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Lymphoma PatientsPhase 2NCT04673266

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

A Phase 2 study testing Romiplostim in people with Lymphoma Patients and Thrombocytopenia, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma Patients, Thrombocytopenia
What is being tested?
Romiplostim
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
7 sitesUnited States
Study dates
14 Dec 2020to 7 Apr 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 one more cycle of chemotherapy.
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  • ECOG Performance Status of ≤ 2 (Karnofsky ≥50%, see Appendix A - ECOG/Karnofsky performance status scale).
  • Patients must have normal organ function as defined below on day 1 of the prior cycle:
  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Memorial Sloan Kettering Basking Ridge (All Protocol Activites)

    Basking Ridge, New Jersey, 07920

  • Memorial Sloan Kettering Commack (All Protocol Activities)

    Commack, New York, 11725

  • Memorial Sloan Kettering Westchester (All Protocol Activities)

    Harrison, New York, 10604

  • Memorial Sloan Kettering Monmouth (All Protocol Activities)

    Middletown, New Jersey, 07748

  • Memorial Sloan Kettering Bergen (All Protocol Activities)

    Montvale, New Jersey, 07645

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New York, 10065

  • Memorial Sloan Kettering Nassau (All Protocol Activities)

    Uniondale, New York, 11553

Other trials in United States

About this study

Official title: Romiplostim for Prevention of Severe Chemotherapy Induced Thrombocytopenia in Lymphoma Patients - Phase II Study

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.

Being tested
Romiplostim
Keywords
Romiplostim, 20-492
Medical subject headings
Thrombocytopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RomiplostimDrug

    All patients will begin weekly (+/- 2 days) romiplostim at 3 mcg/kg subcutaneously. The romiplostim dose will be titrated, based on weekly CBC/platelet counts.

Study groups in NCT04673266
Study groupRoleWhat they receive
romiplostimExperimentalRomiplostim will be administered from the beginning of the next chemotherapy cycle with a starting dose of 3 mcg/kg subcutaneously. Dose will be titrated based on nadir of the platelet counts during the prior cycle. The maximum dose of romiplostim will be 6 mcg/kg.
Receives: Drug: Romiplostim

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. measure of incidence of indication for dose delays

    defined as PLT < 50,000 cells/mcl) at the end of cycle 1 (C1D21±2d); presence of grade 4 thrombocytopenia (<25,000 cells/mcl) at any time throughout the treatment cycle; or indication for a PLT transfusion for thrombocytopenia or for bleeding at any time throughout the treatment cycle.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2020
  2. Study start14 Dec 2020
  3. Primary completion7 Apr 2026
  4. Study completion7 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
A single-center, open-label phase II study.
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04673266
Sponsor's protocol ID
20-492
Status last verified
Apr 2026
First submitted
14 Dec 2020
Last updated
13 Apr 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Romiplostim in people with Lymphoma Patients and Thrombocytopenia, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

measure of incidence of indication for dose delays (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04673266.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

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