Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT03593018
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-05
First Post:
2018-07-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Oral Azacitidine Compared to Investigator's Choice Therapy in Patients with Relapsed or Refractory AITL
Sponsor:
The Lymphoma Academic Research Organisation
Organization:
Study Overview
Official Title:
Randomized Phase 3 Study Evaluating the Efficacy and the Safety of Oral Azacitidine (CC-486) Compared to Investigator's Choice Therapy in Patient with Relapsed or Refractory Angioimmunoblastic T Cell Lymphoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-03
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:
This study evaluates the efficacy of Oral azacitidine versus single-agent Investigator's Choice Therapy in patients with Relapsed or Refractory Angioimmunoblastic T-cell Lymphoma.
Detailed Description:
Compared to B-cell Non-Hodgin Lymphoma (NHL), Angioimmunoblastic T-cell Lymphoma (AITL) is more resistant to conventional chemotherapy and is generally associated with an inferior outcome. In case of relapsed of refractory disease, survival durations are in the range of only a few months.
Several agents have been evaluated in this setting in recent years: romidepsin, bendamustine or belinostat. The response rate with these agents rarely exceeds 30% and responses are usually of limited duration.
Azacitidine is a nucleoside metabolic inhibitor indicated for the treatment of patients with various myelodysplastic syndrome (MDS) subtypes. In this case, azacitidine significantly increase the survival time compared to standard of care option. This response to azacitidine could be correlated to the existence of recurrent mutations and those mutations have also been described in AITL.
The present protocol will use Azacitidine according to the same schedule than in MDS that is continuous treatment until progression or unacceptable toxicity.
Several agents have been evaluated in this setting in recent years: romidepsin, bendamustine or belinostat. The response rate with these agents rarely exceeds 30% and responses are usually of limited duration.
Azacitidine is a nucleoside metabolic inhibitor indicated for the treatment of patients with various myelodysplastic syndrome (MDS) subtypes. In this case, azacitidine significantly increase the survival time compared to standard of care option. This response to azacitidine could be correlated to the existence of recurrent mutations and those mutations have also been described in AITL.
The present protocol will use Azacitidine according to the same schedule than in MDS that is continuous treatment until progression or unacceptable toxicity.
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?: