Modified Conditioning Regimen for CML-BP

NCT07259161 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: IIT2025094
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

CML,Blast Phase; HSCT

Outcome Measures

Primary Outcomes (1)

• overall survival, OS

  2 year

Secondary Outcomes (4)

• Relapse free survival, RFS

  2 year

• TRM

  2 year

• CIR

  2 year

• safety and toxicity of conditioning regimen

  2 year

Study Arms (1)

modified conditioning regimen

EXPERIMENTAL

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

Interventions

Enrolled patients with blast-phase chronic myeloid leukemia received a reduced-toxicity conditioning regimen containing thiotepa, melphalan, and fludarabine prior to undergoing allogeneic hematopoie DRUG

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 5mg/kg on days -8 and -7, melphalan 60mg/m2 on days -5 and -4, Flu 30mg/m2 from day -6 to day -2.

modified conditioning regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• \. (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.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

MeSH Terms

Interventions

Melphalan

Intervention Hierarchy (Ancestors)

Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Erlie Jiang

CONTACT

022-23608569; jiangerlie@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: December 2, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): September 14, 2029
• Study Completion (Estimated): September 14, 2029
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share