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Trial of Haploidentical Stem Cell Transplantation for Haematological Cancers

NCT01597219 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2024-05-03

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Bloodwise

    collaborator OTHER

  • University College, London

    lead OTHER

Principal Investigators

  • Dr Kavita Raj · King's College Hospital NHS Trust

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2024-01-31
Completion
2024-01-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01597219 on ClinicalTrials.gov