Early Prophylactic rhTPO Administration for Thrombocytopenia Associated With EAP Regimen-Based Hematopoietic Stem Cell Mobilization

NCT07848672 | Not Yet Recruiting Phase 2

• 1 other identifier: 2026-EAP-1
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma; Hematopoietic Stem Cell Mobilization; Chemotherapy-Induced Thrombocytopenia

Outcome Measures

Primary Outcomes (2)

• Platelet transfusion rate during mobilization period

  Proportion of participants receiving at least one platelet transfusion in the mobilization phase.

  From initiation of EAP chemotherapy to completion of the last stem-cell apheresis,assessed up to 30 days.

• Incidence of grade ≥2 bleeding events during mobilization period

  Proportion of participants experiencing CTCAE v5.0 grade ≥2 bleeding events throughout the stem-cell mobilization cycle.

  From initiation of EAP chemotherapy to completion of the last stem-cell apheresis,assessed up to 40 days.

Secondary Outcomes (6)

• Nadir platelet count

  From initiation of EAP chemotherapy to completion of the last stem-cell apheresis, assessed up to 40 days.

• Duration of platelet count <20 ×10⁹/L

  From initiation of EAP chemotherapy to completion of the last stem-cell apheresis,assessed up to 40 days.

• Proportion of participants with delayed stem-cell apheresis due to severe thrombocytopenia

  From initiation of EAP chemotherapy to completion of the last stem-cell apheresis,assessed up to 30 days.

• Stem-cell mobilization success rate

  At completion of stem-cell apheresis,assessed up to 30 days.

• Incidence of adverse events

  From start of study intervention to completion of stem-cell collection, assessed up to 40 days.

Study Arms (1)

Prophylactic early-use rhTPO for chemotherapy-induced thrombocytopenia during EAP-based hematopoieti

EXPERIMENTAL

This is the only interventional arm of this multicenter, prospective, single-arm phase II study. Eligible patients with lymphoma or multiple myeloma receive standard EAP mobilization chemotherapy (etoposide 75 mg/m² i.v. d1-2, cytarabine 200 mg/m² q12h i.v. d1-2; pegfilgrastim is administered subcutaneously on day 6 after completion of chemotherapy; dose reduction to 2/3-3/4 of original dose is allowed for patients \> 65 years or creatinine clearance 30-60 mL/min). After EAP chemotherapy, blood routine tests are monitored dynamically. When peripheral platelet count drops to ≤ 80 × 10⁹/L, \*\*prophylactic recombinant human thrombopoietin (rhTPO) 300 U/kg is given subcutaneously once daily\*\*. rhTPO administration continues until completion of stem-cell apheresis, platelet recovery \> 50 × 10⁹/L, or investigator-judged discontinuation. Platelet transfusion is only permitted when platelet count \< 20 × 10⁹/L or active bleeding occurs. Subjects undergo serial laboratory assessments including

Drug: rhTPO prophylaxis plus EAP stem-cell mobilization

Interventions

rhTPO prophylaxis plus EAP stem-cell mobilization DRUG

Standard EAP mobilization chemotherapy (etoposide + cytarabine + pegfilgrastim) plus early prophylactic subcutaneous rhTPO 300 U/kg/day initiated when platelet ≤80 ×10⁹/L. rhTPO stops after stem-cell collection, platelet recovery \>50 ×10⁹/L or investigator's decision. Platelet transfusion follows unified trigger criteria: PLT\<20×10⁹/L or active bleeding.

Prophylactic early-use rhTPO for chemotherapy-induced thrombocytopenia during EAP-based hematopoieti

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Previous history of arterial or venous thromboembolism including pulmonary embolism.
• Liver cirrhosis or baseline alanine transaminase (ALT) \> 2 times upper limit of normal.
• Active uncontrolled infection.
• Confirmed myelofibrosis.
• Pregnant or lactating female subjects.
• Known hypersensitivity to recombinant human thrombopoietin (rhTPO).

Sponsors & Collaborators

• The Affiliated People's Hospital of Ningbo University: lead

MeSH Terms

Conditions

Multiple Myeloma; Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Lymphatic Diseases

Central Study Contacts

Yuxiao Wang

CONTACT

13486889847; 799161574@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 30, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share