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New treatment option for Chronic Myelomonocytic Leukemia (CMML)
Official title Thiotepa-Containing Conditioning Regimen for Allogeneic HSCT in Chronic Myelomonocytic Leukemia
ClinicalTrials.gov ID: NCT07588594
What this study is testing
What is TBF regimen?
TBF regimen is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for chronic myelomonocytic leukemia (cmml).
Also referred to as TBF (Thiotepa, Busulfan, Fludarabine) ± ATG.
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 is a prospective, single-arm clinical study. It aims to evaluate the effectiveness and safety of a conditioning regimen containing thiotepa (in combination with busulfan and fludarabine, with or without ATG) of allogeneic hematopoietic stem cell transplantation (allo-HSCT) in patients with chronic myelomonocytic leukemia (CMML) who have an intermediate-2 or high-risk prognosis.
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
- Age ≥ 18 years, any sex/gender.
- Confirmed diagnosis of chronic myelomonocytic leukemia (CMML) according to the 2022 WHO classification.
- Intermediate-2 or high-risk CMML based on CPSS or CPSS-mol score, and planned to receive allo-HSCT.
- Has a suitable hematopoietic stem cell donor:
- For haploidentical donor: at least 5/10 HLA match at HLA-A, -B, -C, -DQB1, and -DRB1.
You likely can't join if
- Previous allogeneic HSCT for CMML that later relapsed.
- Unwilling or unable to receive the study treatment regimen.
- Active hepatitis B or C, or chronic active hepatitis; known human immunodeficiency virus (HIV) infection.
- Active uncontrolled infection, including: hemodynamic instability related to infection, new or worsening signs/symptoms of infection, new infection...
- History of stroke or intracranial hemorrhage within 6 months before enrollment.
- Known pregnancy (positive urine pregnancy test), or currently breastfeeding.
See the full eligibility criteria
- Age ≥ 18 years, any sex/gender.
- Confirmed diagnosis of chronic myelomonocytic leukemia (CMML) according to the 2022 WHO classification.
- Intermediate-2 or high-risk CMML based on CPSS or CPSS-mol score, and planned to receive allo-HSCT.
- Has a suitable hematopoietic stem cell donor:
- For haploidentical donor: at least 5/10 HLA match at HLA-A, -B, -C, -DQB1, and -DRB1.
- For unrelated donor: at least 9/10 HLA match at the same five loci.
- For matched sibling donor: 10/10 HLA match at the same five loci.
- Hematopoietic cell transplantation comorbidity index (HCT-CI) ≤ 2, with generally good health and no significant organ abnormalities or major comorbidities.
- Adequate organ function as defined below:
- Left ventricular ejection fraction (LVEF) ≥ 50%, and no uncontrolled tachycardia or bradycardia-tachycardia syndrome.
- Total bilirubin ≤ 1.5 × upper limit of normal (ULN); ALT ≤ 2 × ULN; AST ≤ 2 × ULN.
- Serum creatinine ≤ 1.5 × ULN.
- Baseline oxygen saturation \> 92%.
- Pulmonary function: DLCO (corrected for hemoglobin) ≥ 40%, FEV1 ≥ 50%.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Agrees not to participate in any other treatment study during the treatment period.
- Willing and able to provide written informed consent, understand the nature, purpose, and procedures of the study, and voluntarily comply with study requirements.
- Previous allogeneic HSCT for CMML that later relapsed.
- Unwilling or unable to receive the study treatment regimen.
- Active hepatitis B or C, or chronic active hepatitis; known human immunodeficiency virus (HIV) infection.
- Active uncontrolled infection, including: hemodynamic instability related to infection, new or worsening signs/symptoms of infection, new infection lesions on imaging, or persistent fever without explanation despite no...
- History of stroke or intracranial hemorrhage within 6 months before enrollment.
- Known pregnancy (positive urine pregnancy test), or currently breastfeeding.
- Diagnosis of another malignancy within the past 2 years, except for localized skin cancer, superficial bladder cancer, carcinoma in situ of the cervix, breast cancer, or localized prostate cancer (Gleason score ≤ 6)...
- Any other condition that, in the investigator's judgment, makes the patient unsuitable for study participation.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
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 Beijing, China. 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.