Using Romiplostim to Treat Low Platelet Counts During Chemotherapy in People With Lymphoma

  • STATUS
    Recruiting
  • End date
    Dec 16, 2023
  • participants needed
    20
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 16 August 2021
platelet count
cytarabine
neutrophil count
g-csf
romiplostim

Summary

The purpose of this study is to see if the study drug, romiplostim, helps low platelet count caused by standard chemotherapy treatment for lymphoma. This study will also look at whether romiplostim can prevent the need for chemotherapy dose delays, chemotherapy dose reductions, and platelet transfusions. In addition, we will determine how safe it is to give romiplostim to people with lymphoma who have low platelet count from chemotherapy.

Details
Condition Thrombocytopenia, Thrombocytopenia and Thrombocytopenia Prevention, Lymphoma Patients
Treatment romiplostim
Clinical Study IdentifierNCT04673266
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on16 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Adult patients 18 years old diagnosed with any type of lymphoma
Receiving chemotherapy-based treatment known to cause thrombocytopenia. Eligibility is limited to regimens with a 21-day cycle. Previous single-agent anti-CD20 antibody or radiotherapy will not count as a line of treatment. Eligible regimens include those based on a platinum backbone (e.g. ICE, DHAX, DHAP, GemOx, GDP, ESHAP), those based on a doxorubicin backbone (e.g. CHOP, CDOP, HyperCVAD, BEACOPP) or on a high-dose cytarabine backbone (e.g.HiDAC). Of note, treatment programs which involve sequential administration of two or more regimens (e.g. CHOP->ICE or CHOP-DHAX) are eligible as long as the patient is planned for at least two more cycles of the regimen on which the CIT was initially observed. Regimens with inherent dose-adjustments by blood counts (e.g. da-EPOCH) are ineligible unless the treating oncologist is not planning to increase treatment doses on subsequent cycles
History of a severe treatment-related thrombocytopenia during the most recent cycle of treatment, as defined by one or more of the following criteria
PLT < 50,000 on day 1 (- 2 days) of the subsequent treatment cycle
Grade 4 thrombocytopenia, defined as PLT <25,000 cells/mcl and/or transfusion for thrombocytopenia or bleeding. Need for PLT transfusion in order to meet minimal PLT criteria for invasive procedures will not count for eligibility
Patient is planned for at least two more cycles of chemotherapy
Stem cell collection if indicated, planned for end of cycle 2 on study
ECOG Performance Status of 2 (Karnofsky 50%, see Appendix A - ECOG/Karnofsky performance status scale)
Patients must have normal organ function as defined below
Absolute neutrophil count 1,000/mcL - use of gCSF is acceptable for eligibility
Hemoglobin 7 g/dL - transfusion support is acceptable for eligibility
Total bilirubin 3x the institutional ULN
AST and ALT 3x institutional upper limit of normal
Human immunodeficiency virus (HIV)-infected patients on effective antiretroviral therapy with undetectable viral load are eligible for this trial, provided there are no anticipated interactions between antiretroviral treatment and the study drug
Women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
Ability to understand and the willingness to sign a written informed consent document prior to participation in the study and any related procedures being performed. Legally Authorized Representatives are permitted

Exclusion Criteria

History of or concurrent hematological malignancy other than lymphoma (acute or chronic leukemia, myelodysplastic syndrome [MDS], myeloproliferative neoplasm, multiple myeloma). Patient with composite/concurrent lymphoma or Richter's transformation are eligible
History of allogeneic hematopoietic stem cell transplantation (SCT). Patients with a prior autologous SCT or CAR-T treatment are eligible
Patients with history of symptomatic venous thrombotic event (VTE), such as deep vein thrombosis (DVT) or pulmonary embolism (PE) who is unable to tolerate anticoagulation. Patients who have completed their indicated course of anticoagulation prior to enrollment or are tolerating ongoing anticoagulation are eligible. Patients with VTE associated with central venous catheter are eligible
Patients with history of symptomatic arterial thrombotic events such as myocardial infarction, ischemia cerebral vascular accident, or transient ischemic attack within 4 months prior to enrollment
Patients who have thrombocytopenia related to pre-existing ITP
Major surgery within 26 days prior to enrollment, or minor surgery within 3 days prior to enrollment
Solid-tumor malignancy metastatic or locally-advanced unresectable within the last 5 years that could adversely affect subject safety or longevity, create the potential for drug-drug interactions, or compromise the interpretation of study results
Concurrent therapy with other investigational agents
Within 4 months prior to enrollment, any history of active congestive heart failure (New York Heart Association [NYHA] Class III to IV), symptomatic ischemia, uncontrolled arrhythmias, clinically significant electrocardiogram (ECG) abnormalities, screening ECG with corrected QT (QTc) interval of > 470 msec, pericardial disease, or myocardial infarction
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, renal failure requiring hemodialysis, or psychiatric illness/social situations that would limit compliance with study requirements. These include abnormal laboratory values, that could cause unacceptable safety risks or compromise compliance with the protocol
Patients are excluded from this study if pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 180 days after the last dose of trial treatment
Patient has acute viral hepatitis (typically defined by elevated AST/ALT), or a history of chronic or active HBV or HCV infection (HBcAb or HBsAg positive and detectable serum/plasma HBV DNA, or HCV Ab positive and detectable serum/plasma HCV RNA)
Patients with any significant history of non-compliance to medical regimens or unwilling or unable to comply with the instructions given to him/her by the study staff
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