Feasibility of Haploidentical Hematopoietic Stem Cell Transplantation Using CAMPATH-1H
Condition: Leukemia, Myeloid, Acute; Leukemia, Lymphoblastic, Acute
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma
Study type: Interventional
Phase: Phase 1

Summary: 
      Many patients suffering various malignant and non-malignant diseases need hematopoietic stem
      cell transplantation from a healthy person. In the majority of cases there is no matched
      related or unrelated donor.

      Some researchers have been performed transplantation from semi-matched (haploidentical)
      related donors with relatively good results.

      Chinese researchers have been performed this kind of transplantation using CAMPATH-1H and
      their reports indicates good results.

      Chinese populations have more homogenous genetic background than Iranians. In this project,
      we are going to study the feasibility of this method of haploidentical transplantation in
      Iranian patients.
    

Detailed description: 
      Haploidentical hematopoietic stem cell transplantation is a very important therapeutic
      intervention for treatment of some genetic disorders and hematological malignancies.

      In the majority of cases, there is no matched related or unrelated donor. Haploidentical
      hematopoietic stem cell transplantation is a promising alternative for critical cases.

      To avoid severe graft versus host disease (GVHD), two types of T cell depletion (TCD) had
      been used: total TCD and partial TCD.

      Total TCD has disadvantages such as increased rate of rejection and relapse, and increased
      rate of infections due to delayed immune reconstitution.

      Partial TCD has been done by in vivo and/or in vitro methods. In haploidentical
      transplantation, donor partial TCD (ex vivo TCD) without recipient TCD increases the rate of
      rejection and can not prevent severe GVHD successfully.

      In vivo TCD by partial depletion of donor and recipient T cells has been done in
      haploidentical transplantation with good results (to some extent inferior to full matched
      transplantations) by using CAMPATH, ATG, etc.

      Most of these studies have been performed in Chinese and Japanese populations that have more
      homogenous genetic background than other populations.

      In order to study the feasibility of this kind of transplantation in Iranian patients, we
      defined a project to perform haploidentical hematopoietic stem cell transplantation by using
      in vivo CAMPATH-1H.
    

Intervention name(s): Haploidentical hematopoietic stem cell transplantation; Busulfan; Cyclophosphamide; CAMPATH-1H; Cyclosporin A; Methotrexate
Intervention type(s): Procedure; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Cyclosporine; Cyclophosphamide; Busulfan; Methotrexate; Alemtuzumab; Cyclosporins
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hematopoietic Stem Cell Transplantation; Haploidentical; Hematologic Neoplasms; human, Bone Marrow; Granulocyte Colony-stimulating Factor; CAMPATH; Alemtuzumab; AML; ALL; 10. Eligibility