Rituximab Combined With Chidamide and Lenalidomide for r/r AITL

Last updated: March 23, 2021
Sponsor: Zhejiang Cancer Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lymphoma

T-cell Lymphoma

Lymphoproliferative Disorders

Treatment

N/A

Clinical Study ID

NCT04319601
RLC
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subjects must voluntarily participate in this study and sign an informed consent.
  2. 18-70 years old.
  3. ECOG 0-2.
  4. Life expectancy ≥12 weeks.
  5. Histopathology diagnosis of AITL.
  6. A measurable lesion (lymphoma nodule, lymph node mass or other lymphoma lesions asdefined 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 longestdiameter.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.
  7. The patient has received at least one line of systemic chemotherapy and currently hasdisease progression or treatment failure, or the patient refuses or cannot tolerateintravenous chemotherapy.
  8. Adequate bone marrow hematopoietic function reserve and viscera function, as follows: Liver function: ALT, AST≤2.5 times the normal upper limit, if there is liver metastasis, ≤5times the normal upper limit;Total bilirubin, direct bilirubin ≤1.5 times the normal upperlimit. Bone marrow function (growth factor should not be used within 7 days before the firstmedication) : WBC ≥2.0*109/l;The ANC acuity 1.0 * 109 / l;PLT 50 * 109 / l or higher;Hb 8g/dl or higher. Renal function: creatinine ≤1.5 times the normal upper limit or creatinine clearance ≥30ml/min. Cardiac function: LVEF≥50%. Lung function: resting and oxygen saturation ≥95% withoutoxygen inhalation. Coagulation function: international standardized ratio (INR) ≤1.5×ULNand activated partial thromboplastin time (aPTT) ≤1.5×ULN, unless the patient is receivinganticoagulation therapy and the coagulation parameters (prothrombin time [PT/INR] and aPTT)at the time of screening are within the expected range of anticoagulant treatment.Patientswhose prolongation of PT or elevation of INR resulted from the use of clotting factorinhibitors were eligible for inclusion by the investigator.

Exclusion

Exclusion Criteria:

  1. Prior to the first use of the drug in this study, there was an unrelieved drugtoxicity 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).
  2. Presence of active infection, including but not limited to: known active/latenttuberculosis, herpes zoster, pneumonia.

3, Known human immunodeficiency virus (HIV) infection, or reflect the activity of hepatitisb virus (HBV) or hepatitis c virus (HCV) infection of serological status: a. the hepatitisb surface antigen (HBsAg) positive, HBcAb positive, HBsAg positive patients should bedetected HBV - DNA, if not more than 1000 iu/ml and agreed to accept patients treatedagainst HBV virus can enter the group.B. patients with positive HCV antibody are admittedif HCV RNA (<15 IU/mL) is not detected. 4. Patients with heart failure of grade 3 or 4 according to the New York society ofcardiology (NYHA) functional classification, unstable angina, severe poorly controlledventricular arrhythmia, electrocardiogram showing acute ischemia or myocardial infarction 6months prior to screening.Or other cardiac dysfunction assessed by the investigator as notresistant to chemotherapy. 5. Support the treatment of refractory nausea, vomiting, chronic gastrointestinal diseases,capsule dysphagia, or previous surgical resection of the intestinal segment may affect thefull absorption of drugs. 6. The investigator's judgment or other evidence indicates that the patient has serious orpoorly controlled systemic diseases, including poorly controlled hypertension and an activebleeding constitution.At present, patients with thrombotic diseases such as pulmonaryembolism and deep vein thrombosis are also not suitable to participate in this study. 7. Nursing or pregnant women. 8. The researcher judged that the patient had other factorsthat might affect the compliance of the plan.

Study Design

Total Participants: 26
Study Start date:
March 13, 2020
Estimated Completion Date:
December 31, 2022

Study Description

This study is designed to explore the effeicency and toxicities of rituximab combined with chidamide and lenalidomide in patients with relapsed or refractory AITL. The primary end point is PFS, and second end point is OS, ORR and toxicities according to CTCAE 5.0.

Connect with a study center

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang 310022
    China

    Active - Recruiting

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