Clinical trial · Interventional
Secondary Prophylaxis in Non-Hodgkin Lymphoma (NHL) and Chemotherapy-induced Thrombocytopenia
Pilot Phase II Trial on Safety and Activity of Secondary Prophylaxis With Romiplostim in Patients With Non-Hodgkin Lymphoma and Chemotherapy-induced Thrombocytopenia
NCT01516619CI-TRIAL-00060288ProRomcompletedPhase 2ClinicalTrials.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)
This is a monocentric, prospective phase II trial addressing safety and capability to prevent grade-4 Chemotherapy-induced Thrombocytopenia (CIT) of romiplostim in patients with NHL.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Romiplostim | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- romiplostim
- interventionNames
- Drug: Romiplostim
Primary outcomes (1)
- measure
- safety
- timeFrame
- participants will be followed for the duration of experimental treatment, an expected average of 6 months
- description
- evaluation of safety, defined by the incidence of grade \>/= 4 adverse events (NCI CTCAE v. 4.02 Dec 2009)
Secondary outcomes (1)
- measure
- activity
- timeFrame
- From date of registration until the completion of chemotherapy treatment, an expected average of 6 months
- description
- activity defined by the incidence of grade 4 CIT (\</= 25 x 10E9/L) per chemotherapy course during experimental treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient with NHL of any histotype, both at diagnosis or at relapse, who experienced grade 4 CIT after the first course of chemotherapy containing high doses of methotrexate, cytarabine, cisplatin, cyclophosphamide and/or ifosfamide, and/or conventional doses of anthracyclines or purine analogs, with or without rituximab. The same type of chemotherapy where the grade 4 CIT occurred will be continued at the same planned doses for a maximum of 8 courses. * ECOG performance status score \</= 3. * Adequate bone marrow function (ANC \>1.000; Hb \>9,5 g/dL; PLT \> 75.000). Exclusion Criteria: * Patients eligible for high-dose chemotherapy, where stem cell support is planned. * Thrombotic events in the previous 5 years before enrolment. * Other malignancies diagnosed in the previous 5 years before enrolment. * Severe concomitant illnesses/medical conditions (e.g. impaired respiratory and/or cardiac function, uncontrolled diabetes mellitus). * Active infectious disease. * Impaired liver function (bilirubin \>2 x upper normal limit; ALT/AST/GGT \> 3 x upper normal limit) at one month from salvage chemotherapy conclusion. * Impaired renal function (creatinine clearance \<50 ml/min) at one month from salvage chemotherapy conclusion. * Non-cooperative behavior or non-compliance. * Psychiatric diseases or conditions that might impair the ability to give informed consent. * Pregnant or lactating females. * Previous therapy with any TPO-mimetic or similar substances. * Previous therapy supported by transplant of autologous or allogeneic stem cells
References
Publications (0)
Data not yet available
No reference posted for this study.