Haematological malignancies undergoing conditioning treatment before allogeneic HSCT
Conditions
Interventions
10 g/m^2 IV treosulfan will be infused daily, applied as a 2-hour infusion on 3 consecutive days (Days -4, -3, and -2). Within the scope of the conditioning regimen, 30 mg/m^2 IV fludarabine will be i
Sponsors
Mihajlovic Jelena
Eligibility
Inclusion criteria
Inclusion criteria: 1. Have acute myeloid leukaemia (AML), myelodysplastic syndrome(MDS), acute lymphoblastic leukaemia (ALL), chronic myeloid leukaemia (CML), Hodgkins lymphoma (HL) or non-Hodgkins lymphoma (NHL) and are in the health conditions judged to be eligible for allogeneic HSCT and are undergoing first allogeneic HSCT. 2. Are at increased risk for standard conditioning therapies, ie, aged >= 50 years at transplant and/or with an HCT-CI score>2 3. Have available matched-related donor (MRD) or matched-unrelated donor (MUD). 4. Are adults of either sex, age 18 years through 70 years (inclusive). 5. Have a Karnofsky Index of >= 60 percent. 6. Are willing to consent to using a highly effective method of birth control such as condoms, implants, injectables, combined oral contraceptives, intrauterine devices, sexual abstinence or vasectomised partner while on treatment and for at least 6 months thereafter if women of childbearing potential or men capable of reproduction. 7. If women of childbearing potential: a. Have a negative serum pregnancy test, and b. Absence of pregnancy or chances of pregnancy as confirmed by a medical interview. 8. Have provided a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Participants considered not eligible for allogeneic HSCT, for instance due to severe concomitant illness, within the screening period (Day -28 to Day -7). 2. Have a known coronary artery disease, history of myocardial infarction, cardiac dysfunction, including cardiomyopathies, heart failure (New York Heart Association Class II and above), and cardiac arrhythmias (including paroxysmal and permanent atrial fibrillation), interventricular conduction delay and / or bundle branch block (RS duration > 120 ms). 3. Have active malignant involvement of the central nervous system (CNS). 4. Are human immunodeficiency virus (HIV) positive or have an active noncontrolled infectious disease under treatment including fungal infection, active viral liver infection, and known severe acute respiratory syndrome coronavirus 2 viral infection, at the time of enrolment. 5. Have a history of or known interstitial lung disease. 6. Have previously had allogeneic HSCT. 7. Have pleural effusion or ascites of >1.0 L. 8. Are pregnant, breastfeeding, or lactating. 9. Have uncontrolled or severe intercurrent medical condition. 10. Have known hypersensitivity to treosulfan, fludarabine, and / or related ingredients. 11. Are participating in another experimental drug trial within 4 weeks prior to Day -6. 12. Exhibit noncooperative behaviour or noncompliance. 13. Have psychiatric diseases or conditions that might compromise the ability to give informed consent. 14. Any contraindication to treosulfan and/or fludarabine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stage 1 DLTs from administration of treosulfan at Day -4 until Day +28 Stage 2 Time to neutrophil engraftment (the first of 3 consecutive days with an ANC>0.5 x 10^9/L in PB) | — |
Contacts
Public ContactKyuichi Nemoto
Nippon medac Co., Ltd.
Outcome results
None listed