Clinical trial · Interventional
Clofarabine Pre-conditioning With Allogeneic Transplant for Acute Myeloid Leukaemia (AML)
A Pilot Study of Clofarabine Pre-conditioning Prior to Full or Reduced Intensity Allogeneic Transplantation in the Treatment of High Risk Acute Myeloid Leukaemia and Myelodysplasia.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study has been designed to investigate the safety and feasibility of using a chemotherapy drug, Clofarabine, to reduce the disease burden before a donor transplant, in patients with high risk Acute Myeloid Leukaemia or Myelodysplasia (MDS). In this study Clofarabine chemotherapy will be given a few days before a reduced or full intensity donor stem cell transplant and without waiting for normal blood counts to recover. It is hoped that this approach may improve the outcome for patients with high risk AML and MDS after their transplant.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukaemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Myelodysplasia | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clofarabine | Drug | Clofarabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Clofarabine and Full intensity SCT
- description
- Cohort One: Patients suitable for full intensity conditioning will receive Clofarabine pre-conditioning followed by a Cyclophosphamide and Total Body Irradiation conditioned allogeneic stem cell transplant (SCT).
- interventionNames
- Drug: Clofarabine
- type
- EXPERIMENTAL
- label
- Clofarabine and Reduced intensity SCT
- description
- Cohort 2: Patients not suitable for a full intensity TBI-based transplant due to age or co-morbidity will receive Clofarabine pre-conditioning followed by a reduced intensity allogeneic stem cell transplant using Fludarabine, intravenous Busulphan and Campath 1H.
- interventionNames
- Drug: Clofarabine
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Cytologically and immunophenotypically (or immunohistochemically) confirmed diagnosis of high risk AML or MDS * Minimum age of 18 years * Eligible for allogeneic stem cell transplant by local institutional guidelines * Suitable matched-related/sibling or volunteer unrelated donor available, as determined by local institutional guidelines * Negative pregnancy test for females of child-bearing potential within 7 days prior to the start of study treatment * If sexually active, male and female subjects must agree that they will use an effective method of birth control throughout the active study period * Written informed consent * Capable of and willing to comply with scheduled visits, treatment plan and required laboratory tests * Adequate renal and hepatic function Exclusion Criteria: * Psychiatric, addictive or any disorder which compromises ability to give truly informed consent for participation in this study * Previous Allogeneic Bone Marrow or Peripheral Blood Stem Cell Transplant. * Pregnant or lactating women. All female subjects of child-bearing potential must have a negative pregnancy test within 7 days prior to the start of treatment. * Any current active, invasive malignancy excluding AML or MDS
References
Publications (0)
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