Thiotepa-based Conditioning Regimen With De-escalated Post-graft Cyclophosphamide for Allogeneic Stem Cell Transplantation in Hematologic Malignancies

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Sawa Ito, MD
Study ID
NCT07565220
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Acute Leukemia
  • Acute Lymphocytic Leukemia (ALL)
  • Acute Myeloid Leukemia (AML)
  • High-risk Myeloproliferative Neoplasm (MPN)
  • Myelodysplastic Syndrome(MDS)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Thiotepa — DRUG
    Thiotepa is an alkylating agent used in combination with other chemotherapy agents to treat cancer.
  • Fludarabine — DRUG
    Fludarabine is a chemotherapy drug used in the treatment of chronic lymphocytic leukemia. It acts at DNA polymerase alpha, ribonucleotide reductase and DNA primase, results in the inhibition of DNA synthesis, and destroys the cancer cells.
  • Busulfan — DRUG
    Busulfan is a chemotherapy drug used in preparation for a stem cell transplant.
  • PBSC infusion — PROCEDURE
    Peripheral Blood Stem Cell (PBSC) infusion is a medical procedure used to replace diseased or damaged stem cells in patients, particularly after cancer treatments.

Study Details

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).

Key Dates

Start date
Jun 1, 2026
Status verified
Apr 2026
Primary completion
Jun 1, 2029
Completion
Nov 1, 2030

Study Design

Enrollment
48 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: T1FluBu2 (low-intensity)
    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
  • Experimental: Cohort 2: T2FluBu2 (high-intensity)
    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

Primary Outcome Measure

GVHD-free, relapse-free survival (GRFS) [ Time Frame: At 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UMPC Hillman Cancer CenterPittsburghPennsylvania15213
Amy Rogers, RN, BSN
[email protected]
412-623-4036
Linda Elias, RN, BSN
[email protected]
412-623-6037
Sawa Ito, MD (PRINCIPAL_INVESTIGATOR)

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By research site
UMPC Hillman Cancer Center· Pittsburgh, PA

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