Secondary Prophylaxis in Non-Hodgkin Lymphoma (NHL) and Chemotherapy-induced Thrombocytopenia

NCT01516619 | Completed Phase 2

• 1 other identifier: ProRom
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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

Non-Hodgkin Lymphoma

Keywords

NHL; chemotherapy-induced grade-4 thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• safety

  evaluation of safety, defined by the incidence of grade \>/= 4 adverse events (NCI CTCAE v. 4.02 Dec 2009)

  participants will be followed for the duration of experimental treatment, an expected average of 6 months

Secondary Outcomes (1)

• activity

  From date of registration until the completion of chemotherapy treatment, an expected average of 6 months

Study Arms (1)

romiplostim

EXPERIMENTAL

Drug: Romiplostim

Interventions

Romiplostim DRUG

Romiplostim will be administered subcutaneously at a dose of 250 μg on the 1st, 3rd and 5th days after the last day of chemotherapy delivery and, then, every two days until the achievement of 75.000 plt/μL. In the case of unsuccessful use of romiplostim after the second chemotherapy course, dose escalation to 500 μg/day, with the same above-mentioned schedule, will be indicated after the third course and for all the further courses, with a maximum of 8.

Also known as: chemotherapy-induced thrombocytopenia, Nplate

romiplostim

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Andres J. M. Ferreri: lead
• Amgen: collaborator

Study Sites (1)

Dip. Oncoematologia - Fondazione Centro San Raffaele del Monte Tabor

Milan, Italy

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

romiplostim

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Andrés JM Ferreri, MD

  San Raffaele Scientific Institute, Milano, Italy

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 8, 2012
• First Posted: January 25, 2012
• Study Start: November 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: August 12, 2022

Record last verified: 2022-08

Locations

IT (1)