A Modified Dose of Rabbit Anti-thymocyte Globulin (rATG) in Children and Adults Receiving Treatme… (NCT04872595) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Modified Dose of Rabbit Anti-thymocyte Globulin (rATG) in Children and Adults Receiving Treatment to Help Prepare Their Bodies for a Bone Marrow Transplant
United States59 participantsStarted 2021-04-30
Plain-language summary
The purpose of this study is to see if conditioning regimens that include personalized rabbit ATG (P-rATG) help the immune system recover sooner and decrease the chances of transplant-related side effects. Participants in this study will be children and adults who have acute leukemia or myelodysplastic syndrome (MDS), and will receive a standard conditioning regimen to prepare the body for an allogeneic hematopoietic cell transplant (allo-HCT). The conditioning regimen will include r-ATG, one of two combinations of chemotherapy, and possibly total body irradiation (TBI).
Who can participate
Age range4 Years
SexALL
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Inclusion Criteria:
* Patients receiving first peripheral blood mobilized ex-vivo CD34-selected T cell depleted allo-HCT for the following hematologic malignant conditions:
* Acute myeloid leukemia (AML) with intermediate or high-risk features in CR1 or Relapse AML in ≥ CR2.
* Must have MRD \<5% (flow cytometry, molecular and/or cytogenetics accepted).
* Acute leukemias of ambiguous lineage in ≥ CR1.
* Must have MRD \<5% (flow cytometry, molecular and/or cytogenetics accepted).
* Acute lymphoid leukemia (ALL) in CR1 with clinical, flow cytometric, or molecular features indicating a high risk for relapse, or ALL in ≥ CR2.
* Adult Patients - recommended but not required to be MRDnegative (by flow cytometry, molecular and/or cytogenetics).
* Pediatric Patients - Must be MRD-negative by flow cytometry, molecular and/or cytogenetics.
* Myelodysplastic syndromes (MDS) with least one of the following:
* Revised International Prognostic Scoring System risk score of intermediate or higher at the time of transplant evaluation.
* Life-threatening cytopenia.
* Karyotype or genomic changes that indicate high risk for progression to acute myelogenous leukemia, including abnormalities of chromosome 7 or 3, mutations of TP53, or complex or monosomal karyotype.
* Therapy related disease or disease evolving from other malignant processes.
* Able to tolerate cytoreduction
* Patients age:
* Regimen A: 4 - 60 years
* Regimen B - no age restriction
* Adequate organ f…