Study of Non-Myeloablative Haplo-identical Haematopoietic Stem Cell Transplantation in Patients With Haematological Malignancies or Acquired Aplastic Anaemia
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|ClinicalTrials.gov Identifier: NCT01719341|
Recruitment Status : Unknown
Verified December 2013 by National University Hospital, Singapore.
Recruitment status was: Recruiting
First Posted : November 1, 2012
Last Update Posted : December 11, 2013
Allogeneic haematopoietic stem cell transplantation (HSCT) is a potentially curative therapy for patients with both haematological and some non-haematological disorders. However, one of the major limiting factors for transplantation is the inability to identify a suitable HLA-matched donor. Development of an cost-effective and clinically efficacious alternative to HLA-identical sibling or unrelated donor transplantation would significantly expand the availability of allogeneic HSCT to patients in Singapore. Preliminary results indicate that the use of high dose post-transplant cyclophosphamide (Cy) for graft versus host disease (GVHD) prophylaxis in haplo-identical allogeneic HSCT is associated a low incidence of GVHD and low treatment related toxicity. We propose a phase II clinical trial to assess the efficacy of a haplo-identical allogeneic transplantation protocol using high dose post-transplant Cy for the treatment of patients with haematological disorders. A non-myeloablative protocol (Fludarabine-low dose cyclophosphamide-TBI) will be used for patients with bone marrow failure syndromes and indolent lymphoid disease. In view of the higher relapse risk of patients with myeloid malignancies, these patients will be treated with a reduced intensity conditioning regimen (Fludarabine-Busulphan). The primary end-point of the study will be overall survival at one year. Economic cost of the haplo-identical transplantation, as well as treatment timelines will be recorded and compared will other forms of unrelated donor allogeneic transplantation (umbilical cord blood transplantation and unrelated HLA-matched adult donor). Immunological reconstitution of patients following haplo-transplantation will be analysed and data will be utilized to guide future immunotherapy strategies post-transplantation.
One year survival after non-myeloablative haploidentical stem cell transplantation is not inferior to that observed after non-myeloablative volunteer unrelated donor or unrelated cord blood haematopoietic stem cell transplantation.
|Condition or disease|
|Haematological Malignancies Acquired Aplastic Anaemia|
|Study Type :||Observational|
|Estimated Enrollment :||21 participants|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||June 2014|
- 1 year overall survival after HLA-Haploidentical transplantation [ Time Frame: 1 year ]
- Progression free survival one and 2 years post-transplantation [ Time Frame: 2 years ]
- Cumulative incidence of relapse/progression at one and 2 years post-transplant [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01719341
|Contact: Zi Yi Lim, MB ChB||65 6779 5555||Zi_Yi_Lim@nuhs.edu.sg|
|National University Hospital||Recruiting|
|Singapore, Singapore, 119074|
|Contact: Zi Yi Lim, MB ChB 65 6779 5555 Zi_Yi_Lim@nuhs.edu.sg|
|Principal Investigator: Zi Yi Lim, MB ChB|
|Principal Investigator:||Zi Yi Lim, MB ChB||National University Hospital, Singapore|