Poor Graft FunctionPhase 3NCT05907499

Decitabine for Poor Graft Function Post Allo-HSCT

A Phase 3 study testing Decitabine, Granulocyte Colony-Stimulating Factor and Thrombopoietin Receptor Agonist in people with Poor Graft Function, run by The First Affiliated Hospital of Soochow University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This randomized trial aims at validating the efficacy and safety of low-dose decitabine for PGF post allo-HSCT. Read more about this study

Who is it for?: Ages 16 to 70 years
Conditions the study is for: Poor Graft Function
What is being tested?: Decitabine, Granulocyte Colony-Stimulating Factor and Thrombopoietin Receptor Agonist
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 76 participants
Where: 1 siteChina
Study dates: 1 Jul 2023to 1 Jan 2026
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 16 to 70 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Diagnosed as PGF at day 28 post-HSCT or later. PGF was defined as two or three cytopenias, absolute neutrophil count ≤ 1.5 × 109/L, platelet count ≤ 30 × 109/L, hemoglobin ≤ 85g/L, lasting for more than 2 consecutive weeks;
Full donor chimerism;
Primary disease in remission;
No severe GVHD and relapse;
ECOG: 0-2;
Expected survival longer than 1 month

Who cannot join

Allergic to decitabine;
Active infections;
Uncontrolled GVHD;
Severe organ dysfunction;
Relapse of underlying malignancies;
Graft failure;
Received decitabine or participated in other clinical trials within one month before screening.

Trial locations and contacts

1 site in 1 country.

China1 site

The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000

Other trials in China

About this study

Official title: Low Dose Decitabine for Poor Graft Function Post Allogenic Hematopoietic Stem Cell Transplantation

This randomized trial aims at validating the efficacy and safety of low-dose decitabine for PGF post allo-HSCT.

Read the detailed description

Poor graft function (PGF), defined by the presence of multilineage cytopenias in the presence of 100% donor chimerism, is a serious complication of allogeneic stem cell transplant (allo-HSCT). Emerging evidence demonstrates that the inadequate stem cells infusion, bone marrow microenvironment and immune dysregulation play a crucial role in maintaining and regulating hematopoiesis. Current therapies remain debatable, including selected CD34+ cells infusion, mesenchymal stromal cells infusion, prophylactic N-acetyl cysteine administration, etc. Thereafter, the investigators conduct a randomized trial aiming at validating the efficacy and safety of low-dose decitabine in PGF post allo-HSCT patients.

Conditions: Poor Graft Function
Being tested: Decitabine, Granulocyte Colony-Stimulating Factor, Thrombopoietin Receptor Agonist, Recombinant human erythropoietin
Keywords: poor graft function, hematopoietic stem cell transplantation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DecitabineDrug
Also called Dec
Decitabine 6 mg/m2 daily subcutaneously for consecutive 3 days (day 1 to day 3)
Granulocyte Colony-Stimulating FactorDrug
Also called G-CSF
5ug/kg/d when absolute neutrophil count ≤ 1.5 × 109/L
Thrombopoietin Receptor AgonistDrug
Also called Eltrombopag / Avatrombopag
Eltrombopag initial dose: 25 mg orally once a day, may increase to up to 75 mg/day, when platelet count ≤ 30 × 109/L; Avatrombopag initial dose: 20 mg orally once a day, may increase to up to 60 mg/day, when platelet count ≤ 30 × 109/L.
Recombinant human erythropoietinDrug
Also called EPO
10000 U/day when hemoglobin ≤ 85 g/L

Study groups in NCT05907499
Study group	Role	What they receive
Decitabine	Experimental	Decitabine 6 mg/m2 daily subcutaneously for consecutive 3 days (day 1 to day 3) Receives: Drug: Decitabine; Drug: Granulocyte Colony-Stimulating Factor; Drug: Thrombopoietin Receptor Agonist; Drug: Recombinant human erythropoietin
Conventional treatment	Active comparator	The hematologic growth factors (granulocyte-colony stimulating factor, thrombopoietin receptor agonists, recombinant human erythropoietin) Receives: Drug: Granulocyte Colony-Stimulating Factor; Drug: Thrombopoietin Receptor Agonist; Drug: Recombinant human erythropoietin

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Achieving Treatment Response (Hematological Response + Hematological Improvement)
Hematological response (HR) was defined as recovery in all cell lineages (neutrophils ≥ 1.5 x 109/L, platelets ≥ 30 x 109/L and hemoglobin ≥ 85 g/L) without the need for transfusion or growth factor support for consecutive 7 days. Hematological improvement (HI) was defined as recovery of at least 1 lineage. No response (NR) refers to those who failed to reach HR or HI.
Measured: day +28
Overall Survival Rate
Overall survival was calculated from time of random assignment to death from any cause
Measured: 1 year

Secondary outcomes (4)

Number of Participants With Bone Marrow Recovery
Bone marrow recovery was assessed using quantitative morphometric analysis to determine marrow cellularity, the myeloid-to-erythroid ratio, and megakaryocyte counts.
Measured: day +28
Number of Participants With Relapse
Relapse was defined according to the European LeukemiaNet (ELN) guidelines
Measured: 3-month
Event Free Survival Rate
EFS referred to time from random assignment to disease progression /relapse, severe bleeding events, severe infections or death from any cause.
Measured: 1 year
Number of Participants With GVHD
Diagnosis and grading of GVHD was performed according to NCCN Clinical Practice Guidelines, 2020
Measured: 3-month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 20231 Jan 2026

First posted18 Jun 2023
Study start1 Jul 2023
Primary completion1 Jan 2026
Study completion1 Jan 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Poor Graft FunctionStudies of the same condition, open and under way.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 76 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05907499
Sponsor's protocol ID: SOOCHOW-HY-2023-06-06
Status last verified: Apr 2026
First submitted: 8 Jun 2023
Last updated: 23 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: A lot of work

Publications

Alchalby H, Yunus DR, Zabelina T, Ayuk F, Kroger N. Incidence and risk factors of poor graft function after allogeneic stem cell transplantation for myelofibrosis. Bone Marrow Transplant. 2016 Sep;51(9):1223-7. doi: 10.1038/bmt.2016.98. Epub 2016 Apr 18.
PubMed 27088376
Larocca A, Piaggio G, Podesta M, Pitto A, Bruno B, Di Grazia C, Gualandi F, Occhini D, Raiola AM, Dominietto A, Bregante S, Lamparelli T, Tedone E, Oneto R, Frassoni F, Van Lint MT, Pogliani E, Bacigalupo A. Boost of CD34+-selected peripheral blood cells without further conditioning in patients with poor graft function following allogeneic stem cell transplantation. Haematologica. 2006 Jul;91(7):935-40.
PubMed 16818281
Prabahran A, Koldej R, Chee L, Ritchie D. Clinical features, pathophysiology, and therapy of poor graft function post-allogeneic stem cell transplantation. Blood Adv. 2022 Mar 22;6(6):1947-1959. doi: 10.1182/bloodadvances.2021004537.
PubMed 34492685
Ghobadi A, Fiala MA, Ramsingh G, Gao F, Abboud CN, Stockerl-Goldstein K, Uy GL, Grossman BJ, Westervelt P, DiPersio JF. Fresh or Cryopreserved CD34+-Selected Mobilized Peripheral Blood Stem and Progenitor Cells for the Treatment of Poor Graft Function after Allogeneic Hematopoietic Cell Transplantation. Biol Blood Marrow Transplant. 2017 Jul;23(7):1072-1077. doi: 10.1016/j.bbmt.2017.03.019. Epub 2017 Mar 18.
PubMed 28323004
Lubbert M, Suciu S, Baila L, Ruter BH, Platzbecker U, Giagounidis A, Selleslag D, Labar B, Germing U, Salih HR, Beeldens F, Muus P, Pfluger KH, Coens C, Hagemeijer A, Eckart Schaefer H, Ganser A, Aul C, de Witte T, Wijermans PW. Low-dose decitabine versus best supportive care in elderly patients with intermediate- or high-risk myelodysplastic syndrome (MDS) ineligible for intensive chemotherapy: final results of the randomized phase III study of the European Organisation for Research and Treatment of Cancer Leukemia Group and the German MDS Study Group. J Clin Oncol. 2011 May 20;29(15):1987-96. doi: 10.1200/JCO.2010.30.9245. Epub 2011 Apr 11.
PubMed 21483003
Han P, Yu T, Hou Y, Zhao Y, Liu Y, Sun Y, Wang H, Xu P, Li G, Sun T, Hu X, Liu X, Li L, Peng J, Zhou H, Hou M. Low-Dose Decitabine Inhibits Cytotoxic T Lymphocytes-Mediated Platelet Destruction via Modulating PD-1 Methylation in Immune Thrombocytopenia. Front Immunol. 2021 Feb 17;12:630693. doi: 10.3389/fimmu.2021.630693. eCollection 2021.
PubMed 33679776
Han P, Hou Y, Zhao Y, Liu Y, Yu T, Sun Y, Wang H, Xu P, Li G, Sun T, Hu X, Liu X, Li L, Peng J, Zhou H, Hou M. Low-dose decitabine modulates T-cell homeostasis and restores immune tolerance in immune thrombocytopenia. Blood. 2021 Aug 26;138(8):674-688. doi: 10.1182/blood.2020008477.
PubMed 33876188
Zambuzi FA, Cardoso-Silva PM, Castro RC, Fontanari C, Emery FDS, Frantz FG. Decitabine Promotes Modulation in Phenotype and Function of Monocytes and Macrophages That Drive Immune Response Regulation. Cells. 2021 Apr 12;10(4):868. doi: 10.3390/cells10040868.
PubMed 33921194
Kopp LM, Ray A, Denman CJ, Senyukov VS, Somanchi SS, Zhu S, Lee DA. Decitabine has a biphasic effect on natural killer cell viability, phenotype, and function under proliferative conditions. Mol Immunol. 2013 Jul;54(3-4):296-301. doi: 10.1016/j.molimm.2012.12.012. Epub 2013 Jan 16.
PubMed 23328088
Tang Y, Chen J, Liu Q, Chu T, Pan T, Liang J, He XF, Chen F, Yang T, Ma X, Wu X, Hu S, Cao X, Hu X, Hu J, Liu Y, Qi J, Shen Y, Ruan C, Han Y, Wu D. Low-dose decitabine for refractory prolonged isolated thrombocytopenia after HCT: a randomized multicenter trial. Blood Adv. 2021 Mar 9;5(5):1250-1258. doi: 10.1182/bloodadvances.2020002790.
PubMed 33646303
Han Y, Tang Y, Chen J, Liang J, Ye C, Ruan C, Wu D. Low-Dose Decitabine for Patients With Thrombocytopenia Following Allogeneic Hematopoietic Stem Cell Transplantation: A Pilot Therapeutic Study. JAMA Oncol. 2015 May;1(2):249-51. doi: 10.1001/jamaoncol.2014.316. No abstract available.
PubMed 26181032
DeSimone J, Koshy M, Dorn L, Lavelle D, Bressler L, Molokie R, Talischy N. Maintenance of elevated fetal hemoglobin levels by decitabine during dose interval treatment of sickle cell anemia. Blood. 2002 Jun 1;99(11):3905-8. doi: 10.1182/blood.v99.11.3905.
PubMed 12010787

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1/2
Anakinra for Prevention of Poor Graft Function in MDS Allo-HSCT
Poor Graft Function, Myelodysplastic Syndromes
Recruiting
CD34+ Selected Stem Cell for Poor Graft Function or Graft Failure
Graft Failure, Poor Graft Function
Recruiting
Compassionate Access of the Miltenyi Device for CD34+ Cell Selection
Blood And Marrow Transplantation
RecruitingPhase 1
The Safety and Efficacy of Umbilical Cord Blood Mononuclear Cells in Patients With Secondary Poor Graft Function After Hematopoietic Stem Cell Transplantation
Poor Graft Function
Not yet recruitingPhase 1/2
REscuing Bone Marrow Function in Patients with AplaStic AnaEmia and Bone Marrow FaiLure Post AllogEneiC Transplantation 2
Poor Graft Function, Aplastic Anemia Idiopathic

All Poor Graft Function trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Low Dose Decitabine for Poor Graft Function Post Allogenic Hematopoietic Stem Cell Transplantation
ClinicalTrials.gov ID: NCT05907499
Acronym / sponsor ID: SOOCHOW-HY-2023-06-06
Conditions: Poor Graft Function
Keywords: poor graft function, hematopoietic stem cell transplantation
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 76 participants (actual)
Lead sponsor: The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
Study start: 1 Jul 2023 (actual)
Primary completion: 1 Jan 2026 (actual)
Study completion: 1 Jan 2026 (actual)
First posted: 18 Jun 2023 (actual)
Results: Posted 23 Oct 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This randomized trial aims at validating the efficacy and safety of low-dose decitabine for PGF post allo-HSCT.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Decitabine	Experimental	Drug: Decitabine, Drug: Granulocyte Colony-Stimulating Factor, Drug: Thrombopoietin Receptor Agonist, Drug: Recombinant human erythropoietinDecitabine 6 mg/m2 daily subcutaneously for consecutive 3 days (day 1 to day 3)
Conventional treatment	Active comparator	Drug: Granulocyte Colony-Stimulating Factor, Drug: Thrombopoietin Receptor Agonist, Drug: Recombinant human erythropoietinThe hematologic growth factors (granulocyte-colony stimulating factor, thrombopoietin receptor agonists, recombinant human erythropoietin)

Who may qualify

Ages: 16 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

Diagnosed as PGF at day 28 post-HSCT or later. PGF was defined as two or three cytopenias, absolute neutrophil count ≤ 1.5 × 109/L, platelet count ≤ 30 × 109/L, hemoglobin ≤ 85g/L, lasting for more than 2 consecutive weeks;
Full donor chimerism;
Primary disease in remission;
No severe GVHD and relapse;
ECOG: 0-2;

Key exclusion criteria (7 listed)

Allergic to decitabine;
Active infections;
Uncontrolled GVHD;
Severe organ dysfunction;
Relapse of underlying malignancies;

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
DecitabineAlso: DecDecitabine 6 mg/m2 daily subcutaneously for consecutive 3 days (day 1 to day 3)	Drug	Decitabine
Granulocyte Colony-Stimulating FactorAlso: G-CSF5ug/kg/d when absolute neutrophil count ≤ 1.5 × 109/L	Drug	Conventional treatment, Decitabine
Thrombopoietin Receptor AgonistAlso: Eltrombopag / AvatrombopagEltrombopag initial dose: 25 mg orally once a day, may increase to up to 75 mg/day, when platelet count ≤ 30 × 109/L; Avatrombopag initial dose: 20 mg orally once a day, may increase to up to 60 mg/day, when platelet count ≤ 30 × 109/L.	Drug	Conventional treatment, Decitabine
Recombinant human erythropoietinAlso: EPO10000 U/day when hemoglobin ≤ 85 g/L	Drug	Conventional treatment, Decitabine

Primary outcome

Number of Participants Achieving Treatment Response (Hematological Response + Hematological Improvement)
Time frame: day +28
Hematological response (HR) was defined as recovery in all cell lineages (neutrophils ≥ 1.5 x 109/L, platelets ≥ 30 x 109/L and hemoglobin ≥ 85 g/L) without the need for transfusion or growth factor support for consecutive 7 days. Hematological improvement (HI) was defined as recovery of at least 1 lineage. No response (NR) refers to those who failed to reach HR or HI.
Overall Survival Rate
Time frame: 1 year
Overall survival was calculated from time of random assignment to death from any cause

4 secondary outcomes

Number of Participants With Bone Marrow Recovery
Time frame: day +28
Number of Participants With Relapse
Time frame: 3-month
Event Free Survival Rate
Time frame: 1 year
Number of Participants With GVHD
Time frame: 3-month

Results and safety

Results posted to the registry on 23 Oct 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Decitabine	51	51
Conventional Treatment	25	25

Primary outcome: Number of Participants Achieving Treatment Response (Hematological Response + Hematological Improvement)

Time frame: day +28. Count of participants. Unit: Participants

Measure	Decitabine n = 51	Conventional Treatment n = 25
Value	38	9

Primary outcome: Overall Survival Rate

Time frame: 1 year. Number. Unit: percentage

Measure	Decitabine n = 51	Conventional Treatment n = 25
Value	83.7	61.9

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4-week study period. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Decitabine	0 of 51 (0%)	28 of 51 (54.9%)	7 of 51
Conventional Treatment	1 of 25 (4%)	16 of 25 (64%)	9 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 27088376Alchalby H, Yunus DR, Zabelina T, Ayuk F, Kroger N. Incidence and risk factors of poor graft function after allogeneic stem cell transplantation for myelofibrosis. Bone Marrow Transplant. 2016 Sep;51(9):1223-7. doi: 10.1038/bmt.2016.98. Epub 2016 Apr 18.
Background: PubMed 16818281Larocca A, Piaggio G, Podesta M, Pitto A, Bruno B, Di Grazia C, Gualandi F, Occhini D, Raiola AM, Dominietto A, Bregante S, Lamparelli T, Tedone E, Oneto R, Frassoni F, Van Lint MT, Pogliani E, Bacigalupo A. Boost of CD34+-selected peripheral blood cells without further conditioning in patients with poor graft function following allogeneic stem cell transplantation. Haematologica. 2006 Jul;91(7):935-40.
Background: PubMed 34492685Prabahran A, Koldej R, Chee L, Ritchie D. Clinical features, pathophysiology, and therapy of poor graft function post-allogeneic stem cell transplantation. Blood Adv. 2022 Mar 22;6(6):1947-1959. doi: 10.1182/bloodadvances.2021004537.
Background: PubMed 28323004Ghobadi A, Fiala MA, Ramsingh G, Gao F, Abboud CN, Stockerl-Goldstein K, Uy GL, Grossman BJ, Westervelt P, DiPersio JF. Fresh or Cryopreserved CD34+-Selected Mobilized Peripheral Blood Stem and Progenitor Cells for the Treatment of Poor Graft Function after Allogeneic Hematopoietic Cell Transplantation. Biol Blood Marrow Transplant. 2017 Jul;23(7):1072-1077. doi: 10.1016/j.bbmt.2017.03.019. Epub 2017 Mar 18.
Background: PubMed 21483003Lubbert M, Suciu S, Baila L, Ruter BH, Platzbecker U, Giagounidis A, Selleslag D, Labar B, Germing U, Salih HR, Beeldens F, Muus P, Pfluger KH, Coens C, Hagemeijer A, Eckart Schaefer H, Ganser A, Aul C, de Witte T, Wijermans PW. Low-dose decitabine versus best supportive care in elderly patients with intermediate- or high-risk myelodysplastic syndrome (MDS) ineligible for intensive chemotherapy: final results of the randomized phase III study of the European Organisation for Research and Treatment of Cancer Leukemia Group and the German MDS Study Group. J Clin Oncol. 2011 May 20;29(15):1987-96. doi: 10.1200/JCO.2010.30.9245. Epub 2011 Apr 11.
Background: PubMed 33679776Han P, Yu T, Hou Y, Zhao Y, Liu Y, Sun Y, Wang H, Xu P, Li G, Sun T, Hu X, Liu X, Li L, Peng J, Zhou H, Hou M. Low-Dose Decitabine Inhibits Cytotoxic T Lymphocytes-Mediated Platelet Destruction via Modulating PD-1 Methylation in Immune Thrombocytopenia. Front Immunol. 2021 Feb 17;12:630693. doi: 10.3389/fimmu.2021.630693. eCollection 2021.
Background: PubMed 33876188Han P, Hou Y, Zhao Y, Liu Y, Yu T, Sun Y, Wang H, Xu P, Li G, Sun T, Hu X, Liu X, Li L, Peng J, Zhou H, Hou M. Low-dose decitabine modulates T-cell homeostasis and restores immune tolerance in immune thrombocytopenia. Blood. 2021 Aug 26;138(8):674-688. doi: 10.1182/blood.2020008477.
Background: PubMed 33921194Zambuzi FA, Cardoso-Silva PM, Castro RC, Fontanari C, Emery FDS, Frantz FG. Decitabine Promotes Modulation in Phenotype and Function of Monocytes and Macrophages That Drive Immune Response Regulation. Cells. 2021 Apr 12;10(4):868. doi: 10.3390/cells10040868.
Background: PubMed 23328088Kopp LM, Ray A, Denman CJ, Senyukov VS, Somanchi SS, Zhu S, Lee DA. Decitabine has a biphasic effect on natural killer cell viability, phenotype, and function under proliferative conditions. Mol Immunol. 2013 Jul;54(3-4):296-301. doi: 10.1016/j.molimm.2012.12.012. Epub 2013 Jan 16.
Background: PubMed 33646303Tang Y, Chen J, Liu Q, Chu T, Pan T, Liang J, He XF, Chen F, Yang T, Ma X, Wu X, Hu S, Cao X, Hu X, Hu J, Liu Y, Qi J, Shen Y, Ruan C, Han Y, Wu D. Low-dose decitabine for refractory prolonged isolated thrombocytopenia after HCT: a randomized multicenter trial. Blood Adv. 2021 Mar 9;5(5):1250-1258. doi: 10.1182/bloodadvances.2020002790.
Background: PubMed 26181032Han Y, Tang Y, Chen J, Liang J, Ye C, Ruan C, Wu D. Low-Dose Decitabine for Patients With Thrombocytopenia Following Allogeneic Hematopoietic Stem Cell Transplantation: A Pilot Therapeutic Study. JAMA Oncol. 2015 May;1(2):249-51. doi: 10.1001/jamaoncol.2014.316. No abstract available.
Background: PubMed 12010787DeSimone J, Koshy M, Dorn L, Lavelle D, Bressler L, Molokie R, Talischy N. Maintenance of elevated fetal hemoglobin levels by decitabine during dose interval treatment of sickle cell anemia. Blood. 2002 Jun 1;99(11):3905-8. doi: 10.1182/blood.v99.11.3905.
Individual participant dataSharing planned: Undecided. A lot of work

Related trials for Poor Graft Function

Not yet recruitingPhase 1/2
Anakinra for Prevention of Poor Graft Function in MDS Allo-HSCT
Poor Graft Function, Myelodysplastic Syndromes
Recruiting
CD34+ Selected Stem Cell for Poor Graft Function or Graft Failure
Graft Failure, Poor Graft Function
Recruiting
Compassionate Access of the Miltenyi Device for CD34+ Cell Selection
Blood And Marrow Transplantation
RecruitingPhase 1
The Safety and Efficacy of Umbilical Cord Blood Mononuclear Cells in Patients With Secondary Poor Graft Function After Hematopoietic Stem Cell Transplantation
Poor Graft Function
Not yet recruitingPhase 1/2
REscuing Bone Marrow Function in Patients with AplaStic AnaEmia and Bone Marrow FaiLure Post AllogEneiC Transplantation 2
Poor Graft Function, Aplastic Anemia Idiopathic

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. This study is not recruiting at the moment.

Yue Han, Professor principal investigator

The First Affiliated Hospital of Soochow University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 7 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: finished, as of the sponsor's last update on 23 Oct 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Achieving Treatment Response (Hematological Response + Hematological Improvement) (time frame: day +28). The study lists 2 primary outcomes in all. 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 NCT05907499, which also lists 12 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 23 Oct 2026.