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Enzyme

Total Therapy XVII for Leukemia

Q: What are the most popular therapeutic uses of Bortezomib?

Bortezomib is a medication used to treat macular edema. It can also help manage pheochromocytomas, eye, and <a href="https://www.withpower.com/clinical-trials/ulcerative-colitis">ulcerative colitis</a>.

Q: Does the age limit for this clinical trial include people over 65 years old?

The age range for candidates eligible for recruitment into this trial are those that are older than 1 year, but have not yet reached 18 years of age.

Q: What other drugs has Bortezomib been tested with in the past?

The first clinical trial for bortezomib was completed in 1997 at Spectrum Health Hospital - Butterworth Campus. Since then, there have been 4356 completed trials and 2321 live clinical trials. A large concentration of these studies are based in Memphis, <a href="https://www.withpower.com/clinical-trials/tennessee">Tennessee</a>.

Q: What is the primary difference between this clinical trial and others?

Alfacell launched the first clinical trial for Bortezomib in 1997. Just 300 patients were enrolled in the initial study. However, Phase 3 drug approval was received soon after in 1997. Now, 2321 active studies are being conducted for Bortezomib in 3628 cities and 89 countries.

Phase 2 & 3

Waitlist Available

Led By Hiroto Inaba, MD, PhD

Research Sponsored by St. Jude Children's Research Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of B- or T-ALL or LLy by immunophenotyping

LLy participants must have < 25% tumor cells in bone marrow and peripheral blood by morphology and flow cytometry. If any of these show ≥25% blasts, patient will be considered to have leukemia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to week 49 continuation treatment (up to 6 months after last patient completes week 49 continuation)

Awards & highlights

Study Summary

This trial is using novel precision medicine strategies based on inherited and acquired leukemia-specific genomic features and targeted treatment approaches to improve the cure rate and quality of life of children with acute lymphoblastic leukemia (ALL) and acute lymphoblastic lymphoma (LLy).

Who is the study for?

This trial is for children aged 1-18 with newly diagnosed B-cell or T-cell acute lymphoblastic leukemia (ALL) or lymphoma, who haven't had much treatment before. They must be able to give consent and not be pregnant, breastfeeding, or unwilling to use contraception.Check my eligibility

What is being tested?

The study tests a combination of drugs like Calaspargase Pegol and Bortezomib among others, aiming to improve survival rates by targeting specific genetic features of the leukemia. It includes precision medicine strategies and therapies such as CAR T cells for certain patients.See study design

What are the potential side effects?

Potential side effects include allergic reactions to medication components, nerve damage from drugs like Vincristine, increased risk of infections due to immune system suppression, liver problems from medications like Methotrexate and Mercaptopurine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with a type of leukemia.

Select...

My cancer has less than 25% tumor cells in my bone marrow and blood.

Select...

I am between 1 and 18 years old.

Select...

I have been diagnosed with mixed phenotype acute leukemia (MPAL).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 6 months after the last randomized patient completes continuation treatment (week 120).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 6 months after the last randomized patient completes continuation treatment (week 120).

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 months after the last randomized patient completes continuation treatment (week 120). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cumulative incidence of Grade 2 or higher neuropathy in patients with CEP72 CC or CT genotype

Event-free survival of ALL patients (EFS)

Proportion of patients with CEP72TT genotype who develop two or more episodes of Grade 2 or higher neuropathy during Continuation

Secondary outcome measures

5-year OS of LLy patients

5-year overall survival (OS) of ALL patients compared to historical controls

Change in bone mineral density (BMD) in the tibia

+10 more

Other outcome measures

5-year EFS of MPAL patients

5-year OS of MPAL patients

Log odds ratio of pharmacodynamic predictors of treatment outcome (host toxicity or in vivo efficacy)

+4 more

Side effects data

From 2008 Phase 2 trial • 20 Patients • NCT00006184

100%

Injection site reaction

40%

Fatigue (asthenia, lethargy, malaise)

30%

Pruritus

30%

Platelets

30%

Chest pain (non-cardiac and non-pleuritic)

30%

Bone pain

30%

Headache

30%

Myalgia (muscle ache)

30%

SGPT (ALT)

30%

Abdominal pain or cramping

20%

Alkaline phosphatase

20%

Hypokalemia

20%

Dizziness/lightheadedness

20%

Arthralgia (joint pain)

20%

Hypomagnesemia

20%

Pain - Other

20%

Rash/desquamation

20%

Rigors/chills

20%

SGOT (AST)

10%

Hypoalbuminemia

10%

Hypocalcemia

10%

Hot flashes/flushes

10%

Hypophosphatemia

10%

Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)

10%

Lymphopenia

10%

Erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis

10%

Dry skin

10%

Constipation

10%

Hypotension

10%

Joint, muscle, or bone (osseous)- Other (Calf cramping)

10%

Hypercalcemia

10%

Skin-Other (Drug reaction face, hands, neck)

10%

Hematologic-Other (Splenomegaly in donor-resolved)

10%

Dyspnea (shortness of breath)

10%

Rash/desquamation for BMT

10%

Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)

100%

80%

60%

40%

20%

Study treatment Arm

Donor - Vaccination Generation Group

Recipient - Chemotherapy Group

Trial Design

7Treatment groups

Experimental Treatment

Group I: T-ALL and T-LLy, Standard-riskExperimental Treatment18 Interventions

Induction (6 wks), Early Intensification (4 wks), Consolidation (8 wks), and Continuation (120 wks). During Remission Induction therapy, prednisone dose is 60mg/m^2 and 3 doses daunorubicin are given. Dasatinib is given for patients with Ph+ and those with ABL-class fusion. Ruxolitinib is given for patients with activation of JAK-STAT signaling; ALL patients with Day 15 or Day 22 MRD ≥5% and all patients with ETP and T/M MPAL and LLy patients who don't qualify for complete response at end of Remission Induction. Bortezomib is given to patients without targetable lesions and Day 15 or Day 22 MRD ≥ 5%. Interventions: prednisone, vincristine, daunorubicin, pegaspargase (or Erwinase®, Rylaze™ or Calaspargase pegol), cyclophosphamide, cytarabine, mercaptopurine, dasatinib, bortezomib, ruxolitinib, methotrexate, dexamethasone, doxorubicin, nelarabine, thioguanine.

Group II: T-ALL and T-LLy, High-riskExperimental Treatment21 Interventions

Induction (6 wks), Early Intensification (4 wks), Consolidation (8 wks), and Reintensification. During Remission Induction therapy, prednisone dose is 60mg/m^2 and 3 doses daunorubicin are given. Dasatinib, ruxolitinib, and bortezomib given as done for patients with standard-risk T-ALL but are discontinued in Reintensification therapy. Interventions: prednisone, vincristine, daunorubicin, pegaspargase (or Erwinase®, Rylaze™ or Calaspargase pegol), cyclophosphamide, cytarabine, mercaptopurine, dasatinib, bortezomib, ruxolitinib, methotrexate, etoposide, dexamethasone, clofarabine, vorinostat, idarubicin, nelarabine, thioguanine..

Group III: B-ALL and B-LLy, Standard-riskExperimental Treatment18 Interventions

Induction (6wks), Early Intensification (4wks), Consolidation (8wks) and Continuation (120 wks). Remission Induction: Prednisone dose is 40mg/m^2 and 2 doses daunorubicin are given. Dasatinib: given for patients with Ph+ and those with ABL-class fusion. Ruxolitinib: given for patients with activation of JAK-STAT signaling; ALL patients with Day 15 or Day 22 MRD ≥5%, LLy patients who don't qualify for complete response at end of Remission Induction and all patients with ETP and T/M MPAL. Bortezomib is given to patients without targetable lesions and Day 15 or Day 22 MRD >5%. Blinatumomab will be given to patients with residual disease at the end of induction (≥0.01% and <1%), certain genetic subtypes and Down syndrome. Interventions: prednisone, vincristine, daunorubicin, pegaspargase (or Erwinase®, Rylaze™ or Calaspargase pegol), cyclophosphamide, cytarabine, mercaptopurine, dasatinib, bortezomib, ruxolitinib, blinatumomab, thioguanine, methotrexate, dexamethasone, doxorubicin

Group IV: B-ALL and B-LLy, Low-riskExperimental Treatment15 Interventions

Patients with low-risk B ALL and LLy will have Induction (6 weeks), Consolidation (8 weeks), and Continuation (120 weeks). During Remission Induction therapy, prednisone dose is 40mg/m^2 and 1-2 doses of daunorubicin (based on day 8 peripheral blood MRD in patients with ETV6-RUNX1 or hyperdiploid) are given. Dasatinib is given for patients with ABL-class fusion. Blinatumomab will be given to patients with certain genetic subtypes and those with Down syndrome. Interventions: Prednisone, vincristine, daunorubicin, pegaspargase (or Erwinase®, Rylaze™ or Calaspargase pegol), cyclophosphamide, cytarabine, mercaptopurine, dasatinib, thioguanine, methotrexate, dexamethasone, blinatumomab.

Group V: B-ALL and B-LLy, High-riskExperimental Treatment19 Interventions

Induction (6 weeks), Early Intensification (4 weeks), Consolidation (8 weeks), and Immunotherapy (chimeric antigen receptor [CAR] T cells). Patients who do not respond to Immunotherapy will receive Reintensification therapy. During Remission Induction therapy, prednisone dose is 40mg/m^2 and 2 doses of daunorubicin are given. Dasatinib, ruxolitinib, and bortezomib are given as done for patients with standard-risk B-ALL but are discontinued in Immunotherapy and Reintensification therapy. Blinatumomab will be given to patients who are not able to receive CAR T cell therapy and patients with certain genetic subtypes and those with Down syndrome. Interventions: prednisone, vincristine, daunorubicin, pegaspargase (or Erwinase®, Rylaze™ or Calaspargase pegol), cyclophosphamide, cytarabine, mercaptopurine, dasatinib, bortezomib, ruxolitinib, blinatumomab, etoposide, dexamethasone, clofarabine, thioguanine, methotrexate.

Group VI: ALL, CEP72 T/T, VincristineExperimental Treatment1 Intervention

Patients with the CEP72 rs904627T/T genotype (~16% of patients) will be randomized (unblinded design, only those who evaluate neuropathy are blinded) to receive either 1.5 mg/m^2 or 1 mg/m^2 of vincristine after Continuation Week 1. Patients in low- risk will complete vincristine in Week 49 and those in standard/high-risk will complete in Week 101. Intervention: vincristine.

Group VII: ALL, CEP72 C/T or C/C, VincristineExperimental Treatment4 Interventions

Patients with either a CEP72 rs904627 C/T or C/C genotype (~84% of patients) will be randomized (unblinded design, only those who evaluate neuropathy are blinded) to receive vincristine (2 mg/m^2 per dose except during Reinduction I and Reinduction II when 3 weekly doses of 1.5 mg/m^2 will be given) and dexamethasone pulses through Week 49 of Continuation Treatment or through Week 101 of Continuation Treatment. Patients at low-risk will complete vincristine in Week 49. Interventions: vincristine, dexamethasone, methotrexate, mercaptopurine.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bortezomib

2005

Completed Phase 2

~1140

Idarubicin

2014

Completed Phase 4

~4330

Nelarabine

2008

Completed Phase 2

~500

Thioguanine

2012

Completed Phase 4

~10830

Vincristine

2003

Completed Phase 4

~2910

Prednisone

2014

Completed Phase 4

~2370

Daunorubicin

2013

Completed Phase 4

~4940

Pegaspargase

2005

Completed Phase 3

~9010

Cytarabine

2016

Completed Phase 3

~3310

Methotrexate

2013

Completed Phase 4

~3800

Blinatumomab

2014

Completed Phase 3

~1210

Etoposide

2010

Completed Phase 3

~2440

Ruxolitinib

2018

Completed Phase 3

~1140

Dexamethasone

2007

Completed Phase 4

~2590

Mercaptopurine

2012

Completed Phase 4

~12330

Clofarabine

2007

Completed Phase 3

~1130

Vorinostat

2014

Completed Phase 3

~1600

Doxorubicin

2012

Completed Phase 3

~7940

Cyclophosphamide

1995

Completed Phase 3

~3780

Dasatinib

2012

Completed Phase 3

~2320

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

ServierIndustry Sponsor

49 Previous Clinical Trials

42,666 Total Patients Enrolled

St. Jude Children's Research HospitalLead Sponsor

427 Previous Clinical Trials

5,305,787 Total Patients Enrolled

Incyte CorporationIndustry Sponsor

364 Previous Clinical Trials

54,375 Total Patients Enrolled

Media Library

Asparaginase Erwinia chrysanthemi (recombinant)-rywn (Enzyme) Clinical Trial Eligibility Overview. Trial Name: NCT03117751 — Phase 2 & 3

Acute Lymphoblastic Leukemia Research Study Groups: B-ALL and B-LLy, High-risk, B-ALL and B-LLy, Standard-risk, B-ALL and B-LLy, Low-risk, T-ALL and T-LLy, Standard-risk, ALL, CEP72 T/T, Vincristine, T-ALL and T-LLy, High-risk, ALL, CEP72 C/T or C/C, Vincristine

Acute Lymphoblastic Leukemia Clinical Trial 2023: Asparaginase Erwinia chrysanthemi (recombinant)-rywn Highlights & Side Effects. Trial Name: NCT03117751 — Phase 2 & 3

Asparaginase Erwinia chrysanthemi (recombinant)-rywn (Enzyme) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03117751 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the most popular therapeutic uses of Bortezomib?

"Bortezomib is a medication used to treat macular edema. It can also help manage pheochromocytomas, eye, and ulcerative colitis."

Answered by AI

Does the age limit for this clinical trial include people over 65 years old?

"The age range for candidates eligible for recruitment into this trial are those that are older than 1 year, but have not yet reached 18 years of age."

Answered by AI

What other drugs has Bortezomib been tested with in the past?

"The first clinical trial for bortezomib was completed in 1997 at Spectrum Health Hospital - Butterworth Campus. Since then, there have been 4356 completed trials and 2321 live clinical trials. A large concentration of these studies are based in Memphis, Tennessee."

Answered by AI

What is the primary difference between this clinical trial and others?

"Alfacell launched the first clinical trial for Bortezomib in 1997. Just 300 patients were enrolled in the initial study. However, Phase 3 drug approval was received soon after in 1997. Now, 2321 active studies are being conducted for Bortezomib in 3628 cities and 89 countries."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Total Therapy XVII for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia and Lymphoma

2017. "Total Therapy XVII for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia and Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03117751.

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