NCT06807606 Optimized Cord Blood Transplantation for the Treatment of Patients With High-risk Hematologic Malignancies Who Have Relapsed After First Allogeneic Stem Cell Transplantation
| NCT ID | NCT06807606 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Hematologic Malignancies |
| Study Type | INTERVENTIONAL |
| Enrollment | 35 participants |
| Start Date | 2025-03-03 |
| Primary Completion | 2027-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 35 participants in total. It began in 2025-03-03 with a primary completion date of 2027-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical research study is to learn if intermediate-intensity conditioning therapy followed by a cord blood transplant can help to control high-risk hematological malignancies in patients who need a second allogeneic stem cell transplantation.
Eligibility Criteria
Inclusion Criteria: 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: 1. Calculated creatinine clearance \> 50 ml/min. 2. Bilirubin \< 2 mg/dL (unless benign congenital hyperbilirubinemia or hemolysis). 3. ALT \< 5 x upper limit of normal (ULN). 7. Pulmonary function: Spirometry corrected DLCO ≥ 60% predicted. This criteria is waived for patients who are developmentally unable to complete pulmonary function test. 8. Left ventricular ejection fraction (MOD-bp) \> 50%. 9. Graft Criteria: 1. Two CB units will be selected according to the current MDACC CB unit selection algorithm. 2. High resolution 8-allele HLA typing and recipient HLA antibody profile will be performed. 3. Unit selection will occur based on HLA-match, total nucleated cell (TNC), and CD34+ cell dose adjusted per patient body weight. 4. The bank of origin will also be considered. 5. Donor-specific HLA antibodies, if present, will also be taken into consideration. 6. Each CB unit must be at least 3/8 HLA-matched to the patient considering high-resolution 8-allele HLA typing. 7. Each CB unit will be required to have a cryopreserved TNC dose of at least 1.5 x 107 TNC/ recipient body weight (TNC/ kg). 8. Each CB unit will be required to have a cryopreserved CD34+ cell dose of at least 1.0 x 105 CD34+ cells/ recipient body weight (CD34+ cells/kg). 9. A minimum of one unit will be reserved as a backup graft. 10. Each CB unit will be required to be cryopreserved in standard cryovolume. (24- 27 ml/s per unit) and be red blood cell depleted.
Contact & Investigator
Warren Fingrut, MD
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT06807606 clinical trial?
This trial is open to participants of all sexes, up to 60 Years, studying Hematologic Malignancies. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06807606 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06807606 currently recruiting?
Yes, NCT06807606 is actively recruiting participants. Contact the research team at wbfingrut@mdanderson.org for enrollment information.
Where is the NCT06807606 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT06807606 clinical trial?
NCT06807606 is sponsored by M.D. Anderson Cancer Center. The principal investigator is Warren Fingrut, MD at M.D. Anderson Cancer Center. The trial plans to enroll 35 participants.