Clinical trial NCT01621477: T-Cell Replete Haploidentical Donor Hematopoietic Stem Cell Plus Natural Killer (NK) Cell Transplantation in Patients With Hematologic Malignancies Relapsed or Refractory Despite Previous Allogeneic Transplant
Official title: T-Cell Replete Haploidentical Donor Hematopoietic Stem Cell Plus Natural Killer (NK) Cell Transplantation in Patients With Hematologic Malignancies Relapsed or Refractory Despite Previous Allogeneic Transplant
Conditions: Acute Lymphoblastic Leukemia
Acute Myelocytic Leukemia
Chronic Myelocytic Leukemia
Juvenile Myelomonocytic Leukemia
Myelodysplastic Syndrome
Hodgkin or Non-Hodgkin Lymphoma
Sarcoma, Myeloid
Summary: The primary aim of this protocol is to evaluate if the one-year survival is significantly improved in the group of patients who receive a T-cell replete haploidentical donor hematopoietic cell transplant (HCT) with a novel reduced intensity conditioning regimen. Study population will consist of patients (21 years or under) with hematologic malignancies that have relapsed or are refractory after prior allogeneic transplant. Toxicity will be evaluated by the rate of transplant related mortality and the rates of moderate and severe graft-versus-host disease (GvHD) at day 100. The investigators will describe event-free, and disease-free survival at one year, as well as the rates of hematopoietic recovery and donor engraftment and study comprehensively immune reconstitution following T-cell replete haploidentical transplantation.
Interventions:
description: Given on Day -9 and Day -8 (Day 0 is first stem cell infusion). Drug class: antineoplastic agent
name: clofarabine
other_name: CAFdA
Cl-F-Ara-A
Clofarex
Clolar(TM)
type: Drug
description: Given on Day -9 and Day -8 (Day 0 is first stem cell infusion). Drug class: antineoplastic agent
name: cytarabine
other_name: Ara-C
type: Drug
description: Given on Day -7 and Day -6 (Day 0 is first stem cell infusion). Drug class: antineoplastic agent
name: busulfan
other_name: Busulfex
Myleran(R)
type: Drug
description: Given on Day -7 and Day -6 (Day 0 is first stem cell infusion). Drug class: Hematopoietic Stem Cell Mobilizer
name: Plerixafor
other_name: AMD3100
Mozobil(R)
type: Drug
description: Given on Day -5 and Day +4 (Day 0 is first stem cell infusion). Drug class: antineoplastic agent; immunosuppressive agent.
name: cyclophosphamide
other_name: Cytoxan
type: Drug
description: Given on Day -4, Day -3, Day -2, and Day -1 (Day 0 is first stem cell infusion). Drug class: immunosuppressive agent.
name: antithymocyte globulin (rabbit)
other_name: Rabbit ATG
Rabbit Thymoglobulin(R)
type: Drug
description: Patients undergo T cell replete Hematopoietic stem cell infusion on Day 0 and Day +1. Patients undergo natural killer (NK) cell transplantation on day +6 (Day 0 is first stem cell infusion).
name: stem cells
other_name: HSC infusion
type: Biological
description: Given on Day +11 (Day 0 is first stem cell infusion). Drug class: immunosuppressive agent.
name: Tacrolimus
other_name: FK506
Prograf(R)
Protonic(R)
type: Drug
description: Given on Day +11 (Day 0 is first stem cell infusion). Drug class: immunosuppressive agent.
name: mycophenolate mofetil
other_name: CellCept(R)
MMF
type: Drug
Study arms:
design_group_description: All study participants.<br/>Interventions: clofarabine, cytarabine, busulfan, plerixafor, cyclophosphamide, antithymocyte globulin (rabbit), stem cells, tacrolimus, mycophenolate mofetil
design_group_title: Treatment
design_group_type: Experimental
Sponsor: St. Jude Children's Research Hospital, Inc.
Collaborators: The Assisi Foundation of Memphis, Inc.
Drug name mappings:
name: 氯法拉滨
lang: CN
name: Clofarabine
lang: EN
name: クロファラビン
lang: JP
name: 白消安
lang: CN
name: Busulfan
lang: EN
name: ブスルファン
lang: JP
name: 环磷酰胺
lang: CN
name: Cyclophosphamide
lang: EN
name: シクロホスファミド水和物
lang: JP
name: 他克莫司
lang: CN
name: Tacrolimus
lang: EN
name: タクロリムス水和物
lang: JP
name: 普乐沙福
lang: CN
name: Plerixafor
lang: EN
name: プレリキサホル
lang: JP
name: 吗替麦考酚酯
lang: CN
name: Mycophenolate Mofetil
lang: EN
name: ミコフェノール酸 モフェチル
lang: JP
name: 阿糖胞苷
lang: CN
name: Cytarabine
lang: EN
name: シタラビン
lang: JP