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Study of Romiplostim for Chemotherapy Induced Thrombocytopenia

Primary Purpose

Isolated Chemotherapy-induced Thrombocytopenia

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
romiplostim
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Isolated Chemotherapy-induced Thrombocytopenia focused on measuring Romiplostim, Thrombocytopenia, 13-132

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Memorial Sloan Kettering at Basking Ridge
  • Memorial Sloan Kettering Monmouth
  • Memorial Sloan Kettering Bergen
  • Memorial Sloan Kettering Cancer Center @ Suffolk
  • Memorial Sloan Kettering Westchester
  • Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Romiplostim

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Assessment of potential toxicity
Assessment of potential toxicity will be based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.

Full Information

First Posted
January 30, 2014
Last Updated
February 1, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT02052882
Brief Title
Study of Romiplostim for Chemotherapy Induced Thrombocytopenia
Official Title
An Open Label Phase II Study of Romiplostim for Chemotherapy Induced Thrombocytopenia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 30, 2014 (undefined)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Amgen

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Isolated Chemotherapy-induced Thrombocytopenia
Keywords
Romiplostim, Thrombocytopenia, 13-132

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Romiplostim
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
romiplostim
Primary Outcome Measure Information:
Title
Achievement of platelet counts of ≥ 100,000/mcL
Description
The primary therapeutic response is assessed by the platelet count within 3 weeks of treatment.
Time Frame
within 3 weeks after treatment
Secondary Outcome Measure Information:
Title
Assessment of potential toxicity
Description
Assessment of potential toxicity will be based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: Nucleoside Analogue, including gemcitabine and fluorouracil Carboplatin or cisplatin Anthracycline Alkylating agent 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: Patients with history of hematologic malignancies, including leukemia, myeloma, myeloproliferative disease, lymphoma, or myelodysplastic diseases. Patients with known bone metastases, with evidence of corticol bone damage/lytic lesions/blastic lesions on standard imaging studies (CT/MR) 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. 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 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. 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 Pregnant women/lactating mothers Patients unwilling to use contraception.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cy Wilkins, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering at Basking Ridge
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Facility Name
Memorial Sloan Kettering Monmouth
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Facility Name
Memorial Sloan Kettering Bergen
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center @ Suffolk
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan Kettering Westchester
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31545663
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.
Results Reference
derived
Links:
URL
http://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center

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Study of Romiplostim for Chemotherapy Induced Thrombocytopenia

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