Thiotepa-Based Conditioning for Leukemia

Overseen By Linda Elias, RN, BSN

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Sawa Ito, MD

Must not be taking: Checkpoint inhibitors

Disqualifiers: HIV, Uncontrolled infections, Organ dysfunction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase 1 trial will investigate the safety and effectiveness of Thiotepa, Busulfan, and Fludarabine (TBF) conditioning regimen with post-transplant cyclophosphamide (PTCy) in HLA-matched related or unrelated donor allogeneic stem cell transplantation (alloSCT).

Who Is on the Research Team?

Sawa M Ito, MD

Principal Investigator

UPMC Hillman Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

Patients must provide signed and dated informed consent form

Sexually active fertile subjects and their partners must agree to use highly effective contraception

I have a fully HLA-matched donor who can give me stem cells.

Exclusion Criteria

My health limits my daily activities and I need help with self-care.

I have significant problems with certain organs.

For high-intensity regimen: CIBMTR HCT-CI score >5

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Conditioning

Participants receive Thiotepa, Fludarabine, and Busulfan as part of the conditioning regimen prior to stem cell transplantation

5 days

Daily visits for drug administration

Stem Cell Infusion

Participants receive peripheral blood stem cell (PBSC) infusion

1 day

1 visit (in-person)

Post-transplant Monitoring

Participants are monitored for engraftment, GVHD, and other complications

Up to 30 days

Frequent visits for monitoring

Follow-up

Participants are monitored for long-term outcomes including GVHD-free, relapse-free survival

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Busulfan
• Fludarabine
• Thiotepa

How Is the Trial Designed?

Group I: Cohort 2: T2FluBu2 (high-intensity) Experimental Treatment 4 Interventions

Thiotepa: 5 mg/kg - administered on Day -5 prior to PBSC infusion Fludarabine: 40 mg/m2/day - administered on Day -4, Day -3, Day -2 and Day -1 prior to PBSC infusion Busulfan: 3.2 mg/kg/day IV - administered on Day -4 and Day -3 prior to PBSC infusion PBSC infusion: given on Day 0

Group II: Cohort 1: T1FluBu2 (low-intensity) Experimental Treatment 4 Interventions

Thiotepa: 5 mg/kg - administered on Day -5 prior to PBSC infusion Fludarabine: 30 mg/m2/day - administered on Day -4, Day -3, Day -2 and Day -1 prior to PBSC infusion Busulfan: 3.2 mg/kg/day IV - administered on Day -4 and Day -3 prior to PBSC infusion PBSC infusion: given on Day 0

Who Is Running the Clinical Trial?

Sawa Ito, MD

Lead Sponsor

Trials

2

Recruited

50+