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18 Years
70 Years
Open (Enrolling)
Haematological Malignancies, Acquired Aplastic Anaemia

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Trial Information

Inclusion Criteria:

Patient Selection Inclusion criteria

1. Age under 70 years and older than 18 years

2. Absence of HLA fully compatible related donor

3. Need for an urgent transplantation, defined as within 8 weeks of referral to the
transplant centre or absence of HLA-compatible VUD after searching the international
registries. Patients with a HLA-compatible VUD but whose donor is considered by the
transplantation centre as unsuitable will also be eligible. 4. Informed consent.

Disease inclusion criteria:

In general this encompasses all haematological disorders where a volunteer unrelated donor
(UD) transplant is clinically indicated.

1. Acute, chronic leukaemia or myelodysplastic syndrome for which allogeneic
transplantation is considered as the best treatment option.

a. Acute myeloid leukaemia (AML) i. In first complete remission (CR1) with one of the
following characteristics:

1. High risk cytogenetic or molecular alterations (e.g. t(9;22), deletion 7/7q-,
monosomy 5 or del(5q), 3q26 alterations, complex karyotype [3 or more anomalies], p53
alterations, 11q23 especially t(6;11) abnormalities, FLT-3 ITD, monosomal karyotype.

2. Leukocytes at diagnosis > 50 x109/l (except in cases with good prognosis molecular
rearrangements for which leukocytes should be > 100 x 109/l) b. Myelodysplastic
syndromes1. International Prognosis Index (IPSS) above 1 (intermediate group 2 or
high risk)

2. IPSS 0 or 0.5 in the presence of cytopenias requiring treatment. c. Therapy related AML
or MDS in first CRd. AML or MDS in second (CR2) or subsequent CRe. Ph'-positive chronic
myeloid leukaemia i. In first chronic phase if refractory and/or intolerance to tyrosine
kinase inhibitors is clearly demonstrated ii. In second chronic phase 2. Acute
lymphoblastic leukaemia (ALL)a. In CR1 with one of the following characteristics: i. Very
high risk chromosome or molecular alterations (e.g. t(9;22), t(4;11), complex karyotype in
adults, bcr/abl rearrangements, MLL rearrangements) ii. Slow response to induction
treatment defined as the presence of >10% blasts in bone marrow at day 14 of induction
treatmentiii. Adults aged > 30 yearsiv. Adults with B ALL cell line with a number of
leukocytes at diagnosis >25 x 109/L or T ALL cell line with a number of leukocytes at
diagnosis >100X109/Lb. In CR2 or subsequent CR 3. Non-Hodgkin's lymphomaa. Follicular NHL:
in second or subsequent complete or partial remissionb. Mantle cell NHL: in second or
subsequent complete or partial remissionc. High grade NHL: in second complete or very good
partial remission 4. Hodgkin's diseasea. in second or subsequent complete or partial
remission 5. Chronic lymphocytic leukaemia. a. in second or subsequent remissionb. with
adverse risk prognostic features in first remission 6. Acquired Aplastic Anaemia 7.
Myelofibrosis- Lille score -high, Cervantes score-high 8. Other haematological
malignancies for which UD HSCT is indicated

Exclusion Criteria:

1. Patients with an available 7-8/8 HLA-A, -B, -C, -DRB1 matched sibling donor or 7-8/8
unrelated bone marrow donor

2. Availability of suitable UCB unit/s and eligible for an UCB transplant

3. ECOG performance status worse than 2

4. Cardiac insufficiency requiring treatment, symptomatic coronary artery disease or
LVEF less than 35%.

5. Hepatic disease, with total bilirubin greater than 2 times upper limit of normal or
AST > 5 times upper limit of normal.

6. Severe hypoxaemia, pO2 < 70 mm Hg, with decreased DLCO < 50% of predicted; or mild
hypoxemia, pO2 < 80 mm Hg with severely decreased DLCO < 50% of predicted.

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

8. Previous irradiation that precludes the safe administration of an additional dose of
200 cGy of total body irradiation (TBI).

9. HIV positive patients.

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

11. Life expectancy severely limited by diseases other than the disease indication for

12. Serious concurrent uncontrolled infection e.g. active tuberculosis, mycoses or viral

13. Serious psychiatric/ psychological disorders

14. Absence of /inability to provide informed consent

15. Patients with acute leukaemia with >5% bone marrow blasts

16. Intermediate or high grade NHL, mantle cell NHL and Hodgkin's disease that is
refractory to salvage therapy

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

1 year overall survival after HLA-Haploidentical transplantation

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Zi Yi Lim, MB ChB

Investigator Role:

Principal Investigator

Investigator Affiliation:

National University Hospital, Singapore


Singapore: Domain Specific Review Boards

Study ID:




Start Date:

September 2012

Completion Date:

Related Keywords:

  • Haematological Malignancies
  • Acquired Aplastic Anaemia
  • Anemia
  • Anemia, Aplastic
  • Neoplasms
  • Hematologic Neoplasms