NCT01597219

Trial of Haploidentical Stem Cell Transplantation for Haematological Cancers

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: University College, London · Academic / Other
• Sex: All
• Age: 16 Years – 70 Years
• Healthy volunteers: Not accepted

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

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

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2013-03-01
• Primary completion: 2024-01-01
• Completion: 2024-01-01
• First posted: 2012-05-11
• Last updated: 2024-05-03

Locations

12 sites across 1 country: United Kingdom