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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.

Must not have

Isolated CNS or testicular disease

Plan to administer non-protocol chemotherapy, radiation therapy, or immunotherapy during the study period

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 weeks

Awards & highlights

Approved for 60 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer is only in my brain/CNS or testicles.

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I plan to receive other cancer treatments not part of the study.

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I have an ongoing infection that hasn't improved with treatment.

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I am not allergic to the medications used in this study, except for Pegaspargase.

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I have moderate to severe numbness, tingling, or muscle weakness.

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I do not have conditions like Fanconi anemia or Bloom syndrome.

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I have Ph+ or Ph-like ALL and am on TKI therapy.

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I have been treated with a high dose of anthracyclines.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase 1: Dose limiting toxicity (DLT) during block 1 of chemotherapy

Side effects data

From 2021 Phase 4 trial • 45 Patients • NCT03416374

29%

Diarrhoea

24%

White blood cell count decreased

20%

Platelet count decreased

16%

Rash

16%

Neutrophil count decreased

11%

Pneumonia

Constipation

Malaise

Pyrexia

Anaemia

Nasopharyngitis

Decreased appetite

Taste disorder

Acute kidney injury

Influenza

Bile duct stone

Gastroenteritis

Pneumonia bacterial

Bone pain

Febrile neutropenia

Duodenal ulcer

Enterocolitis

Tibia fracture

Interstitial lung disease

Prinzmetal angina

Compression fracture

Spinal compression fracture

Tumour lysis syndrome

100%

80%

60%

40%

20%

Study treatment Arm

[Overall]; Combination Therapy + Ixazomib Therapy

[VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy

[KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy

Awards & Highlights

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.

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