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Report for Clinical Trial NCT03615105
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
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.
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 dosing per nomogram. This dynamic nomogram is based on absolute lymphocyte count at the start of conditioning and can result in either 2 or 3 day ATG administration. If a patient requires 2 day administration the subjequent chemotherapies may be moved forward by one day at the treating physician's discretion.
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 ---