Trial of Haploidentical Stem Cell Transplantation for Haematological Cancer... | Recruiting
Trial of Haploidentical Stem Cell T... | Recruiting
Trial of Haploidentical Stem Cell Transplantation for Haematological Cancers
UK-Haplo

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Medical Conditions
  • 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
  • Other Haematological Malignancies
  • Unrelated HSCT Indicated
Primary Contact Details
Ellice Marwood
+44(0)207 679 9860
See all trial contact details
Recruitment Status
Recruiting
Trial source and source ID number
NCT01597219
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
This trial investigates stem cell transplants from partially mismatched donors in patients with blood and bone marrow cancers. The trial will test two kinds of transplants - a full intensity transplant using a high dose of radiotherapy and chemotherapy, and a reduced intensity transplant with lower doses of chemotherapy and radiotherapy. Patients will be entered for the treatment pathway that is most appropriate for their level of health and fitness
Research Details
    Sorry, this information is not available
Phase
Phase 2
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Procedure : Reduced intensity haplodentical stem cell transplant, Procedure : Myeloablative haploidentical stem cell transplant

Study Arm Groups : Reduced intensity haploidentical transplant, Myeloablative haploidentical stem cell transplant

Intervention Type
See Interventions above
Primary Outcome Measures
    Overall survival; 1 year
Secondary Outcome Measures
    Sorry, this information is not available
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
16 Years - 70 Years
Who Can Participate
Patients
Number of Participants
78
Participant Inclusion Criteria
    Patient Inclusion Criteria

    1. Eligible for an allogeneic transplant in line with the current BSBMT indications for transplant criteria (http://bsbmt.org/indications-table/) accepted by Commissioners

    2. Age 16-70

    3. Adequate physical function

    - Cardiac: LVEF at rest ≥45%, or shortening fraction ≥25%

    - Hepatic: Bilirubin ≤35mmol/l; AST/ALT and alkaline phosphatase <5 x ULN

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

    - Pulmonary: FEV1, FVC, DLCO (diffusion capacity) >50% predicted (corrected for haemoglobin); if clinically unable to perform pulmonary function tests then O2 saturation >92% on room air

    - Performance status: Karnofsky score ≥60%

    4. Donor available aged ≥16 years

    5. Needs an urgent transplant where a 10/10 HLA matched sibling or unrelated donor is unavailable in a timely manner. An unrelated donor search is not required for a patient to be eligible if the clinical situation dictates an urgent transplant. Clinical urgency is defined as 6-8 weeks from referral to transplant centre or low likelihood of finding a matched unrelated donor

    6. HLA typing will be performed at high resolution (allelic) for the HLA-A, HLA-B, HLA-Cw, HLA-DRB1 and HLA-DQB1 loci. A minimum match of 5/10 is required

    7. The donor and recipient must be identical as determined by high resolution typing at at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1 and HLA-DQB1. Fulfilment of this criterion is sufficient evidence that the donor and recipient share one HLA haplotype and typing of additional family members is not required.

    8. Patient must have received cytotoxic chemotherapy within 3 months of the consent date (measured from the start date of the most recent cycle of chemotherapy) except patients with aplastic anaemia, unless otherwise agreed by the TMG (see section 5.3.4). The use of monoclonal antibody therapy may be considered cytotoxic chemotherapy, but must be agreed by the TMG

    9. Written informed consent

    Donor Inclusion Criteria

    1. Donor must be an HLA-haploidentical first degree relative of the patient. Eligible donors include biological parents, siblings, children or half-siblings

    2. Age ≥16 years

    3. Donors must meet the collection centre's usual selection criteria for related allogeneic HPC donors

    Patient Exclusion Criteria

    1. HLA matched, related donor able to donate

    2. Autologous haematopoietic stem cell transplant <3 months prior to enrolment

    3. Pregnancy or breastfeeding

    4. Uncontrolled bacterial, viral or fungal infection (currently taking medication with evidence of progression of clinical symptoms or radiological findings), the inclusion of patients with an uncontrolled viral or fungal infection can be agreed by the TMG

    5. Serious psychiatric or psychological disorders

    6. Absence or inability to provide informed consent

    7. Severe comorbidity (HCT-CI comorbidity score of 3 or more) or disease that prevents treatment with chemotherapy, unless otherwise agreed by the TMG

    8. Positive anti-donor HLA antibody

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

    10. Patients with graft rejection following a previous allograft from either adult or cord blood donors

    Donor Exclusion Criteria

    1. Positive anti-donor HLA antibody in the recipient

    2. Pregnancy or recent birth (within 6 months prior to donating cells)
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Local Institution
Cambridge
Cambridgeshire
Local Institution
Glasgow
Central
Local Institution
London
Greater London
Manchester
Queen Elizabeth Hospital
Birmingham
Heart & Chest Hospital
Liverpool
Sheffield
Local Institution
Newcastle upon Tyne
Tyne and Wear
Leeds
Bristol
Trial Contact(s)
Primary Trial Contact
Ellice Marwood
+44(0)207 679 9860
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
A UK Multicentre Study of Haploidentical Stem Cell Transplantation in Patients With Haematological Malignancies
EudraCT Number
Not available for this trial
Funder(s)
  • Bloodwise
Other Study ID Numbers
UCL/10/0411
Sponsor(s)
University College, London
Key Dates

Recruitment Start Date

Mar 2013

Recruitment End Date

Mar 2018

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

10 May 2012

Date updated in source

26 Apr 2017