Know Cancer

or
forgot password

Pilot Study of Reduced Intensity Haematopoietic Stem Cell Transplantation in Patients With Poor Risk Myelodysplastic Syndrome and Acute Myeloid Leukaemia Utilising Conditioning With Fludarabine, Busulphan and Thymoglobulin


Phase 2
18 Years
N/A
Not Enrolling
Both
Myelodysplastic Syndromes, Leukemia, Myeloid, Acute

Thank you

Trial Information

Pilot Study of Reduced Intensity Haematopoietic Stem Cell Transplantation in Patients With Poor Risk Myelodysplastic Syndrome and Acute Myeloid Leukaemia Utilising Conditioning With Fludarabine, Busulphan and Thymoglobulin


Inclusion Criteria:



Patient Selection

1. Availability of a HLA compatible sibling donor

2. Age >18 years

3. Myelodysplastic Syndromes with IPSS Intermediate-2 or High.

4. Poor risk acute myeloid leukaemia, de novo or transformed from MDS

5. Ineligibility for standard conditioning allograft due to age or co-existing
morbidities

Donor selection

1. Related donors compatible for HLA-A, B, C, DRB1 and DQB1 by molecular typing.

Exclusion Criteria:

Patient selection

1. Cardiac insufficiency requiring treatment or symptomatic coronary artery disease.

2. Hepatic disease, with AST > 2 times normal.

3. Severe hypoxaemia, pO2 < 70 mm Hg, with decreased DLCO < 70% of predicted; or mild
hypoxemia, pO2 < 80 mm Hg with severely decreased DLCO < 60% of predicted.

4. Impaired renal function (creatinine > 2 times upper limit of normal or creatinine
clearance < 50% for age, gender, weight).

5. Patients who have received previous treatment with Thymoglobuline

6. HIV-positive patients.

7. Female patients who are pregnant or breast feeding due to risks to foetus from
conditioning regimen and potential risks to nursing infants.

8. Life expectancy severely limited by diseases other than MDS or MPD.

9. Serious concurrent untreated infection

10. Patients with limited life expectancy for other reasons

11. Serious psychiatric/ psychological disorders

12. Absence of /inability to provide informed consent

Donor selection

1. Age >75 years, unless independently assessed to be medically fit to donate

2. Donors who for any reason are unable to tolerate the leukapheresis procedure and
cannot undergo anaesthesia for marrow harvest.

3. Donors who are HIV-positive, or hepatitis B or C PCR positive.

4. Donors who are medically unsuitable to donate

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Treatment related mortality to Day 100

Outcome Time Frame:

Days 28, 56 and 100

Safety Issue:

Yes

Principal Investigator

Ghulam J Mufti, MB, DM, FRCP, FRCPath

Investigator Role:

Principal Investigator

Investigator Affiliation:

King's College London

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

06CC12

NCT ID:

NCT00915811

Start Date:

June 2007

Completion Date:

June 2011

Related Keywords:

  • Myelodysplastic Syndromes
  • Leukemia, Myeloid, Acute
  • Myelodysplastic Syndromes
  • Leukemia, Myeloid, Acute
  • Haematopoietic stem cell transplantation
  • Fludarabine
  • Busulphan
  • Thymoglobuline
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location