Personalized rATG for Leukemia

Overseen by Kevin Curran

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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).

Research Team

Kevin Curran

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for children and adults with acute leukemia or myelodysplastic syndrome (MDS) who are preparing for their first bone marrow transplant. Participants must have certain levels of disease remission, normal organ function, and be able to tolerate cytoreduction. Pregnant or breastfeeding women, those with active brain cancer or uncontrolled infections, HIV/HTLV-positive individuals, and previous transplant recipients cannot join.

Inclusion Criteria

I am between 2 and 12 years old.

My organs are functioning well.

1 week 40.6 + / - 14.8

Exclusion Criteria

Patient seropositivity for HIV I/II and/or HTLV I/II.

Patients unwilling to use contraception during the study period.

I am not pregnant or breastfeeding.

Treatment Details

Interventions

• Personalized rATG (P-rATG) (Immunosuppressant)

Trial Overview The study tests if a personalized rabbit Anti-thymocyte Globulin (rATG) in the conditioning regimen before a bone marrow transplant can improve immune recovery and reduce side effects. Patients will receive rATG along with chemotherapy combinations and possibly total body irradiation.

Participant Groups

Group I: P-rATG with total body irradiation, thiotepa, cyclophosphamide Experimental Treatment 5 Interventions

P-rATG days (always starting on Day -12 to -10) * Hyper fractionated total body irradiation (1375 - 1500cGy\*) Day -9 to -6 * Thiotepa (5mg/kg/day x 2 day) Day -5 to -4 * Cyclophosphamide (60mg/kg/day x 2 days) Day -3 to -2 * GCSF Day +7 \*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.

Group II: P-rATG with busulfan, melphalan and fludarabine Experimental Treatment 5 Interventions

P-rATG days (Appendix A - always starting on Day -12 to -10) * Busulfan -Day -9 to -7 * Initial dose per table in Appendix B; doses 2-3 to be adjusted per PK for target cumulative exposure of 65 mg\*h/L Melphalan (70mg/m2/day x 2 days) Day -6 to -5 * Fludarabine (25mg/m2/day x 5 days) Day -6 to -2 * GCSF Day +7

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Lisa M. DeAngelis

Memorial Sloan Kettering Cancer Center

Chief Medical Officer since 2021

MD from Columbia University

Selwyn M. Vickers

Memorial Sloan Kettering Cancer Center

Chief Executive Officer since 2022

MD from Johns Hopkins University