Ignite Creation Date:
2024-05-06 @ 6:08 PM
Last Modification Date:
2024-10-26 @ 2:42 PM
Study NCT ID:
NCT05563844
Status:
RECRUITING
Last Update Posted:
2024-01-19
First Post:
2022-09-28
Brief Title:
Study of Purinostat Mesylate for Injection in the Treatment of Diffuse Large B-cell Lymphoma DLBCL
Sponsor:
Chengdu Zenitar Biomedical Technology Co Ltd
Organization:
Chengdu Zenitar Biomedical Technology Co Ltd
Study Overview
Official Title:
An Open-label Multi-center Phase II Clinical Study on the Efficacy and Safety of Purinostat Mesylate for Injection in the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma DLBCL
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Purinostat mesylate for injection PM was the novel and highly potent Class I a and IIb HDAC-selective inhibitors The results of regular blood sampling analysis of the mouse B-cell lymphoma model induced by ighmyc transgenic mice showed that the treatment of PM in each group reduced the proportion of peripheral blood tumor cells in mice Therefore PM has the potential to treat diffuse large B cell lymphoma
The results of in vitro enzymatic activity screening showed that PM has high inhibitory activity on HDAC tumors including HDAC1 2 3 8 subtypes and type II HDACs including HDAC6 10 isoforms which are closely related to tumors in the HDAC family Therefore the results of in vitro enzyme activity screening showed that the IC50 values of PM for inhibiting HDAC1 HDAC2 HDAC3 HDAC8 HDAC6 and HDAC10 subtypes of HDAC class I and HDAC class IIb were 081 14 17 38 115 and 11 nM respectively However the inhibitory activity of HDAC IIa and HDAC IV enzymes was low and its IC50 values for HDAC4 HDAC5 HDAC7 HDAC9 and HDAC11 subtypes of HDAC IIa and HDAC IV were 1072 426 590 622 and 3349 nM respectively These data means PM exist high selectivity for tumor-associated HDAC class I and HDAC IIb
Compared with the blank control group the body weight of the tumor-bearing animals in each dose of PM group did not decrease seriously during the treatment process and the animals were in good condition during the whole experiment indicating that the PM is efficacy and safe
Main purpose
To further explore the safe and effective dose of priinostat mesylate for injection in the treatment of relapsed or refractory diffuse large B-cell lymphoma
To evaluate the objective response rate ORR of priinostat mesylate for injection in the treatment of relapsed or refractory diffuse large B-cell lymphoma
Secondary purpose
To explore the biomarkers related to the efficacy of priinostat mesylate for injection
To evaluate the time to tumor response TTR duration of response DOR disease control rate DCR and progression-free survival PFS in the treatment of relapsed or refractory diffuse large B-cell lymphoma with prilinostat mesylate for injection overall survival OS
Assessing the safety and tolerability of priinostat mesylate for injection in the treatment of relapsed or refractory diffuse large B-cell lymphoma
The results of in vitro enzymatic activity screening showed that PM has high inhibitory activity on HDAC tumors including HDAC1 2 3 8 subtypes and type II HDACs including HDAC6 10 isoforms which are closely related to tumors in the HDAC family Therefore the results of in vitro enzyme activity screening showed that the IC50 values of PM for inhibiting HDAC1 HDAC2 HDAC3 HDAC8 HDAC6 and HDAC10 subtypes of HDAC class I and HDAC class IIb were 081 14 17 38 115 and 11 nM respectively However the inhibitory activity of HDAC IIa and HDAC IV enzymes was low and its IC50 values for HDAC4 HDAC5 HDAC7 HDAC9 and HDAC11 subtypes of HDAC IIa and HDAC IV were 1072 426 590 622 and 3349 nM respectively These data means PM exist high selectivity for tumor-associated HDAC class I and HDAC IIb
Compared with the blank control group the body weight of the tumor-bearing animals in each dose of PM group did not decrease seriously during the treatment process and the animals were in good condition during the whole experiment indicating that the PM is efficacy and safe
Main purpose
To further explore the safe and effective dose of priinostat mesylate for injection in the treatment of relapsed or refractory diffuse large B-cell lymphoma
To evaluate the objective response rate ORR of priinostat mesylate for injection in the treatment of relapsed or refractory diffuse large B-cell lymphoma
Secondary purpose
To explore the biomarkers related to the efficacy of priinostat mesylate for injection
To evaluate the time to tumor response TTR duration of response DOR disease control rate DCR and progression-free survival PFS in the treatment of relapsed or refractory diffuse large B-cell lymphoma with prilinostat mesylate for injection overall survival OS
Assessing the safety and tolerability of priinostat mesylate for injection in the treatment of relapsed or refractory diffuse large B-cell lymphoma
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None