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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

NCT04872595 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2026-05-06

No results posted yet for this study

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

  • Acute Myeloid Leukemia (AML)
  • Acute Lymphoid Leukemia (ALL)
  • Myelodysplastic Syndromes (MDS)

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

Sponsors & Collaborators

Principal Investigators

  • Kevin Curran, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-30
Primary Completion
2027-04-30
Completion
2027-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04872595 on ClinicalTrials.gov