UnknownNot Applicable

Rituximab Combined With Chidamide and Lenalidomide for r/r AITL

China26 participantsStarted 2020-03-13

Plain-language summary

This study is designed to explore the effeicency and toxicities of rituximab combined with chidamide and lenalidomide in patients with relapsed or refractory AITL.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. Subjects must voluntarily participate in this study and sign an informed consent.
✓. 18-70 years old.
✓. ECOG 0-2.
✓. Life expectancy ≥12 weeks.
✓. Histopathology diagnosis of AITL.
✓. A measurable lesion (lymphoma nodule, lymph node mass or other lymphoma lesions as defined in lugano 2014) that can be measured in both diameters on the CT scan, including the longest diameter and the shortest diameter perpendicular to the longest diameter.In addition, the longest diameter of lymph nodes should be greater than 1.5cm, and the longest diameter of external lymph node lesions should be greater than 1.0cm.
✓. The patient has received at least one line of systemic chemotherapy and currently has disease progression or treatment failure, or the patient refuses or cannot tolerate intravenous chemotherapy.
✓. Adequate bone marrow hematopoietic function reserve and viscera function, as follows:

Exclusion criteria

✕. Prior to the first use of the drug in this study, there was an unrelieved drug toxicity greater than CTCAE1 (except for the adverse reactions, such as hair loss, that the investigator assessed did not affect the use of the drug in this study).
✕. Presence of active infection, including but not limited to: known active/latent tuberculosis, herpes zoster, pneumonia.

What they're measuring

PFS

Timeframe: From enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 32 months

Trial details

NCT IDNCT04319601

SponsorZhejiang Cancer Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03-31

Contact for this trial

Cong Li, MD

+8615267115611 licong@zjcc.org.cn

View on ClinicalTrials.gov More Angioimmunoblastic T-cell Lymphoma trials