Actively Recruiting
Fludarabine and Intermediate-dose TBI Followed by PTCy in Patients Undergoing Allo Transplant for Heme Malignancies
Led by Hackensack Meridian Health · Updated on 2026-03-23
209
Participants Needed
3
Research Sites
312 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The Flu-TBI 800 trial is a prospective, single-arm, multicenter, interventional phase 2 study to evaluate whether fludarabine plus intermediate-dose total body irradiation (TBI 800 cGy) with post-transplant cyclophosphamide (PTCy) (experimental regimen) improves the 1-year survival of allogeneic stem cell transplant recipients.
CONDITIONS
Official Title
Fludarabine and Intermediate-dose TBI Followed by PTCy in Patients Undergoing Allo Transplant for Heme Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients ages 18-65 years.
- Diagnosis of one of the following hematologic malignancies: acute myeloid leukemia or chronic myeloid leukemia with no circulating blasts and less than 5% blasts in bone marrow;
- Myelodysplastic syndrome with less than 5% blasts in bone marrow by IHC or flow cytometry;
- Myeloproliferative neoplasms with less than 5% blasts in marrow and peripheral blood;
- Acute lymphoblastic leukemia in complete remission (CR); or lymphoma in CR.
- Eligible for allogeneic stem cell transplant per Transplant Program standards.
- Karnofsky performance status (KPS) of 60% or higher.
- Adequate organ function: cardiac LVEF 50% or higher; pulmonary DLCO 50% or higher; hepatic bilirubin ≤1.5x upper limit of normal (ULN), ALT/AST ≤2.5x ULN; renal creatinine clearance 50 mL/min or higher.
- Use of effective contraception following allo-HSCT according to guidelines.
- Male participants must use effective contraception for at least 12 months post-transplant and avoid fathering a child during this time.
- Female participants of childbearing potential must use highly effective contraception for 12 to 24 months post-transplant or longer if receiving immunosuppressive or teratogenic therapy.
- Suitable donor available: matched sibling, unrelated donor with ≤1 HLA mismatch, or related haploidentical donor.
- Ability to comply with follow-up visits and treatment plans.
- Ability to give informed consent.
You will not qualify if you...
- Hematopoietic cell transplantation comorbidity index above 3.
- Karnofsky performance status (KPS) less than 60%.
- Active infections or other contraindications for allogeneic stem cell transplant.
- Unable or unwilling to give informed consent.
- Prior allogeneic transplant.
- Inability to comply with follow-up visits and treatment plans.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007
Not Yet Recruiting
2
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
3
John Theurer Cancer Center at Jersey Shore University Medical Center
Neptune City, New Jersey, United States, 07753
Not Yet Recruiting
Research Team
O
Oncology Clinical Research Referral Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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