Fractionated Busulfan Conditioning Regimen for Allo-HSCT in Non-remission Myeloid Malignancies

NCT05807659 — Phase 2, Unknown, 18 participants, Sichuan University

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

RegistryNCT05807659
StatusUnknown
PhasePhase 2
Study typeInterventional; na, single group, masking: none, treatment
Enrollment18 (Estimated)
SponsorSichuan University (Other)
ConditionsMyeloid Malignancies
Interventionsfractionated busulfan-based conditioning regimen (Drug)
Datesstart 2023-03-16, primary completion 2025-08-31 (estimated), completion 2025-12-31 (estimated), first posted 2023-04-11, last updated 2023-04-11
Locations1 site in China

Related Papers Related Patents Related Grants Related Experts
All trials for Myeloid Malignancies All trials of fractionated busulfan-based conditioning regimen

-Summary

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.

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+Arms and interventions

ArmTypeInterventionsDescription
fractionated busulfanExperimentalDrug: fractionated busulfan-based conditioning regimenfractionated 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
  • fractionated busulfan-based conditioning regimen (Drug): Drug: Chidamide 30 mg oral twice weekly for 2 weeks Drug: Fludarabine 35 mg/m2 intravenously daily for 5 days in the 2nd week Drug: Cytarabine 1 g/m2 intravenously for 5 days in the 2nd week Drug: Busulfan 3.2 mg/kg intravenously daily for 2 days in the 1st week, 1.6 mg/kg intravenously daily for 4 days in the 2nd week Procedure/Surgery: allogeneic hematopoietic stem cell transplantation

+Outcome measures

Primary outcomes

  • Overall survival (OS) [2 years]: Overall survival of this group of patients at the end of 2 year

Secondary outcomes

  • Non-relapse mortality (NRM) [6 months]: Non-relapse mortality of this group of patients at the end of 6 months
  • Relapse rate [2 years]: Relapse rate of this group of patients at the end of 2 year
  • Cumulative incidence of acute graft versus host disease (aGVHD) [Day +100]: Cumulative incidence of acute graft versus host disease (aGVHD) of this group of patients at day+100
  • Cumulative incidence of chronic graft versus host disease (cGVHD) [2 years]: Cumulative incidence of chronic graft versus host disease (cGVHD) of this group of patients at the end of 2 year

+Eligibility

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

+Locations (1)

FacilityCityCountryStatus
West China Hospital, Sichuan UniversityChengdu, SichuanChinaRecruiting