ABBA CORD: dCBT w/ Abatacept for aGVHD Prophylaxis

PHASE2RecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

February 25, 2025

Primary Completion Date

October 29, 2027

Study Completion Date

October 31, 2028

Conditions
Acute Myelogenous LeukemiaAcute Lymphatic LeukemiaChronic Myelogenous LeukemiaMyelodysplastic SyndromesMyelodysplastic Syndrome OtherChronic Myelomonocytic LeukemiaLymphomaHodgkin Lymphoma
Interventions
DRUG

Cyclophosphamide

Cyclophosphamide (Cy) is one part of the conditioning regimen. 50 mg/kg beginning on day -6.

DRUG

Fludarabine

Fludarabine (Flu) is one part of the conditioning regimen. 150 mg/m2 (30 mg/m2 per day on days -6 to -2)

DRUG

Thiotepa

Thiotepa (Thio) is one part of the conditioning regimen.10 mg/kg (5 mg/kg per day on days -5 and -4)

RADIATION

Total Body Irradiation

400 cGy (200 cGy per day on days -2 and -1).

BIOLOGICAL

Double Umbilical Cord Transplant

Cord blood is a regulated biologic. Selection of cord blood units will be based on published guidelines.

DRUG

Tacrolimus

Tacrolimus will be administered post transplant. Graft-versus-host disease prophylaxis will consist of tacrolimus and mycophenolate mofetil (MMF), starting on day-5. Tacrolimus will continue at least until day 180 and then be tapered off.

DRUG

Mycophenolate Mofetil

MMF will be administered post transplant. Graft-versus-host disease prophylaxis will consist of tacrolimus and mycophenolate mofetil (MMF), starting on day-5. MMF will continue until day 30.

DRUG

Abatacept

Abatacept at a dose of 10mg/kg will be given on days T-1, T+5, T+14 and T+28.

Trial Locations (1)

44106

RECRUITING

University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland

All Listed Sponsors
lead

Leland Metheny

OTHER