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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
ECOG Performance Status of ≤ 2 (Karnofsky ≥50%, see Appendix A - ECOG/Karnofsky performance status scale)
History of a severe treatment-related thrombocytopenia during the most recent cycle of treatment, as defined by one or more of the following criteria:
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 below
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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.
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My organ functions are normal as of the start of my last treatment cycle.
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I am 18 or older and have been diagnosed with lymphoma.
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My hemoglobin level is at least 7 g/dL, transfusions are okay.
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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 have very low platelet counts or needed a transfusion for it.
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I can understand and am willing to sign the consent form myself or have a legal representative do it.
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I agree to use effective birth control or abstain from sex during the study.
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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 am HIV positive, on effective treatment, and have an undetectable viral load.
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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 had severe low platelet counts from my last treatment.
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My white blood cell count is healthy enough for treatment.
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I am scheduled for at least one more round of chemotherapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

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 • NCT00116688
37%
Headache
34%
Nasopharyngitis
32%
Fatigue
30%
Contusion
26%
Upper respiratory tract infection
25%
Epistaxis
25%
Diarrhoea
24%
Nausea
24%
Arthralgia
24%
Cough
19%
Back pain
19%
Pain in extremity
18%
Petechiae
18%
Dizziness
17%
Oropharyngeal pain
16%
Vomiting
15%
Gingival bleeding
15%
Rash
14%
Oedema peripheral
14%
Insomnia
13%
Haematoma
13%
Sinusitis
12%
Pyrexia
12%
Urinary tract infection
12%
Myalgia
11%
Pain
11%
Abdominal pain
10%
Nasal congestion
10%
Paraesthesia
10%
Idiopathic thrombocytopenic purpura
10%
Muscle spasms
10%
Musculoskeletal pain
9%
Constipation
9%
Ecchymosis
9%
Rhinorrhoea
8%
Influenza
8%
Thrombocytopenia
8%
Bronchitis
8%
Pruritus
8%
Asthenia
8%
Dyspnoea
7%
Abdominal pain upper
7%
Dyspepsia
7%
Fall
7%
Anxiety
7%
Depression
7%
Oropharyngeal blistering
7%
Blood blister
7%
Mouth haemorrhage
6%
Procedural pain
6%
Skin lesion
6%
Hypertension
6%
Anaemia
6%
Abdominal discomfort
6%
Toothache
6%
Skin laceration
5%
Injection site haematoma
5%
Seasonal allergy
5%
Migraine
5%
Chest pain
5%
Joint swelling
5%
Dysuria
4%
Joint sprain
4%
Ear infection
4%
Gastroenteritis
4%
Chills
3%
Pneumonia
3%
Excoriation
2%
Myocardial infarction
2%
Cardiac failure congestive
2%
Viral infection
2%
Viral upper respiratory tract infection
2%
Arthropod bite
1%
Gastrointestinal haemorrhage
1%
Hip fracture
1%
Platelet count increased
1%
Urosepsis
1%
Syncope
1%
Dehydration
1%
Bone marrow disorder
1%
Osteoarthritis
1%
Respiratory failure
1%
Transient ischaemic attack
1%
Renal failure acute
1%
Vertigo
1%
Cholelithiasis
1%
Angina unstable
1%
Coronary artery disease
1%
Catheter related infection
1%
Mental status changes
1%
Renal failure
1%
Vaginal haemorrhage
1%
Cardiac failure
1%
Cholecystitis
1%
Hepatic neoplasm malignant
1%
Convulsion
1%
Acute myocardial infarction
1%
Atrial fibrillation
1%
Appendicitis
1%
Cellulitis
1%
Hernia obstructive
1%
Hepatic failure
1%
Colitis
1%
Rectal haemorrhage
1%
Platelet count decreased
1%
Hyperkalaemia
1%
Cerebrovascular accident
1%
Knee arthroplasty
1%
Deep vein thrombosis
1%
Mouth ulceration
1%
Animal bite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Romiplostim in Adults
Romiplostim in Pediatric Population

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
1,928 Previous Clinical Trials
591,797 Total Patients Enrolled
AmgenIndustry Sponsor
1,355 Previous Clinical Trials
1,384,060 Total Patients Enrolled
Tel-Aviv Sourasky Medical CenterOTHER_GOV
564 Previous Clinical Trials
306,929 Total Patients Enrolled

Media Library

Romiplostim Clinical Trial Eligibility Overview. Trial Name: NCT04673266 — Phase 2
Low Platelet Count Research Study Groups: romiplostim
Low Platelet Count Clinical Trial 2023: Romiplostim Highlights & Side Effects. Trial Name: NCT04673266 — Phase 2
Romiplostim 2023 Treatment Timeline for Medical Study. Trial Name: NCT04673266 — Phase 2

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
~4 spots leftby Dec 2025