Trial of Haploidentical Stem Cell Transplantation for Haematological Cancers (UK Haplo)

This study is not yet open for participant recruitment.
Verified May 2012 by University College, London
Sponsor:
Collaborator:
Leukaemia Lymphoma Research
Information provided by (Responsible Party):
University College, London
ClinicalTrials.gov Identifier:
NCT01597219
First received: May 10, 2012
Last updated: NA
Last verified: May 2012
History: No changes posted
  Purpose

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


Condition Intervention Phase
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
Procedure: Reduced intensity haplodentical stem cell transplant
Procedure: Myeloablative haploidentical stem cell transplant
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: A UK Multicentre Study of Haploidentical Stem Cell Transplantation in Patients With Haematological Malignancies

Resource links provided by NLM:


Further study details as provided by University College, London:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 1 year ]

Estimated Enrollment: 78
Arms Assigned Interventions
Experimental: Reduced intensity haploidentical transplant Procedure: Reduced intensity haplodentical stem cell transplant
Fludarabine 30mg/m2 IV days -6 to -2 Cyclophosphamide 14.5 mg/kg IV days -6 and -5 Total body irradiation 2Gy day -1 Stem cell transplant: day 0 Cyclophosphamide 50mg/kg days +3 & +4
Experimental: Myeloablative haploidentical stem cell transplant Procedure: Myeloablative haploidentical stem cell transplant
Total body irradiation 12Gy in 8 fractions days -9 to -6 Donor lymphocyte infusion day -6 Cyclophosphamide 60mg/kg IV days -3 & -2 Stem cell transplant day 0

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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, HLA-Cw, HLA-DRB1 or HLA-DQB1
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01597219

Contacts
Contact: Pip Patrick +44(0)2076799860 uk-haplo@ctc.ucl.ac.uk

Sponsors and Collaborators
University College, London
Leukaemia Lymphoma Research
  More Information

No publications provided

Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT01597219     History of Changes
Other Study ID Numbers: UCL/10/0411
Study First Received: May 10, 2012
Last Updated: May 10, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
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
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms by Site
Anemia, Hemolytic
Anemia

ClinicalTrials.gov processed this record on April 17, 2014