Romiplostim for Lymphoma

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether romiplostim (also known as Nplate or AMG 531) can aid people with lymphoma who have low platelet counts due to chemotherapy. The researchers aim to determine if romiplostim can reduce the need for platelet transfusions and prevent delays or reductions in chemotherapy doses. They will also assess romiplostim's safety for these patients. This trial might suit someone with lymphoma who has experienced low platelet counts during chemotherapy and plans to continue treatment. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that romiplostim is likely to be safe for humans?

Research shows that romiplostim is usually well-tolerated. In past studies, researchers administered it to people with low platelet counts (thrombocytopenia) and found it safe. One study found that romiplostim was effective and safe for long-term use in treating low platelets caused by other conditions. Another study with children showed it was safe and tolerable for them as well.

This trial is in Phase 2, indicating that romiplostim has already passed initial safety tests. Researchers are now studying its effectiveness and safety for people with lymphoma. This phase also examines any side effects that might occur when used with chemotherapy. ^{1 2 3 4}

Why do researchers think this study treatment might be promising?

Unlike standard treatments for lymphoma, which typically focus on chemotherapy or radiation, romiplostim offers a unique approach by specifically targeting platelet production. This drug is a thrombopoietin receptor agonist, which means it helps boost the body's production of platelets, potentially reducing the risk of bleeding associated with low platelet counts during chemotherapy. Researchers are excited about romiplostim because it could improve the safety and effectiveness of existing lymphoma treatments by allowing patients to maintain healthier platelet levels, minimizing treatment interruptions and enhancing overall outcomes.

What evidence suggests that romiplostim might be an effective treatment for low platelet count in lymphoma patients?

Research has shown that romiplostim, the treatment under study in this trial, can effectively increase platelet counts in patients. In studies, 87% of patients experienced higher platelet levels, with many maintaining stability. Among patients with solid tumors, 71% responded well to romiplostim, which prevented chemotherapy dose reductions or treatment delays 79% of the time. Romiplostim has also maintained platelet counts above a safe level (50 × 10^9/L) in patients, regardless of spleen removal. These findings suggest that romiplostim may help manage low platelet counts in lymphoma patients undergoing chemotherapy. ^{2 4 5 6 7}

Who Is on the Research Team?

Zachary Epstein-Peterson, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4888762/

Long-term safety and efficacy of romiplostim for treatment ...

Administration of romiplostim led to a durable platelet response in 16 of the 42 patients (38%) who had undergone a splenectomy and 25 of the 41 patients (61%) ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT00321711

Study Details | NCT00321711 | Determination of Safe and ...

The purpose of this study is to evaluate the effect of Romiplostim (AMG 531) on the incidence of clinically significant thrombocytopenic events (grade 3 or ...

3.

ashpublications.org

ashpublications.org/blood/article/113/10/2161/24354/Safety-and-efficacy-of-long-term-treatment-with

Safety and efficacy of long-term treatment with romiplostim in ...

Platelet responses (platelet count ≥ 50 × 109/L and double baseline) were observed in 87% of all patients and occurred on average 67% of the time in responding ...

4.

haematologica.org

haematologica.org/article/view/9776

A multicenter study of romiplostim for chemotherapy ...

Romiplostim was effective in solid tumor patients: 71% of patients achieved a romiplostim response, 79% avoided chemotherapy dose reductions/treatment delays ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3627322/

The efficacy and safety of romiplostim in adult patients ...

Romiplostim showed efficacy in both splenectomized and nonsplenectomized patients. A platelet count of at least 50 × 109/L was maintained for a mean of 15.2 and ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT00299182

Study of AMG 531 to Evaluate the Safety & Efficacy in ...

The goal of this clinical research study is to find the highest safe dose of AMG 531 that can be given to treat thrombocytopenia (low platelet counts) in ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT00515203

Safety and Efficacy Study of Romiplostim (AMG 531) to ...

The purpose of this study is to evaluate the safety and tolerability of romiplostim (AMG 531) in the treatment of thrombocytopenia in pediatric subjects ...