Status:
UNKNOWN
TPM Regimen (Thalidomide, Prednisone and Methotrexate) in LGLL
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Collaborating Sponsors:
The First Affiliated Hospital of Nanchang University
First Affiliated Hospital of Guangxi Medical University
Conditions:
T-LGL Leukemia
Clpd-Nk
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Large granular lymphocytic leukemia (LGLL) is a lymphoproliferative disease, with LGL infiltration in peripheral blood and bone marrow, hepatosplenomegaly, and cytopenia. Both T-LGLL and CLPD-NK are i...
Detailed Description
Because LGLL has continuously activated cytotoxic T lymphocytes, immunosuppressive therapy is the standard first-line therapy for T-LGLL and CLPD-NK. Previous studies showed that the overall response ...
Eligibility Criteria
Inclusion
- The gender of the patient is not limited, and the age is ≥18 years old;
- Must meet diagnostic criteria of T-LGLL or CLPD-NK according to WHO 2016 version;
- The patient is treatment naive or received single methotrexate less than 4 weeks and without response. If relapsed or refractory patients, the patients must be naive for both thalidomide and methotrexate.
- With LGLL treatment indications, it mainly includes (meets at least one of the following conditions):
- ANC \<0.5 × 10\^9 / L
- HGB \<100g / L or need red blood cell infusion to maintain
- PLT \<50 × 10\^9 / L
- Combining autoimmune diseases that require treatment
- symptomatic splenomegaly
- Severe B symptoms
- Pulmonary hypertension.
- ECOG performance status score is 0-2;
- The patient's expected survival time is ≥ 6 months.
Exclusion
- Unable to understand or follow the research procedure;
- Co-occurrent malignant tumors that has to be treated or course the symptom;
- Other serious diseases, such as liver, kidney, heart, lung, nerve or metabolic diseases, may impede the ability of patients to tolerate methotrexate, cyclophosphamide or cyclosporin A;
- ALAT / ASAT or alkaline phosphatase\> 3 times the normal value;
- Creatinine clearance \<60ml / min;
- Serological evidence of active infection of HIV, hepatitis C or hepatitis B;
- Ineffective contraception;
- Positive pregnancy test;
- Pregnant women.
Key Trial Info
Start Date :
May 20 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 20 2025
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04453345
Start Date
May 20 2013
End Date
May 20 2025
Last Update
July 1 2020
Active Locations (9)
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1
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530000
2
Henan Cancer Hospital
Zhengzhou, Henan, China, 450000
3
Tongji hopital, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
4
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China, 410000