Fractionated Busulfan Combined With Chidamide/Fludarabine/Cytarabine (ChiFAB) With Allogeneic Hematopoietic Stem-Cell Transplantation in Non-remission Myeloid Malignancies: a Phase II Study
| Registry | NCT05807659 |
|---|---|
| Status | Unknown |
| Phase | Phase 2 |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 18 (Estimated) |
| Sponsor | Sichuan University (Other) |
| Conditions | Myeloid Malignancies |
| Interventions | fractionated busulfan-based conditioning regimen (Drug) |
| Dates | start 2023-03-16, primary completion 2025-08-31 (estimated), completion 2025-12-31 (estimated), first posted 2023-04-11, last updated 2023-04-11 |
| Locations | 1 site in China |
Related Papers Related Patents Related Grants Related Experts
All trials for Myeloid Malignancies All trials of fractionated busulfan-based conditioning regimen
The goal of this single-arm phase II study is to test in patients with non-remission myeloid malignancies undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT). The main question it aims to answer are:
* The safety and efficacy of fractionated busulfan Combined With Chidamide/Fludarabine/Cytarabine(ChiFAB) conditioning regimen in increasing the overall survival rate in patients with non-remission myeloid malignancies after allo-HSCT.
* The efficacy of fractionated busulfan conditioning regimen in reducing the recurrence rate in patients with non-remission myeloid malignancies after allo-HSCT.
Participants will receive fractionated busulfan-based ChiFAB conditioning regimen (busulfan 3.2mg/kg d-13, -12, 1.6mg/kg d-6\~-3, fludarabine 35mg/m2 d-6\~-2, cytarabine 1g/m2,d-6\~-2, chidamide 30mg d-13,-10,-6,-3) before allo-HSCT.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| fractionated busulfan | Experimental | Drug: fractionated busulfan-based conditioning regimen | fractionated busulfan-based ChiFAB conditioning regimen: busulfan 3.2mg/kg d-13, -12, 1.6mg/kg d-6\~-3, fludarabine 35mg/m2 d-6\~-2 cytarabine 1g/m2,d-6\~-2 chidamide 30mg d-13,-10,-6,-3 |
Sex: All, ages: 18 Years to 65 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| West China Hospital, Sichuan University | Chengdu, Sichuan | China | Recruiting |