Using fractionated busulfan for treating myeloid malignancies before stem cell transplants

Fractionated Busulfan Combined With Chidamide/Fludarabine/Cytarabine (ChiFAB) With Allogeneic Hematopoietic Stem-Cell Transplantation in Non-remission Myeloid Malignancies: a Phase II Study

This study is testing a new treatment plan using a combination of medications before stem cell transplants to see if it helps people with myeloid cancers live longer and have fewer relapses.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Sichuan University (Academic / other)
• Drugs / interventions: chemotherapy, Fludarabine
• Locations: 1 site (Chendu, Sichuan)
• Trial ID: NCT05807659 on ClinicalTrials.gov

What this trial studies

This phase II clinical trial aims to evaluate the safety and efficacy of a fractionated busulfan conditioning regimen combined with Chidamide, Fludarabine, and Cytarabine (ChiFAB) in patients with non-remission myeloid malignancies undergoing allogeneic hematopoietic stem-cell transplantation (allo-HSCT). The study will assess whether this regimen can improve overall survival rates and reduce recurrence rates in these patients. Participants will receive the conditioning regimen prior to their stem cell transplant, with specific dosages and schedules outlined for each drug involved.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with non-remission myeloid malignancies who have not achieved complete remission after multiple chemotherapy regimens.

Not a fit: Patients with serious underlying organ diseases, uncontrolled infections, or those participating in other clinical studies may not benefit from this trial.

Why it matters

Potential benefit: If successful, this approach could significantly improve survival rates and reduce the risk of recurrence for patients with challenging myeloid malignancies.

How similar studies have performed: While this specific approach is being tested in this trial, similar conditioning regimens have shown promise in other studies involving allo-HSCT for myeloid malignancies.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 18 years old and ≤ 65 years old when signing the Informed Consent Form (ICF);
2. KPS score \> 60 or ECOG score 0-2;
3. The expected survival period \> 3 months;
4. Those who did not achieve complete remission after 2 or more chemotherapy regimens. The proportion of blasts on bone marrow smears before transplantation was ≥5%.
5. Those who have no central nervous system involvement or serious functional damage to important organs of the body;
6. Fully understand and be informed of this study and sign the ICF; willing to follow and have the ability to complete all test procedures;

Exclusion Criteria:

1. Serious basic diseases of important organs: such as myocardial infarction, chronic cardiac insufficiency, decompensated hepatic insufficiency, renal function, gastrointestinal insufficiency, etc.;
2. Uncontrolled active infection (including bacterial, fungal, or viral infection), and drug treatment is ineffective;
3. Participating in other clinical studies, or planning to start treatment in this study and less than 4 weeks before the end of treatment in the previous clinical study;
4. Combined with other malignant tumors and require treatment;
5. Pregnant or lactating females;
6. Patients with known history of human immunodeficiency virus (HIV) virus infection and/or acquired immunodeficiency syndrome;
7. Patients with active chronic hepatitis B or active hepatitis C;
8. History of prolonged QT syndrome;
9. Patients considered by other researchers to be unsuitable for this study

Where this trial is running

Chendu, Sichuan

• West China Hospital, Sichuan University — Chendu, Sichuan, China (Recruiting)

Conditions Myeloid Malignancies; myeloid malignancies; allo-HSCT