Study of Romiplostim for Chemotherapy Induced Thrombocytopenia

An Open Label Phase II Study of Romiplostim for Chemotherapy Induced Thrombocytopenia

This study is to determine if using weekly romiplostim injections will improve the patient's platelet count more effectively than simply waiting for the platelets to improve on its own, and if romiplostim will also allow the patient to receive at least 2 further cycles of chemotherapy without thrombocytopenia.

Study Overview

• Status: Completed
• Conditions: Isolated Chemotherapy-induced Thrombocytopenia
• Intervention / Treatment: Biological: romiplostim

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Memorial Sloan Kettering at Basking Ridge
    • Middletown, New Jersey, United States, 07748
      • Memorial Sloan Kettering Monmouth
    • Montvale, New Jersey, United States, 07645
      • Memorial Sloan Kettering Bergen
  • New York
    • Commack, New York, United States, 11725
      • Memorial Sloan Kettering Cancer Center @ Suffolk
    • Harrison, New York, United States, 10604
      • Memorial Sloan Kettering Westchester
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients (18 years of age or greater) with active non-hematological cancer:

A. The patients have previously received a chemotherapy regimen including one or more of the following agents:

1. Nucleoside Analogue, including gemcitabine and fluorouracil
2. Carboplatin or cisplatin
3. Anthracycline
4. Alkylating agent
5. Other chemotherapy agents with thrombocytopenia as known common toxicity.

2. Patients who have not had any cytotoxic chemotherapy within 14 days of beginning the study.

3. Thrombocytopenia:.

A. Defined as platelet count <100,000/mcL.

B. The patient will have had at least 2 CBCs with platelet counts <100,000/mcL separated by at least 4 weeks, and no platelet count ≥100,000/mcL in the prior 6 week period, despite (1) delay, or (2) modification of chemotherapeutic regimen.

C. A platelet count of >100,000/mcL, that follows within 7 days of a platelet transfusion, will not make the patient ineligible, as long as one or more subsequent platelet counts confirms thrombocytopenia (<100,000/mcL).

D. Patients have undergone bone marrow aspirate and biopsy or peripheral blood test in the prior 3 months without evidence of leukemia or myelodysplasia by fluorescent in situ-hybridization (FISH) E. Dysplastic changes, based on morphology only, will not exclude the patient if FISH panel for MDS is normal.

4.KPS ≥ 50 or ECOG performance status ≤2 .

5.Ability to provide written informed consent.

Exclusion Criteria:

1. Patients with history of hematologic malignancies, including leukemia, myeloma, myeloproliferative disease, lymphoma, or myelodysplastic diseases.
2. Patients with known bone metastases, with evidence of corticol bone damage/lytic lesions/blastic lesions on standard imaging studies (CT/MR)
3. Anemia (Hgb <8.0 gm/dl) or leukopenia (absolute neutrophil count (ANC) <1,000/mcL). Use of red cell transfusions, erythropoietin, or G-CSF, as ordered by the managing oncology service, is acceptable and does not preclude participation.
4. Patients with underlying liver disease, such as cirrhosis or chronic hepatitis, and do not have primary or metastatic cancer in the liver will be excluded if ALT/AST >3X ULN or Total Bili >3X ULN. In the presence of primary or metastatic liver cancer, patients will be excluded if ALT/AST >5X ULN or Total Bili >5X ULN
5. Patients with a history of a prior symptomatic venous thrombotic event such, as DVT or pulmonary embolism and symptomatic arterial thrombotic events such as myocardial infarction, ischemic cerebral vascular accident or transient ischemic attack will be ineligible if they have not tolerated anticoagulation therapy. If patients remain on anticoagulation, or have completed the prescribed course of anticoagulation, they will be eligible for enrollment. A venous thrombotic event associated with a central venous catheter will not make the patient ineligible.
6. Serious concomitant medical condition that could interfere with the conduct of the clinical trial, such as unstable angina, renal failure requiring hemodialysis, or active infection requiring IV antibiotics
7. Pregnant women/lactating mothers
8. Patients unwilling to use contraception.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Romiplostim; All patients will begin weekly romiplostim at 2 mcg/kg, subcutaneously. The romiplostim dose will be titrated on weekly CBC/platelet counts. For titration purposes, the target platelet count is 150,000-200,000/mcL. Treatment can be held up to 16 days if a patient develops an intercurrent medical illness or symptom that is unrelated to study drug therapy. Treatment may be held up to 20 days if the patient unavailable for non- medical reasons, such as vacation or travel.

Biological: romiplostim

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Achievement of platelet counts of ≥ 100,000/mcL	The primary therapeutic response is assessed by the platelet count within 3 weeks of treatment.	within 3 weeks after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of potential toxicity	Assessment of potential toxicity will be based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.	1 year

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: Amgen
• Investigators: Principal Investigator: Cy Wilkins, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

General Publications

• Soff GA, Miao Y, Bendheim G, Batista J, Mones JV, Parameswaran R, Wilkins CR, Devlin SM, Abou-Alfa GK, Cercek A, Kemeny NE, Sarasohn DM, Mantha S. Romiplostim Treatment of Chemotherapy-Induced Thrombocytopenia. J Clin Oncol. 2019 Nov 1;37(31):2892-2898. doi: 10.1200/JCO.18.01931. Epub 2019 Sep 23.

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2014
• Primary Completion (Actual): November 13, 2023
• Study Completion (Actual): November 13, 2023

Study Registration Dates

• First Submitted: January 30, 2014
• First Submitted That Met QC Criteria: January 30, 2014
• First Posted (Estimated): February 3, 2014

Study Record Updates

• Last Update Posted (Estimated): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Thrombocytopenia; Romiplostim; 13-132
• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Platelet Disorders; Thrombocytopenia
• Other Study ID Numbers: 13-132