Optimized Cord Blood Transplantation for the Treatment of Patients With High-risk Hematologic Malignancies Who Have Relapsed After First Allogeneic Stem Cell Transplantation (NCT06807606)

🧪 Interventions in This Study

• Drugs Cyclophosphamide (DRUG)
• Fludarabine (DRUG)
• Thiotepa (DRUG)
• Tacrolimus (DRUG)
• Mycophenolate mofetil (DRUG)

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).

1. Patient aged 0-60 y/o at the time of consent. Adult is defined as patients 18 years of age or older at the time of consent.
2. Patient must have relapsed \>100 days since first transplant.
3. Diagnosis and Disease Status: a. Acute myelogenous leukemia (AML): i. Patients in morphologic remission (\<5% blasts) at the time of transplant, with or without persistent cytogenetic, flow cytometric, or molecular aberrations, or those with hypocellular marrows at time of transplant, are eligible. b. Acute lymphoblastic leukemia (ALL): i. Patients in morphologic remission with less than 5% blasts at time of transplant, with or without persistent cytogenetic, flow cytometric or molecular aberrations, or those or who have hypocellular bone marrows, are eligible. c. Other acute leukemias: i. Acute leukemias of ambiguous lineage or mixed phenotype in morphologic remission with less than 5% blasts at time of transplant, with or without persistent cytogenetic, flow cytometric or molecular aberrations, or those who have hypocellular bone marrows, are eligible. d. Myelodysplastic Syndromes (MDS) or CMML without myelofibrosis. i. Includes MDS with any IPSS risk category.
4. Prior treatment: a. To be eligible for this study, patients need to have received one prior allogeneic stem cell transplantation.
5. Karnofsky score equal or greater than 70% for patients aged 16 years and older or Lansky score equal or greater than 70% for patients less than 16 years old (See Appendix B; inpatient Leukemia service transfers without discharge are acceptable provided patient has equivalent KPS as if were outpatient).
6. Renal and Liver function:
7. Calculated creatinine clearance \> 50 ml/min.
8. Bilirubin \< 2 mg/dL (unless benign congenital hyperbilirubinemia or hemolysis).
9. ALT \< 5 x upper limit of normal (ULN).
10. Pulmonary function: Spirometry corrected DLCO ≥ 60% predicted. This criteria is waived for patients who are developmentally unable to complete pulmonary function test.
11. Left ventricular ejection fraction (MOD-bp) \> 50%.
12. Graft Criteria:

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

📍 All Participating Trial Locations (1 Sites)

• The University of Texas M. D. Anderson Cancer Center — Houston, Texas

📞 Contact the Study Coordinator

Phone: (713) 745-2214

Email: wbfingrut@mdanderson.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.

More studies in Hematologic Malignancies

• A Study of Ruxolitinib for Preventing Graft-Versus-Host Disease in People With a Hematologic Malignancy Who Will Receive a Stem Cell Transplant — Basking Ridge, New Jersey
• Digital Health Intervention for Self-Management and Telemonitoring in Chimeric Antigen Receptor (CAR-T) Therapy — Duarte, California
• PUL-042 Treatment in Patients With Parainfluenza Virus (PIV), Human Metapneumovirus (hMPV) or Respiratory Syncytial Virus (RSV) — Duarte, California
• APG-2575 Study of Safety, Tolerability ,PK/PD in Patients With Hematologic Malignancies — Jacksonville, Florida
• IVIG for Infection Prevention After CAR-T-Cell Therapy — Duarte, California
• Prophylactic TCRaB+ and CD19+ Depleted Donor Lymphocyte Infusion After Allogeneic Stem Cell Transplant in High-Risk Patients With Hematologic Malignancies — Madison, Wisconsin

Explore by condition: All Hematologic Malignancies clinical trials

💡 How to Participate

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