Who is eligible for clinical trial NCT03970096?

Participants must meet the protocol's inclusion criteria for Acute Leukemia. The stated age range is 1 Year to 60 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT03970096 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

Graft Versus Host Disease-Reduction Strategies for Donor Blood Stem Cell Transplant Patients With Acute Leukemia or Myelodysplastic Syndrome (MDS) (NCT03970096)

A Phase II Randomized Controlled Trial Comparing GVHD-Reduction Strategies for Allogeneic Peripheral Blood Transplantation (PBSCT) for Patients With Acute Leukemia or Myelodysplastic Syndrome: Selective Depletion of CD45RA+ Naïve T Cells (TND) vs. Post-Transplantation Cyclophosphamide (PTCy)

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Fred Hutchinson Cancer Center

🩺 Plain-English Summary (8th-Grade Level)

This phase II trial investigates two strategies and how well they work for the reduction of graft versus host disease in patients with acute leukemia or MDS in remission. Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient, they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (19 items) and avoid the listed exclusions (22 items).

Location: Moffitt Cancer Center — Tampa, Florida

Age range: 1 Year to 60 Years

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Patients with central nervous system (CNS) involvement refractory to intrathecal chemotherapy and/or standard cranial-spinal radiation. A patient may have a history of CNS disease. However, any CNS disease must be cleared by the end of the pre-conditioning evaluation time frame. If CNS disease is identified on cerebrospinal fluid (CSF) evaluation within 30 days of the start of the preparative regimen a repeat CSF evaluation must be performed and show no evidence of disease in order for the patient to be eligible for the protocol.
Patients on other experimental protocols for prevention of GVHD.
Patient weight:
Patients with HLA-matched related donors will be excluded if they weigh \>= 110 kg.
Patients with HLA-matched unrelated donors will be excluded if they weigh \>= 110 kg and must be discussed with the Fred Hutch protocol principal investigator (PI) if they weigh \>= 90 kg.
Patients who are positive for human immunodeficiency virus (HIV)-1, HIV-2, human T-cell lymphotropic virus (HTLV)1 or HTLV2.
Patients with uncontrolled infections for whom myeloablative HCT is considered contraindicated by the consulting infectious disease physician; i.e. patients with active infections require infectious disease consultation and documentation by the infectious disease team that myeloablative HCT is not considered to be contraindicated. Upper respiratory tract infection is not considered to represent an uncontrolled infection in this context.
Patients with organ dysfunction, including:
Renal insufficiency (creatinine \> 1.5 mg/dl) at the time of evaluation for the protocol. Patients with a known history of creatinine \> 1.5 mg/dl or a current serum creatinine above the normal range for age must have a current creatinine clearance of \> 60 ml/min/1.73 m\^2 (measured by 24-hr urine specimen or nuclear glomerular filtration rate \[GFR\]).
Left ventricular ejection fraction \< 45%.
Carbon monoxide diffusing capability (DLCO) corrected \< 60%. Patients who are unable to perform pulmonary function tests (for example, due to young age and/or developmental status) will be excluded if the oxygen (O2) saturation is \< 92% on room air.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (3 Sites)

Moffitt Cancer Center — Tampa, Florida
University of Pittsburgh Cancer Institute (UPCI) — Pittsburgh, Pennsylvania
Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington

📞 Contact the Study Coordinator

Phone: (206) 667-6572

Email: mbleakle@fredhutch.org

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗