Romiplostim for Lymphoma

Recruiting in Palo Alto (17 mi)

+7 other locations

Overseen byErel Joffe, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

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.

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.

+12 more

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.

+10 more

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: romiplostimExperimental Treatment1 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.