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:
University College, London
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
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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:
MedlinePlus related topics:
Acute Myeloid Leukemia
Cancer
Chronic Lymphocytic Leukemia
Chronic Myeloid Leukemia
Hodgkin Disease
Leukemia
Lymphoma
Myelodysplastic Syndromes
U.S. FDA Resources
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 May 23, 2013