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Romiplostim for Lymphoma
Phase 2
Waitlist Available
Led By Erel Joffe, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient is planned for at least one more cycle of chemotherapy
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial will study whether a drug called romiplostim can help treat low platelet count caused by standard chemotherapy for lymphoma, as well as whether it can prevent the need for chemotherapy dose delays, reductions, or platelet transfusions.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While not explicitly listed here, common side effects of romiplostim may include headache, dizziness, insomnia, bone/muscle pain, nausea or vomiting; it could also potentially increase the risk of blood clots.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for at least one more round of chemotherapy.
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I am on a chemotherapy treatment that lowers my platelet count and follows a 21-day cycle.
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I am 18 or older and have been diagnosed with lymphoma.
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My organs are functioning normally as of my last treatment cycle.
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I can take care of myself but might not be able to do heavy physical work.
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I had severe low platelet counts from my last treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
measure of incidence of indication for dose delays
Side effects data
From 2010 Phase 3 trial • 313 Patients • NCT0011668850%
Upper respiratory tract infection
45%
Cough
45%
Headache
45%
Pyrexia
45%
Petechiae
40%
Contusion
35%
Fatigue
35%
Vomiting
30%
Oropharyngeal pain
30%
Nasal congestion
25%
Gingival bleeding
25%
Epistaxis
25%
Rhinorrhoea
25%
Rash
25%
Nasopharyngitis
25%
Arthralgia
20%
Abdominal pain upper
20%
Pain
20%
Mouth haemorrhage
20%
Nausea
15%
Abdominal pain
15%
Excoriation
15%
Myalgia
15%
Viral upper respiratory tract infection
10%
Ear infection
10%
Chills
10%
Idiopathic thrombocytopenic purpura
10%
Pain in extremity
10%
Dyspnoea
10%
Diarrhoea
10%
Joint sprain
10%
Gastroenteritis
10%
Scab
10%
Dizziness
10%
Mouth ulceration
10%
Viral infection
10%
Animal bite
10%
Arthropod bite
10%
Procedural pain
5%
Constipation
5%
Migraine
5%
Anaemia
5%
Muscle spasms
5%
Haematoma
5%
Musculoskeletal pain
5%
Abdominal discomfort
5%
Pharyngitis streptococcal
5%
Seasonal allergy
5%
Influenza
5%
Bronchitis
5%
Ecchymosis
5%
Skin lesion
5%
Toothache
5%
Chest pain
5%
Sinusitis
5%
Back pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Romiplostim in Pediatric Population
Romiplostim in Adults
Trial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Romiplostim
2015
Completed Phase 3
~2290
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,937 Previous Clinical Trials
588,309 Total Patients Enrolled
AmgenIndustry Sponsor
1,380 Previous Clinical Trials
1,379,610 Total Patients Enrolled
Tel-Aviv Sourasky Medical CenterOTHER_GOV
566 Previous Clinical Trials
307,218 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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 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.I am 18 or older and have been diagnosed with lymphoma.I have not needed a platelet transfusion for low platelet count or bleeding.I have a blood cancer history, but it's not lymphoma, or I have lymphoma with specific conditions.My organs are functioning normally as of my last treatment cycle.I have had a stem cell transplant from a donor or CAR-T treatment.I have had blood clots but can't take blood thinners, or I've finished or am on a blood thinner treatment.I can take care of myself but might not be able to do heavy physical work.My white blood cell count is healthy enough for treatment.My hemoglobin level is at least 7 g/dL, transfusions are okay.I have a serious cancer that has spread and cannot be surgically removed, diagnosed within the last 5 years.I can understand and am willing to sign the consent form myself or have a legal representative do it.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I have not had major surgery in the last 26 days or minor surgery in the last 3 days.I have low platelet counts due to a condition called ITP.I am HIV positive, on effective treatment, and have an undetectable viral load.I had severe low platelet counts from my last treatment.I haven't had a heart attack or stroke in the last 4 months.
Research Study Groups:
This trial has the following groups:- Group 1: romiplostim
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals can join this clinical research project?
"That is correct. The online information states that the research team is actively looking for 20 individuals to participate in this study at 8 different locations."
Answered by AI
Does Romiplostim have a history of clinical trials?
"Bergen's Memorial Sloan Kettering was the first to study romiplostim back in 2014. As of right now, 41 studies have been completed while 9 are ongoing. The majority of these active trials are based in Commack, New york."
Answered by AI
Does Romiplostim have any dangerous side-effects?
"Romiplostim's safety is based on Phase 2 trial data, which means that while there is evidence suggesting it is safe, there is no supporting data for its efficacy."
Answered by AI
Are there any open slots for this research project?
"Yes, the information on clinicaltrials.gov indicates that this study is still looking for patients to enroll. The original posting was on December 14th 2020 and it has been updated as recently as June 20th of 2022. They are recruiting for a total of 20 participants across 8 locations."
Answered by AI
Is this research being conducted for the first time?
"Romiplostim has been under clinical observation since 2014 when Amgen first sponsored a study. After the initial 60 person trial, Romiplostim received Phase 2 drug approval in 2014. Now, 9 years later, there are active studies involving Romiplostim happening in 62 cities across 23 countries."
Answered by AI
Where are patients able to participate in this research?
"There are 8 active clinical trial sites for this study, which are situated in Commack, Miami, Uniondale and other cities. If you enroll in the study, it is important to try and select a location that is close to minimize travel requirements."
Answered by AI
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