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Efficacy and Safety of Low-dose Ruxoltinib Combined with Thalidomide, Prednisone, and Testosterone Decanoate (TPT) in Patients with Lower and Intermediate Risk Myelofibrosis ---a Single Arm, Multicenter, and Prospective Study

Efficacy and Safety of Low-dose Ruxoltinib Combined with Thalidomide, Prednisone, and Testosterone Decanoate (TPT) in Patients with Lower and Intermediate Risk Myelofibrosis ---a Single Arm, Multicenter, and Prospective Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035444
Enrollment
Unknown
Registered
2020-08-11
Start date
2020-08-09
Completion date
Unknown
Last updated
2020-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelofibrosis

Interventions

Case series:Low-dose Ruxoltinib Combined with Thalidomide, Prednisone, and Testosterone Decanoate (TPT)

Sponsors

The Sixth People's Hospital Affiliated to Shanghai Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
17 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Through hematology, bone marrow smear and biopsy histopathology and cytogenetics and molecular testing meet the diagnostic criteria for WHO 2017 primary bone marrow fibrosis (PMF), Post-PV or Post-ET MF must meet the diagnostic criteria for WHO 2017Post-PV or Post-ET; 2. Primary myelofibrosis (PMF) was stratified into a lower risk group (MIPSS-70=50x10^9/L; Liver function: ALT, AST, TBIL NUL; Renal function: Cr clearance rate >15; HIV,HBV and HCV negative (HBV of which HBV-DNA negative); 6. Sign informed consent; 7. Voluntary adherence to research programs, follow-up plans, laboratory and auxiliary examinations.

Exclusion criteria

Exclusion criteria: 1. Previous history of lymphoma, non-melanoma skin cancer, including basal cell, squamous cell and Merkel cell carcinoma; 2. Any active infections include severe bacterial, mycobacterial, fungal, and viral infections such as herpes zoster virus (HZV); 3. History of progressive multifocal leukoencephalopathy (PML) in subjects; 4. For subjects, any drug in the program has counter indications, such as prostate cancer; 5. Significant organ dysfunction: such as respiratory failure, NYHA grade >=grade 2 chronic congestive heart failure, decompensated liver or kidney dysfunction, hypertension, diabetes, and hyperlipidemia that can not be controlled despite active treatment, with cardiovascular and cerebrovascular thrombotic or hemorrhagic events in the last 12 months; 6. With active digestive tract ulcers; 7. With uncertain tumors; 8. Subjects with mental disorders; 9. Previous exposure to thalidomide allergy or more than grade 2 peripheral neuropathy; 10. Other experimental drugs are being used; 11. Pregnancy or lactation.

Design outcomes

Primary

MeasureTime frame
CR;PR;SD;CI;AR\SR;—

Secondary

MeasureTime frame
PFS;EFS;OS;—

Countries

China

Contacts

Public ContactChunkang CHANG

Department of Hematology, The Sixth People's Hospital Affiliated to Shanghai Jiaotong University

changchunkang7010@aliyun.com+86 021-24058336

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026