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UK-Haplo: Trial of Haploidentical Stem Cell Transplantation for Haematological Cancers

Sponsor
University College, London (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01597219
Collaborator
Bloodwise (Other)
77
Enrollment
12
Locations
2
Arms
103
Duration (Months)
6.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Reduced intensity haplodentical stem cell transplant
  • Procedure: Myeloablative haploidentical stem cell transplant
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
77 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A UK Multicentre Study of Haploidentical Stem Cell Transplantation in Patients With Haematological Malignancies
Study Start Date :
Mar 1, 2013
Anticipated Primary Completion Date :
Oct 1, 2021
Anticipated Study Completion Date :
Oct 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Reduced intensity haploidentical 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

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

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

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

Outcome Measures

Primary Outcome Measures

  1. Overall survival [1 year post transplant]

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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%

  1. Donor available aged ≥16 years

  2. 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

  3. 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

  4. 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.

  5. 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

  6. 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Birmingham Heartlands Birmingham United Kingdom
2 Bristol Royal Infirmary Bristol United Kingdom
3 Addenbrooke's Hospital Cambridge United Kingdom
4 Beatson Hospital Glasgow United Kingdom
5 St James' University Hospital Leeds United Kingdom
6 Royal Liverpool Hospital Liverpool United Kingdom
7 King's College Hospital London United Kingdom
8 St Bartholomew's Hospital London United Kingdom
9 University College Hospital London United Kingdom
10 Manchester Royal Infirmary Manchester United Kingdom
11 Freeman Hospital Newcastle United Kingdom
12 Royal Hallamshire, Sheffield & Weston Park Sheffield United Kingdom

Sponsors and Collaborators

  • University College, London
  • Bloodwise

Investigators

  • Principal Investigator: Dr Kavita Raj, King's College Hospital NHS Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University College, London
ClinicalTrials.gov Identifier:
NCT01597219
Other Study ID Numbers:
  • UCL/10/0411
First Posted:
May 11, 2012
Last Update Posted:
Sep 28, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by University College, London
Haploidentical transplant
Haematological malignancy
Myeloablative
Reduced intensity
Additional relevant MeSH terms:
Lymphoma
Leukemia
Leukemia, Myeloid
Neoplasms
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Hematologic Neoplasms
Myelodysplastic Syndromes
Bone Marrow Failure Disorders
Pancytopenia
Syndrome

Study Results

No Results Posted as of Sep 28, 2021