NCT07848672Not yet recruitingPhase 2/3
Early Prophylactic rhTPO Administration for Thrombocytopenia Associated With EAP Regimen-Based Hematopoietic Stem Cell Mobilization
A Single-Arm, Multicenter, Prospective Phase II Clinical Study of Early Prophylactic rhTPO for the Prevention of Hematopoietic Stem Cell Mobilization-Related Thrombocytopenia During the EAP Regimen
Source: ClinicalTrials.gov · Last updated 30 Sept 2026
Brief summary (registry, in English)
This is a multicenter, prospective, single-arm, phase II clinical study evaluating the early prophylactic use of recombinant human thrombopoietin (rhTPO) to prevent thrombocytopenia associated with the EAP regimen for hematopoietic stem cell mobilization. The EAP regimen consists of etoposide, cytarabine, and pegylated granulocyte colony-stimulating factor (pegfilgrastim) and is used for hematopoietic stem cell mobilization before autologous stem cell transplantation in patients with multiple myeloma and B-cell lymphoma. Severe thrombocytopenia is a common complication during EAP-based stem cell mobilization and may increase the risk of bleeding and the need for platelet transfusions, and may sometimes delay stem cell collection. In this study, patients whose platelet counts decrease to ≤80 × 10⁹/L after EAP chemotherapy will receive rhTPO early as a preventive treatment. The study will evaluate whether early rhTPO administration can reduce the incidence of clinically significant bleeding and the need for platelet transfusion while maintaining adequate hematopoietic stem cell mobilization. The study will also monitor platelet counts, stem cell collection outcomes, and treatment-related adverse events to evaluate the effectiveness and safety of early rhTPO administration.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 2 Sept 2026
- Start date
- 1 Jan 2027
- Primary completion date
- 31 Dec 2029
- Lead sponsor
- The Affiliated People's Hospital of Ningbo University
- Diseases
- Multiple myeloma
- NCT number
- NCT07848672
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 70
- From 1 Jan 2027 to the primary completion date, 31 Dec 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous history of arterial or venous thromboembolism including pulmonary embolism.
Other illness
- Active uncontrolled infection.
- Known hypersensitivity to recombinant human thrombopoietin (rhTPO).
Lab values
- Liver cirrhosis or baseline alanine transaminase (ALT) \> 2 times upper limit of normal.
Other
- Confirmed myelofibrosis.
- Pregnant or lactating female subjects.
Who the study is looking for
- Age between 18 and 75 years old.
- Confirmed diagnosis of multiple myeloma or B-cell lymphoma, eligible for autologous hematopoietic stem-cell transplantation and planned to receive EAP-based stem-cell mobilization.
- Baseline peripheral platelet count ≥ 80 × 10⁹/L.
- Adequate cardiac, hepatic and renal function to tolerate EAP-combination chemotherapy.
- Willing and able to complete the full-study follow-up procedures.
- Voluntarily provide written informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.