CompletedPhase 1

A Study of PN20 for the Prevention of Chemotherapy-induced Thrombocytopenia in Lymphoma or Solid Tumor Patients

China24 participantsStarted 2023-12-06

Plain-language summary

The main aim of this clinical trial is to assess the safety and tolerability of PN20 in adult patients with chemotherapy-induced thrombocytopenia (CID). The main questions it aims to answer are: * Is PN20 safe in these patients? * Could these patients potentially benefit from PN20 prevention? Participants will * Receive subcutaneous injections of PN20 according to weight on the first day of chemotherapy cycle, within 1 hour before the administration of chemotherapy drugs, * Visit the clinic on Day 1 (D1), D2, D3, D4, D5, D8, D11, D13, D15 and D21 for assessment.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Aged ≥ 18 years, regardless of gender;
✓. Diagnosed with lymphoma or solid tumor by pathological histology or cytology examination;
✓. Currently receiving a 21-day chemotherapy regimen, using one or more of the following or similar drugs: gemcitabine; platinums, including carboplatin, nedaplatin, cisplatin, lobaplatin, etc.; anthracyclines, including doxorubicin, daunorubicin, epirubicin, etc.; taxanes, including paclitaxel, docetaxel, etc.; alkylating agents, including cyclophosphamide, ifosfamide, etc.;
✓. The current chemotherapy regimen should be consistent with that of the previous chemotherapy cycle before enrollment, including the type and dosage of the drugs, and no medication or dosage adjustments are allowed;
✓. Platelet count (PLT) was between 75 and 150×10\^9/L (including the critical value) one day before the start of chemotherapy in the first treatment cycle or before enrollment;
✓. There was a decrease in PLT to 25×10\^9/L≤ PLT \<75×10\^9/L during the previous chemotherapy cycle before enrollment;
✓. Expected survival ≥ 12 weeks;
✓. Eastern Cooperative Oncology Group (ECOG) Physical Score is ≤ 2;

Exclusion criteria

What they're measuring

AE in single-dose phase

Timeframe: Day 1-21 of Cycle 1 (each cycle is 21 days)

The proportion of patients with PLT ≥ 100×10^9/L in multiple-dose phase

Timeframe: Day 21 of Cycle 2 (each cycle is 21 days)

Trial details

NCT IDNCT06521931

SponsorChongqing Peg-Bio Biopharm Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-01-13

View on ClinicalTrials.gov More Thrombocytopenia trials