Ruxolitinib and Chidamide Intensified Bu/CY Conditioning Regimen

Phase 2

• Conditions: Peripheral Blood Stem Cell Transplantation
• Interventions: Drug: Ruxolitinib combined with Chidamide.

• Registration Number: NCT05088226
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-05-25
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-20
• Last Update Submitted: 2021-10-20
• Study First Posted: 2021-10-21
• Last Update Posted: 2021-10-21
• Study Start: 2021-12-01
• Primary Completion: 2022-06-01
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ruxolitinib combined with Chidamide	Ruxolitinib combined with Chidamide.	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)

Primary Outcome Measures

Name	Time	Method
Proportion 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 Outcome Measures

Name	Time	Method
Failure-free survival (FFS)	365 days after transplantation	Defined as the time from tranplantation to the earliest date that a participant died, had a relapse/progression of the underlying malignancy, required additional therapy for aGVHD, or demonstrated signs or symptoms of chronic graft-versus-host disease (cGVHD).
TRM(treatment-related mortality )	365 days after transplantation	Defined as the proportion of subjects who died due to causes other than malignancy relapse.
Proportion of participants with aGVHD as assessed by acute graft versus host disease grading criteria (refer to Glucksberg criteria)	365 days after transplantation	Defined as the proportion of participants who developed acute GVHD.
OS(overall survival )	365 days after transplantation	OS was defined as the time from transplantation to death due to any cause.
infection rate	365 days after transplantation	Defined as the proportion of participants who developed all kinds of infection.
DFS(disease-free survival )	365 days after transplantation	DFS was defined as survival with no evidence of relapse or progression.
Proportion 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.

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China