ABBA CORD: dCBT w/ Abatacept for aGVHD Prophylaxis

Summary

The goal of this clinical trial is to see if adding abatacept to tacrolimus and MMF prevents or reduces the chances of acute graft versus host disease which is a complication that can occur after transplant in participants with blood cancer. The usual therapy for graft versus host disease prevention after a cord blood transplant includes tacrolimus and MMF. The main question this clinical trial aims to answer is whether or not abatacept will be safe and effective in reducing aGVHD rates in dCBT.

Participants will:

* Partake in exams, tests, and procedures as part of usual cancer care.
* Partake in conditioning, which is the treatment that is given before a transplant.
* Have a cord blood transplant.
* Partake in radiation following the transplant.

Conditions

• Acute Myelogenous Leukemia
• Acute Lymphatic Leukemia
• Chronic Myelogenous Leukemia
• Myelodysplastic Syndromes
• Myelodysplastic Syndrome Other
• Chronic Myelomonocytic Leukemia
• Lymphoma
• Hodgkin 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.

Sponsors & Collaborators

• Leland Metheny

  lead OTHER

Principal Investigators

• Leland Metheny, MD · University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-25

Primary Completion

2027-10-29

Completion

2028-10-31

FDA Drug

Yes

Countries

• United States

Study Locations