Trials / Active Not Recruiting
Active Not RecruitingNCT04872595
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
Phase 2 Study of Personalized r-ATG Dosing to Improve Survival Through Enhanced Immune Reconstitution in Pediatric and Adult Patients Undergoing Ex-vivo CD34-Selected Allogeneic-HCT (PRAISE-IR)
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 59 (actual)
- Sponsor
- Memorial Sloan Kettering Cancer Center · Academic / Other
- Sex
- All
- Age
- 4 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Personalized rATG (P-rATG) | P-rATG days (always starting on Day -12 to -10) |
| RADIATION | Hyper fractionated total body irradiation | (1375 - 1500cGy\*) Day -9 to -6 \*TBI dose in 125cGy fractions (with lung shielding) and total dose to be determined by treating physician/radiation oncology and is based off age, stage of disease, and anesthesia requirements. |
| DRUG | Thiotepa | (5mg/kg/day x 2 day) Day -5 to -4 |
| DRUG | Cyclophosphamide | (60mg/kg/day x 2 days) Day -3 to -2 |
| DRUG | GCSF | Day +7 |
| DRUG | Busulfan | Day -9 to -7 doses 2-3 to be adjusted per PK for target cumulative exposure of 65 mg\*h/L |
| DRUG | Melphalan | (70mg/m2/day x 2 days) Day -6 to -5 |
| DRUG | Fludarabine | (25mg/m2/day x 5 days) Day -6 to -2 |
Timeline
- Start date
- 2021-04-30
- Primary completion
- 2026-04-01
- Completion
- 2026-04-01
- First posted
- 2021-05-04
- Last updated
- 2025-09-04
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04872595. Inclusion in this directory is not an endorsement.