Rituximab Combined With Chidamide and Lenalidomide for r/r AITL

NCT04319601 | Unknown

• 1 other identifier: RLC
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Angioimmunoblastic T-cell Lymphoma; Chemotherapy Effect; Chemotherapeutic Toxicity

Outcome Measures

Primary Outcomes (1)

• PFS

  progression free survival

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

Secondary Outcomes (2)

• ORR

  From enrollment until date of completion of chemotherapy, assessed up to 9 months

• toxicities

  from enrollment to 30 days after completion of chemotherapy, assessed up to 9 months

Study Arms (1)

rituximab combined with chidamde and lenalidomide

EXPERIMENTAL

rituximab and chidamide, lenalidomide

Drug: Rituximab

Interventions

Rituximab DRUG

a new chemotherapy regimen

Also known as: chidamide, lenalidomde

rituximab combined with chidamde and lenalidomide

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must voluntarily participate in this study and sign an informed consent.
• 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:
• 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.

You may not qualify if:

• 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.
• , 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.
• \. 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.
• \. 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.
• \. 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.
• \. Nursing or pregnant women. 8. The researcher judged that the patient had other factors that might affect the compliance of the plan.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Immunoblastic Lymphadenopathy

Interventions

Rituximab; N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide

Condition Hierarchy (Ancestors)

Lymphadenopathy; Lymphatic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Ming Chen, PhD

  Zhejiang Cancer Hospital

  STUDY CHAIR

Central Study Contacts

Cong Li, MD

CONTACT

+8615267115611; licong@zjcc.org.cn

Yan Ha Yang, PhD

CONTACT

+8613857182590; Yanghy@zjcc.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of lymphoma oncology

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: March 24, 2020
• Study Start: March 13, 2020
• Primary Completion: March 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 24, 2021

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)