Carfilzomib for Leukemia, Lymphoid
Phase-Based Progress Estimates
Effectiveness
Safety
Leukemia, Lymphoid+3 More
Carfilzomib - DrugEligibility
< 65
All Sexes
What conditions do you have?
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Eligibility
< 65
All Sexes
What conditions do you have?
Select
Study Summary
This trial is for children with relapsed or refractory acute lymphoblastic leukemia. The goal is to see if carfilzomib is safe and effective when combined with other drugs.
Eligible Conditions
- Leukemia, Lymphoid
- Acute Lymphoblastic Leukemia (ALL)
Treatment Effectiveness
Effectiveness Progress
Study Objectives
11 Primary · 22 Secondary · Reporting Duration: 36 months
29 months
Minimal Residual Disease (MRD) Status in Subjects with Complete Response (CR), CR with Incomplete Recovery of Platelets (CRp), CR with Partial Hematological Recovery (CRh) or CR with Incomplete Hematological Recovery (CRi)
Number of Subjects who Experience a Stem Cell Transplant or Chimeric Antigen Receptor T Cell Therapy (CAR-T)
Phase 2: Area Under the Concentration-time Curve (AUC)
Phase 2: Duration of Response (DOR)
Phase 2: Event Free Survival (EFS)
Phase 2: Half-life (t1/2) of Carfilzomib
Phase 2: Maximum Plasma Concentration (Cmax)
Phase 2: Minimal Residual Disease (MRD) Status in all Subjects
Phase 2: Number of Subjects who Experience Complete Response (CR), Complete Response with Incomplete Recovery of Platelets (CRp), or Complete Response with Incomplete Hematological Recovery (CRi)
Phase 2: Number of Subjects who Experience a Clinically Significant Change from Baseline in Laboratory Analytes
Phase 2: Number of Subjects who Experience a Laboratory Abnormality
Phase 2: Number of Subjects who Experience a Severe Adverse Event
Phase 2: Number of Subjects who Experience a Treatment-emergent Adverse Event (TEAE)
Phase 2: Number of Subjects who Experience a Treatment-related Adverse Event
Phase 2: Overall Survival (OS)
36 months
Phase 1b: Maximum Tolerated Dose (MTD)
Phase 1b: Maximum plasma concentration (Cmax)
Phase 1b: Minimal Residual Disease (MRD) Status
Phase 1b: Number of Subjects who Experience Complete Response (CR) or Complete Response with Incomplete Hematological Recovery (CRi)
Phase 1b: Number of Subjects who Experience One or More Adverse Events (AE)
Phase 1b: Number of Subjects who Experience One or More Serious Adverse Events (SAEs)
Phase 1b: Number of Subjects who Experience a Clinically Significant Change from Baseline in Physical Findings
Phase 1b: Number of Subjects who Experience a Clinically Significant Change from Baseline in Vital Signs
Phase 1b: Number of Subjects who Experienced a Clinically Significant Change from Baseline in Key Laboratory Analytes
Phase 1b: Time to Toxicity
Phase 1b: Total Plasma Exposure - Area Under the Curve (AUC)
Day 29 and 45
Number of Subjects who Experience Complete Response (CR), CR with Incomplete Recovery of Platelets (CRp), or CR with Incomplete Hematological Recovery (CRi) After Consolidation Therapy in Subjects Aged Greater Than or Equal to 12 Months at Screening
Day 36 to 50
Number of Subjects who Experience Complete Response (CR), CR with Incomplete Recovery of Platelets (CRp), or CR with Incomplete Hematological Recovery (CRi) After Consolidation Therapy in Subjects Aged Less than 12 Months at Screening
Number of Subjects who Experience Complete Response (CR), CR with Incomplete Recovery of Platelets (CRp), or CR with Incomplete Hematological Recovery (CRi) After Consolidation Therapy in Subjects Aged ≥ 12 Months at Screening
Day 45
Phase 2: Complete Response (CR) Rate After Induction Therapy in Subjects Aged Greater Than or Equal to 12 Months at Screening
Phase 2: Complete Response (CR) Rate After Induction Therapy in Subjects Aged ≥ 12 Months at Screening
Day 50
Phase 2: Complete Response (CR) Rate After Induction Therapy in Subjects Aged < 12 Months at Screening
Phase 2: Complete Response (CR) Rate After Induction Therapy in Subjects Aged Less Than 12 Months at Screening
Trial Safety
Safety Progress
Side Effects for
Carfilzomib With Dexamethasone
62%Anaemia
49%Platelet count decreased
49%Upper respiratory tract infection
39%White blood cell count decreased
38%Hypertension
35%Hypokalaemia
30%Neutrophil count decreased
28%Lymphocyte count decreased
23%Pneumonia
21%Cough
19%Insomnia
19%Blood creatinine increased
18%Pyrexia
17%Hyperuricaemia
17%Diarrhoea
16%Blood lactate dehydrogenase increased
16%Hypoalbuminaemia
16%Hypocalcaemia
16%Neutrophil count increased
15%Blood uric acid increased
15%Blood pressure increased
15%Lung infection
14%Blood bilirubin increased
14%White blood cell count increased
14%Hyperglycaemia
14%Blood glucose increased
14%Constipation
12%Blood urea increased
12%Neutrophil percentage increased
11%Hyponatraemia
11%Alanine aminotransferase increased
11%Hypercalcaemia
10%Blood potassium decreased
10%Productive cough
10%Lymphocyte percentage decreased
10%Oedema peripheral
10%Bronchitis
10%Neuropathy peripheral
10%Aspartate aminotransferase increased
9%Leukocytosis
8%Hypoproteinaemia
8%Blood phosphorus increased
8%Blood albumin decreased
8%Influenza
7%Mean cell volume increased
7%Cataract
7%Hypophosphataemia
7%Back pain
7%Bilirubin conjugated increased
7%Prealbumin decreased
7%Vomiting
7%Peripheral swelling
7%Nasopharyngitis
7%Abdominal distension
6%Thrombocytopenia
6%Nausea
6%Hypoglycaemia
6%Respiratory tract infection
6%Vision blurred
6%Hyperkalaemia
6%Gamma-glutamyltransferase increased
6%Hepatic function abnormal
3%Acute kidney injury
3%Plasma cell myeloma
2%Cardiac amyloidosis
2%Bone pain
2%Localised infection
1%Interstitial lung disease
1%Pleural effusion
1%Otitis media
1%Pancreatitis acute
1%Cerebral ischaemia
1%Spinal compression fracture
1%Periodontitis
1%Soft tissue infection
1%Dysuria
1%Infusion site extravasation
1%Obstructive airways disorder
1%Lipoma
1%Organising pneumonia
1%Pathological fracture
1%Pain
1%Device related infection
1%Disease progression
1%Asthma
1%Nerve compression
1%Myolipoma
1%Escherichia sepsis
1%Deep vein thrombosis
1%Myelopathy
1%Cardiac failure acute
1%Bronchiolitis
1%Supraventricular tachycardia
1%Chronic kidney disease
1%Neuralgia
1%Hypotension
Trial Design
4 Treatment Groups
Phase 2: Aged < 12 months at screening
1 of 4
Phase 1b: Dose Escalation 2
1 of 4
Phase 2: Aged ≥ 12 months at screening
1 of 4
Phase 1b: Dose Escalation 1
1 of 4
Experimental Treatment
118 Total Participants · 4 Treatment Groups
Primary Treatment: Carfilzomib · No Placebo Group · Phase 1
Phase 2: Aged < 12 months at screeningExperimental Group · 10 Interventions: PEG-asparaginase, Intrathecal Triple Therapy (Intrathecal Cytarabine, Hydrocortisone, and Methotrexate), Cytarabine, Vincristine, Carfilzomib, Intrathecal (IT) Methotrexate, Dexamethasone, 6-Mercaptopurine, Cyclophosphamide, Daunorubicin · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug
Phase 1b: Dose Escalation 2Experimental Group · 10 Interventions: PEG-asparaginase, Intrathecal Triple Therapy (Intrathecal Cytarabine, Hydrocortisone, and Methotrexate), Cytarabine, Vincristine, Carfilzomib, Intrathecal (IT) Methotrexate, Dexamethasone, 6-Mercaptopurine, Cyclophosphamide, Daunorubicin · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug
Phase 2: Aged ≥ 12 months at screeningExperimental Group · 10 Interventions: PEG-asparaginase, Intrathecal Triple Therapy (Intrathecal Cytarabine, Hydrocortisone, and Methotrexate), Cytarabine, Vincristine, Carfilzomib, Intrathecal (IT) Methotrexate, Dexamethasone, 6-Mercaptopurine, Cyclophosphamide, Daunorubicin · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug
Phase 1b: Dose Escalation 1Experimental Group · 10 Interventions: Mitoxantrone, PEG-asparaginase, Intrathecal Triple Therapy (Intrathecal Cytarabine, Hydrocortisone, and Methotrexate), Cytarabine, Vincristine, Carfilzomib, Intrathecal (IT) Methotrexate, Dexamethasone, 6-Mercaptopurine, Cyclophosphamide · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mitoxantrone
FDA approved
Pegaspargase
FDA approved
Cytarabine
FDA approved
Vincristine
FDA approved
Carfilzomib
FDA approved
Dexamethasone
FDA approved
Mercaptopurine
FDA approved
Cyclophosphamide
FDA approved
Daunorubicin
FDA approved
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 36 months
Who is running the clinical trial?
Innovative Therapies For Children with Cancer ConsortiumOTHER
8 Previous Clinical Trials
1,823 Total Patients Enrolled
1 Trials studying Leukemia, Lymphoid
2 Patients Enrolled for Leukemia, Lymphoid
Therapeutic Advances in Childhood Leukemia & Lymphoma (TACL) - Study Design & Execution CollaboratorUNKNOWN
AmgenLead Sponsor
1,291 Previous Clinical Trials
1,326,961 Total Patients Enrolled
31 Trials studying Leukemia, Lymphoid
12,092 Patients Enrolled for Leukemia, Lymphoid
MDStudy DirectorAmgen
834 Previous Clinical Trials
896,211 Total Patients Enrolled
14 Trials studying Leukemia, Lymphoid
4,221 Patients Enrolled for Leukemia, Lymphoid
Eligibility Criteria
Age < 65 · All Participants · 10 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:Patients who were 21 years or younger at the time of their initial ALL diagnosis and were > 1 year old at the time of study treatment initiation were eligible for this study.
Patients must have a diagnosis of relapsed or refractory leukemia with ≥ 5% blasts in the bone marrow, with or without extramedullary disease.
Before enrolling in the study, subjects must have fully recovered from the acute toxic effects of all previous chemotherapy, immunotherapy, or radiotherapy treatment.
The total bilirubin level should be less than 1.5 times the institutional ULN, with the exception of Gilbert Syndrome.
The patient's performance status is good, with a Karnofsky or Lansky score of ≥ 50 for those over 16 years old or ≤ 16 years old, respectively.
The subject's legal representative has provided informed consent when the subject is too young to provide informed consent
First relapse of leukemia that occurs after the original diagnosis, no matter how long it has been since the original diagnosis was made, or whether the person has had one or more relapses.
Excluded are subjects with chronic kidney disease (CKD) who are estimated to have a GFR ≤ 30 mL/min/1.73 m2, subjects with a serum creatinine level > 1.5 × ULN, and subjects for whom a reliable serum creatinine value is not available
Alanine aminotransferase below the institutional upper limit of 5.
You have a relapse within 36 months of achieving a CR (B-ALL) or within 12 months of achieving a CR (T-ALL).
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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