Chronic Myelomonocytic Leukemia (CMML)NCT07588594
Thiotepa-Containing Conditioning Regimen for Allogeneic HSCT in Chronic Myelomonocytic Leukemia
A study testing TBF regimen in people with Chronic Myelomonocytic Leukemia (CMML), run by Peking University People's Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myelomonocytic Leukemia (CMML)
- What is being tested?
- TBF regimen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- 13 Feb 2026to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, 100044
Yuqian Sun, MD, +86 010-88326666, sunyuqian83@hotmail.com
About this study
Official title: 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.
- Conditions
- Chronic Myelomonocytic Leukemia (CMML)
- Being tested
- TBF regimen
- Keywords
- Chronic Myelomonocytic Leukemia (CMML), Hematopoietic Stem Cell Transplantation (HSCT), Thiotepa
- Medical subject headings
- Leukemia, Myelomonocytic, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TBF regimenDrug
Also called TBF (Thiotepa, Busulfan, Fludarabine) ± ATG
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.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm: Thiotepa + Busulfan + Fludarabine ± ATG | Experimental | 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. Receives: Drug: TBF regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
One-year relapse-free survival (RFS) 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.
Measured: At 12 months after allogeneic hematopoietic stem cell transplantation.
Secondary outcomes (7)
One-year overall survival (OS)
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.
Measured: At 12 months after allogeneic hematopoietic stem cell transplantation.
One-year cumulative incidence of relapse (RR)
Relapse is defined as recurrence of CMML . Non-relapse mortality is treated as a competing risk.
Measured: At 12 months after allogeneic hematopoietic stem cell transplantation.
One-year non-relapse mortality (NRM)
Non-relapse mortality is defined as death from any cause other than disease relapse or progression. Relapse is treated as a competing risk.
Measured: At 12 months after allogeneic hematopoietic stem cell transplantation.
Regimen toxicity at day +30
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.
Measured: Up to day +30 post-transplant
Incidence and severity of adverse events (AEs)
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.
Measured: At 12 months after allogeneic hematopoietic stem cell transplantation.
Incidence and severity of acute graft-versus-host disease (aGVHD)
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.
Measured: Up to day +100 post-transplant
Incidence and severity of chronic graft-versus-host disease (cGVHD)
Chronic GVHD is diagnosed and graded according to the NIH consensus criteria (mild, moderate, severe). Overall incidence and severity distribution are reported.
Measured: From day +100 up to 1 year post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start13 Feb 2026
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myelomonocytic Leukemia (CMML)Studies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sun Yuqian, Peking University People's Hospital
- Investigators
- Yuqian Sun, MD, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07588594
- Sponsor's protocol ID
- 2025PHD048-001
- Status last verified
- Sep 2026
- First submitted
- 6 May 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Single-Arm Clinical Study of Thiotepa-Containing Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation in Chronic Myelomonocytic Leukemia
- ClinicalTrials.gov ID
- NCT07588594
- Acronym / sponsor ID
- 2025PHD048-001
- Conditions
- Chronic Myelomonocytic Leukemia (CMML)
- Keywords
- Chronic Myelomonocytic Leukemia (CMML), Hematopoietic Stem Cell Transplantation (HSCT), Thiotepa
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 13 Feb 2026 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm: Thiotepa + Busulfan + Fludarabine ± ATG | Experimental | Drug: TBF regimenPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TBF regimenAlso: TBF (Thiotepa, Busulfan, Fludarabine) ± ATGIntravenous 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. | Drug | Single Arm: Thiotepa + Busulfan + Fludarabine ± ATG |
Primary outcome
One-year relapse-free survival (RFS) after allogeneic hematopoietic stem cell transplantation
Time frame: 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.
7 secondary outcomes
One-year overall survival (OS)
Time frame: At 12 months after allogeneic hematopoietic stem cell transplantation.
One-year cumulative incidence of relapse (RR)
Time frame: At 12 months after allogeneic hematopoietic stem cell transplantation.
One-year non-relapse mortality (NRM)
Time frame: At 12 months after allogeneic hematopoietic stem cell transplantation.
Regimen toxicity at day +30
Time frame: Up to day +30 post-transplant
Incidence and severity of adverse events (AEs)
Time frame: At 12 months after allogeneic hematopoietic stem cell transplantation.
Incidence and severity of acute graft-versus-host disease (aGVHD)
Time frame: Up to day +100 post-transplant
Incidence and severity of chronic graft-versus-host disease (cGVHD)
Time frame: From day +100 up to 1 year post-transplant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yuqian Sun, MD principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TBF regimen in people with Chronic Myelomonocytic Leukemia (CMML), run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuqian Sun, MD (+86 88326666, sunyuqian83@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One-year relapse-free survival (RFS) after allogeneic hematopoietic stem cell transplantation (time frame: At 12 months after allogeneic hematopoietic stem cell transplantation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.