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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03593018
Study type Interventional
Source The Lymphoma Academic Research Organisation
Contact
Status Active, not recruiting
Phase Phase 3
Start date November 9, 2018
Completion date June 2024

See also
  Status Clinical Trial Phase
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Active, not recruiting NCT03278782 - Study of Pembrolizumab (MK-3475) in Combination With Romidepsin Phase 1/Phase 2
Terminated NCT03075553 - Nivolumab in Treating Patients With Relapsed or Refractory Peripheral T-cell Lymphoma Phase 2
Withdrawn NCT04795869 - Brentuximab Vedotin and Pembrolizumab in Treating Patients With Recurrent Peripheral T-Cell Lymphoma Phase 2
Active, not recruiting NCT03598998 - Pembrolizumab and Pralatrexate in Treating Patients With Relapsed or Refractory Peripheral T-Cell Lymphomas Phase 1/Phase 2
Recruiting NCT06176027 - Azacytidine Plus CAOLD Regimen in Relapsed/Refractory Angioimmunoblastic T Cell Lymphoma Phase 1/Phase 2
Recruiting NCT03017820 - VSV-hIFNbeta-NIS in Treating Patients With Relapsed or Refractory Multiple Myeloma, Acute Myeloid Leukemia or Lymphoma Phase 1