Clinical trial NCT02052882: Study of Romiplostim for Chemotherapy Induced Thrombocytopenia
Official title: An Open Label Phase II Study of Romiplostim for Chemotherapy Induced Thrombocytopenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Isolated Chemotherapy-induced Thrombocytopenia
Keywords: Romiplostim
Thrombocytopenia
13-132
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Amgen
First posted: 2014-02-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Who Achieved Platelet Counts of ≥ 100,000/mcL
timeFrame: within 3 weeks after treatment
Secondary outcomes:
measure: Number of Participants Evaluated for Toxicity
timeFrame: 1 year
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering at Basking Ridge
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Suffolk
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Cy Wilkins, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.