High risk Acute Myeloid Leukaemia and Myelodysplasia MedDRA version: 14.1 Level: LLT Classification code 10028532 Term: Myelodysplasia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: PT Classification code 10000880 Term: Acute myeloid leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Evoltra
Product Name: Clofarabine
Product Code: Not applicable
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Clofarabine
Other descriptive name: 2-chloro-
Sponsors
University Hospital Southampton NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Cytologically and immunophenotypically (or immunohistochemically) confirmed diagnosis of high risk AML or MDS as defined by the following criteria: • Primary refractory disease as defined by failure to achieve complete remission after one course of intensive chemotherapy appropriate for the therapy of AML • Early relapse following induction or consolidation chemotherapy (within 12 months) • Second or subsequent relapse • AML secondary to documented myelodysplasia, myeloproliferative disorder or prior chemotherapy/radiation • Progressive myelodysplasia with excess blasts. • Poor risk cytogenetics 2.Minimum age of 18 years 3.Eligible for allogeneic stem cell transplant by local institutional guidelines 4.Suitable matched-related/sibling or volunteer unrelated donor available, as determined by local institutional guidelines 5.Negative pregnancy test for females of child-bearing potential within 7 days prior to the start of study treatment 6.If sexually active, male and female subjects must agree that they will use an effective method of birth control throughout the active study period 7.Written informed consent 8.Capable of and willing to comply with scheduled visits, treatment plan and required laboratory tests 9.Adequate renal and hepatic function as indicated by defined laboratory criteria Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1.Psychiatric, addictive or any disorder which compromises ability to give truly informed consent for participation in this study 2.Previous Allogeneic Bone Marrow or Peripheral Blood Stem Cell Transplant. 3.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. 4.Any current active, invasive malignancy excluding AML or MDS
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is to investigate the feasibility and safety of using Clofarabine as pre-conditioning therapy in allogeneic transplant conditioning schedules for the treatment of high risk acute myeloid leukaemia or myelodysplasia. The overall feasibility and safety of this approach will be determined by analysis of: 1. Time to engraftment 2. Incidence of severe (grade III-IV) Graft versus Host Disease 3. Incidence of other treatment-related toxicities 4. Early and late treatment related mortality and overall survival in this group of patients. ;Secondary Objective: Secondary objectives will be to evaluate: 1.The efficacy of this approach to induce durable remission in patients with high risk AML and MDS. 2.Relapse rate. 3.The role of Donor Lymphocyte Infusions in this setting 4.Recipient immune reconstitution parameters following this approach 5.The effect of this approach on overall duration of in-patient stay ;Primary end point(s): Treatment related mortality (TRM) measured at day 100 and 1 year post transplant and cause of mortality | — |
Countries
United Kingdom
Outcome results
None listed