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

NCT06807606 | Recruiting Phase 2 DMC

• 2 other identifiers: 2024-1605NCI-2025-00794
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematologic Malignancies

Outcome Measures

Primary Outcomes (1)

• Safety and Adverse Events (AEs)

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year.

Study Arms (1)

Optimized CBT

EXPERIMENTAL

Participants enrollment on trial will be determined by consultation with the physicians of the SCT Service.

Drug: Drugs Cyclophosphamide; Drug: Fludarabine; Drug: Thiotepa; Drug: Tacrolimus; Drug: Mycophenolate mofetil

Interventions

Drugs Cyclophosphamide DRUG

Given as standard of care treatment through IV infusion

Optimized CBT

Fludarabine DRUG

Given as standard of care treatment through IV infusion

Optimized CBT

Thiotepa DRUG

Given as standard of care treatment through IV infusion

Optimized CBT

Tacrolimus DRUG

Given as standard of care treatment through IV infusion

Optimized CBT

Mycophenolate mofetil DRUG

Given as standard of care treatment through IV infusion

Optimized CBT

Eligibility Criteria

• Age: Up to 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• Patient must have relapsed \>100 days since first transplant.
• 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.
• Prior treatment:
• a. To be eligible for this study, patients need to have received one prior allogeneic stem cell transplantation.
• 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).
• Renal and Liver function:
• Calculated creatinine clearance \> 50 ml/min.
• Bilirubin \< 2 mg/dL (unless benign congenital hyperbilirubinemia or hemolysis).
• ALT \< 5 x upper limit of normal (ULN).
• Pulmonary function: Spirometry corrected DLCO ≥ 60% predicted. This criteria is waived for patients who are developmentally unable to complete pulmonary function test.
• Left ventricular ejection fraction (MOD-bp) \> 50%.
• Graft Criteria:
• Two CB units will be selected according to the current MDACC CB unit selection algorithm.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

fludarabine; Thiotepa; Tacrolimus; Mycophenolic Acid

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Phosphoramides; Organophosphorus Compounds; Organic Chemicals; Triethylenephosphoramide; Aziridines; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Macrolides; Lactones; Caproates; Acids, Acyclic; Carboxylic Acids; Fatty Acids; Lipids

Study Officials

• Warren Fingrut, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Warren Fingrut, MD

CONTACT

713-745-2214; wbfingrut@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 4, 2025
• Study Start: March 3, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2029
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

US (1)