Fludarabine and TBI for Blood Cancers Before Transplant
This study is testing a new way to prepare patients for an allogeneic stem cell transplant (a transplant using cells from a donor) for certain blood cancers. It combines the drugs fludarabine and post-transplant cyclophosphamide (PTCy) with intermediate-dose total body irradiation (TBI), a type of radiation therapy. Researchers want to see if this combination improves how long patients live after one year. You might be able to join if you are 18-65 years old and have certain types of acute myeloid leukemia, chronic myeloid leukemia, or myelodysplastic syndrome. The study is currently unclear about its recruitment status.
- Study design
- This is a single-arm study, meaning all participants receive the same treatment. It plans to enroll 209 participants.
- What's involved
- You would receive fludarabine for 5 days, TBI for 2 days, and then PTCy for 2 days after your stem cell transplant. You would also receive tacrolimus and mycophenolate mofetil (MMF) for a period after the transplant.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your survival will be checked for up to one year after the treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07214688
Fludarabine and Intermediate-dose TBI Followed by PTCy in Patients Undergoing Allo Transplant for Heme Malignancies
Recruiting
PHASE2Ages 18–65InterventionalTreatmentHackensack Meridian HealthInvestigator-initiated
~209 participants
Updated 2026-03-23 on ClinicalTrials.gov
What's tested:FludarabineIntermediate-dose Total Body Irradiation (TBI)Post-transplant Cyclophosphamide (PTCy)TacrolimusMycophenolate mofetil (MMF)
At a glance
Recruiting sites
1 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall survival (OS) at 1-year following treatment with fludarabine plus intermediate-dose total body irradiation (TBI 800 cGy) with post-transplant cyclophosphamide (PTCy)
Measured over Patient status (dead or alive) will be reviewed (e.g., through patient chart review,patient phone call, etc.) up through a period of 1 year
Conditions
Where it's being run
3 sites across 2 statesNew Jersey2
District of Columbia1
Study leadership
- Michele Donato, MD · PRINCIPAL_INVESTIGATOR · Hackensack Meridian Health
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Patients ages 18-65 years.
Patients with a 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 the bone marrow;
Myelodysplastic syndrome with less than 5% blasts in the bone marrow by IHC or flow cytometry whichever is highest;
Myeloproliferative neoplasms with less than 5% blast in the marrow and peripheral blood;
Acute lymphoblastic leukemia in CR (CIBMTR criteria); or Lymphoma in CR (CIBMTR criteria).
Patients who are eligible for allogeneic stem cell transplant per Transplant Program SOPs.
Patients with a Karnofsky performance status (KPS) of ≥60%.
Patients with adequate organ function defined by:
Cardiac: LVEF ≥50%
Pulmonary: DLCO ≥50% of predicted
Hepatic: Bilirubin ≤1.5x ULN, ALT/AST ≤2.5x ULN
Renal: Creatinine clearance ≥50 mL/min
All participants of reproductive potential must use effective contraception following allogeneic hematopoietic stem cell transplantation (allo-HSCT), in accordance with guidelines from the American Society for Transplantation and Cellular Therapy (ASTCT), the FDA, and other expert bodies.
For Male Participants:
For Female Participants:
Female participants of childbearing potential are required to use highly effective contraception for a minimum of 12 to 24 months post-transplant, or longer if still receiving immunosuppressive or teratogenic therapy. For drugs such as MMF, sirolimus, or ruxolitinib, contraception must continue for 3 months after the last dose.
A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements.15-17
Patients with a suitable donor for allogeneic stem cell transplant defined by:
Matched sibling donors willing to donate mobilized peripheral blood (PBSC) or bone marrow (BM), meeting all institutional criteria for donation;
Unrelated donors at \>7/8 (i.e., mismatched at only one of the HLA-A, HLA-B, HLA-C, and HLA-DRB1 loci) willing to donate mobilized PBSC or BM, and medically eligible to donate cells according to National Marrow Donor Program criteria; or Related Haploidentical donors willing to donate PBSC or BM and meeting criteria for donation.
Patients who are able to comply with follow-up visits and treatment plans.
Patients who are able to give informed consent.
Exclusion
Hematopoietic cell transplantation comorbidity index above 3.
Patients with a Karnofsky performance status (KPS) of \<60%.
Patients with active infections or other contraindications for allogeneic stem cell transplant.
Patients who are unable or unwilling to give informed consent.
Patients who have received a prior allogeneic transplant.
Patients who are unable to comply with follow-up visits and treatment plans.
What this trial measures
- Overall survival (OS) at 1-year following treatment with fludarabine plus intermediate-dose total body irradiation (TBI 800 cGy) with post-transplant cyclophosphamide (PTCy)Patient status (dead or alive) will be reviewed (e.g., through patient chart review,patient phone call, etc.) up through a period of 1 year
OS is defined as the time from the first dose of study treatment to the time of death due to any cause. Patients who are still alive will be censored at the date last known alive of the data cut-off date (if applicable), whichever is earlier.