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New treatment option for Acute Lymphocytic Leukemia (ALL)
Official title Thiotepa-based Conditioning Regimen With De-escalated Post-graft Cyclophosphamide for Allogeneic Stem Cell Transplantation in Hematologic Malignancies
ClinicalTrials.gov ID: NCT07565220
What this study is testing
What is Thiotepa?
Thiotepa is an investigational medicine, being studied as a potential treatment for acute lymphocytic leukemia (all).
Also referred to as Tepadina.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must be considered appropriate candidates for either the low- or high-intensity conditioning regimen for allogeneic hematopoietic stem cell...
- Age 50-70 years old or
- Age 18-49 and unfit for a conventional myeloablative conditioning regimen per the treating physician
- Patients have one of the following diagnoses:
- Acute lymphocytic leukemia (ALL) in first or subsequent morphological remission (\<5% marrow blasts by morphology).
You likely can't join if
- people will be excluded from the study if they meet any of the following criteria. For high-intensity regimen:
- 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.
- Patients with uncontrolled infections for whom alloSCT is considered contraindicated by the consulting infectious disease physician.
See the full eligibility criteria
Who can join
- Patients must be considered appropriate candidates for either the low- or high-intensity conditioning regimen for allogeneic hematopoietic stem cell transplantation based on the following age-related criteria:
- Age 50-70 years old or
- Age 18-49 and unfit for a conventional myeloablative conditioning regimen per the treating physician
- Patients have one of the following diagnoses:
- 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.
- Other acute leukemia or related neoplasm (including but not limited to 'mixed phenotype' 'biphenotypic', 'acute undifferentiated' or 'ambiguous lineage' acute leukemia, blastic plasmacytoid dendritic cell neoplasm...
- Myelodysplastic syndrome (MDS) with a history of excess blasts, with \>5% marrow blasts by morphology after receiving at least one cycle of treatment, including but not limited to hypomethylating agent, BCL-2 inhibitor...
- High-risk myeloproliferative neoplasm (MPN) with no evidence of high-grade bone marrow fibrosis or massive splenomegaly at the time of enrollment.
- Patients with an 8/8 HLA-matched (HLA-A, B, C, DRB1) related or unrelated donor capable of donating peripheral blood stem cells (PBSC)
- Provision of signed and dated informed consent form
- Sexually active fertile people and their partners must agree to use highly effective methods of contraception prior to study entry, during the course of the study, and until tacrolimus or other immunosuppressive therapy...
- Female people of childbearing potential must not be pregnant or breastfeeding at screening. Female people are considered to be of childbearing potential unless one of the following criteria is met:
- Permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman \> 45 years-of-age in the absence of other...
What rules you out
- people will be excluded from the study if they meet any of the following criteria. For high-intensity regimen:
- 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.
- Patients with uncontrolled infections for whom alloSCT is considered contraindicated by the consulting infectious disease physician.
- Patients with organ dysfunction, including:
- Renal insufficiency creatinine clearance \<45 ml/min/1.72m2 measured by 24-hr urine specimen
- Left ventricular ejection fraction \<45%
- Diffusing capacity of the lung for carbon monoxide (DLCO) corrected \<50% or FEV1 \<50%
- Liver function abnormality: total bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) \>5 times the upper limit of normal should be evaluated by a gastroenterologist. If a gastroenterologist...
- Patients who have received previous allogeneic transplantation.
- Patients with a life expectancy \<12 months due to co-existing diseases other than hematologic malignancies.
- Patients with any other significant medical conditions that would make them unsuitable for transplantation, as determined by the PI.
- Patients with a known hypersensitivity to cyclophosphamide, thiotepa, fludarabine, busulfan, tacrolimus, or mycophenolate mofetil (MMF).
- Patients who have received checkpoint inhibitors within three months of transplantation, unless an exception is made by the PI. For low-intensity regimen
- Poor performance status with Karnofsky Score \<60%
- Patients with active CNS involvement refractory to intrathecal chemotherapy and/or standard craniospinal radiation.
- Patients who are positive for HIV-1, HIV-2, HTLV1 or HTLV2.
- Patients with uncontrolled infections for whom alloSCT is considered contraindicated by the consulting infectious disease physician.
- Patients with organ dysfunction, including:
- Renal insufficiency creatinine clearance \<40 ml/min/1.72m2 measured by 24-hr urine specimen
- Left ventricular ejection fraction \<40%
- DLCO corrected\< 50% or FEV1\<50%
- Liver function abnormality: total bilirubin, AST, ALT\>5 times the upper limit of normal should be evaluated by a gastroenterologist. If a gastroenterologist considers that alloSCT is contraindicated, the patient will...
- Patients who have received previous allogeneic transplantation.
- Patients with a life expectancy \<12 months from co-existing disease other than hematologic malignancies
- Patients with any other significant medical conditions that would make them unsuitable for transplantation, as determined by the PI.
- Patients with a known hypersensitivity to cyclophosphamide, thiotepa, fludarabine, busulfan, tacrolimus, or mycophenolate mofetil (MMF).
- Patients who have received checkpoint inhibitors within three months of transplantation, unless an exception is made by the PI.
The study team makes the final eligibility decision.
Where it's taking place
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.