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Rituximab Combined With Chidamide and Lenalidomide for r/r AITL (AITL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04319601
Recruitment Status : Recruiting
First Posted : March 24, 2020
Last Update Posted : March 24, 2020
Information provided by (Responsible Party):
Yang haiyan, Zhejiang Cancer Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Angioimmunoblastic T-cell Lymphoma Chemotherapy Effect Chemotherapeutic Toxicity Drug: Rituximab Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-arm, Multiple Centers, Phase II Study Evaluating Rituximab in Combination With Chidamide and Lenalidomide for Relapsed or Refractory Angioimmunoblastic T-cell Lymphoma (AITL)
Estimated Study Start Date : March 31, 2020
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : December 31, 2022

Arm Intervention/treatment
Experimental: rituximab combined with chidamde and lenalidomide
rituximab and chidamide, lenalidomide
Drug: Rituximab
a new chemotherapy regimen
Other Names:
  • chidamide
  • lenalidomde

Primary Outcome Measures :
  1. PFS [ Time Frame: From enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 32 months ]
    progression free survival

Secondary Outcome Measures :
  1. ORR [ Time Frame: From enrollment until date of completion of chemotherapy, assessed up to 9 months ]
    overall response rate

  2. toxicities [ Time Frame: from enrollment to 30 days after completion of chemotherapy, assessed up to 9 months ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 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.
  7. 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.
  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, ≤5 times the normal upper limit;Total bilirubin, direct bilirubin ≤1.5 times the normal upper limit.

Bone marrow function (growth factor should not be used within 7 days before the first medication) : WBC ≥2.0*109/l;The ANC acuity 1.0 * 109 / l;PLT 50 * 109 / l or higher;Hb 8 g/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% without oxygen inhalation. Coagulation function: international standardized ratio (INR) ≤1.5×ULN and activated partial thromboplastin time (aPTT) ≤1.5×ULN, unless the patient is receiving anticoagulation therapy and the coagulation parameters (prothrombin time [PT/INR] and aPTT) at the time of screening are within the expected range of anticoagulant treatment.Patients whose prolongation of PT or elevation of INR resulted from the use of clotting factor inhibitors were eligible for inclusion by the investigator.

Exclusion Criteria:

  1. 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).
  2. Presence of active infection, including but not limited to: known active/latent tuberculosis, herpes zoster, pneumonia.

3, Known human immunodeficiency virus (HIV) infection, or reflect the activity of hepatitis b virus (HBV) or hepatitis c virus (HCV) infection of serological status: a. the hepatitis b surface antigen (HBsAg) positive, HBcAb positive, HBsAg positive patients should be detected HBV - DNA, if not more than 1000 iu/ml and agreed to accept patients treated against HBV virus can enter the group.B. patients with positive HCV antibody are admitted if HCV RNA (<15 IU/mL) is not detected.

4. Patients with heart failure of grade 3 or 4 according to the New York society of cardiology (NYHA) functional classification, unstable angina, severe poorly controlled ventricular arrhythmia, electrocardiogram showing acute ischemia or myocardial infarction 6 months prior to screening.Or other cardiac dysfunction assessed by the investigator as not resistant 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 the full absorption of drugs.

6. The investigator's judgment or other evidence indicates that the patient has serious or poorly controlled systemic diseases, including poorly controlled hypertension and an active bleeding constitution.At present, patients with thrombotic diseases such as pulmonary embolism 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 factors that might affect the compliance of the plan.

Information from the National Library of Medicine

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 identifier (NCT number): NCT04319601

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Contact: Cong Li, MD +8615267115611
Contact: Yan Ha Yang, PhD +8613857182590

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China, Zhejiang
Zhejiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Haiyan Yang, PhD    0086-571-88122192   
Contact: Cong Li, MD    0086-571-88122192   
Sub-Investigator: Cong Li, MD         
Sponsors and Collaborators
Zhejiang Cancer Hospital
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Study Chair: Ming Chen, PhD Zhejiang Cancer Hospital
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Responsible Party: Yang haiyan, Head of lymphoma oncology, Zhejiang Cancer Hospital Identifier: NCT04319601    
Other Study ID Numbers: RLC
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma, T-Cell
Immunoblastic Lymphadenopathy
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents