Philadelphia Chromosome Negative B-cell Precursor Acute Lymphoblastic LeukemiaPhase 3AUDAXNCT07223190
A Study Evaluating Subcutaneous Versus Intravenous Blinatumomab in Newly Diagnosed Adults With B-cell Precursor Acute Lymphoblastic Leukaemia
A Phase 3 study testing Blinatumomab and HyperCVAD in people with Philadelphia Chromosome Negative B-cell Precursor Acute Lymphoblastic Leukemia, run by Amgen.
Trial summary
The main objective of this trial is to demonstrate that subcutaneous (SC) blinatumomab in conjunction with chemotherapy (Arm B) is non-inferior to continuous intravenous infusion (cIV) blinatumomab in conjunction with chemotherapy (Arm A) in overall survival (OS) in newly diagnosed participants with Philadelphia… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Philadelphia Chromosome Negative B-cell Precursor Acute Lymphoblastic Leukemia
- What is being tested?
- Blinatumomab and HyperCVAD
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2028to 29 Aug 2035
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with newly diagnosed Philadelphia (Ph)-negative B-cell precursor acute lymphoblastic leukemia (ALL).
- Age ≥18 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤2, higher ECOG score allowed if due to underlying leukemia.
- Adequate organ function as described below:
- Renal: estimated glomerular filtration rate (GFR) ≥30 mL/min/1.73m^2 per the Modification of Diet in Renal Disease for adult participants equation
- Hepatic function: total bilirubin ≤3.0 mg/dL prior to start of treatment; unless due to Gilbert's Disease or if liver involvement with leukemia
- Cardiac: left ventricular ejection fraction (LVEF) ≥50% and no clinically significant, uncontrolled, or active cardiovascular, cerebrovascular, or peripheral vascular disease, or history of or active venous thromboembolism (VTE) disease.
Who cannot join
- Other Medical Conditions
- Isolated extramedullary disease.
- History or presence of clinically relevant central nervous system (CNS) pathology or event such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis.
- Current autoimmune disease or history of autoimmune disease with potential CNS involvement.
- History of other malignancy within the past 3 years, except for malignancy treated with curative intent with low risk for recurrence. Exceptions include:
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
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- Adequately treated cervical carcinoma in situ without evidence of disease.
- Adequately treated breast ductal carcinoma in situ without evidence of disease.
- Prostatic intraepithelial neoplasia without evidence of prostate cancer.
- Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ.
- Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B or hepatitis C virus.
- Participant with symptoms and/or clinical signs and/or radiographic and/or sonographic signs that indicate an acute or uncontrolled chronic infection, any other concurrent disease or medical condition that could be exacerbated by the treatment or would seriously complicate compliance with the protocol.
- Prior/Concomitant Therapy • Prior cancer chemotherapy/immunotherapy for this newly diagnosed B-ALL before the start of protocol-required therapy with the exception of intrathecal (IT) chemotherapy or pre-phase chemotherapy. Localized radiation for pain or disease control is allowed.
- Prior/Concurrent Clinical Trial Experience
- •Currently receiving a trial intervention, or less than 30 days or 5 half-lives if known (whichever is later) since ending a trial intervention in another investigational device or drug trial.
- Other Exclusions
- History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator, would pose a risk to participant safety.
- Female participants of childbearing potential unwilling to use contraception.
- Female participants who are breastfeeding or who plan to breastfeed.
- Female participants planning to become pregnant or donate eggs.
- Female participants of childbearing potential with a positive pregnancy test assessed at screening by a highly sensitive urine or serum pregnancy test.
- Male participants with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception.
- Male participants with a pregnant partner who are unwilling to practice abstinence or use a condom.
- Male participants unwilling to abstain from donating sperm.
- Participant has known sensitivity to any of the products or components to be administered during dosing.
- Participant considered unlikely to be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, Clinical Outcome Assessments) to the best of the participant and investigator's knowledge; exception - unavailability of a patient-reported outcome (PRO) in the participants' preferred/native language is not prohibitive to enrollment for eligible participants.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 3, Open-label, Randomized, Controlled Trial of Subcutaneous Versus Intravenous Blinatumomab in Newly Diagnosed Adults With Philadelphia Chromosome Negative B-cell Precursor Acute Lymphoblastic Leukaemia
The main objective of this trial is to demonstrate that subcutaneous (SC) blinatumomab in conjunction with chemotherapy (Arm B) is non-inferior to continuous intravenous infusion (cIV) blinatumomab in conjunction with chemotherapy (Arm A) in overall survival (OS) in newly diagnosed participants with Philadelphia chromosome (Ph) negative B-cell precursor acute lymphoblastic leukemia (B-ALL) who are in complete remission (CR) or CR with incomplete peripheral count recovery (CRi) after induction.
- Being tested
- Blinatumomab, HyperCVAD
- Keywords
- Blinatumomab, Lymphoblastic Leukemia, HyperCVAD
- 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.
BlinatumomabDrug
Blinatumomab will be administered as a SC injection.
BlinatumomabDrug
Blinatumomab will be administered as a cIV infusion.
HyperCVADDrug
HyperCVAD will administer as the chemo regimen as part of the standard of care (SOC) regimen.
| Study group | Role | What they receive |
|---|---|---|
| HyperCVAD + cIV Blinatumomab in Consolidation | Active comparator | Participants with Ph-negative B-ALL will receive cIV blinatumomab infusion for cycles 1, 2, 5 and 6 (each cycle will be 35 days), in conjunction with chemotherapy (HyperCVAD) for cycles 3, 4, 7 and 8 (each cycle will be 2-4 weeks). Receives: Drug: Blinatumomab; Drug: HyperCVAD |
| HyperCVAD + SC Blinatumomab in Consolidation | Experimental | Participants with Ph-negative B-ALL will receive SC injections of blinatumomab for cycles 1, 2, 5 and 6 (each cycle will be 35 days), in conjunction with chemotherapy (HyperCVAD) for cycles 3, 4, 7 and 8 (each cycle will be 2-4 weeks). Receives: Drug: Blinatumomab; Drug: HyperCVAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Measured: Up to 5 years from randomization
Secondary outcomes (13)
Number of Participants who Experience Treatment-emergent Adverse Events (TEAEs)
Number of participants who experience TEAEs, serious TEAEs, treatment-related adverse events, and adverse events of interest.
Measured: Up to 5 years from randomization
Area Under the Concentration-time Curve in Cycle 1 (AUCcycle 1) for SC Blinatumomab
Measured: Up to Cycle 1 Day 35 (Cycle length = 35 days)
AUCcycle 1 for cIV Blinatumomab
Measured: Up to Cycle 1 Day 35 (Cycle length = 35 days)
Average Concentration Following Cycle 1 Day 19 Dosing (Cavgd19dose) for SC Blinatumomab
Measured: From predose on Cycle 1 Day 19 to predose on Cycle 1 Day 22 (Cycle length = 35 days)
Steady-state Concentration (Css) for cIV Blinatumomab
Measured: Up to Cycle 1 Day 29 (Cycle length = 35 days)
Relapse-free Survival (RFS)
RFS is defined as time from randomization until relapse, death from any cause or measurable residual disease (MRD) non-response, whichever is earlier.
Measured: Up to 5 years from randomization
Number of Participants With CR With MRD Response
CR with MRD response is defined as MRD <10^-4. CR with MRD response is defined as <5% bone marrow (BM) blasts by cytomorphology with full recovery of peripheral blood counts (absolute neutrophil count [ANC] >1000/µl and platelets >100,000/µl) and MRD < 10^4 and no evidence of extramedullary disease (EMD).
Measured: Up to 5 years from randomization
Number of Participants With Deep CR With MRD Response
Deep CR with MRD response is defined as MRD <10^-6. Deep CR with MRD response is defined as <5% BM blasts by cytomorphology with full recovery of peripheral blood counts (ANC > 1000/µl and platelets > 100,000/µl) and MRD ≤ 10^6 and no evidence of extramedullary disease.
Measured: Up to 5 years from randomization
Change from Day 1 Consolidation Cycle 1 to End of Consolidation in Role Functioning as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Measured: Consolidation Cycles 1, 2, 5 and 6 Day 1 (Cycles length=35 days); Consolidation Cycles 3, 4, 7 and 8 Day 15 (Cycles length=2-4 weeks); Maintenance Cycle 1 Day 1 (Cycle length=28 days)
Change from Day 1 Consolidation Cycle 1 to End of Consolidation in Overall Quality of Life as Measured by EORTC QLQ-C30
Measured: Consolidation Cycles 1, 2, 5 and 6 Day 1 (Cycles length=35 days); Consolidation Cycles 3, 4, 7 and 8 Day 15 (Cycles length=2-4 weeks); Maintenance Cycle 1 Day 1 (Cycle length=28 days)
Change from Day 1 Consolidation Cycle 1 to End of Consolidation in All Other Domains/Items as Measured by EORTC QLQ-C30
Measured: Consolidation Cycles 1, 2, 5 and 6 Day 1 (Cycles length=35 days); Consolidation Cycles 3, 4, 7 and 8 Day 15 (Cycles length=2-4 weeks); Maintenance Cycle 1 Day 1 (Cycle length=28 days)
Change From Day 1 Consolidation Cycle 1 to End of Consolidation in the Visual Analogue Scale (VAS)
Change in the VAS will be measured from European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L).
Measured: Consolidation Cycles 1, 2, 5 and 6 Day 1 (Cycles length=35 days); Consolidation Cycles 3, 4, 7 and 8 Day 15 (Cycles length=2-4 weeks); Maintenance Cycle 1 Day 1 (Cycle length=28 days)
Percentage of Time on Treatment With High Side Effect Bother From Consolidation Cycle 1 to End of Consolidation
Percentage of time on treatment with high side effect bother (score 3-4) from consolidation cycle 1 to end of consolidation will be measured by Functional Assessment of Chronic Illness Therapy (FACIT) GP5.
Measured: Consolidation Cycle 1 up to Day 8 and then weekly until end of Consolidation Cycle (Cycle length = 35 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2025
- Study start30 Jun 2028 (estimated)
- Primary completion30 Dec 2031 (estimated)
- Study completion29 Aug 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Philadelphia Chromosome Negative B-cell Precursor Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07223190
- Sponsor's protocol ID
- 20240113
- Other IDs
- 2025-523291-23, 2025
- Acronym
- AUDAX
- Status last verified
- Sep 2026
- First submitted
- 29 Oct 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Open-label, Randomized, Controlled Trial of Subcutaneous Versus Intravenous Blinatumomab in Newly Diagnosed Adults With Philadelphia Chromosome Negative B-cell Precursor Acute Lymphoblastic Leukaemia
- ClinicalTrials.gov ID
- NCT07223190
- Acronym / sponsor ID
- AUDAX / 20240113
- Keywords
- Blinatumomab, Lymphoblastic Leukemia, HyperCVAD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2028 (estimated)
- Primary completion
- 30 Dec 2031 (estimated)
- Study completion
- 29 Aug 2035 (estimated)
- First posted
- 31 Oct 2025 (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 main objective of this trial is to demonstrate that subcutaneous (SC) blinatumomab in conjunction with chemotherapy (Arm B) is non-inferior to continuous intravenous infusion (cIV) blinatumomab in conjunction with chemotherapy (Arm A) in overall survival (OS) in newly diagnosed participants with Philadelphia chromosome (Ph) negative B-cell precursor acute lymphoblastic leukemia (B-ALL) who are in complete remission (CR) or CR with incomplete peripheral count recovery (CRi) after induction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HyperCVAD + cIV Blinatumomab in Consolidation | Active comparator | Drug: Blinatumomab, Drug: HyperCVADParticipants with Ph-negative B-ALL will receive cIV blinatumomab infusion for cycles 1, 2, 5 and 6 (each cycle will be 35 days), in conjunction with chemotherapy (HyperCVAD) for cycles 3, 4, 7 and 8 (each cycle will be 2-4 weeks). |
| HyperCVAD + SC Blinatumomab in Consolidation | Experimental | Drug: Blinatumomab, Drug: HyperCVADParticipants with Ph-negative B-ALL will receive SC injections of blinatumomab for cycles 1, 2, 5 and 6 (each cycle will be 35 days), in conjunction with chemotherapy (HyperCVAD) for cycles 3, 4, 7 and 8 (each cycle will be 2-4 weeks). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants with newly diagnosed Philadelphia (Ph)-negative B-cell precursor acute lymphoblastic leukemia (ALL).
- Age ≥18 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤2, higher ECOG score allowed if due to underlying leukemia.
- Adequate organ function as described below:
Key exclusion criteria (26 listed)
- Other Medical Conditions
- Isolated extramedullary disease.
- History or presence of clinically relevant central nervous system (CNS) pathology or event such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis.
- Current autoimmune disease or history of autoimmune disease with potential CNS involvement.
- History of other malignancy within the past 3 years, except for malignancy treated with curative intent with low risk for recurrence. Exceptions include:
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 |
|---|---|---|
| BlinatumomabBlinatumomab will be administered as a SC injection. | Drug | HyperCVAD + SC Blinatumomab in Consolidation |
| BlinatumomabBlinatumomab will be administered as a cIV infusion. | Drug | HyperCVAD + cIV Blinatumomab in Consolidation |
| HyperCVADHyperCVAD will administer as the chemo regimen as part of the standard of care (SOC) regimen. | Drug | HyperCVAD + SC Blinatumomab in Consolidation, HyperCVAD + cIV Blinatumomab in Consolidation |
Primary outcome
Overall Survival (OS)
Time frame: Up to 5 years from randomization
13 secondary outcomes
Number of Participants who Experience Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 5 years from randomization
Area Under the Concentration-time Curve in Cycle 1 (AUCcycle 1) for SC Blinatumomab
Time frame: Up to Cycle 1 Day 35 (Cycle length = 35 days)
AUCcycle 1 for cIV Blinatumomab
Time frame: Up to Cycle 1 Day 35 (Cycle length = 35 days)
Average Concentration Following Cycle 1 Day 19 Dosing (Cavgd19dose) for SC Blinatumomab
Time frame: From predose on Cycle 1 Day 19 to predose on Cycle 1 Day 22 (Cycle length = 35 days)
Steady-state Concentration (Css) for cIV Blinatumomab
Time frame: Up to Cycle 1 Day 29 (Cycle length = 35 days)
Relapse-free Survival (RFS)
Time frame: Up to 5 years from randomization
Number of Participants With CR With MRD Response
Time frame: Up to 5 years from randomization
Number of Participants With Deep CR With MRD Response
Time frame: Up to 5 years from randomization
Change from Day 1 Consolidation Cycle 1 to End of Consolidation in Role Functioning as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Time frame: Consolidation Cycles 1, 2, 5 and 6 Day 1 (Cycles length=35 days); Consolidation Cycles 3, 4, 7 and 8 Day 15 (Cycles length=2-4 weeks); Maintenance Cycle 1 Day 1 (Cycle length=28 days)
Change from Day 1 Consolidation Cycle 1 to End of Consolidation in Overall Quality of Life as Measured by EORTC QLQ-C30
Time frame: Consolidation Cycles 1, 2, 5 and 6 Day 1 (Cycles length=35 days); Consolidation Cycles 3, 4, 7 and 8 Day 15 (Cycles length=2-4 weeks); Maintenance Cycle 1 Day 1 (Cycle length=28 days)
Change from Day 1 Consolidation Cycle 1 to End of Consolidation in All Other Domains/Items as Measured by EORTC QLQ-C30
Time frame: Consolidation Cycles 1, 2, 5 and 6 Day 1 (Cycles length=35 days); Consolidation Cycles 3, 4, 7 and 8 Day 15 (Cycles length=2-4 weeks); Maintenance Cycle 1 Day 1 (Cycle length=28 days)
Change From Day 1 Consolidation Cycle 1 to End of Consolidation in the Visual Analogue Scale (VAS)
Time frame: Consolidation Cycles 1, 2, 5 and 6 Day 1 (Cycles length=35 days); Consolidation Cycles 3, 4, 7 and 8 Day 15 (Cycles length=2-4 weeks); Maintenance Cycle 1 Day 1 (Cycle length=28 days)
Percentage of Time on Treatment With High Side Effect Bother From Consolidation Cycle 1 to End of Consolidation
Time frame: Consolidation Cycle 1 up to Day 8 and then weekly until end of Consolidation Cycle (Cycle length = 35 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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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.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Blinatumomab and HyperCVAD in people with Philadelphia Chromosome Negative B-cell Precursor Acute Lymphoblastic Leukemia, run by Amgen.
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 7 inclusion and 26 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: opening soon, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amgen Call Center (866-572-6436, medinfo@amgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: Up to 5 years from randomization). 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 15 Sep 2026.