A Phase 3 interventional study of Decitabine and rhTPO in Thrombocytopenia and Hematologic Diseases, sponsored by The First Affiliated Hospital of Soochow University. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2020-05-06.
Sponsored by The First Affiliated Hospital of Soochow University · Phase 3, Interventional, and Treatment
Isolated thrombocytopenia is a common and severe complication of HSCT, which often leads to an increased risk of life-threatening hemorrhage, frequent requirement of platelet transfusions and extended hospital stays, representing a challenging clinical problem. Current treatments for thrombocytopenia after HSCT are frequently unsatisfactory in platelet recovery and for preventing potentially fatal bleeding complications. Therefore, it is urgent to explore an effective therapy to improve the outcomes of thrombocytopenia after HSCT. Previous studies have demonstrated that decitabine, a hypomethylating agent, may reduce platelet transfusions in myelodysplastic syndrome (MDS) patients. The investigators conducted an prospective clinical trial to evaluate the safety and efficiency of rhTPO and decitabine in the treatment of thrombocytopenia following HSCT.
Isolated thrombocytopenia is a frequent and severe complication of hematopoietic stem cell transplantation (HSCT). It often leads to an increased risk of life-threatening hemorrhage, frequent requirement of platelet transfusions and extended hospital stays, representing a challenging clinical problem. Current treatments for thrombocytopenia after HSCT, including thrombopoietin, interleukin-11, immunoglobulin, methylprednisolone and rituximab, are frequently unsatisfactory in platelet recovery. Therefore, it is urgent to explore an effective therapy to improve the outcomes of thrombocytopenia after HSCT. Thrombopoietin (TPO) is a cytokine that drives thrombopoiesis by stimulating the differentiation of stem cells into megakaryocytes and promoting megakaryocyte proliferation and polyploidization. Decitabine was approved for the treatment of myelodysplastic syndrome (MDS) as a DNA methylation inhibitors. Studies in vitro show that decitabine enhances platelet release and megakaryocyte maturation. Here, the investigators performed a prospective clinical trial, in order to investigate the safety and efficiency of rhTPO and decitabine in the treatment of thrombocytopenia following HSCT.
697 studies on the registry are indexed under Thrombocytopenia; 153 are open to participants now.
This study's enrollment of 97 is above the median of 55 across 472 interventional studies indexed under Thrombocytopenia.
Browse Thrombocytopenia studies →The First Affiliated Hospital of Soochow University is the lead sponsor of 252 studies on the registry; 148 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Decitabine in combination with rhTPO.
Drug: Decitabine · Drug: rhTPO
Decitabine
Drug: Decitabine
Conventional treatment except decitabine.
Other: Conventional Treatment
Decitabine
Also known as: 5-Aza-2'-deoxycytidine
rhTPO
Also known as: Thrombopoietin
immunoglobulin, glucocorticoid etc
Number of Participants With Platelet Count Recovery
Platelet response refers to a sustained increase (stable or increasing level) of at least 30×10E9/L independent of transfusion for 3 days.
Time frame: Up to 4 weeks after the treatment
Megakaryocyte Count
The total number of megakaryocytes as well as the platelet-shedding megakaryocytes of bone marrow smears (per cm2) was counted and cross-checked by blinded observers.
Time frame: Up to 4 weeks after the treatment
Two participants from different institutions submitted the applications at the same time when there was only one quota left. Both of them met the inclusion criteria and were enrolled.
| Milestone | Experimental Group 1 | Experimental Group 2 | Control Group |
|---|---|---|---|
| Started | 32 | 33 | 32 |
| Completed | 30 | 30 | 31 |
| Not completed | 2 | 3 | 1 |
Platelet response refers to a sustained increase (stable or increasing level) of at least 30×10E9/L independent of transfusion for 3 days.
| Participants | Experimental Group 1 | Experimental Group 2 | Control Group |
|---|---|---|---|
| Number of Participants With Platelet Count Recovery | 20 | 22 | 6 |
The total number of megakaryocytes as well as the platelet-shedding megakaryocytes of bone marrow smears (per cm2) was counted and cross-checked by blinded observers.
| cells/cm^2 | Experimental Group 1 | Experimental Group 2 | Control Group |
|---|---|---|---|
| Megakaryocyte Count | 6.7 (1.2 to 10.0) | 7.5 (3.1 to 14.1) | 3.3 (1.8 to 6.0) |
Collected over Study period (4 weeks). Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental Group 1 | 1/30 (3.3%) | 4/30 (13.3%) | 8/30 (26.7%) |
| Experimental Group 2 | 0/30 (0%) | 1/30 (3.3%) | 5/30 (16.7%) |
| Control Group | 1/31 (3.2%) | 3/31 (9.7%) | 7/31 (22.6%) |
| Event | Experimental Group 1 | Experimental Group 2 | Control Group |
|---|---|---|---|
| InfectionsInfections and infestations | 2/30 | 0/30 | 2/31 |
| Bleeding eventsBlood and lymphatic system disorders | 1/30 | 1/30 | 0/31 |
| ShockCardiac disorders | 1/30 | 0/30 | 1/31 |
| Event | Experimental Group 1 | Experimental Group 2 | Control Group |
|---|---|---|---|
| Bleeding eventsBlood and lymphatic system disorders | 3/30 | 2/30 | 3/31 |
| HypohepatiaHepatobiliary disorders | 2/30 | 1/30 | 1/31 |
| FatigueGeneral disorders | 2/30 | 1/30 | 1/31 |
| FeverInfections and infestations | 1/30 | 2/30 | 1/31 |
| Chest distressCardiac disorders | 1/30 | 1/30 | 0/31 |
| AnorexiaGastrointestinal disorders | 1/30 | 0/30 | 0/31 |
| HeadacheNervous system disorders | 1/30 | 0/30 | 0/31 |
| NauseaGastrointestinal disorders | 1/30 | 0/30 | 0/31 |
| Blurred visionEye disorders | 0/30 | 1/30 | 0/31 |
| HypeluricemiaMetabolism and nutrition disorders | 0/30 | 1/30 | 0/31 |
| Age, Continuous(years) | Experimental Group 1 | Experimental Group 2 | Control Group | Total |
|---|---|---|---|---|
| Median | 30 (23 to 43) | 36 (27 to 46) | 36 (28 to 51) | 31 (25 to 44) |
| Sex: Female, Male(Participants) | Experimental Group 1 | Experimental Group 2 | Control Group | Total |
|---|---|---|---|---|
| Female | 5 | 12 | 15 | 32 |
| Male | 25 | 18 | 16 | 59 |
| Race and Ethnicity Not Collected(Participants) | Experimental Group 1 | Experimental Group 2 | Control Group | Total |
|---|---|---|---|---|
| Count of participants | — | — | — | 0 |
| Region of Enrollment(Participants) | Experimental Group 1 | Experimental Group 2 | Control Group | Total |
|---|---|---|---|---|
| China | 30 | 30 | 31 | 91 |
| Diagnosis(Participants) | Experimental Group 1 | Experimental Group 2 | Control Group | Total |
|---|---|---|---|---|
| Acute lymphocytic leukemia | 8 | 10 | 11 | 29 |
| Acute myeloid leukemia | 15 | 14 | 12 | 41 |
| Chronic myeloid leukemia | 0 | 2 | 1 | 3 |
| Myelodyplastic syndrome | 5 | 4 | 4 | 13 |
| Non-Hodgkin lymphoma | 2 | 0 | 3 | 5 |
| Transplant Donor(Participants) | Experimental Group 1 | Experimental Group 2 | Control Group | Total |
|---|---|---|---|---|
| Haploidentical donor | 23 | 20 | 21 | 64 |
| Matched related donor | 5 | 8 | 6 | 19 |
| Matched unrelated donor | 2 | 2 | 4 | 8 |
| ABO compatitibilty(Participants) | Experimental Group 1 | Experimental Group 2 | Control Group | Total |
|---|---|---|---|---|
| ABO matched | 15 | 13 | 18 | 46 |
| ABO mismatched | 15 | 17 | 13 | 45 |
| Conditioning(Participants) | Experimental Group 1 | Experimental Group 2 | Control Group | Total |
|---|---|---|---|---|
| Busulfan / cyclophosphamide | 26 | 27 | 29 | 82 |
| Others | 4 | 3 | 2 | 9 |
5 further baseline measures are reported on the registry.
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Plan to share: No
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The First Affiliated Hospital of Soochow University