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Not yet recruiting NCT07259161

Modified Conditioning Regimen for CML-BP

Phase II Interventional CML,Blast Phase HSCT

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Enrolled patients with blast-phase chronic myeloid leukemia received a reduced-toxicity conditioning regimen containing thiotepa, melphalan, and fludarabine prior to undergoing allogeneic hematopoie.
Who it may be relevant to
Registry conditions: CML,Blast Phase, HSCT. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Prospective, Single-Arm Study on the Efficacy of a Reduced-Toxicity Conditioning Regimen Containing Thiotepa and Melphalan for Patients With Blast Phase Chronic Myeloid Leukemia

Overview

Study on the Efficacy and Safety of a Reduced-Toxicity Conditioning Regimen Containing Thiotepa and Melphalan in Patients with Blast Phase Chronic Myeloid Leukemia

Interventions

  • Drug Enrolled patients with blast-phase chronic myeloid leukemia received a reduced-toxicity conditioning regimen containing thiotepa, melphalan, and fludarabine prior to undergoing allogeneic hematopoie
    This study is a prospective, interventional clinical trial recruiting patients with blast-phase chronic myeloid leukemia from the Stem Cell Transplantation Center of the Institute of Hematology \& Blood Diseases Hospital, Chinese Academy of Medical Sciences, with an anticipated enrollment of 40 cases. Enrolled patients are scheduled to receive a reduced-toxicity conditioning regimen containing thiotepa, melphalan, and fludarabine for allogeneic hematopoietic stem cell transplantation. Thiotepa 5

Primary outcome measures

  • overall survival, OS [Time frame: 2 year]
Secondary outcome measures (4)
  • Relapse free survival, RFS [Time frame: 2 year]
  • TRM [Time frame: 2 year]
  • CIR [Time frame: 2 year]
  • safety and toxicity of conditioning regimen [Time frame: 2 year]

Eligibility criteria

Inclusion criteria

  • (1) Confirmed diagnosis of blast-phase chronic myeloid leukemia, with diagnostic criteria referring to the 2020 Chinese Guidelines for Diagnosis and Treatment of Chronic Myeloid Leukemia.

Diagnostic criteria for chronic myeloid leukemia: Typical clinical manifestations combined with the presence of Philadelphia chromosome and/or BCR-ABL fusion gene positivity confirm the diagnosis.

Diagnostic criteria for blast phase:

  • Peripheral blood or bone marrow blasts ≥20%
  • Aggregates of blasts on bone marrow biopsy
  • Extramedullary blast cell infiltration (2) Age ≥18 years (3) Ability to provide self-signed informed consent (4) Must meet adequate organ function requirements:

Renal and hepatic function as follows:

AST, ALT and ALP <2× upper limit of normal (ULN) Total bilirubin <1.5× ULN Creatinine clearance >50 mL/min

Pancreatic function:

Serum amylase ≤1.5× ULN Serum lipase ≤1.5× ULN

Normal cardiac function:

Ejection fraction (EF) >60% Pulmonary artery systolic pressure ≤50 mmHg (5) HIV negative, HBV negative, HCV negative (6) Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-2 (7) Signed informed consent must be obtained before study procedures begin. For subjects aged 18 years or older, informed consent shall be signed by the patient themselves or direct family members. Considering the patient's medical condition, if the patient's own signature is medically inadvisable, the informed consent shall be signed by a legal guardian or the patient's direct family member.

Exclusion criteria

  • 1\. (1) Patients with previous autologous or allogeneic stem cell transplantation; (2) Patients concurrently diagnosed with other malignant tumors; patients assessed by investigators as having concomitant diseases that severely endanger their life safety or affect their ability to complete this study; (3) Patients with psychiatric disorders or other medical conditions that cannot comply with the requirements of study treatment and monitoring; (4) Patients unable or unwilling to sign the consent form; (5) Pregnant or lactating women; (6) Patients assessed by investigators as ineligible due to other special circumstances.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07259161 · IIT2025094

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗