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Proteasome Inhibitor
Ixazomib + Chemotherapy for Leukemia
Phase 1 & 2
Waitlist Available
Research Sponsored by Therapeutic Advances in Childhood Leukemia Consortium
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Prior Therapy F. XRT: Craniospinal XRT is prohibited during protocol therapy
Performance Level Karnofsky ≥ 50% for patients > 16 years of age and Lansky ≥ 50% for patients ≤ 16 years of age.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 weeks
Awards & highlights
Study Summary
This trial is testing a new cancer drug, Ixazomib, to see if it is safe and effective when used with other chemotherapy drugs to treat leukemia.
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) or Lymphoblastic Lymphoma (LLy). Participants must have tried previous therapies, have a certain level of physical ability, and not be breastfeeding. They can't join if they've had too much exposure to anthracyclines, specific CNS diseases, ongoing infections without improvement, significant concurrent illnesses that could affect safety or compliance, DNA fragility syndromes, certain levels of neuropathy, or are on disallowed medications.Check my eligibility
What is being tested?
The study tests Ixazomib combined with chemotherapy drugs Vincristine, Dexamethasone, Asparaginase and Doxorubicin in patients who haven't responded well to other treatments. It's designed in two phases: Phase 1 focuses on the drug's safety and tolerability while Phase 2 evaluates its effectiveness against ALL/LLy.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system such as allergies; blood disorders; nerve damage which might cause sensory changes like numbness; heart problems due to prior use of similar drugs; liver and kidney function issues; fatigue from treatment intensity; digestive disturbances from chemotherapy agents.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have not had craniospinal radiation therapy during this treatment.
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I am mostly able to care for myself, regardless of my age.
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I have received less than 400 mg/m^2 of anthracyclines in my lifetime.
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I am 21 years old or younger.
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I have relapsed or refractory acute lymphoblastic leukemia or lymphoblastic lymphoma.
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I agree not to breastfeed while participating in this study.
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I have relapsed or refractory ALL or LLy, but not Burkitt-like leukemia.
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I am 21 years old or younger.
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It has been over 2 weeks since my last strong chemotherapy.
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My leukemia shows more than 5% of cells are immature.
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I have relapsed or refractory ALL or LLy, not including certain types.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1: Dose limiting toxicity (DLT) during block 1 of chemotherapy
Side effects data
From 2021 Phase 4 trial • 45 Patients • NCT0341637426%
Diarrhoea
23%
White blood cell count decreased
21%
Platelet count decreased
15%
Neutrophil count decreased
13%
Pneumonia
8%
Rash
8%
Anaemia
8%
Constipation
8%
Malaise
8%
Pyrexia
5%
Acute kidney injury
5%
Nasopharyngitis
5%
Influenza
3%
Pneumonia bacterial
3%
Tumour lysis syndrome
3%
Febrile neutropenia
3%
Prinzmetal angina
3%
Bile duct stone
3%
Gastroenteritis
3%
Interstitial lung disease
3%
Taste disorder
3%
Enterocolitis
3%
Duodenal ulcer
100%
80%
60%
40%
20%
0%
Study treatment Arm
[KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy
[Overall]; Combination Therapy + Ixazomib Therapy
[VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy
Trial Design
4Treatment groups
Experimental Treatment
Group I: Ixazomib Dose Level 2 (Stratum A)Experimental Treatment7 Interventions
Patients will be treated on ixazomib at 2.0 mg/m^2/day on Days 1, 4, 8, and 11. Vincristine IV at 1.5 mg/m^2 on Days 1, 8, 15 and 22. Pegaspargase IV/IM at 2500 IU/m^2 on Days 2 and 15, Doxorubicin at 60 mg/m^2 on Days 1, Dexamethasone IV/PO at 10 mg/m^2 continuous starting on Day 1 thru Day 14, and IT chemotherapy dependent on patient's CNS status at time of enrollment. Patients will be treated at this arm Dose Level once patient accrual at Dose Level 1 has been completed and dose escalation is allowed as defined by the 3+3 design.
Group II: Ixazomib Dose Level 1 (Stratum B)Experimental Treatment8 Interventions
Patients will be treated on ixazomib at 1.6 mg/m^2/day on Days 1, 4, 8, and 11. Vincristine IV at 1.5 mg/m^2 on Days 1, 8, 15 and 22. Pegaspargase IV/IM at 2500 IU/m^2 on Days 2 and 15, Doxorubicin at 60 mg/m^2 on Days 1, Dexamethasone IV/PO at 10 mg/m^2 continuous starting on Day 1 thru Day 14, and IT chemotherapy dependent on patient's CNS status at time of enrollment. Leucovorin PO/IV at 5 mg/m^2/dose X 2 doses given 24 and 30 hours after IT Methotrexate or Triple IT will also be given on this arm. This arm is only for patients with Down syndrome (Stratum B).
Group III: Ixazomib Dose Level 1 (Stratum A)Experimental Treatment7 Interventions
Patients will be treated on ixazomib at 1.6 mg/m^2/day on Days 1, 4, 8, and 11. Vincristine IV at 1.5 mg/m^2 on Days 1, 8, 15 and 22. Pegaspargase IV/IM at 2500 IU/m^2 on Days 2 and 15, Doxorubicin at 60 mg/m^2 on Days 1, Dexamethasone IV/PO at 10 mg/m^2 continuous starting on Day 1 thru Day 14, and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.
Group IV: Ixazomib Dose Level -1 (Stratum A)Experimental Treatment7 Interventions
Patients will be treated on ixazomib at 1.2 mg/m^2/day on Days 1, 4, 8, and 11. Vincristine IV at 1.5 mg/m^2 on Days 1, 8, 15 and 22. Pegaspargase IV/IM at 2500 IU/m^2 on Days 2 and 15, Doxorubicin at 60 mg/m^2 on Days 1, Dexamethasone IV/PO at 10 mg/m^2 continuous starting on Day 1 thru Day 14, and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm Dose Level -1 is needed only if de-escalation from Dose Level 1 is required.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ixazomib
FDA approved
Vincristine
FDA approved
Dexamethasone
FDA approved
Asparaginase Escherichia coli
FDA approved
Doxorubicin
FDA approved
Leucovorin
2005
Completed Phase 4
~5730
Find a Location
Who is running the clinical trial?
Therapeutic Advances in Childhood Leukemia ConsortiumLead Sponsor
20 Previous Clinical Trials
646 Total Patients Enrolled
TakedaIndustry Sponsor
1,202 Previous Clinical Trials
4,178,231 Total Patients Enrolled
Children's Hospital Los AngelesOTHER
232 Previous Clinical Trials
5,076,737 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is only in my brain/CNS or testicles.I have not had craniospinal radiation therapy during this treatment.I plan to receive other cancer treatments not part of the study.It's been over 3 weeks since my last monoclonal antibody treatment.I am mostly able to care for myself, regardless of my age.I have tried treatments for my condition before.I have received less than 400 mg/m^2 of anthracyclines in my lifetime.I have recovered from side effects of my last cancer treatment.I am 21 years old or younger.My heart is functioning well.My kidneys are working well.I am under 18 and part of the first 9 young patients to enroll.My treatment is in Phase 2 of clinical trials.I am not taking any experimental drugs, anti-GVHD medications after a transplant, or CYP3A4 agents.Patients must have a way to measure their disease through medical tests or physical exams.I haven't taken any blood cell growth factors in the last 7 to 14 days.I had a positive response to a proteasome inhibitor with chemotherapy.I am mostly capable of self-care and daily activities.It has been over 30 days since my last immunotherapy treatment.I have an ongoing infection that hasn't improved with treatment.I can start or continue maintenance therapy until 24 hours before my new treatment begins.It's been over a week since my last biologic treatment.I am not allergic to the medications used in this study, except for Pegaspargase.I have relapsed or refractory acute lymphoblastic leukemia or lymphoblastic lymphoma.I agree not to breastfeed while participating in this study.I can start or keep taking hydroxyurea until 24 hours before my treatment begins.I have ALL or LLy and have undergone previous treatments without success.I am under 18 and eligible for the initial phase of the trial.I have moderate to severe numbness, tingling, or muscle weakness.My liver is working well.I am a woman who can have children and have a recent negative pregnancy test.I have relapsed or refractory ALL or LLy, but not Burkitt-like leukemia.I am 21 years old or younger.It has been over 2 weeks since my last strong chemotherapy.I understand the study's risks and benefits and can sign the consent.I am under 18 years old.My leukemia shows more than 5% of cells are immature.I am under 18 and eligible for the initial phase of the trial.I do not have conditions like Fanconi anemia or Bloom syndrome.I have Ph+ or Ph-like ALL and am on TKI therapy.I have been treated with a high dose of anthracyclines.You have LLy and your disease can be measured by physical exam, imaging, or biopsy.I have relapsed or refractory ALL or LLy, not including certain types.I had a stem cell transplant over 90 days ago and don't have GVHD.
Research Study Groups:
This trial has the following groups:- Group 1: Ixazomib Dose Level 1 (Stratum A)
- Group 2: Ixazomib Dose Level 2 (Stratum A)
- Group 3: Ixazomib Dose Level -1 (Stratum A)
- Group 4: Ixazomib Dose Level 1 (Stratum B)
Awards:
This trial has 3 awards, including:- Approved for 60 Other Conditions - This treatment demonstrated efficacy for 60 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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 conditions that Ixazomib is FDA-approved for?
"Ixazomib has a wide range of potential uses, including the treatment of synovitis, ophthalmia, and sympathetic. Additionally, ixazomib can be used to manage branch retinal vein occlusion and small cell lung cancer (sclc)."
Answered by AI
Is this the first time Ixazomib has been studied?
"Ixazomib was first trialed in 1997 at Spectrum Health Hospital - Butterworth Campus. So far, there have been a total of 1910 completed clinical trials. Out of these, 997 are actively recruiting patients right now. A majority of these studies are based in Philadelphia, Pennsylvania."
Answered by AI
Who meets the eligibility criteria for this trial?
"This trial is looking for 31 participants that meet the following criteria: they must have relapsed/refractory ALL or LLy, be between 1 year old and 21 years old, have a performance level of Karnofsky ≥ 50% (if over 16) or Lansky ≥ 50% (if 16 or younger), and must not have had any prior therapeutic attempts."
Answered by AI
Are we currently enrolling people for this research project?
"This trial, as advertised on clinicaltrials.gov, is seeking patients at this time. The original posting was on February 12th, 2019 and the listing was updated for accuracy on August 11th, 2022."
Answered by AI
Does this research require participants to be of a certain age?
"This specific clinical trial is only looking for patients that fall between 1 year old to 21 years old. In general, there are 850 medical studies available for minors and 3384 trials for senior citizens."
Answered by AI
Are there different control centers for this research?
"So far, this clinical trial has recruited participants from Children's Hospital of Philadelphia, Texas Children's Hospital/Baylor University, and the University of Miami. There are 17 other locations currently enrolling patients."
Answered by AI
How many people are participating in this clinical trial?
"In order for this clinical trial to run, 31 eligible patients must be recruited. Takeda, the sponsor of the study, will manage recruitment from various hospitals including Children's Hospital of Philadelphia and Texas Children's Hospital/Baylor University."
Answered by AI
Have these treatments been tested before on humans?
"Ixazomib clinical trials are ongoing in 2693 cities and 80 countries. The first study began in 1997 and, to date, 1910 total trials have been completed with 300 patients."
Answered by AI
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