Your session is about to expire
← Back to Search
Proteasome Inhibitor
Carfilzomib + Chemotherapy for Acute Lymphoblastic Leukemia
Phase 1
Recruiting
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Performance status: Karnofsky or Lansky scores ≥ 50 for subjects > 16 years old or ≤ 16 years old, respectively
Serum creatinine level ≤ 1.5 × institutional upper limit of normal (ULN) according to age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
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.
Who is the study for?
This trial is for children and young adults up to 21 years old with relapsed or refractory acute lymphoblastic leukemia (ALL). They must have had a previous remission, good kidney and heart function, recovered from past treatments, and not be allergic to any study drugs. Pregnant or breastfeeding individuals can't join, nor those unwilling to use contraception.Check my eligibility
What is being tested?
The trial tests Carfilzomib combined with chemotherapy in two phases: Phase 1b determines the safest dose of Carfilzomib with chemo; Phase 2 compares how well this combination works against standard treatment by measuring complete remission rates after induction therapy.See study design
What are the potential side effects?
Possible side effects include reactions related to infusion of the drugs, impact on blood cells leading to increased infection risk, potential damage to organs like the liver and kidneys, nausea, vomiting, fatigue, and possible allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can do most activities by myself, regardless of my age.
Select...
My kidney function, measured by creatinine, is within the normal range for my age.
Select...
My liver functions within normal limits, except I may have Gilbert Syndrome.
Select...
My leukemia has returned or is not responding to treatment, with significant presence in my bone marrow.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete Remission (CR) Rate After Induction Therapy in Subjects Aged Less Than 12 Months at Screening
Complete Remission (CR) after induction therapy
Phase 1b: Maximum Tolerated Dose (MTD)
+6 moreSecondary outcome measures
Minimal Residual Disease (MRD) Status in Subjects with Complete Remission (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 Complete Remission (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
Number of Subjects who Experience Complete Remission (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
+18 moreSide effects data
From 2021 Phase 3 trial • 126 Patients • NCT0302923462%
Anaemia
49%
Upper respiratory tract infection
49%
Platelet count decreased
39%
White blood cell count decreased
38%
Hypertension
35%
Hypokalaemia
30%
Neutrophil count decreased
28%
Lymphocyte count decreased
23%
Pneumonia
21%
Cough
19%
Blood creatinine increased
19%
Insomnia
18%
Pyrexia
17%
Hyperuricaemia
17%
Diarrhoea
16%
Hypoalbuminaemia
16%
Hypocalcaemia
16%
Neutrophil count increased
16%
Blood lactate dehydrogenase increased
15%
Blood uric acid increased
15%
Blood pressure increased
15%
Lung infection
14%
Hyperglycaemia
14%
White blood cell count increased
14%
Blood bilirubin increased
14%
Blood glucose increased
14%
Constipation
12%
Blood urea increased
12%
Neutrophil percentage increased
11%
Alanine aminotransferase increased
11%
Hyponatraemia
11%
Hypercalcaemia
10%
Aspartate aminotransferase increased
10%
Blood potassium decreased
10%
Bronchitis
10%
Neuropathy peripheral
10%
Productive cough
10%
Oedema peripheral
10%
Lymphocyte percentage decreased
9%
Leukocytosis
8%
Blood phosphorus increased
8%
Influenza
8%
Blood albumin decreased
8%
Hypoproteinaemia
7%
Prealbumin decreased
7%
Bilirubin conjugated increased
7%
Peripheral swelling
7%
Nasopharyngitis
7%
Hypophosphataemia
7%
Back pain
7%
Abdominal distension
7%
Vomiting
7%
Cataract
7%
Mean cell volume increased
6%
Gamma-glutamyltransferase increased
6%
Hyperkalaemia
6%
Thrombocytopenia
6%
Vision blurred
6%
Respiratory tract infection
6%
Hepatic function abnormal
6%
Nausea
6%
Hypoglycaemia
3%
Plasma cell myeloma
3%
Acute kidney injury
2%
Bone pain
2%
Cardiac amyloidosis
2%
Localised infection
1%
Pain
1%
Periodontitis
1%
Myelopathy
1%
Device related infection
1%
Dysuria
1%
Pleural effusion
1%
Otitis media
1%
Pancreatitis acute
1%
Spinal compression fracture
1%
Lipoma
1%
Cerebral ischaemia
1%
Deep vein thrombosis
1%
Cardiac failure acute
1%
Soft tissue infection
1%
Nerve compression
1%
Chronic kidney disease
1%
Hypotension
1%
Asthma
1%
Bronchiolitis
1%
Pathological fracture
1%
Myolipoma
1%
Neuralgia
1%
Escherichia sepsis
1%
Interstitial lung disease
1%
Obstructive airways disorder
1%
Organising pneumonia
1%
Supraventricular tachycardia
1%
Disease progression
1%
Infusion site extravasation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Carfilzomib With Dexamethasone
Trial Design
4Treatment groups
Experimental Treatment
Group I: Phase 2: Aged ≥ 12 months at screeningExperimental Treatment10 Interventions
All subjects aged ≥ 12 months at screening.
Subjects will receive the recommended phase 2 dose (RP2D) of carfilzomib determined in Phase 1b.
Subjects will receive a 4 week cycle of carfilzomib and induction chemotherapy comprising of a VXLD backbone of vincristine, dexamethasone, PEG asparaginase and daunorubicin. Subjects will then have the option to receive a 4 week cycle of carfilzomib in combination with consolidation chemotherapy Children's Oncology Group (COG) modified Berlin Frankfurt Münster (BFM) chemotherapy backbone (6 mercaptopurine, cyclophosphamide, cytarabine, PEG asparaginase, vincristine) if subjects showed no disease progression at the end of the Induction Cycle.
Group II: Phase 2: Aged < 12 months at screeningExperimental Treatment10 Interventions
All subjects aged < 12 months at screening.
Subjects will receive the recommended phase 2 dose (RP2D) of carfilzomib determined in Phase 1b.
Subjects will receive a modified 5 week cycle (based on Interfant-06) of carfilzomib and induction chemotherapy comprising of a VXLD backbone of vincristine, dexamethasone, PEG asparaginase and daunorubicin. Subjects will then have the option to receive a 5 week cycle (modified based on Interfant-06) of carfilzomib in combination with consolidation chemotherapy Children's Oncology Group (COG) modified Berlin Frankfurt Münster (BFM) chemotherapy backbone (6 mercaptopurine, cyclophosphamide, cytarabine, PEG asparaginase, vincristine), if subjects showed no disease progression at the end of the Induction Cycle.
Group III: Phase 1b: Dose Escalation 2Experimental Treatment10 Interventions
Subjects will receive carfilzomib in combination with induction chemotherapy, comprising a VXLD backbone of vincristine, dexamethasone, PEG asparaginase, and daunorubicin.
Subjects will receive a 4 week cycle of carfilzomib and induction chemotherapy and then have the option to receive a 4 week cycle of consolidation chemotherapy (Children's Oncology Group (COG) modified Berlin Frankfurt Münster (BFM) chemotherapy backbone (6 mercaptopurine, cyclophosphamide, cytarabine, PEG asparaginase, vincristine), if stable disease or better response is achieved at the end of the Induction Cycle.
Group IV: Phase 1b: Dose Escalation 1Experimental Treatment10 Interventions
Subjects will receive carfilzomib in combination with induction chemotherapy, comprising an R3 backbone of dexamethasone, mitoxantrone, PEG asparaginase, and vincristine.
Subjects will have a 1 week carfilzomib single agent Lead in Window prior to the Induction Cycle.
Subjects will receive a 4 week cycle of induction chemotherapy and have the option to receive a 4 week cycle of consolidation chemotherapy (Children's Oncology Group (COG) modified Berlin Frankfurt Münster (BFM) chemotherapy backbone (6 mercaptopurine, cyclophosphamide, cytarabine, PEG asparaginase, vincristine), if stable disease or better response is achieved at the end of the Induction Cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PEG-asparaginase
2006
Completed Phase 3
~340
Cytarabine
2016
Completed Phase 3
~3310
Vincristine
2003
Completed Phase 4
~2910
Carfilzomib
2017
Completed Phase 3
~1440
Dexamethasone
2007
Completed Phase 4
~2590
Mitoxantrone
2008
Completed Phase 3
~1510
6-Mercaptopurine
2011
Completed Phase 4
~220
Cyclophosphamide
1995
Completed Phase 3
~3770
Daunorubicin
2013
Completed Phase 4
~4940
Find a Location
Who is running the clinical trial?
Therapeutic Advances in Childhood Leukemia & Lymphoma (TACL) - Study Design & Execution CollaboratorUNKNOWN
Innovative Therapies For Children with Cancer ConsortiumOTHER
12 Previous Clinical Trials
1,968 Total Patients Enrolled
AmgenLead Sponsor
1,370 Previous Clinical Trials
1,377,558 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can do most activities by myself, regardless of my age.My kidney function, measured by creatinine, is within the normal range for my age.My liver functions within normal limits, except I may have Gilbert Syndrome.I am receiving treatment for active graft-versus-host disease.I have Hepatitis B with detectable virus levels.I have been treated with carfilzomib before.My leukemia has returned or is not responding to treatment, with significant presence in my bone marrow.I have undergone at least one treatment for my condition.I still have side effects from previous cancer treatments.My cancer has returned outside the bone marrow.I cannot tolerate or am allergic to the drugs in the VXLD chemotherapy regimen.I have had a severe pancreatitis attack in the last 6 months.I had a stem cell transplant using my own cells within the last 6 weeks.I am of childbearing age and not currently pregnant.I currently have an active viral infection.My heart rhythm is irregular or my ECG shows a QTc over 470 msec.I am willing to abstain from donating semen or sperm.I have no lingering side effects from past cancer treatments.I am a man who will not use condoms or abstain from sex with my partner who can have children.I am not pregnant, breastfeeding, nor planning to during treatment.I will not use a condom or abstain if my partner is pregnant.I had a stem cell transplant from a donor within the last 3 months.I was 21 or younger when first diagnosed with ALL and am now over 1 year old.I have no significant health issues other than my current condition.I am not willing to use a highly effective birth control method.I am currently on medication for graft-versus-host disease.I have had a severe inflammation of the pancreas.I have another active cancer besides the one being studied.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1b: Dose Escalation 1
- Group 2: Phase 1b: Dose Escalation 2
- Group 3: Phase 2: Aged ≥ 12 months at screening
- Group 4: Phase 2: Aged < 12 months at screening
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.
What are the primary treatments where Carfilzomib is prescribed?
"Carfilzomib is typically utilized to handle pheochromocytomas, yet it has been found effective for a plethora of other maladies including ocular conditions, ulcerative colitis, and varicella-zoster virus acute retinal necrosis."
Answered by AI
Does this trial include participants aged 25 or older?
"The criteria for inclusion in this medical study requires patients to be between one month and twenty-one years old. According to the data, there are 891 trials available for minors while 2494 exist for people 65 or older."
Answered by AI
How many participants are observing the effects of this research project?
"Amgen, the sponsor of this medical trial, requires 118 participants to meet its inclusionary criteria. This research project will be running out of multiple sites, with Children's Mercy Hospital in Columbus and Children's Healthcare of Atlanta, Egleston located within Kansas City being two examples."
Answered by AI
Do I qualify to participate in this clinical exploration?
"In order to qualify for this trial, individuals must possess the diagnosis of leukemia and/or lymphoid malignancy, as well as be aged between 1 month and 21 years. This medical study is seeking a total of 118 participants."
Answered by AI
Could you enumerate the other investigations which have examined Carfilzomib?
"Carfilzomib was initially studied at the National Institutes of Health Clinical Center back in 1995. To date, 3012 clinical trials have been conducted on this drug and 1639 are currently recruiting participants- a large portion being based out of Columbus, Missouri."
Answered by AI
Are there any known risks associated with Carfilzomib administration?
"Due to a lack of data concerning safety and efficacy, Carfilzomib was assigned a score of 1."
Answered by AI
Are individuals able to experience the advantages of this clinical trial currently?
"According to clinicaltrials.gov, this research is still open for enrolment. The trial was originally made available on February 16th 2015 and has seen its most recent edit as of November 14th 2022."
Answered by AI
Are there a plethora of medical facilities conducting this investigation in the state?
"This investigation is available at 38 distinct locations, such as Children's Mercy Hospital in Columbus, Children's Healthcare of Atlanta and Egleston in Kansas City. Moreover, Lurie Children’s Hospital of Chicago is also among other sites participating in the trial."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger