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Monoclonal Antibodies
Daratumumab for Lymphoma
Phase 2
Recruiting
Led By Kathryn A Lurain, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 9 and 17 weeks, and every 12 weeks from week 25 to the end of therapy
Awards & highlights
Study Summary
This trial tests if a drug treatment can help people with a rare cancer (PEL) that does not respond to standard treatments.
Who is the study for?
Adults with Primary Effusion Lymphoma (PEL) that's resistant to standard treatment or those who can't receive it. Eligible participants include any HIV status, but if positive, they must have a certain CD4 count and be on effective antiretroviral therapy. They should have adequate blood and kidney function, not be pregnant, agree to contraception use during the study, and sign consent.Check my eligibility
What is being tested?
The trial is testing Daratumumab SC as an injection for PEL patients. It involves initial weekly treatments for 8 weeks, then every two weeks for 16 weeks followed by monthly doses up to two years. Participants will undergo various tests including biopsies, scans, lumbar punctures and thoracentesis over a period of up to five years.See study design
What are the potential side effects?
Potential side effects are not explicitly listed in the provided information; however, common side effects of Daratumumab may include reactions at the injection site, fatigue, nausea, fever and potential risks associated with procedures like lumbar puncture or thoracentesis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 9 and 17 weeks, and every 12 weeks from week 25 to the end of therapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 9 and 17 weeks, and every 12 weeks from week 25 to the end of therapy
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response rate (ORR)
Secondary outcome measures
Safety of daratumumab
Side effects data
From 2024 Phase 3 trial • 498 Patients • NCT0213613460%
Thrombocytopenia
50%
Peripheral sensory neuropathy
47%
Peripheral Sensory Neuropathy
36%
Upper respiratory tract infection
36%
Diarrhoea
29%
Cough
28%
Anaemia
23%
Fatigue
23%
Upper Respiratory Tract Infection
23%
Constipation
21%
Back pain
20%
Arthralgia
20%
Oedema peripheral
19%
Neutropenia
19%
Dyspnoea
18%
Insomnia
17%
Pyrexia
16%
Oedema Peripheral
15%
Nausea
14%
Lymphopenia
14%
Pain in extremity
14%
Nasopharyngitis
14%
Bronchitis
14%
Neuralgia
13%
Back Pain
13%
Dizziness
12%
Decreased appetite
12%
Vomiting
12%
Headache
12%
Hypertension
11%
Conjunctivitis
11%
Asthenia
11%
Pneumonia
11%
Hypokalaemia
10%
Muscle spasms
10%
Musculoskeletal chest pain
9%
Urinary tract infection
9%
Leukopenia
9%
Bone pain
9%
Decreased Appetite
9%
Hyperglycaemia
9%
Pain in Extremity
9%
Bronchospasm
8%
Weight decreased
8%
Muscle Spasms
8%
Abdominal pain upper
8%
Alanine aminotransferase increased
7%
Hypophosphataemia
7%
Herpes zoster
7%
Influenza
7%
Hypocalcaemia
7%
Alanine Aminotransferase Increased
7%
Rash
6%
Musculoskeletal Chest Pain
6%
Myalgia
6%
Aspartate aminotransferase increased
6%
Nasal congestion
6%
Abdominal pain
5%
Bone Pain
5%
Hypotension
5%
Abdominal Pain Upper
5%
Weight Decreased
5%
Chills
5%
Productive cough
5%
Throat irritation
5%
Herpes Zoster
5%
Oedema
5%
Paraesthesia
5%
Epistaxis
4%
Dyspepsia
2%
Atrial fibrillation
2%
Acute kidney injury
2%
Sepsis
2%
Atrial Fibrillation
1%
Acute myocardial infarction
1%
Pneumonia cytomegaloviral
1%
Pleural effusion
1%
Rib fracture
1%
Lower Respiratory Tract Infection
1%
Pulmonary sepsis
1%
Pulmonary Sepsis
1%
Hypercalcaemia
1%
Pneumonia Cytomegaloviral
1%
Cardiac failure congestive
1%
Acute coronary syndrome
1%
Lower respiratory tract infection
1%
Hip fracture
1%
Angina unstable
1%
Cerebrovascular accident
1%
Ischaemic stroke
1%
Bronchitis chronic
1%
Humerus fracture
1%
Respiratory failure
1%
Gastroenteritis
1%
Pathological fracture
1%
Femur fracture
1%
Febrile neutropenia
1%
Squamous cell carcinoma of skin
1%
Ischaemic Stroke
1%
Respiratory Failure
1%
Pathological Fracture
1%
Febrile Neutropenia
1%
Cardiac Failure Congestive
1%
Bronchopneumonia
1%
Femur Fracture
1%
Humerus Fracture
1%
Acute Kidney Injury
1%
Pleural Effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Daratumumab + Bortezomib and Dexamethasone (DVd)
Bortezomib + Dexamethasone (Vd)
Switch From Bortezomib + Dexamethasone (Vd) to Daratumumab Monotherapy
Trial Design
1Treatment groups
Experimental Treatment
Group I: Arm 1Experimental Treatment1 Intervention
Treatment with daratumumab SC
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,672 Previous Clinical Trials
40,926,774 Total Patients Enrolled
Kathryn A Lurain, M.D.Principal InvestigatorNational Cancer Institute (NCI)
3 Previous Clinical Trials
86 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My lymphoma has returned or didn't respond to initial treatment, and it's confirmed by NCI.I haven't had cancer treatment in the last 2 weeks, or it was for a cancer that won't affect this trial. Any side effects from past treatments are mild.My HIV status is any, and if positive, my CD4 count meets the required levels.I am not pregnant and do not have a severe uncontrolled illness.I am 18 years old or older.I do not have serious heart issues, severe asthma, or very poor lung function.My liver function tests are high, and my blood counts are low, but not due to severe illness.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1
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.
Does the age criterion for this experiment encompass those over fifty years of age?
"The age parameters for this trial are 18 to 120, meaning adults of any age can join."
Answered by AI
Is this medical experiment still enrolling participants?
"According to the clinicaltrials.gov website, recruitment for this trial has been halted since June 16th 2023; it was initially posted on June 22nd of that year. Although no longer enrolling participants, 1703 other studies are currently recruiting patients across the world."
Answered by AI
Has the FDA granted clearance to Arm1?
"Arm1 has been rated a 2 on the safety scale, as clinical trials have only proved its security and not yet provided evidence for therapeutic effects."
Answered by AI
Would I meet the requirements to join this clinical trial?
"Only those with primary effusion lymphoma and between 18-120 years of age qualify for this trial. Thus far, 16 participants have been successfully enrolled in the study."
Answered by AI
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