Phase II of Lenalidomide After Salvage Therapy in R/R Non-Hodgkin T-cell Lymphoma (Lemon-T)
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|ClinicalTrials.gov Identifier: NCT03730740|
Recruitment Status : Recruiting
First Posted : November 5, 2018
Last Update Posted : May 20, 2019
T-cell lymphoma that has relapsed after primary treatment or is refractory to treatment generally requires salvage therapy. In case of partial or complete response to such salvage therapy (partial response is determined by CT), consolidation therapy is performed to maintain the response and prevent relapse and autologous stem cell transplantation after high-dosage chemotherapy is generally adopted. However, autologous stem cell transplantation is unavailable if patient is over 65 years of age or not in a good full-body condition and additional treatment plans are required to prevent relapse in such cases. Allogenic stem cell transplantation after salvage therapy is also available in limited events in case of relapse after autologous stem cell transplantation and the effect of allogenic stem cell transplantation still not definite but experimental.
As a result, the treatment results of T-cell lymphoma that has relapsed are very poor despite active application of salvage therapy and overall survival (OS) and progression-free survival (PFS) have only been 5.5 and 3.1 months as a result of a previous study on 153 patients. Also, 3-year PFS after primary relapse was reportedly 16%. Likewise, overall survival (OS) of patients with T-cell lymphoma who experienced relapse or progression within first 24 months of diagnosis was 4.9 months (95% CI: 3.8-5.9 months). Therefore, additional therapy strategies are required to prevent relapse or progression of disease in patients who received salvage therapy for relapsed and/or refractory T-cell lymphoma.
Recently, the results of phase 2 study were reported where progressive survival period was effectively extended with Lenalidomide Maintenance for patients with relapsed and/or refractory diffuse large B cell lymphoma in cases where autologous stem cell transplantation is unattainable after salvage therapy.
Lenalidomide controls the immune system to activate the T cells or NK cells in the microenvironment of tumor for anti-tumor effects. Also, it combines with cerebron to lower IKZF1 and IKZF3 and inhibit MYC through the NF-kB route. MYC inhibition by Lenalidomide eventually lowers IRF4 to increase apoptosis and inhibit cell proliferation and induce anti-cancer effect accordingly . As a result, Lenalidomide was recognized as a treatment for multiple myeloma and lymphoma.
The results of clinical studies on the effect of Lenalidomide for T-cell lymphoma are still limited, but 26% OS has been reported for patients with T-cell lymphoma as a result of phase 2 clinical test where 25 mg (Day 1 - Day21, every 28 days) Lenalidomide was used as the only drug. Also, it has been proven that the increase of IRF4/MUM1, one of the major targets of Lenalidomide, is related to the poor prognosis of T-cell lymphoma, so the effect of Lenalidomide can be expected for T-cell lymphoma. Therefore, this study was conducted to evaluate the efficacies and safety of Lenalidomide Maintenance on patients who have shown partial response or complete response to salvage therapy for T-cell lymphoma that have been progressive after one or more therapies or relapsed after treatment.
|Condition or disease||Intervention/treatment||Phase|
|Relapsed and/or Refractory Non-Hodgkin T-cell Lymphoma||Drug: Lenalidomide 25mg||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||79 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Lenalidomide Maintenance After Salvage Therapy in Patients With Relapsed and/or Refractory Non-Hodgkin T-cell Lymphoma|
|Actual Study Start Date :||November 16, 2018|
|Estimated Primary Completion Date :||November 15, 2021|
|Estimated Study Completion Date :||November 15, 2023|
Drug: Lenalidomide 25mg
Lenalidomide 25mg, day 1 - day 21 (1cycle=28days) for 2yeas
- Non-progressive survival period [ Time Frame: 2year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03730740
|Contact: Won-seog Kim, MD, Ph.Dfirstname.lastname@example.org|
|Korea, Republic of|
|Samsung Medical Center||Recruiting|
|Seoul, Gangnam-gu, Korea, Republic of, 06351|
|Contact: Won-seog Kim, MD, Ph.D|