NCT06807606

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

Optimized CBT for Pts With High-risk Hematologic Malignancies Who Have Relapsed After First ASCT

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary Objective: To evaluate 1-year overall survival (OS) following CBT with intermediate dose intensity conditioning for patients in need of a second allogeneic stem cell transplantation. Secondary Objectives: Speed and success of neutrophil and platelet engraftment. Incidences of graft failure. • Incidence of day 100 grade II-IV and III-IV aGVHD and day 180 grades II-IV and III-IV aGVHD. Incidence of 1-year, 2-year, and 3-year cGVHD. Incidence of TRM (100 days, 6 months, 1 and 2 years). The probabilities of relapse, OS, PFS, and GRFS at 1 year, 2, and 3 years as listed in the secondary endpoints in section 2.2. Correlative laboratory studies investigating graft versus leukemia biology.

Conditions

• Hematologic Malignancies

Interventions

Type	Name	Description
DRUG	Drugs Cyclophosphamide	Given as standard of care treatment through IV infusion
DRUG	Fludarabine	Given as standard of care treatment through IV infusion
DRUG	Thiotepa	Given as standard of care treatment through IV infusion
DRUG	Tacrolimus	Given as standard of care treatment through IV infusion
DRUG	Mycophenolate mofetil	Given as standard of care treatment through IV infusion

Timeline

• Start date: 2025-03-03
• Primary completion: 2027-11-30
• Completion: 2029-11-30
• First posted: 2025-02-04
• Last updated: 2025-12-04

Locations

1 site across 1 country: United States