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Status:

TERMINATED

Pilot Study of Unrelated Cord Blood Transplantation

Lead Sponsor:

King's College Hospital NHS Trust

Conditions:

Leukemia, Myeloid, Acute

Myelodysplastic Syndromes

Eligibility:

All Genders

18-70 years

Phase:

PHASE2

Brief Summary

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 m...

Eligibility Criteria

Inclusion

  • 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)
  • Myelodysplastic syndromes
  • 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
  • Non-Hodgkin's lymphoma
  • 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
  • Hodgkin's disease
  • 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
  • PATIENT SELECTION
  • Inclusion criteria: myeloablative conditioning regimen
  • Aged under 35 years and greater than 18 years
  • Absence of HLA compatible related donor.
  • Need for an urgent transplantation 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.
  • Availability of suitable UD-UCB unit/s.
  • Informed consent.
  • Exclusion criteria: myeloablative conditioning regimen
  • Patients with an available 5-6/6 HLA-A, -B, -DRB1 matched sibling donor or 10/10 unrelated bone marrow donor
  • ECOG performance status worse than 2
  • Cardiac insufficiency requiring treatment, symptomatic coronary artery disease or LVEF less than 40%.
  • Hepatic disease, with total bilirubin above 20umol/l or AST \> 3 times upper limit of normal.
  • 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.
  • Impaired renal function (creatinine \> 2 times upper limit of normal or creatinine clearance \< 50% for age, gender, weight).
  • Patients who have received previous treatment with Thymoglobulin®
  • HIV or HTLV positive patients.
  • Female patients who are pregnant or breast feeding due to risks to foetus from conditioning regimen and potential risks to nursing infants.
  • Life expectancy severely limited by diseases other than the disease indication for transplant
  • Serious concurrent untreated infection e.g. active tuberculosis, mycoses or viral infection
  • Serious psychiatric/ psychological disorders
  • Absence of /inability to provide informed consent
  • Serious diseases that prevent treatments with chemotherapy
  • Myelofibrosis
  • Inclusion criteria: reduced-intensity conditioning regimen (For both FluMel \& FluCyTBI regimens):
  • Age under 70 years and older than 18 years
  • Absence of HLA compatible related donor.
  • Need for an urgent transplantation 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.
  • Availability of suitable UD-UCB unit/s.
  • Informed consent.
  • Exclusion Criteria: reduced-intensity conditioning regimen (For both FluMel \& FluCyTBI regimens):
  • Patients with an available 5-6/6 HLA-A, -B, -DRB1 matched sibling donor or 10/10 unrelated bone marrow donor
  • ECOG performance status worse than 2
  • Cardiac insufficiency requiring treatment, symptomatic coronary artery disease or LVEF less than 35%.
  • Hepatic disease, with total bilirubin greater than 2 times upper limit of normal or AST \> 5 times upper limit of normal.
  • 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.
  • Impaired renal function (creatinine \> 2 times upper limit of normal or creatinine clearance \< 50% for age, gender, weight).
  • Previous irradiation that precludes the safe administration of an additional dose of 200 cGy of total body irradiation (TBI).
  • Patients who have received previous treatment with Thymoglobulin®
  • HIV or HTLV positive patients.
  • Female patients who are pregnant or breast feeding due to risks to foetus from conditioning regimen and potential risks to nursing infants.
  • Life expectancy severely limited by diseases other than the disease indication for transplant
  • Serious concurrent uncontrolled infection e.g. active tuberculosis, mycoses or viral infection
  • Serious psychiatric/ psychological disorders
  • Absence of /inability to provide informed consent
  • Within 6 months of prior myeloablative transplant.
  • Patients with acute leukaemia in morphological relapse/ persistent/ progressive disease
  • Intermediate or high grade NHL, mantle cell NHL and Hodgkin's disease that is refractory or progressive on salvage therapy.
  • Myelofibrosis

Exclusion

    Key Trial Info

    Start Date :

    September 1 2009

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    March 1 2012

    Estimated Enrollment :

    40 Patients enrolled

    Trial Details

    Trial ID

    NCT00916045

    Start Date

    September 1 2009

    End Date

    March 1 2012

    Last Update

    February 11 2015

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    King's College Hosptial NHS Foundation Trust

    London, United Kingdom, SE5 9RS