Clinical trial · Interventional
Myloablative Cord Blood Transplant in Haematological Malignancies (MAC UCBT)
Transplantation Of Umbilical Cord Blood From Unrelated Donors In Patients With Haematological Diseases Using A Myeloablative Conditioning Regimen
NCT02310997CI-TRIAL-00018052MAC UCBTterminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Trial closed early due to poor recruitment
Summary
Brief summary (as posted)
This trial is looking at using umbilical cord blood from unrelated donors after high dose chemotherapy. It is for people who have cancer of the bone marrow or lymphatic system including leukaemia and lymphoma, or a blood disorder called myelodysplastic syndrome (MDS). The trial is for babies over 4 weeks old, children, and adults up to the age of 45.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Busulfan | Drug | Busulfan | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Melphalan | Drug | Melphalan | ALIAS |
| Total body irradiation | Radiation | — | UNRESOLVED |
| Umbilical Cord Blood Transplant | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Fludarabine + Cyclophosphamide + TBI
- description
- Patients aged 2-45 years (excluding AML, JMML and MDS patients aged \<16 years) will receive an umbilical cord blood transplant using a myeloablative conditioning regimen comprising: Fludarabine 25mg/m\^2/day day -8 to -6 (total 75mg/m\^2) Cyclophosphamide 60mg/kg day -7 and -6 (total 120mg/kg) Total body irradiation 13 - 14.4Gy in 6-8 fractions
- interventionNames
- Other: Umbilical Cord Blood Transplant
- Drug: Cyclophosphamide
- Radiation: Total body irradiation
- Drug: Fludarabine
- type
- EXPERIMENTAL
- label
- Busulfan + Cyclophosphamide + Melphalan
- description
- Patients aged \< 2 years and AML, JMML and MDS patients \<16 years will receive an umbilical cord blood transplant using a myeloablative conditioning regimen comprising: Busulfan 3.2mg/kg/day in 2 or 4 doses per day, days -9 to -6 (total 12.8mg/kg). Cyclophosphamide 60mg/kg days -4 and -3 (total 120mg/kg) Melphalan 140mg/m\^2 day -2
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 28 Days
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects must be \< 45 years of age and ≥ 28 days old * Patients with high risk, advanced or poorly responding haematological disease for which there is published evidence that haematopoietic stem cell transplantation using myeloablative conditioning is likely to be effective * The individual patient's disease status is such that there is no alternative therapy likely to achieve cure or provide a significant prolongation of disease-free survival * Left ventricular ejection fraction \>45% * Transaminases and bilirubin \< twice the upper limit of the normal range * Creatinine clearance \> 60mls/min * Comorbidity index of 0 or 1 Exclusion Criteria: * Patients with a suitably matched sibling donor or 10/10 unrelated volunteer donor available within an acceptable time period. * Pregnancy or breastfeeding. * Evidence of HIV or HTLV (I+II) infection or known HIV or HTLV positive serology * Current active serious infection, in particular uncontrolled fungal infection -Previous irradiation that precludes the safe administration of an additional dose of 13- 14.4 Gy of total body irradiation (TBI) in patients aged 2-45 years * Prior autograft * CML in first chronic phase responding to Imatinib or refractory blast crisis * Patients with acute leukaemia in morphological relapse/ persistent disease (defined as \> 5% blasts in normocellular bone marrow) * Patients with acute myeloid leukaemia with relapse/persistent disease unresponsive to re-induction chemotherapy (defined as \>20% blasts in normocellular bone marrow) * Malignant disease that is refractory to or progressive on salvage therapy * Myelofibrosis. * Aplastic anaemia
References
Publications (0)
Data not yet available
No reference posted for this study.