← Back to Search

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

Must not have

Patient has acute viral hepatitis (typically defined by elevated AST/ALT), or a history of chronic or active HBV or HCV infection (HBcAb or HBsAg positive and detectable serum/plasma HBV DNA, or HCV Ab positive and detectable serum/plasma HCV RNA)

Within 4 months prior to enrollment, any history of active congestive heart failure (New York Heart Association [NYHA] Class III to IV), symptomatic ischemia, uncontrolled arrhythmias, clinically significant electrocardiogram (ECG) abnormalities, screening ECG with corrected QT (QTc) interval of > 470 msec, pericardial disease, or myocardial infarction

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

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.

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.

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

Select...

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

Select...

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

Select...

I am 18 or older and have been diagnosed with lymphoma.

Select...

My organs are functioning normally as of my last treatment cycle.

Select...

I can take care of myself but might not be able to do heavy physical work.

Select...

I had severe low platelet counts from my last treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have or had hepatitis with active infection indicators.

Select...

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

Select...

I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

Select...

I have not had major surgery in the last 26 days or minor surgery in the last 3 days.

Select...

I have low platelet counts due to a condition called ITP.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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%

Diarrhoea

25%

Epistaxis

24%

Cough

24%

Nausea

24%

Arthralgia

19%

Pain in extremity

19%

Back pain

18%

Dizziness

18%

Petechiae

17%

Oropharyngeal pain

16%

Vomiting

15%

Gingival bleeding

15%

Rash

14%

Insomnia

14%

Oedema peripheral

13%

Haematoma

13%

Sinusitis

12%

Myalgia

12%

Pyrexia

12%

Urinary tract infection

11%

Abdominal pain

11%

Pain

10%

Idiopathic thrombocytopenic purpura

10%

Paraesthesia

10%

Muscle spasms

10%

Nasal congestion

10%

Musculoskeletal pain

Constipation

Rhinorrhoea

Ecchymosis

Thrombocytopenia

Dyspnoea

Influenza

Bronchitis

Pruritus

Asthenia

Depression

Oropharyngeal blistering

Abdominal pain upper

Dyspepsia

Anxiety

Fall

Blood blister

Mouth haemorrhage

Procedural pain

Anaemia

Abdominal discomfort

Skin lesion

Hypertension

Toothache

Skin laceration

Dysuria

Migraine

Injection site haematoma

Seasonal allergy

Chest pain

Joint swelling

Joint sprain

Gastroenteritis

Ear infection

Chills

Excoriation

Pneumonia

Myocardial infarction

Cardiac failure congestive

Viral infection

Viral upper respiratory tract infection

Arthropod bite

Vertigo

Atrial fibrillation

Dehydration

Colitis

Bone marrow disorder

Syncope

Osteoarthritis

Respiratory failure

Appendicitis

Renal failure acute

Catheter related infection

Mouth ulceration

Hyperkalaemia

Cholelithiasis

Urosepsis

Knee arthroplasty

Hepatic failure

Gastrointestinal haemorrhage

Cellulitis

Hepatic neoplasm malignant

Platelet count increased

Hip fracture

Transient ischaemic attack

Angina unstable

Coronary artery disease

Mental status changes

Renal failure

Vaginal haemorrhage

Cardiac failure

Cholecystitis

Convulsion

Acute myocardial infarction

Hernia obstructive

Rectal haemorrhage

Platelet count decreased

Cerebrovascular accident

Deep vein thrombosis

Animal bite

100%

80%

60%

40%

20%

Study treatment Arm

Romiplostim in Adults

Romiplostim in Pediatric Population

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2240

0 / 11Eligibility criteria met