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Thiotepa-Containing Conditioning Regimen for Allogeneic HSCT in Chronic Myelomonocytic Leukemia

11. september 2026 opdateret af: Sun Yuqian, Peking University People's Hospital

Prospective Single-Arm Clinical Study of Thiotepa-Containing Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation in Chronic Myelomonocytic Leukemia

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.

The main goal is to evaluate 1 year RFS and OS. Other goals include assessing engraftment, overall survival, transplant-related complications, and side effects. A total of 31 participants will be enrolled.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

31

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Kina
      • Beijing, Kina, 100044
        • Rekruttering
        • Peking University People's Hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion 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 interventional 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.

Exclusion Criteria:

  • 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 symptoms/signs.
  • 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) that has been treated with curative intent.
  • Any other condition that, in the investigator's judgment, makes the patient unsuitable for study participation.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Single Arm: Thiotepa + Busulfan + Fludarabine ± ATG
Patients with intermediate-2 or high-risk chronic myelomonocytic leukemia (CMML) per CPSS/CPSS-mol criteria, who are scheduled to receive allogeneic hematopoietic stem cell transplantation (allo-HSCT) with a thiotepa-containing conditioning regimen.
Medicin: TBF regimen
Intravenous thiotepa 5 mg/kg/d on days -11,-10; busulfan 3.2 mg/kg/d on days -8,-7,-6; fludarabine 30 mg/m²/d on days -6 to -2; ATG per donor type (haplo/unrelated: 2.5 mg/kg/d days -5 to -2; MSD: 1.125 mg/kg/d days -5 to -2). Allogeneic stem cells infused on day 0. GVHD prophylaxis: CsA, MMF, MTX per protocol.
Andre navne:
  • TBF (Thiotepa, Busulfan, Fludarabine) ± ATG

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
One-year relapse-free survival (RFS) after allogeneic hematopoietic stem cell transplantation
Tidsramme: At 12 months after allogeneic hematopoietic stem cell transplantation.
Time from stem cell infusion to hematologic/extramedullary relapse or death, censored at 12 months for event-free participants.
At 12 months after allogeneic hematopoietic stem cell transplantation.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
One-year overall survival (OS)
Tidsramme: At 12 months after allogeneic hematopoietic stem cell transplantation.
Overall survival is defined as the time from stem cell infusion to death from any cause. Participants alive at 12 months are censored at the last follow-up.
At 12 months after allogeneic hematopoietic stem cell transplantation.
One-year cumulative incidence of relapse (RR)
Tidsramme: At 12 months after allogeneic hematopoietic stem cell transplantation.
Relapse is defined as recurrence of CMML . Non-relapse mortality is treated as a competing risk.
At 12 months after allogeneic hematopoietic stem cell transplantation.
One-year non-relapse mortality (NRM)
Tidsramme: At 12 months after allogeneic hematopoietic stem cell transplantation.
Non-relapse mortality is defined as death from any cause other than disease relapse or progression. Relapse is treated as a competing risk.
At 12 months after allogeneic hematopoietic stem cell transplantation.
Regimen toxicity at day +30
Tidsramme: Up to day +30 post-transplant
Toxicity is graded according to NCI CTCAE v5.0. Any grade 3-5 non-hematologic toxicity occurring within 30 days after stem cell infusion is reported.
Up to day +30 post-transplant
Incidence and severity of adverse events (AEs)
Tidsramme: At 12 months after allogeneic hematopoietic stem cell transplantation.
AEs are coded using MedDRA and graded per NCI CTCAE v5.0. All AEs, serious AEs (SAEs), and AEs leading to treatment discontinuation are summarized.
At 12 months after allogeneic hematopoietic stem cell transplantation.
Incidence and severity of acute graft-versus-host disease (aGVHD)
Tidsramme: Up to day +100 post-transplant
Acute GVHD is diagnosed and graded according to the modified Glucksberg criteria or MAGIC criteria. Both overall incidence and grade II-IV/III-IV severity are reported.
Up to day +100 post-transplant
Incidence and severity of chronic graft-versus-host disease (cGVHD)
Tidsramme: From day +100 up to 1 year post-transplant
Chronic GVHD is diagnosed and graded according to the NIH consensus criteria (mild, moderate, severe). Overall incidence and severity distribution are reported.
From day +100 up to 1 year post-transplant

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Peking University People's Hospital

Samarbejdspartnere

Jiangsu Hengrui Pharmaceutical Co., Ltd.

Efterforskere

  • Ledende efterforsker: Yuqian Sun, MD, Peking University People's Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

13. februar 2026

Primær færdiggørelse (Anslået)

1. maj 2028

Studieafslutning (Anslået)

1. maj 2028

Datoer for studieregistrering

Først indsendt

6. maj 2026

Først indsendt, der opfyldte QC-kriterier

6. maj 2026

Først opslået (Faktiske)

15. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2025PHD048-001

Plan for individuelle deltagerdata (IPD)

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IPD-planbeskrivelse

Individual participant data will not be shared with other researchers.

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