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 - Clofarabine pre-conditioning with allogeneic transplant for AM

• Conditions: High risk Acute Myeloid Leukaemia and Myelodysplasia; MedDRA version: 14.1Level: LLTClassification code 10028532Term: MyelodysplasiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: PTClassification code 10000880Term: Acute myeloid leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2008-007043-14-GB
• Lead Sponsor: niversity Hospital Southampton NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08-27
• Last Update Posted: 21 August 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 0

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified