Precursor Cell Lymphoblastic Leukemia-lymphomaPhase 1NCT03888534
Intravenous Ixazomib in Pediatric Participants With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LLy)
A Phase 1 study testing Ixazomib in people with Precursor Cell Lymphoblastic Leukemia-lymphoma, run by Millennium Pharmaceuticals, Inc. at 7 sites in 2 countries.
Trial summary
The purpose of this study is to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D), safety and toxicity, and pharmacokinetics (PK) of ixazomib administered intravenously in combination with multiagent reinduction chemotherapy in pediatric participants with relapsed/refractory ALL or LLy. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Precursor Cell Lymphoblastic Leukemia-lymphoma
- What is being tested?
- Ixazomib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 31 Oct 2020to 30 Aug 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of relapsed/refractory ALL with or without extramedullary disease, including central nervous system (CNS)2 (<5 white blood cell [WBC]/mcL] in the cerebrospinal fluid [CSF] with blasts) and CNS3 (>=5 WBC/mcL in the CSF with blasts), or relapsed/refractory LLy. Participants with mixed-phenotype ALL or mature (Burkitt-like) leukemia are excluded.
- Relapsed/refractory ALL must have >=5% blasts in the bone marrow by morphology.
- Relapsed/refractory LLy participants must have measurable disease documented by clinical, radiologic, and histologic criteria.
- A Karnofsky performance status of >=50% (for participants aged >16 years) and a Lansky performance status of >=50% (for participants aged <=16 years).
- Adequate organ function.
- Failure of 1 or more therapeutic attempts.
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- Full recovery from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy before entering this study, as follows:
- Cytoreduction with hydroxyurea: Hydroxyurea can be initiated and continued for up to 24 hours before the start of protocol therapy.
- Cytotoxic therapy: At least 14 days must have elapsed since the completion of the last dose of chemotherapy, except intrathecal (IT) chemotherapy and/or maintenance therapy, such as vincristine (VCR), mercaptopurine, methotrexate, or glucocorticoids. There is no waiting period for those relapsing on maintenance therapy.
- Hematopoietic stem cell transplantation (HSCT): Participants who have relapsed after HSCT are eligible, provided they have no evidence of acute or chronic graft-versus-host disease (GVHD), are not receiving GVHD prophylaxis or treatment, and are at least 90 days posttransplant at the time of enrollment.
- Hematopoietic growth factors: At least 7 days must have elapsed since the completion of therapy with granulocyte colony-stimulating factor (G-CSF) or other growth factor at the time of enrollment. At least 14 days must have elapsed since the completion of therapy with pegfilgrastim.
- Biologic (antineoplastic agent): At least 7 days must have elapsed since the last dose of a biologic agent. For agents that have known adverse events (AEs) occurring beyond 7 days after the end of administration, this period must be extended beyond the time during which AE are known to occur. The duration of this interval must be approved by the project clinician (or designee).
- Monoclonal antibodies: At least 3 half-lives must have elapsed after the last dose of an administered monoclonal antibody.
- Immunotherapy: At least 30 days must have elapsed after the completion of any type of immunotherapy (example, tumor vaccines, chimeric antigen receptor T-cells).
- Photon radiotherapy (XRT): Craniospinal XRT is prohibited during protocol therapy. No washout period is necessary for radiation given to any extramedullary site other than the CNS; >=90 days must have elapsed if prior total body irradiation or craniospinal XRT was given.
- Anthracyclines: Participants must have had a lifetime exposure of <400 mg/m^2 of doxorubicin equivalents of anthracyclines.
- Proteasome inhibitors: Participants with a prior exposure to proteasome inhibitor (PIs) (example, bortezomib, carfilzomib) are eligible as long as the participant demonstrated at least a partial response to chemotherapy with a PI.
Who cannot join
- ALL participants: have isolated extramedullary disease, including CNS or testicular disease.
- Have Grade >=2 peripheral sensory or motor neuropathy, defined by the Modified "Balis" Pediatric Scale of Pediatric Neuropathies, at the time of enrollment.
- Have a planned administration of chemotherapy, radiation therapy, or immunotherapy, other than the study drugs used for this protocol.
- Have deoxyribonucleic acid fragility syndromes (example, Fanconi anemia, Bloom syndrome).
- Have Down syndrome.
- Are receiving cyclosporine, tacrolimus, or other agents to prevent graft-versus host disease (GVHD) after HSCT.
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- Have Philadelphia chromosome (Ph)-positive ALL or Ph-like ALL and are currently receiving tyrosine kinase inhibitor therapy.
- Are receiving systemic treatment with strong inducers of cytochrome P450 3A (CYP3A)(example,rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital, St. John's wort) within 14 days before study enrollment.
- Are receiving systemic treatment with strong CYP3A inhibitors within 14 days before study enrollment.
- Are receiving systemic treatment with inhibitors or inducers of P-glycoprotein (P-gp) within 14 days before study enrollment.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States4 sites
University of Mississippi Medical Center
Jackson, Mississippi, 39216
St Jude Children's Research Hospital
Memphis, Tennessee, 38105
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Washington University School of Medicine
St Louis, Missouri, 63110
Spain3 sites
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, 8035
C.H. Regional Reina Sofia
Córdoba, 14004
Hospital Universitario La Paz
Madrid, 28046
About this study
Official title: Open-Label Phase 1 Study to Assess the Maximum Tolerated Dose, Pharmacokinetics, and Safety of Ixazomib Administered Intravenously to Pediatric Patients Aged 0 to <18 Years With Relapsed or Refractory Acute Lymphoblastic Leukemia, With or Without Extramedullary Disease, or Relapsed or Refractory Lymphoblastic Lymphoma
The purpose of this study is to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D), safety and toxicity, and pharmacokinetics (PK) of ixazomib administered intravenously in combination with multiagent reinduction chemotherapy in pediatric participants with relapsed/refractory ALL or LLy.
Read the detailed description
29-Apr-2020 Enrollment of new patients into this study has been paused due to the COVID-19 situation. The duration of this pause is dependent on the leveling and control of the COVID-19 pandemic.
The drug being tested in this study is called Ixazomib. Ixazomib is being tested to determine the MTD or RP2D of intravenous ixazomib when administered in combination with multiagent chemotherapy (reinduction therapy) in pediatric participants with relapsed or refractory ALL or relapsed/refractory LLy.
The study will enroll approximately 18 participants. Doses of ixazomib will be escalated according to a standard 3+3 dose escalation schema. Participants aged >= 1 year will receive the starting dose of 1.0 mg/m^2 and participants aged <1 year will receive the starting dose of 0.03 mg/kg. Ixazomib will be administered in combination with multiagent reinduction therapy. The dose escalation phase will determine the MTD and/or RP2D of ixazomib. Dose escalation will be based on the observed safety and tolerability data.
Participants aged <1 year will be assessed separately and will not contribute to the dose escalation assessment.
This multi-center trial will be conducted in the United States and Spain. The overall time to participate in this study is approximately 30 months. Participants will be followed up to Day 60 after the first dose of study drug for a follow-up assessment.
- Being tested
- Ixazomib
- Keywords
- Drug Therapy
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IxazomibDrug
Also called MLN9708
Ixazomib intravenous injection in combination with reduction chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Ixazomib | Experimental | Ixazomib, injection, intravenously, once on Days 1, 4, 8, and 11 in a single 29-day treatment cycle in combination with multiagent reinduction therapy. Participants >= 1 year will receive the starting dose of 1.0 milligram per square meter (mg/m^2) and <1 year will receive the starting dose of 0.03 milligram per kilogram (mg/kg). The dose escalation phase will determine the MTD or RP2D of Ixazomib. Dose of Ixazomib will be escalated based on the observed safety and tolerability data. Receives: Drug: Ixazomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Dose-limiting Toxicities (DLT) During Reinduction Chemotherapy
DLT: Grade 4 nonhematologic toxicity after first dose of ixazomib and is probably/definitely attributable to the ixazomib treatment regimen, with exceptions, example fever/infection with/without hospitalization, fatigue and gastrointestinal symptoms, hypofibrinogenemia, metabolic/laboratory abnormalities that resolve to less than or equal to(<=)Grade 2 within 7 days. Any Grade 3/4 nonhematologic toxicity after first dose of ixazomib that is possibly/probably/definitely attributable to the ixazomib treatment regimen and results in omission of subsequent dose of chemotherapy, with exception of fever/infection. Hematologic toxicities: Failure to recover a peripheral absolute neutrophil count (ANC) ≥0.5*10^9 per liter (/L) and a platelet count ≥50*10^9/L due to documented bone marrow hypoplasia (cellularity <10 20%) within 42 days after the beginning of systemic chemotherapy without evidence of active disease by bone marrow evaluation or active infection.
Measured: Up to Day 29
Number of Participants With Grade 3 or Higher Treatment Emergent Adverse Events (TEAEs) Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Measured: Up to 30 months
Number of Participants With Worst Shift From Baseline Values to Post-baseline Values in Clinical Laboratory Parameters
Measured: Up to 30 months
AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for Ixazomib
Measured: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose and Day 11 pre-dose and at multiple time points (up to 264 hours) post-dose
Cmax: Maximum Observed Plasma Concentration for Ixazomib
Measured: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose and Day 11 pre-dose and at multiple time points (up to 264 hours) post-dose
Secondary outcomes (1)
Overall Response Rate (ORR)
ORR is defined as the percentage of participants with complete response (CR) or CR with incomplete platelet recovery (CRp) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR is defined as bone marrow with less than 5 percent (%) blast by morphology, no evidence of circulating blasts or extramedullary disease, and recovery of peripheral counts (ANC >=1.0*10^9/L and a platelet count >=100*10^9/L). CRp is defined as bone marrow with <5% blasts by morphology, no evidence of circulating blasts or extramedullary disease, and recovery of ANC (>1000/mcL) but insufficient recovery of platelets (counts <100, 000/mcL).
Measured: Up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start31 Oct 2020 (estimated)
- Primary completion30 Aug 2022 (estimated)
- Study completion30 Aug 2022 (estimated)
Why it stopped: Business decision (no safety or efficacy concerns)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Precursor Cell Lymphoblastic Leukemia-lymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Millennium Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03888534
- Sponsor's protocol ID
- C16051
- Other IDs
- U1111-1225-3528, 2018-003907-20, 2018
- Status last verified
- Sep 2020
- First submitted
- 22 Mar 2019
- Last updated
- 28 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Phase 1 Study to Assess the Maximum Tolerated Dose, Pharmacokinetics, and Safety of Ixazomib Administered Intravenously to Pediatric Patients Aged 0 to <18 Years With Relapsed or Refractory Acute Lymphoblastic Leukemia, With or Without Extramedullary Disease, or Relapsed or Refractory Lymphoblastic Lymphoma
- ClinicalTrials.gov ID
- NCT03888534
- Acronym / sponsor ID
- C16051
- Keywords
- Drug Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business decision (no safety or efficacy concerns)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Oct 2020 (estimated)
- Primary completion
- 30 Aug 2022 (estimated)
- Study completion
- 30 Aug 2022 (estimated)
- First posted
- 25 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D), safety and toxicity, and pharmacokinetics (PK) of ixazomib administered intravenously in combination with multiagent reinduction chemotherapy in pediatric participants with relapsed/refractory ALL or LLy.
Detailed description
29-Apr-2020 Enrollment of new patients into this study has been paused due to the COVID-19 situation. The duration of this pause is dependent on the leveling and control of the COVID-19 pandemic.
The drug being tested in this study is called Ixazomib. Ixazomib is being tested to determine the MTD or RP2D of intravenous ixazomib when administered in combination with multiagent chemotherapy (reinduction therapy) in pediatric participants with relapsed or refractory ALL or relapsed/refractory LLy.
The study will enroll approximately 18 participants. Doses of ixazomib will be escalated according to a standard 3+3 dose escalation schema. Participants aged >= 1 year will receive the starting dose of 1.0 mg/m^2 and participants aged <1 year will receive the starting dose of 0.03 mg/kg. Ixazomib will be administered in combination with multiagent reinduction therapy. The dose escalation phase will determine the MTD and/or RP2D of ixazomib. Dose escalation will be based on the observed safety and tolerability data.
Participants aged <1 year will be assessed separately and will not contribute to the dose escalation assessment.
This multi-center trial will be conducted in the United States and Spain. The overall time to participate in this study is approximately 30 months. Participants will be followed up to Day 60 after the first dose of study drug for a follow-up assessment.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ixazomib | Experimental | Drug: IxazomibIxazomib, injection, intravenously, once on Days 1, 4, 8, and 11 in a single 29-day treatment cycle in combination with multiagent reinduction therapy. Participants >= 1 year will receive the starting dose of 1.0 milligram per square meter (mg/m^2) and <1 year will receive the starting dose of 0.03 milligram per kilogram (mg/kg). The dose escalation phase will determine the MTD or RP2D of Ixazomib. Dose of Ixazomib will be escalated based on the observed safety and tolerability data. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (17 listed)
- Diagnosis of relapsed/refractory ALL with or without extramedullary disease, including central nervous system (CNS)2 (<5 white blood cell [WBC]/mcL] in the cerebrospinal fluid [CSF] with blasts) and CNS3 (>=5 WBC/mcL in the CSF with blasts), or relapsed/refractory LLy. Participants with mixed-phenotype ALL or mature (Burkitt-like) leukemia are excluded.
- Relapsed/refractory ALL must have >=5% blasts in the bone marrow by morphology.
- Relapsed/refractory LLy participants must have measurable disease documented by clinical, radiologic, and histologic criteria.
- A Karnofsky performance status of >=50% (for participants aged >16 years) and a Lansky performance status of >=50% (for participants aged <=16 years).
- Adequate organ function.
Key exclusion criteria (10 listed)
- ALL participants: have isolated extramedullary disease, including CNS or testicular disease.
- Have Grade >=2 peripheral sensory or motor neuropathy, defined by the Modified "Balis" Pediatric Scale of Pediatric Neuropathies, at the time of enrollment.
- Have a planned administration of chemotherapy, radiation therapy, or immunotherapy, other than the study drugs used for this protocol.
- Have deoxyribonucleic acid fragility syndromes (example, Fanconi anemia, Bloom syndrome).
- Have Down syndrome.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IxazomibAlso: MLN9708Ixazomib intravenous injection in combination with reduction chemotherapy. | Drug | Ixazomib |
Primary outcome
Number of Participants with Dose-limiting Toxicities (DLT) During Reinduction Chemotherapy
Time frame: Up to Day 29
DLT: Grade 4 nonhematologic toxicity after first dose of ixazomib and is probably/definitely attributable to the ixazomib treatment regimen, with exceptions, example fever/infection with/without hospitalization, fatigue and gastrointestinal symptoms, hypofibrinogenemia, metabolic/laboratory abnormalities that resolve to less than or equal to(<=)Grade 2 within 7 days. Any Grade 3/4 nonhematologic toxicity after first dose of ixazomib that is possibly/probably/definitely attributable to the ixazomib treatment regimen and results in omission of subsequent dose of chemotherapy, with exception of fever/infection. Hematologic toxicities: Failure to recover a peripheral absolute neutrophil count (ANC) ≥0.5*10^9 per liter (/L) and a platelet count ≥50*10^9/L due to documented bone marrow hypoplasia (cellularity <10 20%) within 42 days after the beginning of systemic chemotherapy without evidence of active disease by bone marrow evaluation or active infection.
Number of Participants With Grade 3 or Higher Treatment Emergent Adverse Events (TEAEs) Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Time frame: Up to 30 months
Number of Participants With Worst Shift From Baseline Values to Post-baseline Values in Clinical Laboratory Parameters
Time frame: Up to 30 months
AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for Ixazomib
Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose and Day 11 pre-dose and at multiple time points (up to 264 hours) post-dose
Cmax: Maximum Observed Plasma Concentration for Ixazomib
Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose and Day 11 pre-dose and at multiple time points (up to 264 hours) post-dose
1 secondary outcome
Overall Response Rate (ORR)
Time frame: Up to 30 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2020.
- Individual participant dataSharing planned: Yes. Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Millennium Pharmaceuticals, Inc.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ixazomib in people with Precursor Cell Lymphoblastic Leukemia-lymphoma, run by Millennium Pharmaceuticals, Inc. at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Dose-limiting Toxicities (DLT) During Reinduction Chemotherapy (time frame: Up to Day 29). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2020.