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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.


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Acute Myeloid Leukaemia, Myelodysplasia

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Trial Information

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.


This is a pilot study. Twenty patients in total will be treated in two cohorts of 10
patients each.

- 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.

- Cohort Two: 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.

The cohorts will be recruited concurrently. It is anticipated that recruitment of the 20
subjects will be achieved in 18 months to two years.

The study will be conducted at a single centre (Southampton, UK) in the first instance.

This design allows the use of a full intensity, TBI-based transplant conditioning schedule,
for younger patients able to tolerate this approach but also the use of a reduced intensity
transplant conditioning schedule in older or less fit patients who may still benefit from
pre-conditioning with Clofarabine followed by an allogeneic stem cell transplant. This
design, therefore, does not restrict potential recruitment to the study on age or
performance status alone (within the limits set by ability to tolerate intensive
chemotherapy and a transplant procedure).


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Treatment related mortality (TRM)

Outcome Description:

Treatment related mortality (TRM) measured at day 100 and 1 year post transplant and cause of mortality

Outcome Time Frame:

day 100 and 1 year post transplant

Safety Issue:

Yes

Principal Investigator

Deborah S Richardson, MA MB BChir MD FRCP FRCPath

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital Southampton NHS Foundation Trust.

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

RHM CAN0638

NCT ID:

NCT01422603

Start Date:

February 2011

Completion Date:

September 2013

Related Keywords:

  • Acute Myeloid Leukaemia
  • Myelodysplasia
  • High risk
  • AML
  • MDS
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia

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