Ruxolitinib and Chidamide Intensified Bu/CY Conditioning Regimen

Chinese PLA General Hospital (301 Hospital)

Status and phase: Unknown; Phase 2

Conditions: Peripheral Blood Stem Cell Transplantation

Treatments: Drug: Ruxolitinib combined with Chidamide.

Study type: Interventional

Funder types: Other

Identifiers

NCT05088226

S2020-483-01

Details and patient eligibility

About

The purpose of this study is to determine the efficacy and safety of Ruxolitinib and Chidamide intensified conditioning regimen in patients with Acute B cell Lymphoblast leukemia Underwenting Haploidenticl Peripheral blood Stem Cell Transplantation.

Full description

Haploidenticl Peripheral blood Stem Cell Transplantation should be offered to eligible patients with Acute B cell Lymphoblast leukemia whenever feasible. To further improve the outcome of transplantation patients with Acute B cell Lymphoblast leukemia, we developed a modified Bu/Cy conditioning regimen intensified by Ruxolitinib and Chidamide. In this study, we tested the efficacy and feasibility of the modified Bu/Cy conditioning regimen intensified by Ruxolitinib and Chidamide in patients with Acute B cell Lymphoblast leukemia undergoing allogeneic peripheral blood stem cell transplantation.

Enrollment: 50 estimated patients

Sex: All

Ages: 12 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. pregnant women;
2. Patients with mental illness or other states unable to comply with the protocol;
3. ALL patients with Ph positive;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Ruxolitinib combined with Chidamide

Experimental group

Description:

Experimental: Ruxolitinib combined with Chidamide. All recipients in this arm received the modified Bu/Cy conditioning regimen intensified by Ruxolitinib and Chidamide. The conditioning regimen for allogeneic hematopoietic stem cell transplantation consist of ruxolitinib (35 mg bid \[p.o.\], days -15 to -10, diminishing to day -1), chidamide (30 mg/day, twice per week from days -15 to -2), cytarabine (4g/m2/day, days -10 to -9), busulfan (0.8mg/kg, Q6h, days -8 to -6), cyclophosphamide (1.8 g/m2/day, days -5 to -4), carmustine(BCNU) (250mg/m2/day, day -3)

Treatment:

Drug: Ruxolitinib combined with Chidamide.