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ACTIVE NOT RECRUITING
NCT04872595
PHASE2

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

Sponsor: Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

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).

Official title: 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)

Key Details

Gender

All

Age Range

4 Years - Any

Study Type

INTERVENTIONAL

Enrollment

59

Start Date

2021-04-30

Completion Date

2026-04

Last Updated

2025-09-04

Healthy Volunteers

No

Interventions

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

Locations (1)

Memorial Sloan Kettering Cancer Center

New York, New York, United States