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A UK Multicentre Study of Haploidentical Stem Cell Transplantation in Patients With Haematological Malignancies

Phase 2
18 Years
70 Years
Not Enrolling
Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma, Acute Myeloid Leukaemia, Acute Lymphoblastic Leukaemia, Myelodysplastic Syndrome, Chronic Myeloid Leukaemia, Chronic Lymphocytic Leukaemia, Acquired Bone Marrow Failure Syndromes

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Trial Information

A UK Multicentre Study of Haploidentical Stem Cell Transplantation in Patients With Haematological Malignancies

Inclusion Criteria:

- Aged 18-70 years of age with a diagnosis of a haematological malignancy that requires
an allograft, with a partially HLA mismatched donor (<5/6)

- Adequate organ function, defined as:

- LVEF >/= 45%

- DLCO, FEV1, FVC >/= 50% predicted

- Total bilirubin <35umol/L

- AST/ALT and alkaline phosphatase <5x upper limit of normal

- Serum creatinine within normal range, or if outside normal range for age, then
creatinine clearance >40ml/min/1.73m2

- Karnofsky performance score 60-100

- Donor available aged >/= 18 years

- Needs an urgent transplant where a suitable HLA matched sibling or unrelated donor is
unavailable in a timely manner.

- Donor available who is at least a 5/10 mathch

- Donor and recipient identical at at least one of the following alleles: HLA-A, HLA-B,

- Patient must have received cytotoxic chemotherapy within 3 months of consent date

- Written informed consent

Exclusion Criteria:

- HLA matched, related donor able to donate

- Autologous haematopoietic stem cell transplant <3 months prior to enrolment

- Pregnancy or breastfeeding

- Uncontrolled bacterial, viral or fungal infection

- Serious psychiatric or psychological disorders

- Absence of, or inability to provide, informed consent

- Severe comorbidity (Seattle comorbidity score of 3 or more) or disease that prevents
treatment with chemotherapy

- Positive anti-donor HLA antibody

- Unable to receive 2Gy TBI (RIC pathway) or 12Gy TBI (MAC pathway)

- Patient with graft rejection following a previous allograft from either adult or cord
blood donors

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

1 year


United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Hodgkin's Lymphoma
  • Non-Hodgkin's Lymphoma
  • Acute Myeloid Leukaemia
  • Acute Lymphoblastic Leukaemia
  • Myelodysplastic Syndrome
  • Chronic Myeloid Leukaemia
  • Chronic Lymphocytic Leukaemia
  • Acquired Bone Marrow Failure Syndromes
  • Hodgkin Disease
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Myelodysplastic Syndromes
  • Preleukemia
  • Pancytopenia
  • Hematologic Neoplasms
  • Hemoglobinuria, Paroxysmal