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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
Must not have
Previous treatment with a hypomethylating agent (such as azacitidine, decitabine or investigational hypomethylating agent)
Patient has any of the following cardiac abnormalities: (a) Uncontrolled, symptomatic congestive heart failure as designated by the treating physician (b) Myocardial infarction ≤ 6 months prior to enrollment (c) Unstable angina pectoris as designated by the treating physician (d) Serious uncontrolled cardiac arrhythmia as designated by the treating physician. (e) Uncontrolled hypertension as designated by the treating physician
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 months
Awards & highlights
No Placebo-Only Group
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.
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.
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.
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I can take care of myself and perform daily activities.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been treated with a drug that changes how my genes work.
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I have serious heart problems as diagnosed by my doctor.
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I have a history of HIV, Hepatitis B, or Hepatitis C.
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I do not have active or untreated latent tuberculosis.
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I have had a bone marrow or organ transplant for a blood disorder or other disease.
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I haven't taken TNF or IL-1 targeting drugs in the last 28 days.
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I have not received a live-virus vaccine in the last 30 days.
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I am allergic to darbepoetin alfa or components of the study drug.
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I am pregnant or breastfeeding.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Phase 1b: Maximum Tolerated Dose (MTD)
Phase 2: Rate of Hematologic Improvement-Erythroid (HI-E) response
Secondary study objectives
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 • NCT0077351332%
Hypertension
19%
Diarrhoea
16%
Procedural hypotension
14%
Muscle spasms
14%
Urinary tract infection
13%
Nasopharyngitis
13%
Bronchitis
13%
Pneumonia
12%
Anaemia
11%
Arteriovenous fistula site complication
11%
Hyperparathyroidism secondary
11%
Cough
10%
Hyperphosphataemia
10%
Headache
10%
Constipation
9%
Arthralgia
9%
Upper respiratory tract infection
9%
Vomiting
9%
Pain in extremity
9%
Hypotension
9%
Hyperkalaemia
8%
Atrial fibrillation
8%
Pruritus
8%
Fluid overload
8%
Back pain
8%
Dyspnoea
7%
Gastroenteritis
7%
Nausea
7%
Abdominal pain
7%
Insomnia
7%
Pyrexia
6%
Abdominal pain upper
6%
Oedema due to renal disease
6%
Asthenia
6%
Dizziness
6%
Osteoarthritis
6%
Arteriovenous fistula thrombosis
5%
Cataract
5%
Depression
5%
Sepsis
5%
Respiratory tract infection
5%
Lower respiratory tract infection
5%
Influenza
5%
Musculoskeletal pain
4%
Acute myocardial infarction
4%
Oedema peripheral
4%
Dyspepsia
4%
Cardiac arrest
4%
Myocardial infarction
4%
Epistaxis
3%
Death
3%
Sudden death
3%
Septic shock
3%
Peritonitis
2%
Acute coronary syndrome
2%
Angina unstable
2%
Transient ischaemic attack
2%
Angina pectoris
2%
Cardiac failure
2%
Arteriovenous graft thrombosis
2%
Gangrene
2%
Gastrointestinal haemorrhage
2%
Cellulitis
2%
Femur fracture
2%
Arteriovenous fistula site haemorrhage
2%
Peripheral ischaemia
2%
Peripheral arterial occlusive disease
2%
Cerebrovascular accident
2%
Pleural effusion
2%
End stage renal disease
1%
Arteriovenous fistula site infection
1%
Non-cardiogenic pulmonary oedema
1%
Chronic obstructive pulmonary disease
1%
Cholelithiasis
1%
Cardiopulmonary failure
1%
Haematoma
1%
Coronary artery disease
1%
Myocardial ischaemia
1%
Steal syndrome
1%
Musculoskeletal chest pain
1%
Staphylococcal infection
1%
Orthostatic hypotension
1%
Syncope
1%
Cerebral haemorrhage
1%
General physical health deterioration
1%
Chest pain
1%
Respiratory failure
1%
Basal cell carcinoma
1%
Device related sepsis
1%
Staphylococcal sepsis
1%
Bacteraemia
1%
Viral infection
1%
Bradycardia
1%
Atrioventricular block complete
1%
Coronary artery stenosis
1%
Femoral neck fracture
1%
Gastric ulcer
1%
Inguinal hernia
1%
Cholecystitis
1%
Peripheral vascular disorder
1%
Subdural haematoma
1%
Hypertensive crisis
1%
Peripheral artery stenosis
1%
Confusional state
1%
Infection
1%
Diabetic foot infection
1%
Erysipelas
1%
Cardiac failure acute
1%
Hip fracture
1%
Rib fracture
1%
Large intestine polyp
1%
Rectal haemorrhage
1%
Hypoglycaemia
1%
Cachexia
1%
Device malfunction
1%
Device related infection
1%
Cardiac failure congestive
1%
Cardio-respiratory arrest
1%
Aortic valve stenosis
1%
Multiple fractures
1%
Extremity necrosis
1%
Ischaemic stroke
1%
Cerebral infarction
1%
Pulmonary oedema
1%
Acute pulmonary oedema
1%
Pneumonia aspiration
1%
Renal impairment
1%
Haematuria
1%
Skin ulcer
1%
Diabetic foot
1%
Thrombosis in device
1%
Urosepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Methoxy Polyethylene Glycol-Epoetin Beta
Erythropoiesis Stimulating Agents
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
2,909 Previous Clinical Trials
4,210,123 Total Patients Enrolled
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
561 Previous Clinical Trials
144,788 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.
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