Phase II of Lenalidomide After Salvage Therapy in R/R Non-Hodgkin T-cell Lymphoma

NCT03730740 | Unknown Phase 2 DMC

• 1 other identifier: 2018-04-010
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Relapsed and/or Refractory Non-Hodgkin T-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Non-progressive survival period

  The incidence of tumor progression or death from any cause up to 1 year from the first test drug administration

  1 year

Study Arms (1)

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.

Drug: Lenalidomide 25mg

Interventions

Lenalidomide 25mg DRUG

Lenalidomide 25mg, day 1 - day 21 (1cycle=28days) for 2yeas

Also known as: Lenalidomide

Lenalidomide

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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);
• 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.);

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, Gangnam-gu, 06351, South Korea

RECRUITING

MeSH Terms

Interventions

Lenalidomide

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Won-seog Kim, MD, Ph.D

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Won-seog Kim, MD, Ph.D

CONTACT

82-2-3410-6548; wonseog.kim@samsung.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Ph.D, Division of Hematology-Oncology

Study Record Dates

• First Submitted: November 2, 2018
• First Posted: November 5, 2018
• Study Start: November 16, 2018
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2023
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)