Clinical Study of Azacitidine Combined With Ruxolitinib in the Treatment of Higher-risk MDS/MPN

Sponsor
The First Affiliated Hospital with Nanjing Medical University
Study ID
NCT05817955
Phase
PHASE2
Status
Recruiting
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Conditions

  • MDS/MPN

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Azacitidine (AZA) with Ruxolitinib — DRUG
    1. Antibiotics: Antibiotic treatment is positively given when symptoms related to infection, and other support treatment is strengthened. 2. Blood products: Infuse the blood products according to the patient's blood routine test. Drugs that need to be used by other diseases must be recorded in detail in the case report form, including the general name of the drug, the dosage of the medication, and the frequency of administration. Drugs are not allowed to be combined: Avoiding the use of granulocyte colony-stimulating factor (G-CSF), there may be risk of spleen rupture.

Study Details

This study observes the safety and efficacy of Azacitidine (AZA) combined with ruxolitinib to treat higher-risk Myelodysplastic Syndromes∕Myeloproliferative Neoplasms(MDS/MPN)

Key Dates

Start date
Nov 1, 2022
Status verified
Apr 2023
Primary completion
Jan 1, 2025
Completion
Dec 30, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Azacitidine (AZA) with Ruxolitinib
    The treatment phase of each course of treatment is based on Azacitidine (AZA)+Ruxolitinib. Specific scheme: (1) Azacitidine+Ruxolitinib scheme: Azacitidine (AZA) 75mg · m-2 · D-1, D1 to D7, subcutaneous injection; Ruxolitinib, D1 to D28, orally, select Ruxolitinib initial dose according to platelet level: ① PLT\> 100X10\*9/L: 20mg BID orally; ② PLT (50-100) X10\*9/L: 15mg BID orally; ③ PLT \<50X10\*9/L: 10mg Bid orally. The above schemes are all 28 days of treatment. If the patient has serious adverse reactions (such as infection and bone marrow suppression), appropriately delay the next course of treatment or adjust the amount of RUXOLITINIB. Termination of the scheme treatment.

Primary Outcome Measure

complete response rate [ Time Frame: From randomization to the end of Cycle 6 (each cycle is 28 days) ]

Central Contacts

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