Trial of Haploidentical Stem Cell Transplantation for Haematological Cancers

Phase 2

Completed

• Conditions: Hodgkin's Lymphoma; Chronic Myeloid Leukaemia; Non-Hodgkin's Lymphoma; Acute Lymphoblastic Leukaemia; Acute Myeloid Leukaemia; Myelodysplastic Syndrome; Acquired Bone Marrow Failure Syndromes; Other Haematological Malignancies; Unrelated HSCT Indicated; Chronic Lymphocytic Leukaemia
• Interventions: Procedure: Reduced intensity haplodentical stem cell transplant; Procedure: Myeloablative haploidentical stem cell transplant

• Registration Number: NCT01597219
• Lead Sponsor: University College, London

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-10
• Study First Submitted QC: 2012-05-10
• Study First Posted: 2012-05-11
• Study Start: 2013-03
• Primary Completion: 2024-01
• Study Completion: 2024-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-01
• Last Update Posted: 2024-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Reduced intensity haploidentical transplant	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
Myeloablative haploidentical stem cell transplant	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

Primary Outcome Measures

Name	Time	Method
Overall survival	1 year post transplant

Trial Locations

Locations (12)

Bristol Royal Infirmary; 🇬🇧 Bristol, United Kingdom

Birmingham Heartlands; 🇬🇧 Birmingham, United Kingdom

Addenbrooke's Hospital; 🇬🇧 Cambridge, United Kingdom

Beatson Hospital; 🇬🇧 Glasgow, United Kingdom

King's College Hospital; 🇬🇧 London, United Kingdom

St James' University Hospital; 🇬🇧 Leeds, United Kingdom

Royal Liverpool Hospital; 🇬🇧 Liverpool, United Kingdom

St Bartholomew's Hospital; 🇬🇧 London, United Kingdom

University College Hospital; 🇬🇧 London, United Kingdom

Manchester Royal Infirmary; 🇬🇧 Manchester, United Kingdom

Royal Hallamshire, Sheffield & Weston Park; 🇬🇧 Sheffield, United Kingdom

Freeman Hospital; 🇬🇧 Newcastle, United Kingdom