Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)Phase 4NCT07101588
Ruxolitinib-Decitabine Intensified Conditioning Regimen for AML: A Randomized Trial
A Phase 4 study testing Ruxolitinib, Decitabine in people with Allogeneic Hematopoietic Stem Cell Transplantation (HSCT), run by Chinese PLA General Hospital at 1 site in China.
Trial summary
This study aims to determine whether the recurrence rate of high-risk acute myeloid leukemia CR1 patients who received allogeneic hematopoietic stem cell transplantation with the Ruxolitinib, Decitabine combined with Bu/Cy or BuF intensive pretreatment regimen is reduced compared with the traditional Bu/Cy or… Read more about this study
- Who is it for?
- Ages 14 to 75 years
- Conditions the study is for
- Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
- What is being tested?
- Ruxolitinib, Decitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 30 Dec 2028
- Phase
- Phase 4
- 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 14 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1) Acute myeloid leukemia with indications for allogeneic hematopoietic stem cell transplantation, CR1 2) Have HLA-matched sibling donors or haploidentical donors or ≥8/10 HLA-matched unrelated donors 3) The patients' ages range from 12 to 64 years old 4) Liver function: ALT and AST≤2.5 times the upper limit of normal values, bilirubin ≤2 times the upper limit of normal values 5) Renal function: Creatinine ≤ the upper limit of the normal value 6) There are no uncontrollable infections or serious mental and psychological disorders 7) Sign the informed consent form.
Who cannot join
- 1. Patients with acute promyelocytic leukemia (M3) 2. One of the donor and recipient is pregnant 3. Suffering from mental illness or other conditions that prevent one from following the plan.
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
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Dai-hong Liu, Dr., daihongrm@163.com
About this study
Official title: Ruxolitinib and Decitabine-Enhanced Conditioning Versus Modified Bu/Cy or BuF Conditioning for the Impact on Relapse of Acute Myeloid Leukemia in First Complete Remission (CR1)After Allogeneic Hematopoietic Stem Cell Transplantation: A Multicenter, Prospective Randomized Controlled Trial
This study aims to determine whether the recurrence rate of high-risk acute myeloid leukemia CR1 patients who received allogeneic hematopoietic stem cell transplantation with the Ruxolitinib, Decitabine combined with Bu/Cy or BuF intensive pretreatment regimen is reduced compared with the traditional Bu/Cy or BuFpretreatment regimen.
Read the detailed description
Allogeneic hematopoietic stem cell transplantation is the only radical treatment for high-risk acute myeloid leukemia (AML), but the traditional Bu/Cy pretreatment regimen is highly toxic and has a high recurrence rate after transplantation (the long-term survival rate is only 10-30%). Although the existing improved regimens such as sequential chemotherapy can reduce the leukemia burden, they lead to prolonged myelosuppression time (17-39 days) and a non-relapse mortality rate as high as 17.2%. There is an urgent need to develop new pretreatment regimens that have both strong anti-leukemia effects and low toxicity.
Studies have found that the JAK-STAT signaling pathway is generally abnormally activated in hematological tumors such as AML. The objective response rate of Ruxolitinib (a JAK1/2 inhibitor) as a monotherapy for relapsed/refractory leukemia reached 45%. When combined with the demethylated drug decitabine, it can synergistically inhibit leukemia cells. Clinical data show that decitabine reduces the recurrence rate after transplantation by 20% (15.0% vs 38.3%), and the combination of the two has good safety. The main adverse reaction is grade 1-2 hematological toxicity.
Our center innovatively proposed the Rux-Dec-mBu/Cy or BuF combined regimen: integrating Ruxolitinib (step-based dose reduction) and decitabine (20mg/m²/d) on the basis of the classic Bu/Cy or BuF. Previous single-arm studies have shown that the one-year recurrence rate of CR1 patients is 0%, and the incidence of toxicity above grade 3 is less than 11%. This study intends to conduct a multicenter randomized controlled trial to verify the superiority of this regimen in reducing recurrence after transplantation in patients with high-risk AML CR1. Its core advantage lies in simultaneously achieving anti-leukemia enhancement (through JAK-STAT targeting and epigenetic regulation) and controllable toxicity (The median grain deficiency time was shortened to 14 days).
- Being tested
- Ruxolitinib, Decitabine
- Keywords
- HSCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ruxolitinib, DecitabineCombination product
- Decitabine: 20 mg/m²/day, administered from Day -15 to Day -10.
- Ruxolitinib:
- 10 mg twice daily (bid), Day -15 to Day -5
- 5 mg twice daily (bid), Day -4 to Day -3
- 5 mg once daily (Qd), Day -2
| Study group | Role | What they receive |
|---|---|---|
| Assigned Interventions | Active comparator | 1. Decitabine: 20 mg/m²/day, administered from Day -15 to Day -10.
2. Ruxolitinib(with Voriconazole):
* 10 mg twice daily (bid), Day -15 to Day -5
* 5 mg twice daily (bid), Day -4 to Day -3
* 5 mg once daily (Qd), Day -2
3. Busulfan (Bu): 0.8 mg/kg every 6 hours (Q6h), Day -8 to Day -6.
4. Carmustine (BCNU): 250 mg every 8 hours (Q8h), Day -3.
5. Cytarabine (Ara-C):
* 4 g/m²/day, Day -10 to Day -9 (for unrelated or haploidentical donors)
* 4 g/m²/day, Day -9 only (for matched sibling donors)
6. Cyclophosphamide (CTX): 50 mg/kg/day, Day -5 to Day -4. or Fludarabine 30mg/m2/day, iv, Day -6 to Day -2;
7. Antithymocyte Globulin (ATG):
* 10 mg/kg/day, Day -5 to Day -2 (for unrelated or haploidentical donors)
* 5 mg/kg/day, Day -5 to Day -2 (for matched sibling donors) Receives: Combination Product: Ruxolitinib, Decitabine |
| The control group | No intervention | 1. Busulfan (Bu): 0.8 mg/kg every 6 hours (Q6h), Day -8 to Day -6. 2. Carmustine (BCNU): 250 mg every 8 hours (Q8h), Day -3. 3. Cytarabine (Ara-C): * 4 g/m²/day, Day -10 to Day -9 (for unrelated or haploidentical donors) * 4 g/m²/day, Day -9 only (for matched sibling donors) 4. Cyclophosphamide (CTX): 50 mg/kg/day, Day -5 to Day -4. or Fludarabine 30mg/m2/day, iv, Day -6 to Day -2; 5. Antithymocyte Globulin (ATG): * 10 mg/kg/day, Day -5 to Day -2 (for unrelated or haploidentical donors) * 5 mg/kg/day, Day -5 to Day -2 (for matched sibling donors) |
What is being measured
The primary outcome is the main question the study is designed to answer.
GRFS
GVHD-free, relapse-free survival (GRFS) was defined as a composite endpoint of death from any cause, disease relapse, grade Ⅲ-Ⅳ acute GVHD, or chronic GVHD requiring systemic immunosuppression therapy.
Measured: 1 year
Secondary outcomes (13)
Cumulative recurrence rate (CIR)
Calculated from the first day after stem cell infusion to the last follow-up, the number of patients with hematological or MRD recurrence/the total number of cases ×100%. The definition of hematological recurrence: After remission, patients present with one of the following three conditions: (1) ≥5% of primary lymphocytes and immature lymphocytes in the bone marrow; (2) Extramedullary leukemia occurs; (3) Leukemia cells were found in peripheral blood smears. The definition of MRD recurrence: Leukemia cells are detected by flow cytometry or molecular biology.
Measured: 1 years after transplantation
Progression-Free Survival（PFS）
The time from the date of transplantation to the recurrence of leukemia or death for any reason.
Measured: 1 years after transplantation
CR rate
The proportion of bone marrow in complete remission from the first day after stem cell infusion to +30 days.
Measured: 30 days after transplantation
The incidence of aGVHD
Calculated from the first day after stem cell infusion, the time from the occurrence of aGVHD, the time of recurrence or death. The actual incidence rate is the number of patients who occur/the total number of cases ×100%.
Measured: 100 days after transplantation
The incidence of cGVHD
Calculated from the first day after stem cell infusion, the time from the occurrence of cGVHD, the time of recurrence or death. The actual incidence rate is the number of patients who occur/the total number of cases ×100%.
Measured: 1 years after transplantation
Disease-free survival rate (DFS)
Disease-free survival rate (DFS) refers to the survival period without evidence of recurrence or progression.
Measured: 1 years after transplantation
Treatment-related safety indicators
Mainly include bacterial infection, viral infection, fungal infection, and PTLD from the time calculated after transplantation to the last follow-up.
Measured: 1 years after transplantation
Non-relapse mortality
Non-relapse mortality (NRM) was defined as death from any cause other than disease relapse.
Measured: 1 year
The cumulative incidence of virus reactivation
The cumulative incidence of virus reactivation by Day +180 days post-transplantation was defined as the proportion of virus reactivation occurring at any monitoring point during days 180 post-transplant.
Measured: Day +180 days post-transplantation
Graft failure
Graft failure was defined as non-engraftment (ie, autologous reconstitution) or graft rejection (ie, secondary loss of donor chimerism) at +28 days
Measured: +28 days after transplantation
Neutrophil engraftment
Neutrophil engraftment was defined as the first of three consecutive days with a neutrophil count >0.5 ×109/L.
Measured: +28 days after transplantation
Platelet engraftment
Platelet engraftment was defined as the first of seven consecutive days with a platelet count >20×109/L without transfusion support.
Measured: +28 days after transplantation
CD4+T cell reconstitution
CD4+T cell reconstitution was defined as CD4+ T cell count ≥ 50/μL in two consecutive measurements within the first 100 days post-transplantation.
Measured: the first 100 days post-transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start1 Jan 2025
- Primary completion1 Jan 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)Studies of the same condition, open and under way.
- More trials run by Chinese PLA General 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Random Group Assignment
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Zhengzhou University, Peking University People's Hospital
- Responsible party
- Principal investigator, Daihong Liu, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07101588
- Sponsor's protocol ID
- S2024-678-01
- Status last verified
- Jul 2025
- First submitted
- 1 Jun 2025
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data contain sensitive personal health information
Publications
Xuan L, Dai M, Jiang E, Wang Y, Huang F, Fan Z, Xu N, Nie D, Liang X, Chen H, Ye J, Shi P, Liu H, Jin H, Lin R, Yan C, Zhang Y, Sun J, Han M, Liu Q. The effect of granulocyte-colony stimulating factor, decitabine, and busulfan-cyclophosphamide versus busulfan-cyclophosphamide conditioning on relapse in patients with myelodysplastic syndrome or secondary acute myeloid leukaemia evolving from myelodysplastic syndrome undergoing allogeneic haematopoietic stem-cell transplantation: an open-label, multicentre, randomised, phase 3 trial. Lancet Haematol. 2023 Mar;10(3):e178-e190. doi: 10.1016/S2352-3026(22)00375-1. Epub 2023 Jan 23.
PubMed 36702138Li Z, Shi W, Lu X, Lu H, Cao X, Tang L, Yan H, Zhong Z, You Y, Xia L, Hu Y, Wang H. Decitabine-Intensified Modified Busulfan/Cyclophosphamide Conditioning Regimen Improves Survival in Acute Myeloid Leukemia Patients Undergoing Related Donor Hematopoietic Stem Cell Transplantation: A Propensity Score Matched Analysis. Front Oncol. 2022 Mar 16;12:844937. doi: 10.3389/fonc.2022.844937. eCollection 2022.
PubMed 35371981Watanabe T. [Drug tolerance in microorganisms, with special reference to genetic study of its transmission]. Nihon Saikingaku Zasshi. 1969 Oct;24(9):418-25. No abstract available. Japanese.
PubMed 4908810Tang X, Valdez BC, Ma Y, Zhang Q, Qu C, Dai H, Yin J, Li Z, Xu T, Xu Y, Chen J, Zhu X, Chen Z, Wu D, Andersson BS. Low-dose decitabine as part of a modified Bu-Cy conditioning regimen improves survival in AML patients with active disease undergoing allogeneic hematopoietic stem cell transplantation. Bone Marrow Transplant. 2021 Jul;56(7):1674-1682. doi: 10.1038/s41409-021-01238-5. Epub 2021 Feb 26.
PubMed 33637882Tsukada T, Fukushima M, Takebe H, Nakai Y. Vasoactive intestinal peptide gene expression in the rat pheochromocytoma cell line PC12. Mol Cell Endocrinol. 1995 Feb;107(2):231-9. doi: 10.1016/0303-7207(94)03448-3.
PubMed 7768335Schmid C, Schleuning M, Schwerdtfeger R, Hertenstein B, Mischak-Weissinger E, Bunjes D, Harsdorf SV, Scheid C, Holtick U, Greinix H, Keil F, Schneider B, Sandherr M, Bug G, Tischer J, Ledderose G, Hallek M, Hiddemann W, Kolb HJ. Long-term survival in refractory acute myeloid leukemia after sequential treatment with chemotherapy and reduced-intensity conditioning for allogeneic stem cell transplantation. Blood. 2006 Aug 1;108(3):1092-9. doi: 10.1182/blood-2005-10-4165. Epub 2006 Mar 21.
PubMed 16551971Pankhurst R. The earliest history of famine and pestilence in Ethiopia and a note on the "Egyptian Deaths" of 17th and 18th century Ethiopia. Ethiop Med J. 1973 Jul;11(3):233-6. No abstract available.
PubMed 4602511Thomas HC, McSween RN, White RG. Role of the liver in controlling the immunogenicity of commensal bacteria in the gut. Lancet. 1973 Jun 9;1(7815):1288-91. doi: 10.1016/s0140-6736(73)91300-7. No abstract available.
PubMed 4126078Camera A, Rinaldi CR, Palmieri S, Cantore N, Mele G, Mettivier V, Miraglia E, Mastrullo L, Grimaldi F, Luciano L, Guerriero A, Rotoli B, Ferrara F. Sequential continuous infusion of fludarabine and cytarabine associated with liposomal daunorubicin (DaunoXome) (FLAD) in primary refractory or relapsed adult acute myeloid leukemia patients. Ann Hematol. 2009 Feb;88(2):151-8. doi: 10.1007/s00277-008-0571-z. Epub 2008 Aug 16.
PubMed 18709502Fiegl M, Unterhalt M, Kern W, Braess J, Spiekermann K, Staib P, Gruneisen A, Wormann B, Schondube D, Serve H, Reichle A, Hentrich M, Schiel X, Sauerland C, Heinecke A, Rieger C, Beelen D, Berdel WE, Buchner T, Hiddemann W; German AML Cooperative Group (AMLCG). Chemomodulation of sequential high-dose cytarabine by fludarabine in relapsed or refractory acute myeloid leukemia: a randomized trial of the AMLCG. Leukemia. 2014 May;28(5):1001-7. doi: 10.1038/leu.2013.297. Epub 2013 Oct 22.
PubMed 24150216
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ruxolitinib and Decitabine-Enhanced Conditioning Versus Modified Bu/Cy or BuF Conditioning for the Impact on Relapse of Acute Myeloid Leukemia in First Complete Remission (CR1)After Allogeneic Hematopoietic Stem Cell Transplantation: A Multicenter, Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07101588
- Acronym / sponsor ID
- S2024-678-01
- Keywords
- HSCT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Zhengzhou University, Peking University People's Hospital
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 3 Aug 2025 (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 study aims to determine whether the recurrence rate of high-risk acute myeloid leukemia CR1 patients who received allogeneic hematopoietic stem cell transplantation with the Ruxolitinib, Decitabine combined with Bu/Cy or BuF intensive pretreatment regimen is reduced compared with the traditional Bu/Cy or BuFpretreatment regimen.
Detailed description
Allogeneic hematopoietic stem cell transplantation is the only radical treatment for high-risk acute myeloid leukemia (AML), but the traditional Bu/Cy pretreatment regimen is highly toxic and has a high recurrence rate after transplantation (the long-term survival rate is only 10-30%). Although the existing improved regimens such as sequential chemotherapy can reduce the leukemia burden, they lead to prolonged myelosuppression time (17-39 days) and a non-relapse mortality rate as high as 17.2%. There is an urgent need to develop new pretreatment regimens that have both strong anti-leukemia effects and low toxicity.
Studies have found that the JAK-STAT signaling pathway is generally abnormally activated in hematological tumors such as AML. The objective response rate of Ruxolitinib (a JAK1/2 inhibitor) as a monotherapy for relapsed/refractory leukemia reached 45%. When combined with the demethylated drug decitabine, it can synergistically inhibit leukemia cells. Clinical data show that decitabine reduces the recurrence rate after transplantation by 20% (15.0% vs 38.3%), and the combination of the two has good safety. The main adverse reaction is grade 1-2 hematological toxicity.
Our center innovatively proposed the Rux-Dec-mBu/Cy or BuF combined regimen: integrating Ruxolitinib (step-based dose reduction) and decitabine (20mg/m²/d) on the basis of the classic Bu/Cy or BuF. Previous single-arm studies have shown that the one-year recurrence rate of CR1 patients is 0%, and the incidence of toxicity above grade 3 is less than 11%. This study intends to conduct a multicenter randomized controlled trial to verify the superiority of this regimen in reducing recurrence after transplantation in patients with high-risk AML CR1. Its core advantage lies in simultaneously achieving anti-leukemia enhancement (through JAK-STAT targeting and epigenetic regulation) and controllable toxicity (The median grain deficiency time was shortened to 14 days).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Random Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Assigned Interventions | Active comparator | Combination Product: Ruxolitinib, Decitabine1. Decitabine: 20 mg/m²/day, administered from Day -15 to Day -10. 2. Ruxolitinib(with Voriconazole): * 10 mg twice daily (bid), Day -15 to Day -5 * 5 mg twice daily (bid), Day -4 to Day -3 * 5 mg once daily (Qd), Day -2 3. Busulfan (Bu): 0.8 mg/kg every 6 hours (Q6h), Day -8 to Day -6. 4. Carmustine (BCNU): 250 mg every 8 hours (Q8h), Day -3. 5. Cytarabine (Ara-C): * 4 g/m²/day, Day -10 to Day -9 (for unrelated or haploidentical donors) * 4 g/m²/day, Day -9 only (for matched sibling donors) 6. Cyclophosphamide (CTX): 50 mg/kg/day, Day -5 to Day -4. or Fludarabine 30mg/m2/day, iv, Day -6 to Day -2; 7. Antithymocyte Globulin (ATG): * 10 mg/kg/day, Day -5 to Day -2 (for unrelated or haploidentical donors) * 5 mg/kg/day, Day -5 to Day -2 (for matched sibling donors) |
| The control group | No intervention | –1. Busulfan (Bu): 0.8 mg/kg every 6 hours (Q6h), Day -8 to Day -6. 2. Carmustine (BCNU): 250 mg every 8 hours (Q8h), Day -3. 3. Cytarabine (Ara-C): * 4 g/m²/day, Day -10 to Day -9 (for unrelated or haploidentical donors) * 4 g/m²/day, Day -9 only (for matched sibling donors) 4. Cyclophosphamide (CTX): 50 mg/kg/day, Day -5 to Day -4. or Fludarabine 30mg/m2/day, iv, Day -6 to Day -2; 5. Antithymocyte Globulin (ATG): * 10 mg/kg/day, Day -5 to Day -2 (for unrelated or haploidentical donors) * 5 mg/kg/day, Day -5 to Day -2 (for matched sibling donors) |
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 1) Acute myeloid leukemia with indications for allogeneic hematopoietic stem cell transplantation, CR1 2) Have HLA-matched sibling donors or haploidentical donors or ≥8/10 HLA-matched unrelated donors 3) The patients' ages range from 12 to 64 years old 4) Liver function: ALT and AST≤2.5 times the upper limit of normal values, bilirubin ≤2 times the upper limit of normal values 5) Renal function: Creatinine ≤ the upper limit of the normal value 6) There are no uncontrollable infections or serious mental and psychological disorders 7) Sign the informed consent form.
Key exclusion criteria (1 listed)
- 1. Patients with acute promyelocytic leukemia (M3) 2. One of the donor and recipient is pregnant 3. Suffering from mental illness or other conditions that prevent one from following the plan.
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 |
|---|---|---|
| Ruxolitinib, Decitabine1. Decitabine: 20 mg/m²/day, administered from Day -15 to Day -10. 2. Ruxolitinib: * 10 mg twice daily (bid), Day -15 to Day -5 * 5 mg twice daily (bid), Day -4 to Day -3 * 5 mg once daily (Qd), Day -2 | Combination product | Assigned Interventions |
Primary outcome
GRFS
Time frame: 1 year
GVHD-free, relapse-free survival (GRFS) was defined as a composite endpoint of death from any cause, disease relapse, grade Ⅲ-Ⅳ acute GVHD, or chronic GVHD requiring systemic immunosuppression therapy.
13 secondary outcomes
Cumulative recurrence rate (CIR)
Time frame: 1 years after transplantation
Progression-Free Survival（PFS）
Time frame: 1 years after transplantation
CR rate
Time frame: 30 days after transplantation
The incidence of aGVHD
Time frame: 100 days after transplantation
The incidence of cGVHD
Time frame: 1 years after transplantation
Disease-free survival rate (DFS)
Time frame: 1 years after transplantation
Treatment-related safety indicators
Time frame: 1 years after transplantation
Non-relapse mortality
Time frame: 1 year
The cumulative incidence of virus reactivation
Time frame: Day +180 days post-transplantation
Graft failure
Time frame: +28 days after transplantation
Neutrophil engraftment
Time frame: +28 days after transplantation
Platelet engraftment
Time frame: +28 days after transplantation
CD4+T cell reconstitution
Time frame: the first 100 days post-transplantation
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 20 Mar 2026.
- Background: PubMed 36702138Xuan L, Dai M, Jiang E, Wang Y, Huang F, Fan Z, Xu N, Nie D, Liang X, Chen H, Ye J, Shi P, Liu H, Jin H, Lin R, Yan C, Zhang Y, Sun J, Han M, Liu Q. The effect of granulocyte-colony stimulating factor, decitabine, and busulfan-cyclophosphamide versus busulfan-cyclophosphamide conditioning on relapse in patients with myelodysplastic syndrome or secondary acute myeloid leukaemia evolving from myelodysplastic syndrome undergoing allogeneic haematopoietic stem-cell transplantation: an open-label, multicentre, randomised, phase 3 trial. Lancet Haematol. 2023 Mar;10(3):e178-e190. doi: 10.1016/S2352-3026(22)00375-1. Epub 2023 Jan 23.
- Background: PubMed 35371981Li Z, Shi W, Lu X, Lu H, Cao X, Tang L, Yan H, Zhong Z, You Y, Xia L, Hu Y, Wang H. Decitabine-Intensified Modified Busulfan/Cyclophosphamide Conditioning Regimen Improves Survival in Acute Myeloid Leukemia Patients Undergoing Related Donor Hematopoietic Stem Cell Transplantation: A Propensity Score Matched Analysis. Front Oncol. 2022 Mar 16;12:844937. doi: 10.3389/fonc.2022.844937. eCollection 2022.
- Background: PubMed 4908810Watanabe T. [Drug tolerance in microorganisms, with special reference to genetic study of its transmission]. Nihon Saikingaku Zasshi. 1969 Oct;24(9):418-25. No abstract available. Japanese.
- Background: PubMed 33637882Tang X, Valdez BC, Ma Y, Zhang Q, Qu C, Dai H, Yin J, Li Z, Xu T, Xu Y, Chen J, Zhu X, Chen Z, Wu D, Andersson BS. Low-dose decitabine as part of a modified Bu-Cy conditioning regimen improves survival in AML patients with active disease undergoing allogeneic hematopoietic stem cell transplantation. Bone Marrow Transplant. 2021 Jul;56(7):1674-1682. doi: 10.1038/s41409-021-01238-5. Epub 2021 Feb 26.
- Background: PubMed 7768335Tsukada T, Fukushima M, Takebe H, Nakai Y. Vasoactive intestinal peptide gene expression in the rat pheochromocytoma cell line PC12. Mol Cell Endocrinol. 1995 Feb;107(2):231-9. doi: 10.1016/0303-7207(94)03448-3.
- Background: PubMed 16551971Schmid C, Schleuning M, Schwerdtfeger R, Hertenstein B, Mischak-Weissinger E, Bunjes D, Harsdorf SV, Scheid C, Holtick U, Greinix H, Keil F, Schneider B, Sandherr M, Bug G, Tischer J, Ledderose G, Hallek M, Hiddemann W, Kolb HJ. Long-term survival in refractory acute myeloid leukemia after sequential treatment with chemotherapy and reduced-intensity conditioning for allogeneic stem cell transplantation. Blood. 2006 Aug 1;108(3):1092-9. doi: 10.1182/blood-2005-10-4165. Epub 2006 Mar 21.
- Background: PubMed 4602511Pankhurst R. The earliest history of famine and pestilence in Ethiopia and a note on the "Egyptian Deaths" of 17th and 18th century Ethiopia. Ethiop Med J. 1973 Jul;11(3):233-6. No abstract available.
- Background: PubMed 4126078Thomas HC, McSween RN, White RG. Role of the liver in controlling the immunogenicity of commensal bacteria in the gut. Lancet. 1973 Jun 9;1(7815):1288-91. doi: 10.1016/s0140-6736(73)91300-7. No abstract available.
- Background: PubMed 18709502Camera A, Rinaldi CR, Palmieri S, Cantore N, Mele G, Mettivier V, Miraglia E, Mastrullo L, Grimaldi F, Luciano L, Guerriero A, Rotoli B, Ferrara F. Sequential continuous infusion of fludarabine and cytarabine associated with liposomal daunorubicin (DaunoXome) (FLAD) in primary refractory or relapsed adult acute myeloid leukemia patients. Ann Hematol. 2009 Feb;88(2):151-8. doi: 10.1007/s00277-008-0571-z. Epub 2008 Aug 16.
- Background: PubMed 24150216Fiegl M, Unterhalt M, Kern W, Braess J, Spiekermann K, Staib P, Gruneisen A, Wormann B, Schondube D, Serve H, Reichle A, Hentrich M, Schiel X, Sauerland C, Heinecke A, Rieger C, Beelen D, Berdel WE, Buchner T, Hiddemann W; German AML Cooperative Group (AMLCG). Chemomodulation of sequential high-dose cytarabine by fludarabine in relapsed or refractory acute myeloid leukemia: a randomized trial of the AMLCG. Leukemia. 2014 May;28(5):1001-7. doi: 10.1038/leu.2013.297. Epub 2013 Oct 22.
- Individual participant dataSharing planned: No. Data contain sensitive personal health information
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Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingObservational study
Natural History Study to Determine Drug Metabolism Phenotype and Appropriate Germline Source DNA in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant
Leukemia, Lymphoma
Enrolling by invitationPhase 2
Thiotepa + TBI + Fludarabine + Etoposide for Allo-HSCT in Patients With R/R or High-risk Acute Leukemia
Acute Leukemia, High Risk, Acute Leukemia Refractory
RecruitingPhase 1/2
Phase I/II Study of Pacritinib, A JAK2/IRAK1/CSF1R Inhibitor, in Refractory Chronic Graft-Versus-Host Disease (cGVHD) After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Graft vs Host Disease
RecruitingPhase 2
Romiplostim for Platelet Engraftment After Haploidentical or Matched Unrelated Donor Allogeneic Hematopoietic Stem Cell Transplantation
Hematologic Diseases
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ruxolitinib, Decitabine in people with Allogeneic Hematopoietic Stem Cell Transplantation (HSCT), run by Chinese PLA General 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 1 inclusion and 1 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 20 Mar 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Li-ping Dou, Dr. (86-10-66937079, lipingruirui@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GRFS (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07101588, which also lists 10 linked publications.
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 20 Mar 2026.