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NCT Number: NCT05088226

Ruxolitinib and Chidamide Intensified Bu/CY Conditioning Regimen

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.

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Key information

Conditions

Peripheral Blood Stem Cell Transplantation

Age range

12 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • pregnant women;
  • Patients with mental illness or other states unable to comply with the protocol;
  • ALL patients with Ph positive;

Treatment and study plan

Ruxolitinib combined with Chidamide.

Drug

Drug: modified By/Cy conditioning regimen intensified by Ruxolitinib and Chidamide .

Day -15 # Ruxolitinib 70mg bid, Chidamide 30 mg once; Day -14 # Ruxolitinib 70mg bid; Day -13 # Ruxolitinib 70mg bid; Day -12 # Ruxolitinib 70mg bid, Chidamide 30 mg once; Day -11 # Ruxolitinib 70mg bid; Day-10# Cytarabine 4g/m2/day CI , Ruxolitinib 60mg bid; Day- 9# Cytarabine 4g/m2/day CI, Ruxolitinib 60mg bid; Day- 8 # Busulfan 0.8mg/ kg Q6h iv, Ruxolitinib 50mg bid, Chidamide 30 mg once; Day- 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, Chidamide 30 mg once; 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, Chidamide 30 mg/day; Day-1# Ruxolitinib 5mg qd;

Other names: Modified By/Cy conditioning regimen intensified by Ruxolitinib and Chidamide

Primary outcomes

  1. Proportion of participants relapse as assessed by NCCN (National Comprehensive Cancer Network ) criteria

    Time frame: 365 days after transplantation

    Defined as the proportion of participants whose underlying malignancy relapsed.

Secondary outcomes

  1. DFS(disease-free survival )

    Time frame: 365 days after transplantation

    DFS was defined as survival with no evidence of relapse or progression.

  2. TRM(treatment-related mortality )

    Time frame: 365 days after transplantation

    Defined as the proportion of subjects who died due to causes other than malignancy relapse.

  3. Proportion of participants with aGVHD as assessed by acute graft versus host disease grading criteria (refer to Glucksberg criteria)

    Time frame: 365 days after transplantation

    Defined as the proportion of participants who developed acute GVHD.

  4. Proportion of participants with cGVHD as assessed by chronic graft versus host disease grading criteria (refer to NIH criteria)

    Time frame: 365 days after transplantation

    Defined as the proportion of participants who developed chronic GVHD.

  5. OS(overall survival )

    Time frame: 365 days after transplantation

    OS was defined as the time from transplantation to death due to any cause.

  6. Failure-free survival (FFS)

    Time frame: 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).

  7. infection rate

    Time frame: 365 days after transplantation

    Defined as the proportion of participants who developed all kinds of infection.

Study contacts

Contact information is provided by the study sponsor or research team.

Daihong Liu

CONTACT

[email protected]

86-13681171597

Liping Dou

CONTACT

[email protected]

96-13681207138

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Official study title

Ruxolitinib and Chidamide Intensified Bu/CY Conditioning Regimen for Patients With Acute B Cell Lymphoblast Leukemia Underwenting Haploidenticl Peripheral Blood Stem Cell Transplantation

Important dates

Study start
2021
Primary completion
2030
Study completion
2031
First posted
Oct 21, 2021
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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