Relapsed and/or Refractory Non-Hodgkin T-cell LymphomaPhase 2Lemon-TNCT03730740
Phase II of Lenalidomide After Salvage Therapy in R/R Non-Hodgkin T-cell Lymphoma
A Phase 2 study testing Lenalidomide 25mg in people with Relapsed and/or Refractory Non-Hodgkin T-cell Lymphoma, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This study is to evaluate the efficacy and safety of lenalidomide maintenance therapy in patients with T-cell lymphoma who have undergone more than one treatment or relapsed after treatment and who acquired a response of more than a partial response after rescue chemotherapy. This is a phase 2 clinical trial. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Relapsed and/or Refractory Non-Hodgkin T-cell Lymphoma
- What is being tested?
- Lenalidomide 25mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Nov 2018to Nov 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- The following subtypes of T-cell lymphoma histologically diagnosed based on WHO classification:
- Peripheral T-cell lymphoma, not otherwise specified
- Angioimmunoblastic T-cell lymphoma
- Anaplastic large cell lymphoma, ALK-/+
- Enteropathy-associated T-cell lymphoma
- Monomorphic epitheliotropic intestinal T-cell lymphoma
Show all 32Show fewer
- Subcutaneous panniculitis-like T-cell lymphoma
- Cutaneous T-cell lymphoma including mycosis fungoides and sezary syndrome
- Relapse or progression after one or more previous therapies.
- Partial response or more to a salvage therapy and at least 4 cycles of that salvage therapy at the time of participation in the clinical study.
- Where autologous stem cell transplantation is unattainable due to poor physical conditions over 65 years of age or secondary transplantation is unattainable due to relapse after primary autologous stem cell transplantation.
- Non-pregnant female patients who satisfy the following:
- Natural menopause for at least 24 consecutive months before registering for the study or patients who had undergone hysterectomy or bilateral oophorectomy.
- Male patients who can satisfy the following even if they are surgically infertile (with vasectomy):
- Men must use an effective method of contraception during participation in the clinical test and for up to 4 weeks after administration.
- Men must use condoms during administration of clinical drug, during temporary suspension of dosage, and for up to 4 weeks after administration if their partners are pregnant and not using an appropriate form of contraception (even after vasectomy).
- Men must not donate their sperms during administration of clinical drug and for up to 4 weeks after administration and must immediately notify the researchers if their partners are pregnant during administration of clinical drug or right after suspending administration.
- Must comply with the control plans for Lenalidomide (Appendix G).
- 0 - 2 points in performance ability based on the classification of the eastern Cooperative Oncology Group (ECOG).
- Appropriate condition of bone marrow, kidney, and liver.
- White blood cells ≥ 4,000/μL
- Neutrophes ≥ 1,500/μL
- Platelets ≥ 75,000/μL (possible if ≥ 50,000/μL in case of intrusion in bone marrow)
- Hemoglobin ≥ 9.0 g/dL (examination value is possible after correction through blood transfusion.)
- Total bilirubin ≤ 1.5 x normal max.
- AST/ALT ≤ 2.5 x normal max.
- Creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula)
- If the impact of all toxicity from the previous therapy is below Grade 1 based on Common Terminology Criteria for Adverse Events, Version 4.03.
- Patients who are thought to perform and comply with the clinical test plan based on researcher's judgment.
- Patients who have voluntarily agreed to participate in the clinical test and signed the consent.
- Patients who have agreed to donate tissue slides and peripheral blood samples for participation in the clinical study.
- In case of healthy Type B hepatitis carriers, patients are participatory if they can also undergo preventive antiviral treatment.
Who cannot join
- Anyone classified into a histological subtype outside the selection criteria;
- When autologous or allogenic stem cell transplantation is planned after salvage therapy;
- Patients with symptomatic or uncontrolled angina pectoris or congestive heart failure, arrhythmia requiring chemotherapy, or major hazards anticipated due to clinically significant myocardial infarction that occurred 6 months in prior to participating in this clinical test;
- In case of an infection exceeding Grade 2 under Common Terminology Criteria for Adverse Events, Version 4.03;
- Anyone with an accompanied disease that is severe and uncontrolled;
- Anyone with uncontrolled active Type B or C hepatitis (excluding healthy Type B hepatitis carriers who can be controlled by preventive antiviral agents);
Show all 21Show fewer
- Anyone infected with human immunodeficiency virus (HIV);
- Anyone with allogenic organ transplantation or allogenic stem cell transplantation;
- Anyone with history of a malignant tumor excluding the following diseases:
- Anyone who has not received treatment for the target tumor or has not had any disease at least for the past 5 years; and
- Anyone who has spent at least 1 year since complete removal of basal cell carcinoma/squamous cell carcinoma or successful treatment of cervical intraepithelial neoplasia;
- Serious gastrointestinal bleeding exceeding Grade 2 under Common Terminology Criteria for Adverse Events, Version 4.03 within 30 days before screen;
- Thrombosis or embolism within 6 months before screen;
- If it is impossible to administer the clinical drug due to intrusion into the central nervous system (except for cases where the drug can be administered;
- Any patient who is hypersensitive to this drug or a substance in this drug (ex: angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis, etc.);
- Anyone with genetic problems, including galactose intolerance, Lapp lactase deficiency, and glucose-galactose malabsorption;
- Anyone in an unstable state that may harm a patient's safety and compliance with the test;
- Any patient with seizure disorder that requires drug administration;
- Any drug abuse or medical, mental, or social disorder that may affect a patient's participation in clinical test or evaluation of clinical test results; and
- Women who may be pregnant:
- Anyone who has not undergone hysterectomy or bilateral oophorectomy and has not reached natural menopause for at least 24 consecutive months (not including no menstruation after anti-cancer treatment) (in that words, had menstruation anytime within the past 24 months).
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, Gangnam-gu, 06351
Won-seog Kim, MD, Ph.D
About this study
Official title: Phase II Study of Lenalidomide Maintenance After Salvage Therapy in Patients With Relapsed and/or Refractory Non-Hodgkin T-cell Lymphoma
This study is to evaluate the efficacy and safety of lenalidomide maintenance therapy in patients with T-cell lymphoma who have undergone more than one treatment or relapsed after treatment and who acquired a response of more than a partial response after rescue chemotherapy. This is a phase 2 clinical trial.
Read the detailed description
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.
- Being tested
- Lenalidomide 25mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lenalidomide 25mgDrug
Also called Lenalidomide
Lenalidomide 25mg, day 1 - day 21 (1cycle=28days) for 2yeas
| Study group | Role | What they receive |
|---|---|---|
| Lenalidomide | Experimental | Administer the study drug in the following way with 28 days as one cycle. Lenalidomide 25mg Days 1-21 Dosing continues until disease progression is confirmed. Receives: Drug: Lenalidomide 25mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-progressive survival period
The incidence of tumor progression or death from any cause up to 1 year from the first test drug administration
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2018
- Study start16 Nov 2018
- Primary completionNov 2021 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed and/or Refractory Non-Hodgkin T-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 79 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won Seog Kim, Samsung Medical Center
- Investigators
- Won-seog Kim, MD, Ph.D, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03730740
- Sponsor's protocol ID
- 2018-04-010
- Acronym
- Lemon-T
- Status last verified
- Oct 2020
- First submitted
- 2 Nov 2018
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Lenalidomide Maintenance After Salvage Therapy in Patients With Relapsed and/or Refractory Non-Hodgkin T-cell Lymphoma
- ClinicalTrials.gov ID
- NCT03730740
- Acronym / sponsor ID
- Lemon-T / 2018-04-010
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 79 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 16 Nov 2018 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 5 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to evaluate the efficacy and safety of lenalidomide maintenance therapy in patients with T-cell lymphoma who have undergone more than one treatment or relapsed after treatment and who acquired a response of more than a partial response after rescue chemotherapy. This is a phase 2 clinical trial.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lenalidomide | Experimental | Drug: Lenalidomide 25mgAdminister the study drug in the following way with 28 days as one cycle. Lenalidomide 25mg Days 1-21 Dosing continues until disease progression is confirmed. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (32 listed)
- The following subtypes of T-cell lymphoma histologically diagnosed based on WHO classification:
- Relapse or progression after one or more previous therapies.
- Partial response or more to a salvage therapy and at least 4 cycles of that salvage therapy at the time of participation in the clinical study.
- Where autologous stem cell transplantation is unattainable due to poor physical conditions over 65 years of age or secondary transplantation is unattainable due to relapse after primary autologous stem cell transplantation.
- Non-pregnant female patients who satisfy the following:
Key exclusion criteria (21 listed)
- Anyone classified into a histological subtype outside the selection criteria;
- When autologous or allogenic stem cell transplantation is planned after salvage therapy;
- Patients with symptomatic or uncontrolled angina pectoris or congestive heart failure, arrhythmia requiring chemotherapy, or major hazards anticipated due to clinically significant myocardial infarction that occurred 6 months in prior to participating in this clinical test;
- In case of an infection exceeding Grade 2 under Common Terminology Criteria for Adverse Events, Version 4.03;
- Anyone with an accompanied disease that is severe and uncontrolled;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lenalidomide 25mgAlso: LenalidomideLenalidomide 25mg, day 1 - day 21 (1cycle=28days) for 2yeas | Drug | Lenalidomide |
Primary outcome
Non-progressive survival period
Time frame: 1 year
The incidence of tumor progression or death from any cause up to 1 year from the first test drug administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Individual participant dataSharing planned: No
Related trials for Relapsed and/or Refractory Non-Hodgkin T-cell Lymphoma
Active, not recruitingObservational study
Multi-omics Profiling of Relapsed Extranodal Natural Killer (NK)/T-cell Lymphoma
Extranodal NK/T-cell Lymphoma, Nasal Type
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
RecruitingPhase 2
Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggressive B-cell Lymphoma
High Grade B-Cell Lymphoma With MYC and BCL6 Rearrangements, Recurrent Diffuse Large B-Cell Lymphoma
Active, not recruitingPhase 1
A Study of Radiation Therapy Before CAR T Cell Therapy for People With B Cell Lymphoma
Non-Hodgkin Lymphoma, Non-Hodgkin's Lymphoma, Relapsed
Active, not recruitingPhase 1
A Study of Ruxolitinib and Duvelisib in People With Lymphoma
T-cell Lymphomas, NK-Cell Lymphomas
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Won-seog Kim, MD, Ph.D principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lenalidomide 25mg in people with Relapsed and/or Refractory Non-Hodgkin T-cell Lymphoma, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 32 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Won-seog Kim, MD, Ph.D (82-2-3410-6548, wonseog.kim@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-progressive survival period (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.