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

ConditionsAcute Lymphocytic Leukemia (ALL)Acute Myeloid Leukemia (AML)Acute LeukemiaMyelodysplastic Syndrome(MDS)Myeloproliferative Neoplasm (MPN)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSawa Ito, MD

About 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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 50-70 years old or

Age 18-49 and unfit for a conventional myeloablative conditioning regimen per the treating physician

Acute lymphocytic leukemia (ALL) in first or subsequent morphological remission (<5% marrow blasts by morphology).

Acute myeloid leukemia (AML) in first or subsequent morphological remission (<5% marrow blasts by morphology) with or without hematologic recovery.

Disqualifiers

Poor performance status with Karnofsky Score <70%

Center for International Blood and Marrow Transplant Research (CIBMTR) hematopoietic cell transplant co-morbidity index (HCT-CI) score >5

Patients with active central nervous system (CNS) involvement refractory to intrathecal chemotherapy and/or standard craniospinal radiation.

Patients who are positive for HIV-1, HIV-2, HTLV1 or HTLV2.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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/Surgery

    Peripheral Blood Stem Cell (PBSC) infusion is a medical procedure used to replace diseased or damaged stem cells in patients, particularly after cancer treatments.

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: Cohort 1: T1FluBu2 (low-intensity)Experimental treatment 4 interventions
Group B: Cohort 2: T2FluBu2 (high-intensity)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

GVHD-free, relapse-free survival (GRFS)

Graft Versus Host Disease (GVHD)-free, relapse-free survival (GRFS) is defined by survival without a qualifying event including Death, Relapse of primary disease, Grade III-IV acute graft-versus-host disease (GVHD), graded via MAGIC criteria, Chronic moderate or severe GVHD requiring systemic immunosuppression, graded via NIH consensus criteria.

Time frame
At 1 year

Secondary outcomes

1

Median time to neutrophil engraftment

Median time to neutrophil engraftment will be defined as the median number of days from transplant at which the cumulative engraftment rate reaches 50%.

Time frame
Up to 30 days
2

Median time to platelet engraftment

Median number of days from transplant at which the cumulative engraftment rate of platelet recovery to 20,000/mm3 and 50,000/mm3 reaches 50% respectively.

Time frame
Up to 30 days
3

Frequency of severe mucositis

Percentage of patients experiencing severe mucositis, defined as grade 3-4 by WHO criteria.

Time frame
Up to 30 days post-transplant
4

Frequency of total parental nutrition

Percentage of patients who require TPN at any time from the start of conditioning through day +30 post-transplant.

Time frame
Up to 30 days post-transplant

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sawa Ito, MD

Lead sponsor

University of Pittsburgh

Sponsor institution

Source ClinicalTrials.gov
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