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Monoclonal Antibodies
Canakinumab + Darbepoetin Alfa for Myelodysplastic Syndrome
Phase 1 & 2
Recruiting
Led By David A Sallman, MD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documented diagnosis of MDS by World Health Organization (WHO) criteria, further meeting the following criteria according to disease risk classification
Patients must be transfusion dependent, defined as requirement for transfusion of at least 3 units of Packed Red Blood cells (PRBCs) 16 weeks for a Hgb<9.0g/dL or, in non-transfusion dependent patients (<3 units of PRBCs transfused in the preceding 16 weeks), must have a baseline Hgb of <9.0 g/dL at time of study enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 months
Awards & highlights
Study Summary
This trial is testing a new combination treatment for patients with a blood disorder who have failed other treatments.
Who is the study for?
This trial is for patients with lower-risk Myelodysplastic Syndrome (MDS) who didn't respond to previous Erythropoietin Stimulating Agent treatment. Participants must have adequate organ function, be transfusion dependent or have low hemoglobin levels, and not be pregnant or breastfeeding. They should agree to use contraception and cannot have had certain heart conditions, other cancers within 2 years, or treatments like hypomethylating agents.Check my eligibility
What is being tested?
The study tests the combination of Canakinumab Injection with Darbepoetin Alfa in MDS patients who failed prior ESA therapy. It's an open-label Phase 1b/2 trial assessing both the safety (toxicity) and effectiveness (efficacy) of this drug combo.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to the drugs' components, increased risk of infections due to immune system suppression by Canakinumab, and typical medication-related issues such as fatigue, nausea, or headaches.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with MDS according to WHO standards.
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I need blood transfusions regularly or my hemoglobin is below 9.0 g/dL.
Select...
I can take care of myself and perform daily activities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1b: Maximum Tolerated Dose (MTD)
Phase 2: Rate of Hematologic Improvement-Erythroid (HI-E) response
Secondary outcome measures
Phase 1b and Phase 2: Degree in reduction of PRBC Transfusions
Phase 1b and Phase 2: Duration of Hematologic Improvement-Erythroid (HI-E) response
Phase 2: Duration of Response
+3 moreSide effects data
From 2017 Phase 4 trial • 2825 Patients • NCT0077351331%
Hypertension
19%
Diarrhoea
16%
Procedural hypotension
15%
Muscle spasms
14%
Bronchitis
14%
Urinary tract infection
14%
Cough
12%
Pneumonia
12%
Nasopharyngitis
12%
Constipation
12%
Arteriovenous fistula site complication
11%
Back pain
11%
Hyperparathyroidism secondary
11%
Upper respiratory tract infection
10%
Vomiting
10%
Anaemia
10%
Hypotension
10%
Hyperkalaemia
10%
Hyperphosphataemia
9%
Headache
9%
Fluid overload
9%
Atrial fibrillation
9%
Pain in extremity
8%
Arthralgia
8%
Pruritus
8%
Insomnia
8%
Arteriovenous fistula thrombosis
8%
Dyspnoea
7%
Osteoarthritis
7%
Gastroenteritis
7%
Nausea
7%
Pyrexia
6%
Dyspepsia
6%
Dizziness
6%
Abdominal pain
6%
Sepsis
6%
Influenza
6%
Musculoskeletal pain
6%
Oedema due to renal disease
5%
Oedema peripheral
5%
Acute myocardial infarction
5%
Cataract
5%
Depression
5%
Abdominal pain upper
5%
Respiratory tract infection
5%
Epistaxis
4%
Asthenia
4%
Myocardial infarction
4%
Lower respiratory tract infection
3%
Peritonitis
3%
Septic shock
3%
Cardiac arrest
3%
Angina pectoris
2%
Sudden death
2%
Device related sepsis
2%
Cardiac failure
2%
Acute coronary syndrome
2%
Cardiac failure congestive
2%
Syncope
2%
Cellulitis
2%
Gastrointestinal haemorrhage
2%
Device related infection
2%
Coronary artery disease
2%
Femur fracture
2%
Peripheral ischaemia
2%
Peripheral arterial occlusive disease
2%
Ischaemic stroke
2%
Cerebrovascular accident
2%
Death
2%
Pleural effusion
2%
Non-cardiogenic pulmonary oedema
2%
End stage renal disease
1%
Cholecystitis
1%
Non-cardiac chest pain
1%
Gangrene
1%
Staphylococcal bacteraemia
1%
Atrial flutter
1%
Subdural haematoma
1%
Femoral neck fracture
1%
Gastric ulcer haemorrhage
1%
General physical health deterioration
1%
Intestinal obstruction
1%
Hypertensive crisis
1%
Deep vein thrombosis
1%
Staphylococcal sepsis
1%
Bacteraemia
1%
Catheter site infection
1%
Cardiogenic shock
1%
Arteriovenous fistula aneurysm
1%
Arteriovenous fistula site infection
1%
Myocardial ischaemia
1%
Arteriovenous graft thrombosis
1%
Angina unstable
1%
Cardio-respiratory arrest
1%
Intestinal ischaemia
1%
Seizure
1%
Pancreatitis acute
1%
Colitis
1%
Cholecystitis acute
1%
Chest pain
1%
Arthritis bacterial
1%
Lung infection
1%
Hip fracture
1%
Pelvic fracture
1%
Peripheral artery stenosis
1%
Confusional state
1%
Infected skin ulcer
1%
Diverticulitis
1%
Erysipelas
1%
Endocarditis
1%
Peripheral vascular disorder
1%
Aortic stenosis
1%
Post procedural haemorrhage
1%
Rib fracture
1%
Head injury
1%
Large intestine polyp
1%
Rectal haemorrhage
1%
Gastritis
1%
Hypoglycaemia
1%
Cachexia
1%
Hyperglycaemia
1%
Diabetic foot infection
1%
Postoperative wound infection
1%
Bradycardia
1%
Aortic valve stenosis
1%
Arteriovenous fistula site haemorrhage
1%
Fall
1%
Extremity necrosis
1%
Transient ischaemic attack
1%
Pulmonary oedema
1%
Acute pulmonary oedema
1%
Chronic obstructive pulmonary disease
1%
Pneumonia aspiration
1%
Pulmonary embolism
1%
Renal impairment
1%
Skin ulcer
1%
Diabetic foot
1%
Urosepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Erythropoiesis Stimulating Agents
Methoxy Polyethylene Glycol-Epoetin Beta
Trial Design
3Treatment groups
Experimental Treatment
Group I: Phase 2: Treatment at Maximum Tolerated DoseExperimental Treatment2 Interventions
Patients will be treated with Darbepoetin alfa subcutaneously at a dose of 300 mg on days 1 and 15 of each cycle plus the maximum tolerated dose of Canakinumab.
Group II: Phase 1b: Dose Level 2Experimental Treatment2 Interventions
Patients will be treated at dose level 2: Canakinumab 300 mg by subcutaneous injection on day 1 of each 28 day cycle. Darbepoetin alfa will be administered subcutaneously at a dose of 300mg on days 1 and 15 of each cycle.
Group III: Phase 1b: Dose Level 1Experimental Treatment2 Interventions
Patients will be treated at dose level 1: Canakinumab 150 mg by subcutaneous injection on day 1 of each 28 day cycle. Darbepoetin alfa will be administered subcutaneously at a dose of 300mg on days 1 and 15 of each cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Darbepoetin Alfa
2008
Completed Phase 4
~5950
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsIndustry Sponsor
2,855 Previous Clinical Trials
4,197,313 Total Patients Enrolled
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
542 Previous Clinical Trials
135,451 Total Patients Enrolled
David A Sallman, MDPrincipal InvestigatorMoffitt Cancer Center
2 Previous Clinical Trials
239 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have serious heart problems as diagnosed by my doctor.I have been diagnosed with MDS according to WHO standards.I can take care of myself and perform daily activities.I do not have an active, serious infection or uncontrolled fever.I am allergic to darbepoetin alfa or components of the study drug.I have been treated with a drug that changes how my genes work.I haven't used any chemotherapy or experimental drugs for MDS in the last 14 days.I have a history of HIV, Hepatitis B, or Hepatitis C.I have had a bone marrow or organ transplant for a blood disorder or other disease.I haven't taken TNF or IL-1 targeting drugs in the last 28 days.My organ functions are within normal ranges.I haven't taken high-dose steroids in the last 14 days.I am not using growth factors, or will stop them two weeks before the study, except for short-term G-CSF for febrile neutropenia.I do not have active or untreated latent tuberculosis.I haven't had any cancer except for minor ones like skin or superficial bladder cancer in the last 2 years.I have not received a live-virus vaccine in the last 30 days.I am pregnant or breastfeeding.I agree to use effective birth control or practice abstinence during the study.I need blood transfusions regularly or my hemoglobin is below 9.0 g/dL.I have taken a pregnancy test in the last 28 days and it was negative.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1b: Dose Level 1
- Group 2: Phase 2: Treatment at Maximum Tolerated Dose
- Group 3: Phase 1b: Dose Level 2
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.
Are there open positions available for this clinical trial?
"According to information available on clinicaltrials.gov, this medical experiment is currently seeking participants. It was inaugurated on March 30th 2021 and its parameters were last revised November 21st 2022."
Answered by AI
What is the extent of participation in this research initiative?
"Correct. Clinicaltrials.gov's records reveal that this medical trial, which was first published on March 30th 2021, is currently recruiting participants. A total of 41 patients are required at a single research centre."
Answered by AI
Have any prior investigations been conducted concerning Darbepoetin Alfa?
"Presently, Darbepoetin Alfa is the subject of 21 clinical trials. Of these studies, 5 are at Phase 3 and primary research sites are located in Houston, TX; however there exist over 600 other medical centres also conducting experiments involving this drug."
Answered by AI
In what ways is Darbepoetin Alfa typically employed?
"Darbepoetin Alfa is effective at addressing active systemic juvenile idiopathic arthritis and a range of other disorders such as Nomid, CKD, and anemia."
Answered by AI
What aims is this investigation attempting to accomplish?
"This clinical trial has two primary goals. The first is to evaluate the Maximum Tolerated Dose of canakinumab over an 8-12 week period from baseline. Secondary objectives include assessing Duration of Response, Overall Survival and Progression Free Survival in accordance with International Working Group criteria."
Answered by AI
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