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NCT07259161Not yet recruitingPhase 2

Modified Conditioning Regimen for CML-BP

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

Source: ClinicalTrials.gov · Last updated 2 Dec 2025

Brief summary (registry, in English)

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

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
40 (estimated)
First submitted
25 Sept 2025
Start date
15 Dec 2025
Primary completion date
14 Sept 2029
Lead sponsor
Institute of Hematology & Blood Diseases Hospital, China
NCT number
NCT07259161

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 40
  • From 15 Dec 2025 to the primary completion date, 14 Sept 2029
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Who the study is looking for

  • (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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.