Pilot Study of Unrelated Cord Blood Transplantation
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ClinicalTrials.gov Identifier: NCT00916045
Recruitment Status :
The purpose of this study is to determine the safety and feasibility of unrelated double and single cord blood transplantation in patients with haematological malignancies using reduced-intensity or myeloablative conditioning regimens.
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Ages Eligible for Study:
18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
DISEASE INCLUSION CRITERIA:
In general this encompasses all haematological disorders where a volunteer unrelated donor transplant is clinically indicated.
Acute, chronic leukaemia or myelodysplastic syndrome for which allogeneic transplantation is considered as the best treatment option.
Acute myeloid leukaemia (AML) in first complete remission (CR1) with one of the following characteristics:
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)
Leukocytes at diagnosis > 50 x109/l (except in cases with good prognosis molecular rearrangements for which leukocytes should be > 100 x 109/l)
International Prognosis Index (IPSS) above 1 (intermediate group 2 or high risk)
IPSS 0 or 0.5 in the presence of cytopenias requiring treatment.
Therapy related AML or MDS in first CR
AML or MDS in second (CR2) or subsequent CR
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
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 treatment iii. Adults aged > 30 years iv. 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/L
b. In CR2 or subsequent CR
Follicular NHL: in second or subsequent complete or partial remission
Mantle cell NHL: in second or subsequent complete or partial remission
High grade NHL: in second complete or very good partial remission
a. in second or subsequent complete or partial remission
Chronic lymphocytic leukaemia.
in second or subsequent remission
with adverse risk prognostic features in first remission
Acquired bone marrow failure syndromes
Other haematological malignancies for which UD bone marrow transplantation is indicated