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Ruxolitinib and Chidamide for Acute T Cell Lymphoblast Leukemia/ Lymphoblastic Lymphoma

Recruiting
12 - 65 years of age
Both
Phase 1/2

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Overview

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

Description

Haploidenticl Peripheral blood Stem Cell Transplantation should be offered to eligible patients with Acute T cell Lymphoblast leukemia/ lymphoblastic lymphoma whenever feasible. To further improve the outcome of transplantation patients with Acute T cell Lymphoblast leukemia/ lymphoblastic lymphoma, 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 T cell Lymphoblast leukemia/ lymphoblastic lymphoma undergoing allogeneic peripheral blood stem cell transplantation.

Eligibility

Inclusion Criteria:

  1. high risk Acute T cell Lymphoblast leukemia/ lymphoblastic lymphoma with the indications for allogeneic transplantation;
  2. Have 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;

Study details

Peripheral Blood Stem Cell Transplantation

NCT05075681

Chinese PLA General Hospital

25 January 2024

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