Romiplostim for Lymphoma

Recruiting at 7 trial locations

Overseen By Zachary Epstein-Peterson, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Investigational agents

Disqualifiers: Leukemia, MDS, Myeloma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

11 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on antiretroviral therapy for HIV, you can continue as long as there are no interactions with the study drug.

What safety data exists for Romiplostim (Nplate, AMG 531) in humans?

There is a report of a skin rash occurring in a patient with autoimmune lymphoproliferative syndrome after taking Romiplostim. This suggests that while Romiplostim is generally used safely, it may cause skin reactions in some individuals. ^{1 2 3 4 5}

Research Team

Zachary Epstein-Peterson, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

Adults over 18 with lymphoma undergoing chemotherapy that causes low platelet counts are eligible. They must have had severe thrombocytopenia in the past, need at least one more chemo cycle, and have certain levels of blood cells and liver function. HIV-positive patients can join if their viral load is undetectable. Participants must use birth control and be able to consent.

Inclusion Criteria

I am scheduled for at least one more round of chemotherapy.

I agree to use effective birth control or abstain from sex during the study.

I am on a chemotherapy treatment that lowers my platelet count and follows a 21-day cycle.

Exclusion Criteria

I have or had hepatitis with active infection indicators.

I haven't had serious heart issues like heart failure or a heart attack in the last 4 months.

I have a blood cancer history, but it's not lymphoma, or I have lymphoma with specific conditions.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Romiplostim is administered from the beginning of the next chemotherapy cycle to manage low platelet counts

1 year

Visits aligned with chemotherapy cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Romiplostim

Trial Overview The trial tests romiplostim's effectiveness in increasing platelet counts during chemotherapy for lymphoma patients. It aims to see if this drug can reduce the need for treatment delays, dose reductions, or transfusions due to low platelets while assessing its safety.

Participant Groups

Group I: romiplostim Experimental Treatment 1 Intervention

Romiplostim 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.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Amgen

Industry Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

Tel-Aviv Sourasky Medical Center

Collaborator

Trials

584

Recruited

331,000+

Findings from Research

Romidepsin, an antitumor drug that inhibits histone deacetylase (HDAC), showed a treatment response rate of 42.5% in a phase II study involving 40 Japanese patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).

The safety profile of romidepsin was deemed acceptable, with common severe side effects including lymphopenia (74%), neutropenia (54%), and leukocytopenia (46%), leading to its approval for PTCL treatment in Japan in July 2017.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Romidepsin (Istodax® for intravenous injection 10 mg): pharmacokinetics, pharmacodynamics and clinical study outcome]. Ro, T., Nakayama, N., Achiwa, H., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Erythematous rash following romiplostim administration in a patient with autoimmune lymphoproliferative syndrome. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

Romidepsin (FK228) combined with cisplatin stimulates DNA damage-induced cell death in ovarian cancer. [2021]

3. Japan pubmed.ncbi.nlm.nih.gov

Romidepsin in Japanese patients with relapsed or refractory peripheral T-cell lymphoma: a phase I/II and pharmacokinetics study. [2018]

4. Japan pubmed.ncbi.nlm.nih.gov

[Romidepsin (Istodax® for intravenous injection 10 mg): pharmacokinetics, pharmacodynamics and clinical study outcome]. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Phase II multi-institutional trial of the histone deacetylase inhibitor romidepsin as monotherapy for patients with cutaneous T-cell lymphoma. [2022]