Ruxolitinib and Decitabine for High Risk Hematological Malignancies

Conditions

Peripheral Blood Stem Cell Transplantation

Brief summary

The purpose of this study is to determine the efficacy and safety of Ruxolitinib and Decitabine intensified Conditioning Regimen in Patients with High Risk hematological malignancies undergoing allogeneic peripheral blood stem cell transplantation.

Detailed description

Allogeneic hematopoietic stem cell transplantation should be offered to eligible patients with high risk hematological malignancies whenever feasible. To further improve the outcome of transplantation patients with high risk hematological malignancies, the investigators developed a modified Bu/Cy conditioning regimen intensified by Ruxolitinib and Decitabine. In this study, the investigators tested the efficacy and feasibility of the modified Bu/Cy conditioning regimen intensified by Ruxolitinib and Decitabine in Patients with high risk hematological malignancies undergoing allogeneic peripheral blood stem cell transplantation.

Daihong Liu, Liping Dou, Weiqi Li

Blood2025-11-03

10.1182/blood-2025-5969

Ruxolitinib and decitabine plus a busulfan–cyclophosphamide conditioning regimen for relapse prophylaxis in patients with high-risk acute myeloid leukemia or myelodysplastic syndromes

Yujun Wei, Songhua Luan, Lu Wang, Lili Wang, Fei Li et al. (13 authors)

Frontiers in Immunology2025-08-18

10.3389/fimmu.2025.1586512

Addition of ruxolitinib and decitabine to modified busulfan/cyclophosphamide conditioning regimen for prophylaxis relapse in high-risk acute myeloid leukemia: the phase 2 prospective study.

Wei Y, Qian K, Le N, Wang L, Li F, Luan S, Wang L, Jin X, Peng B, Wang N, Dou L, Liu D.

2024-09-071 citations

10.1007/s00277-024-05972-w

S247: ADDING RUXOLITINIB AND DECITABINE TO BU/CY CONDITIONING REGIMENS TO PROPHYLAXIS POST-TRANSPLANT RELAPSE IN HIGH-RISK AML IS SAFE AND EFFECTIVE: A PROSPECTIVE, PHASE II STUDY

Yujun Wei, Kun Qian, Lili Wang, Fei Li, Nan Wang et al. (12 authors)

HemaSphere2023-08-01

10.1097/01.hs9.0000967900.54514.e6

Interventions

DRUGmodified By/Cy conditioning regimen intensified by Ruxolitinib and Decitabine

Day -15 to -14 ： Decitabine 20 mg/m2/day, Ruxolitinib 70mg bid; Day-10： Cytarabine 1.6 g/m2/day CI (only for Haploidentical and unrelated donor), Ruxolitinib 60mg bid; Day- 9： Cytarabine 4g/m2/day CI, Ruxolitinib 60mg bid; Day- 8 to -7： Busulfan 0.8mg/kg Q6h iv, Ruxolitinib 50mg bid; Day-6: Busulfan 0.8mg/kg Q6h iv, Ruxolitinib 40mg bid; Day-5： Cyclophosphamide 1.8 g/m2/day CI, Ruxolitinib 30mg bid; Day-4： Cyclophosphamide 1.8 g/m2/day CI, Ruxolitinib 20mg bid; Day-3： Carmustine 250mg/m2/day iv, Ruxolitinib 10mg bid; Day-2： Ruxolitinib 5mg bid; Day-1： Ruxolitinib 5mg qd;

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to 65 Years

Healthy volunteers

No

Inclusion criteria

1. Relapsed/refractory acute leukemia with indications for allogeneic hematopoietic stem cell transplantation; High risk acute leukemia with indications for allogeneic hematopoietic stem cell transplantation; 2. Medium to high risk myelodysplastic syndrome, myeloproliferative disease, myelodysplastic syndrome/myeloproliferative disease, Chronic myelomonocytic leukemia; 3. Have matched sibling donors, ≥8/10 HLA matched unrelated donors or haploidentical donors 4. All patients should aged 12 to 65 years; 5. Liver function: ALT and AST≤2.5 times the upper limit of normal , bilirubin≤2 times the upper limit of normal; 6. Renal function: creatinine ≤the upper limit of normal; 7. Patients without any uncontrolled infections , without organ dysfunction or without severe mental illness; 8. Eastern Cooperative Oncology Group (ECOG) performance status ≤2; 9. Have signed informed consent.

Exclusion criteria

1. pregnant women; 2. Patients with mental illness or other states unable to comply with the protocol; 3. AML patients with t (15;17);

Design outcomes

Primary

Measure	Time frame	Description
Number of participants relapse as assessed by NCCN (National Comprehensive Cancer Network )criteria	365 days after transplantation	Defined as the proportion of participants whose underlying malignancy relapsed.

Secondary

Measure	Time frame	Description
TRM(treatment-related mortality )	365 days after transplantation	Defined as the proportion of subjects who died due to causes other than malignancy relapse.
Number of participants with aGVHD as assessed by acute graft versus host disease grading criteria (refer to Glucksberg criteria)	100 days after transplantation	Defined as the proportion of participants who developed acute GVHD.
Number of participants with cGVHD as assessed by chronic graft versus host disease grading criteria (refer to NIH criteria)	365 days after transplantation	Defined as the proportion of participants who developed chronic GVHD.
DFS(disease-free survival )	365 days after transplantation	DFS was defined as survival with no evidence of relapse or progression.
GRFS (GVHD free, relapse free survival)	365 days after transplantation	GVHD-free, relapse-free survival (GRFS) was defined as survival with no evidence of grade III-IV acute GVHD or cGVHD requiring immunosuppressive treatment, and without disease recurrence or death from any cause during the first year after transplantation.
infection rate	365 days after transplantation	Defined as the proportion of participants who developed all kinds of infection.
OS(overall survival )	365 days after transplantation	OS was defined as the time from transplantation to death due to any cause.

Countries

China

Contacts

Primary ContactDaihong Liu

daihongrm@163.com86-13681171597

Backup ContactLiping Dou

lipingruirui@163.com96-13681207138

Outcome results

None listed