Ruxolitinib-Decitabine Intensified Conditioning Regimen for AML: A Randomized Trial

NCT07101588 | Recruiting Phase 4 DMC

• 1 other identifier: S2024-678-01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to determine whether the recurrence rate of high-risk acute myeloid leukemia CR1 patients who received allogeneic hematopoietic stem cell transplantation with the Ruxolitinib, Decitabine combined with Bu/Cy or BuF intensive pretreatment regimen is reduced compared with the traditional Bu/Cy or BuFpretreatment regimen.

Conditions

Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Keywords

HSCT

Outcome Measures

Primary Outcomes (1)

• GRFS

  GVHD-free, relapse-free survival (GRFS) was defined as a composite endpoint of death from any cause, disease relapse, grade Ⅲ-Ⅳ acute GVHD, or chronic GVHD requiring systemic immunosuppression therapy.

  1 year

Secondary Outcomes (13)

• Cumulative recurrence rate (CIR)

  1 years after transplantation

• Progression-Free Survival（PFS）

  1 years after transplantation

• CR rate

  30 days after transplantation

• The incidence of aGVHD

  100 days after transplantation

• The incidence of cGVHD

  1 years after transplantation

Study Arms (2)

Assigned Interventions

ACTIVE COMPARATOR

1. Decitabine: 20 mg/m²/day, administered from Day -15 to Day -10. 2. Ruxolitinib(with Voriconazole): * 10 mg twice daily (bid), Day -15 to Day -5 * 5 mg twice daily (bid), Day -4 to Day -3 * 5 mg once daily (Qd), Day -2 3. Busulfan (Bu): 0.8 mg/kg every 6 hours (Q6h), Day -8 to Day -6. 4. Carmustine (BCNU): 250 mg every 8 hours (Q8h), Day -3. 5. Cytarabine (Ara-C): * 4 g/m²/day, Day -10 to Day -9 (for unrelated or haploidentical donors) * 4 g/m²/day, Day -9 only (for matched sibling donors) 6. Cyclophosphamide (CTX): 50 mg/kg/day, Day -5 to Day -4. or Fludarabine 30mg/m2/day, iv, Day -6 to Day -2; 7. Antithymocyte Globulin (ATG): * 10 mg/kg/day, Day -5 to Day -2 (for unrelated or haploidentical donors) * 5 mg/kg/day, Day -5 to Day -2 (for matched sibling donors)

Combination Product: Ruxolitinib, Decitabine

The control group

NO INTERVENTION

1. Busulfan (Bu): 0.8 mg/kg every 6 hours (Q6h), Day -8 to Day -6. 2. Carmustine (BCNU): 250 mg every 8 hours (Q8h), Day -3. 3. Cytarabine (Ara-C): * 4 g/m²/day, Day -10 to Day -9 (for unrelated or haploidentical donors) * 4 g/m²/day, Day -9 only (for matched sibling donors) 4. Cyclophosphamide (CTX): 50 mg/kg/day, Day -5 to Day -4. or Fludarabine 30mg/m2/day, iv, Day -6 to Day -2; 5. Antithymocyte Globulin (ATG): * 10 mg/kg/day, Day -5 to Day -2 (for unrelated or haploidentical donors) * 5 mg/kg/day, Day -5 to Day -2 (for matched sibling donors)

Interventions

Ruxolitinib, Decitabine COMBINATION_PRODUCT

1. Decitabine: 20 mg/m²/day, administered from Day -15 to Day -10. 2. Ruxolitinib: * 10 mg twice daily (bid), Day -15 to Day -5 * 5 mg twice daily (bid), Day -4 to Day -3 * 5 mg once daily (Qd), Day -2

Assigned Interventions

Eligibility Criteria

• Age: 14 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Acute myeloid leukemia with indications for allogeneic hematopoietic stem cell transplantation, CR1 2) Have HLA-matched sibling donors or haploidentical donors or ≥8/10 HLA-matched unrelated donors 3) The patients' ages range from 12 to 64 years old 4) Liver function: ALT and AST≤2.5 times the upper limit of normal values, bilirubin ≤2 times the upper limit of normal values 5) Renal function: Creatinine ≤ the upper limit of the normal value 6) There are no uncontrollable infections or serious mental and psychological disorders 7) Sign the informed consent form.

You may not qualify if:

• \. Patients with acute promyelocytic leukemia (M3) 2. One of the donor and recipient is pregnant 3. Suffering from mental illness or other conditions that prevent one from following the plan.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead
• The First Affiliated Hospital of Zhengzhou University, Zhengzhou: collaborator
• Peking University People's Hospital: collaborator

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Related Publications (10)

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MeSH Terms

Interventions

ruxolitinib; Decitabine

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Central Study Contacts

Li-ping Dou, Dr.

CONTACT

86-10-66937079; lipingruirui@163.com

Dai-hong Liu, Dr.

CONTACT

86-10-66937079; lipingruirui@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: Random Group Assignment

Study Record Dates

• First Submitted: June 1, 2025
• First Posted: August 3, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: March 20, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)