SNPMiner Trials (Home Page)
Report for Clinical Trial NCT04098393
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
The purpose of this study is to see if a condensed version of the chemotherapy regimen
busulfan, melphalan, fludarabine (bu/mel/flu) and the drug antithymocyte globulin (ATGāalso
referred to as rATG or thymoglobulin) can have the same or fewer number of severe side
effects in people with various blood cancers 30 days after they receive an allogeneic
hematopoietic cell transplantation.
Name: Busulfan 3.2 mg/kg/day
Description: Busulfan 3.2 mg/kg/day, with dose adjustments made according to pharmacokinetic (PK) levels.
Type: Drug
Group Labels: 1 patients hematologic malignancies other than multiple myeloma
Name: Fludarabine
Description: Fludarabine (25mg/m2/ day) administered on days -6, -5, -4, -3, and -2.
Type: Drug
Group Labels: 2 patients hematologic malignancies other than multiple myeloma patients with multiple myeloma
Name: Melphalan
Description: Melphalan (70mg/m2/day) administered on days -6 and -5.
Type: Drug
Group Labels: 2 patients hematologic malignancies other than multiple myeloma patients with multiple myeloma
Name: Antithymocyte globulin (ATG)
Description: Anti-thymocyte globulin (ATG) 2.5 mg/kg/day on days -3 and -2
Type: Drug
Group Labels: 2 patients hematologic malignancies other than multiple myeloma patients with multiple myeloma
Name: Busulfan 0.8 mg/kg
Description: Busulfan 0.8 mg/kg every 6 hours x 10 doses, with dose adjustments made according to PK levels.
Type: Drug
Group Labels: 1 patients with multiple myeloma
Name: Allogeneic hematopoietic cell transplantation (Allo-HCT)
Description: Allogeneic hematopoietic cell transplantation following the conditioning regimen.
Type: Procedure
Group Labels: 2 patients hematologic malignancies other than multiple myeloma patients with multiple myeloma
Primary Outcomes
Description: All grade 4 CTCAEv5.0 toxicities are included except for hematologic toxicities that are considered expected for patients receiving myeloablative conditioning.
Measure: the number of grade 4 toxicities
Time: in the first 30 days post-HCT
Purpose: Treatment
Allocation: Non-Randomized
Parallel Assignment
There is one SNP
SNPs
1 T315I
- CML with BCR-ABL mutation consistent with poor response to TKIs (e.g., T315I
mutation)
- CML in accelerated phase or blast crisis with <10% blasts after therapy, or in
second chronic phase. --- T315I ---
HPO Nodes
HPO: Protein Mutations 0
SNP 0