Using Romiplostim to Treat Low Platelet Counts During Chemotherapy in People With Lymphoma
Using Romiplostim to Treat Low Platelet Counts During Chemotherapy in People With Lymphoma
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.
Inclusion Criteria:

 -  Adult patients ≥ 18 years old diagnosed with any type of lymphoma.

 -  Receiving chemotherapy-based treatment known to cause thrombocytopenia as first or
 second systemic line for treatment of lymphoma. 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.

 -  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.