Clinical trial · Interventional
Megakaryocytic Progenitor Cells for Prophylaxis and Treatment of Thrombocytopenia
Megakaryocytic Progenitor Cells for Prophylaxis and Treatment of Thrombocytopenia in Patients With Acute Leukemia Receiving Chemotherapy
NCT02241031CI-TRIAL-00015624unknownPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the efficacy of ex vivo generated megakaryocytic progenitor cells (MPs) in prophylaxis and treatment of thrombocytopenia caused by chemotherapy in patients with acute leukemia (AL).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematological Diseases | — | UNRESOLVED | — |
| Thrombocytopenia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MPs | Biological | — | UNRESOLVED |
| thrombopoietin (TPO) and interleukin-11 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- MPs
- description
- MPs will be intravenously infused within 48 hours after chemotherapy. During the study period, patients can receive platelet infusion but can not receive platelet stimulating factors.
- interventionNames
- Biological: MPs
- type
- ACTIVE_COMPARATOR
- label
- Non-MPs
- description
- Patients can receive platelet infusion but can not receive platelet stimulating factors.
- interventionNames
- Drug: thrombopoietin (TPO) and interleukin-11
Primary outcomes (1)
- measure
- Platelet recovery after infusion of MPs
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * age：14-65 years * achieve complete remission of acute leukemia * the first course of consolidation chemotherapy * ECOG grades 0 or 1 * expected survival time ≥ three months * Subjects (or their legally acceptable representatives) must have signed an informed consent document. Exclusion Criteria: * cardiac dysfunction (particularly congestive heart failure), hepatic abnormalities (bilirubin ≥ 3 mg/dL, aminotransferase\> 2 times the upper limit of normal), renal dysfunction (creatinine clearance rate \< 30 mL/min) * Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) * Patients with any conditions not suitable for the trial (investigators' decision)
References
Publications (1)
- BACKGROUNDXi J, Zhu H, Liu D, Nan X, Zheng W, Liu K, Shi W, Chen L, Lv Y, Yan F, Li Y, Xie X, Wang Y, Yue W, Xu X, Wei X, Zhu J, Huang X, Pei X. Infusion of megakaryocytic progenitor products generated from cord blood hematopoietic stem/progenitor cells: results of the phase 1 study. PLoS One. 2013;8(2):e54941. doi: 10.1371/journal.pone.0054941. Epub 2013 Feb 4. PMID 23390507