Adult T Cell Leukemia/Lymphoma Clinical Trial
Official title:
A Phase II Study of Lenalidomide in Patients With Relapsed or Refractory HTLV-1 Associated Adult T Cell Leukemia/Lymphoma
This is a research study for subjects who have been diagnosed with Adult T cell
Leukemia/Lymphoma, a rare and aggressive peripheral T cell neoplasm caused by the virus
HTLV1. Currently, there is no accepted standard therapy for this disease. The purpose of
this research study is to evaluate the use of the investigational drug lenalidomide in the
treatment of Adult T cell Leukemia/Lymphoma.
Lenalidomide is a drug that alters the immune system and it may also interfere with the
development of tiny blood vessels that help support tumor growth. Therefore, in theory, it
may reduce or prevent the growth of cancer cells.
Lenalidomide is approved by the Food and Drug Administration (FDA) for the treatment of
specific types of myelodysplastic syndrome (MDS) and in combination with dexamethasone for
patients with multiple myeloma (MM) who have received at least 1 prior therapy. MDS and MM
are cancers of the blood. It is currently being tested in a variety of cancer conditions. In
this case it is considered experimental.
The Primary Objective is to determine the efficacy of lenalidomide monotherapy in relapsed
or refractory HTLV 1 associated Adult T Cell Leukemia/Lymphoma. Efficacy will be assessed by
measuring the response rate, tumor control rate, duration of response, time to progression
and progression free survival.
The Secondary Objective is to evaluate the safety of lenalidomide monotherapy as treatment
for subjects with relapsed or refractory HTLV 1 associated Adult T Cell Leukemia/Lymphoma.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04703192 -
Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)
|
Phase 2 |