoFA) hours postdose. C1D15: PoFA; 0.5, 1, 2, 4, 6, 8, 12 and 24 (C1D16, PoFA) hours postdose. C2D1, C3D1 and C4D1: PoFA
Title
Median time to reach maximum concentration (Tmax) of HMPL-689 in blood
Description
Tmax is defined as the time from dosing to reach the maximum observed concentration a drug achieves in a specified compartment or test area of the body after the drug has been administered. Plasma concentration-time profiles of HMPL-689 will be plotted using non-compartmental analysis and will be analyzed to determine Tmax. Tmax will be summarized as the median (min, max) for all participants
Time Frame
Cycle (C) 1, Day (D) 1: predose of first administration (PoFA); 0.5, 1, 2, 4, 6, 8, 12 and 24 (C1D2, PoFA) hours postdose. C1D15: PoFA; 0.5, 1, 2, 4, 6, 8, 12 and 24 (C1D16, PoFA) hours postdose. C2D1, C3D1 and C4D1: PoFA
Title
Geomean area under the drug concentration-time curve (AUC) of HMPL-689 after administration of HMPL-689
Description
AUC represents the total drug exposure over a defined period of time. AUC will be calculated using the linear trapezoidal rule. Plasma concentrations of HMPL-689 will be analyzed using a non-compartmental analysis approach to determine individual participant estimates of AUC. AUC will be summarized as the geomean and geomean CV% for all participants.
Time Frame
Cycle (C) 1, Day (D) 1: predose of first administration (PoFA); 0.5, 1, 2, 4, 6, 8, 12 and 24 (C1D2, PoFA) hours postdose. C1D15: PoFA; 0.5, 1, 2, 4, 6, 8, 12 and 24 (C1D16, PoFA) hours postdose
Title
Geomean minimum observed concentration at steady-state (Cmin) of HMPL-689 in blood
Description
Cmin is defined as the minimum observed concentration at steady-state during one dosing interval. Cmin will be summarized as the geomean and geomean CV% for all participants
Time Frame
C1D15, C1D16, C2D1, C3D1 and C4D1: PoFA
Title
To investigate the preliminary efficacy and PK correlation
Description
The efficacy of participants as assessed by Lugano2014 from different dose groups, to assess the correlation of efficacy and PK of tazemetostat and HMPL-689
Time Frame
through study completion, an average of 2 years
Title
To investigate the preliminary tolerability and PK relationship
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 from different dose groups, to assess the correlation of safety and PK of tazemetostat and HMPL-689
Time Frame
through study completion, an average of 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Criteria: Inclusion Criteria: Willing and able to give informed consent, as documented by signed ICF Age ≥ 18 years Patients with histologically confirmed R/R lymphoma: • Phase IIa (dose escalation study): patients with relapsed or refractory lymphoma who have failed standard treatment and have no standard treatment options • Phase IIb( expansion Study ): Cohort 1 (DLBCL, FL 3b) Histologically confirmed DLBCL, FL 3b (including primary mediastinal B-cell lymphoma) with relapsed/refractory disease Cohort 2 (FL) patients with histologically confirmed R/R FL (Grade 1, 2, 3a) Cohort 3 (MCL): Patients with R/R MCL who had prior therapies Cohort 4 (PTCL): Patients with histologically confirmed R/R PTCL who have failed or cannot tolerate standard therapy Patients must have at least one measurable lesion Life expectancy ≥ 12 weeks Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 Adequate bone marrow function, renal function and hepatic function: Currently human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or cytomegalovirus (CMV) is inactive Female patients of childbearing potential must agree to use a double contraception method and male patients with partners of childbearing potential must also use an effective double contraception method during the study period and for 3 months after the final dose Exclusion Criteria: Patients who have previously used EZH2 inhibitors and PI3K inhibitors, or previously could not tolerate EZH2 inhibitors or PI3K inhibitors Patients with brain metastases or leptomeningeal invasion Has thrombocytopenia, neutropenia, or anemia of Grade ≥3 (per CTCAE 5.0 criteria) and any prior history of myeloid malignancies, including myelodysplastic syndrome (MDS / AML/MPN) Has abnormalities known to be associated with MDS (e.g. del 5q, chr 7 abn) and multiple primary neoplasms (MPN) (e.g. JAK2 V617F) observed in cytogenetic testing and DNA sequencing
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ronghua Zhang
Phone
+86 1526711056
Email
ronghuaz@hutch-med.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chao Pan
Phone
+86 15215192478
Email
chaop@hutch-med.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bin Yang
Organizational Affiliation
Hutchison Medipharma Limited
Official's Role
Study Director
Facility Information:
Facility Name
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ciming Cai
Phone
13621999905
Email
cmc_girl@163.com
First Name & Middle Initial & Last Name & Degree
Weili Zhao

12. IPD Sharing Statement

Plan to Share IPD
No

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A Study of Tazemetostat in Combination With HMPL-689 in Patients With Relapsed/Refractory Lymphoma

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