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Report for Clinical Trial NCT03615105

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Allogeneic Hematopoietic Cell Transplantation Using α/β+ T-lymphocyte Depleted Grafts From HLA Mismatched Donors

This study is being done to learn whether a new method to prevent rejection between the donor immune system and the patient's body is effective.

NCT03615105 Acute Lymphoid Leukemia (ALL) Acute Myeloid Leukemia (AML) Chronic Myeloid Leukemia (CML) Hodgkin Lymphoma Non-Hodgkin Lymphoma Chronic Lymphocytic Leukemia
MeSH:Lymphoma Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Myelogenous, Chronic, BCR-ABL Positive Precursor Cell Lymphoblastic Leukemia-Lymphoma
HPO:Acute megakaryocytic leukemia Acute myeloid leukemia Chronic lymphatic leukemia Chronic myelogenous leukemia Leukemia Lymphoid leukemia Lymphoma Myeloid leukemia

10 Interventions

Name: Hyperfractionated total body irradiation

Description: Hyperfractionated TBI is administered by a linear accelerator at a dose rate of <20 cGy/minute. Doses of 125 cGy/fraction are administered at a minimum interval of 4 hours between fractions, three times/day for a total of 11 or 12 doses (1,375 or 1,500 cGy) over 4 days (days -9 through -6).
Type: Radiation
Group Labels: 3

Radiation, Thiotepa Radiation, Thiotepa & Radiation, Thiotepa & Cyclophosphamide

Name: Thiotepa

Description: Thiotepa 5 mg/kg IV
Type: Drug
Group Labels: 6

Clofarabine, Thiotepa Clofarabine, Thiotepa & Clofarabine, Thiotepa & Melphalan Radiation, Thiotepa Radiation, Thiotepa & Radiation, Thiotepa & Cyclophosphamide

Name: Cyclophosphamide

Description: Cyclophosphamide 60 mg/kg IV
Type: Drug
Group Labels: 3

Radiation, Thiotepa Radiation, Thiotepa & Radiation, Thiotepa & Cyclophosphamide

Name: Busulfan

Description: Busulfan (adult/ped dose)
Type: Drug
Group Labels: 3

Busulfan, Fludarabine Busulfan, Fludarabine & Busulfan, Fludarabine & Melphalan

Name: Fludarabine

Description: Fludarabine 25 mg/m2 IV
Type: Drug
Group Labels: 3

Busulfan, Fludarabine Busulfan, Fludarabine & Busulfan, Fludarabine & Melphalan

Name: Melphalan

Description: Melphalan 70 mg/m2 IV
Type: Drug
Group Labels: 6

Busulfan, Fludarabine Busulfan, Fludarabine & Busulfan, Fludarabine & Melphalan Clofarabine, Thiotepa Clofarabine, Thiotepa & Clofarabine, Thiotepa & Melphalan

Name: Clofarabine

Description: Clofarabine 20-30 mg/m2 IV
Type: Drug
Group Labels: 3

Clofarabine, Thiotepa Clofarabine, Thiotepa & Clofarabine, Thiotepa & Melphalan

Name: HPC(A) stem cell allograft

Description: All patients will receive anti-thymocyte globulin based conditioning followed by a G-CSF mobilized, peripheral blood hematopoietic progenitor cell HPC(A) product depleted of TCR-α/β+ Tlymphocytes using the CliniMACS system.
Type: Procedure
Group Labels: 9

Busulfan, Fludarabine Busulfan, Fludarabine & Busulfan, Fludarabine & Melphalan Clofarabine, Thiotepa Clofarabine, Thiotepa & Clofarabine, Thiotepa & Melphalan Radiation, Thiotepa Radiation, Thiotepa & Radiation, Thiotepa & Cyclophosphamide

Name: Rituximab

Description: Rituximab 200 mg IV flat dose
Type: Drug
Group Labels: 9

Busulfan, Fludarabine Busulfan, Fludarabine & Busulfan, Fludarabine & Melphalan Clofarabine, Thiotepa Clofarabine, Thiotepa & Clofarabine, Thiotepa & Melphalan Radiation, Thiotepa Radiation, Thiotepa & Radiation, Thiotepa & Cyclophosphamide

Name: Rabbit antithymocyte globulin

Description: Rabbit antithymocyte globulin 2.5 mg/kg IV
Type: Device
Group Labels: 9

Busulfan, Fludarabine Busulfan, Fludarabine & Busulfan, Fludarabine & Melphalan Clofarabine, Thiotepa Clofarabine, Thiotepa & Clofarabine, Thiotepa & Melphalan Radiation, Thiotepa Radiation, Thiotepa & Radiation, Thiotepa & Cyclophosphamide


Primary Outcomes

Description: The intervention will be considered unpromising if the rate of GVHD is greater than 40% and promising if the rate is 20% or less.

Measure: the number of incidences of grade 3-4 acute GVHD

Time: 2 years

Purpose: Treatment

Allocation: Non-Randomized

Parallel Assignment


There is one SNP

SNPs


1 T351I

T351I mutation). --- T351I ---



HPO Nodes


HPO:
Protein Mutations 0
SNP 0