New hope for tough CML: milder chemo before transplant shows promise
NCT ID NCT07259161
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests a reduced-toxicity chemotherapy regimen (thiotepa, melphalan, fludarabine) before a stem cell transplant in 40 people with blast-phase chronic myeloid leukemia (CML), an advanced and hard-to-treat stage. The goal is to see if this gentler approach can improve overall survival and reduce treatment-related deaths. Researchers will also track relapse rates and side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- thiotepa, melphalan, and fludarabine (chemotherapy drugs)
- What this could lead to
- If successful, this could offer a safer way to prepare patients with advanced CML for a stem cell transplant, potentially improving survival and reducing severe side effects.
- What could go wrong
- This is a small, early-phase trial with only 40 participants, so results may not apply to everyone. The treatment still carries risks like infection, organ damage, or graft-versus-host disease.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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Sep 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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: 1. Peripheral blood or bone marrow blasts ≥20% 2. Aggregates of blasts on bone marrow biopsy 3. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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