Leukemia, Lymphocytic, Acute, AdultNCT06649422
Reduced-Dose Chemo Followed by 14 Days of Blinatumomab for Newly Diagnosed Adult B-ALL Patients: a Multicenter Study
An observational study of Leukemia, Lymphocytic, Acute, Adult, run by Shandong University.
Trial summary
This is a prospective, multicenter, observational study aimed at exploring the efficacy and safety of reduced-dose chemotherapy followed by frontline therapy with blinatumomab in patients aged 15-65 with newly diagnosed Ph-negative B-ALL. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Leukemia, Lymphocytic, Acute, Adult
- What is being tested?
- Blinatumomab
- Type of treatment
- Injection or infusion
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to Dec 2027
- Phase
- Observational
- 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 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients aged 15-65 years newly diagnosed with Philadelphia chromosome-negative acute B-lymphoblastic leukemia, confirmed at Qilu Hospital of Shandong University and other participating institutions in Shandong Province.
Who may be able to join
- Age 15-65 years, both male and female are eligible;
- Untreated newly diagnosed Ph-negative B-ALL patients; Diagnosis is defined by using morphological, immunological, cytogenetic, and molecular (MICM) diagnostic models, with immunotyping showing >20% primitive lymphoid cells in the bone marrow; bone marrow cytogenetics showing Philadelphia chromosome (Ph) negative (after observing at least 20 metaphases) and/or fluorescence in situ hybridization (FISH) BCR/ABL negative and/or molecular BCR/ABL fusion gene negative;
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2;
- Organ function tests must meet all the following criteria: Total bilirubin <1.5×upper limit of normal (ULN); Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) <2.5×ULN (if liver is involved, then ALT and AST <5×ULN are allowed); Creatinine <1.5×ULN; Serum amylase and lipase ≤1.5×ULN; Alkaline phosphatase ≤2.5× ULN; Serum electrolytes potassium, magnesium, phosphorus within normal limits.
- Cardiac color Doppler echocardiography ejection fraction ≥45%;
- Female patients of childbearing potential must have a negative pregnancy test (within 7 days prior to enrollment).
Who cannot join
- Previous or ongoing systemic anti-acute lymphoblastic leukemia (ALL) treatment (including but not limited to radiotherapy), except for appropriate pretreatment;
- Clinical manifestations of central nervous system or extramedullary involvement at the time of diagnosis;
- Patients participating in other clinical studies simultaneously;
- Accompanying diseases that, in the judgment of the investigator, pose a serious risk to patient safety or affect the patient's ability to complete the study;
- A history of definite neurological or psychiatric disorders, including epilepsy or dementia;
- Major surgery within the last 4 weeks or not recovered from previous surgery;
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- Having other malignant tumors, unless the other primary malignant tumor is currently stable or does not require active intervention;
- Women of childbearing age or men who cannot use sufficient methods for contraception, including pregnant or lactating women;
- Clinically significant severe uncontrollable heart disease (including but not limited to a history of myocardial infarction, stroke, or revascularization; unstable angina or transient ischemic attack within 6 months before enrollment; congestive heart failure or left ventricular ejection fraction (LVEF) below the local institutional standard lower limit within 6 months before enrollment; a history of clinically significant (determined by the attending physician) atrial arrhythmia; a history of ventricular arrhythmia; a history of venous thromboembolism, including deep vein thrombosis or pulmonary embolism, uncontrollable hypertension, etc.);
- Confirmed positive status for human immunodeficiency;
- Active severe infections that cannot be controlled by oral or intravenous antibiotics;
- Patients known to be allergic or contraindicated to the study drug (active pharmaceutical ingredient and/or excipients);
- Existence of bleeding disorders unrelated to ALL.
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: Clinical Study on the Efficacy and Safety of Reduced-Dose Chemotherapy Followed by 14 Days of Blinatumomab in Adult Patients with Newly Diagnosed Ph-Negative B-ALL: a Prospective, Multicenter, Observational Study.
This is a prospective, multicenter, observational study aimed at exploring the efficacy and safety of reduced-dose chemotherapy followed by frontline therapy with blinatumomab in patients aged 15-65 with newly diagnosed Ph-negative B-ALL.
Read the detailed description
The 14-day blinatumomab combined with reduced-dose chemotherapy is used for the induction treatment of newly diagnosed Ph-chromosome negative acute B-lymphoblastic leukemia. On day 14, an intrathecal injection of chemotherapy is administered; on days 28-35, bone marrow is assessed, and patients who do not achieve complete remission are withdrawn from the study. Patients with positive minimal residual disease (MRD) after induction treatment undergo transplant typing and proceed to allogeneic hematopoietic stem cell transplantation (Allo-HSCT) after early intensification. Patients with negative MRD receive alternating treatment with multi-drug combination chemotherapy and blinatumomab, for a total of 8 consolidation courses, including 3 courses of blinatumomab. Maintenance therapy lasts for at least 18 months, using the POMP regimen with or without one cycle of blinatumomab every six months. Throughout the entire treatment phase, at least 12 preventive intrathecal injections are administered.
- Conditions
- Leukemia, Lymphocytic, Acute, Adult
- Being tested
- Blinatumomab
- Keywords
- blinatumomab, newly diagnosed Ph-chromosome negative acute B-lymphoblastic leukemia, induction treatment, reduced-dose chemotherapy
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlinatumomabDrug
Also called Combination chemotherapy with multiple drugs., preventive intrathecal injections
The 14-day blinatumomab combined with reduced-dose chemotherapy is used for the induction treatment of newly diagnosed Ph-chromosome negative acute B-lymphoblastic leukemia.
| Study group | Role | What they receive |
|---|---|---|
| Reduced-dose chemotherapy followed by blinatumomab induction treatment group | Patients aged 15-65 with newly diagnosed Ph-negative B-ALL undergoing frontline induction therapy with reduced-dose chemotherapy followed by blinatumomab. Receives: Drug: Blinatumomab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The overall response rate
The overall response rate after induction therapy = Complete Remission (CR) + CR with partial hematologic recovery (CRh) + CR with incomplete hematologic recovery (Cri).
Measured: At the end of induction treatment from day 28 to day 35
Minimal Residual Disease (MRD) negativity rate after induction therapy
MRD negativity refers to a flow cytometry test result where MRD is less than 0.01%.
Measured: At the end of induction treatment from day 28 to day 35
Secondary outcomes (4)
Complete molecular remission rate.
Complete molecular remission rate is defined as undetectable Ig rearrangement by next-generation sequencing, with a detection sensitivity of at least less than 10^-5.
Measured: At the end of induction treatment from day 28 to day 35
One-year overall survival rate.
The proportion of patients who are still alive one year after the date of disease diagnosis, out of the total number of subjects enrolled in the study.
Measured: From diagnosis of the disease to the end of the first year
One-year event-free survival rate
The proportion of patients who have not experienced disease progression, been diagnosed with another cancer, or died from any cause one year after the date of disease diagnosis, out of the total number of subjects enrolled in the study.
Measured: From diagnosis of the disease to the end of the first year
Safety
Safety endpoints are defined, graded, and evaluated according to the CTCAE version 5.0 criteria.
Measured: From enrollment until withdrawal from the study or the end of follow-up up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Leukemia, Lymphocytic, Acute, AdultStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong Provincial Hospital, The Affiliated Hospital of Qingdao University, Tangshan Central Hospital, Qianfoshan Hospital, Yantai Yuhuangding Hospital, Qilu Hospital of Shandong University (Qingdao), Qingdao Central Hospital, Qingdao Municipal Hospital, Affiliated Hospital of Jining Medical University, Affiliated Hospital of Binzhou Medical College, Linyi People's Hospital, The Second Hospital of Shandong University, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Shandong First Medical University, Shengli Oilfield Hospital, Heze Municipal Hospital, Zibo Central Hospital, Zaozhuang Municipal Hospital, Weihai Municipal Hospital
- Responsible party
- Principal investigator, Chunyan Ji, Qilu Hospital of Shandong University
- Investigators
- Chunyan Ji, Doctor, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06649422
- Sponsor's protocol ID
- QLCR20240289
- Status last verified
- Jul 2024
- First submitted
- 6 Sep 2024
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Davis KL, Yao CC, Zimmerman JAO, Rau RE. Immunotherapy in B-Cell Acute Lymphoblastic Leukemia. J Natl Compr Canc Netw. 2025 Dec;23(12):e257067. doi: 10.6004/jnccn.2025.7067.
PubMed 41671463
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Efficacy and Safety of Reduced-Dose Chemotherapy Followed by 14 Days of Blinatumomab in Adult Patients with Newly Diagnosed Ph-Negative B-ALL: a Prospective, Multicenter, Observational Study.
- ClinicalTrials.gov ID
- NCT06649422
- Acronym / sponsor ID
- QLCR20240289
- Conditions
- Leukemia, Lymphocytic, Acute, Adult
- Keywords
- blinatumomab, newly diagnosed Ph-chromosome negative acute B-lymphoblastic leukemia, induction treatment, reduced-dose chemotherapy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Collaborators
- Shandong Provincial Hospital, The Affiliated Hospital of Qingdao University, Tangshan Central Hospital, Qianfoshan Hospital, Yantai Yuhuangding Hospital, Qilu Hospital of Shandong University (Qingdao), Qingdao Central Hospital, Qingdao Municipal Hospital, Affiliated Hospital of Jining Medical University, Affiliated Hospital of Binzhou Medical College, Linyi People's Hospital, The Second Hospital of Shandong University, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Shandong First Medical University, Shengli Oilfield Hospital, Heze Municipal Hospital, Zibo Central Hospital, Zaozhuang Municipal Hospital, Weihai Municipal Hospital
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 Oct 2024 (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.
This is a prospective, multicenter, observational study aimed at exploring the efficacy and safety of reduced-dose chemotherapy followed by frontline therapy with blinatumomab in patients aged 15-65 with newly diagnosed Ph-negative B-ALL.
Detailed description
The 14-day blinatumomab combined with reduced-dose chemotherapy is used for the induction treatment of newly diagnosed Ph-chromosome negative acute B-lymphoblastic leukemia. On day 14, an intrathecal injection of chemotherapy is administered; on days 28-35, bone marrow is assessed, and patients who do not achieve complete remission are withdrawn from the study. Patients with positive minimal residual disease (MRD) after induction treatment undergo transplant typing and proceed to allogeneic hematopoietic stem cell transplantation (Allo-HSCT) after early intensification. Patients with negative MRD receive alternating treatment with multi-drug combination chemotherapy and blinatumomab, for a total of 8 consolidation courses, including 3 courses of blinatumomab. Maintenance therapy lasts for at least 18 months, using the POMP regimen with or without one cycle of blinatumomab every six months. Throughout the entire treatment phase, at least 12 preventive intrathecal injections are administered.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reduced-dose chemotherapy followed by blinatumomab induction treatment group | – | Drug: BlinatumomabPatients aged 15-65 with newly diagnosed Ph-negative B-ALL undergoing frontline induction therapy with reduced-dose chemotherapy followed by blinatumomab. |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients aged 15-65 years newly diagnosed with Philadelphia chromosome-negative acute B-lymphoblastic leukemia, confirmed at Qilu Hospital of Shandong University and other participating institutions in Shandong Province.
Key inclusion criteria (6 listed)
- Age 15-65 years, both male and female are eligible;
- Untreated newly diagnosed Ph-negative B-ALL patients; Diagnosis is defined by using morphological, immunological, cytogenetic, and molecular (MICM) diagnostic models, with immunotyping showing >20% primitive lymphoid cells in the bone marrow; bone marrow cytogenetics showing Philadelphia chromosome (Ph) negative (after observing at least 20 metaphases) and/or fluorescence in situ hybridization (FISH) BCR/ABL negative and/or molecular BCR/ABL fusion gene negative;
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2;
- Organ function tests must meet all the following criteria: Total bilirubin <1.5×upper limit of normal (ULN); Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) <2.5×ULN (if liver is involved, then ALT and AST <5×ULN are allowed); Creatinine <1.5×ULN; Serum amylase and lipase ≤1.5×ULN; Alkaline phosphatase ≤2.5× ULN; Serum electrolytes potassium, magnesium, phosphorus within normal limits.
- Cardiac color Doppler echocardiography ejection fraction ≥45%;
Key exclusion criteria (13 listed)
- Previous or ongoing systemic anti-acute lymphoblastic leukemia (ALL) treatment (including but not limited to radiotherapy), except for appropriate pretreatment;
- Clinical manifestations of central nervous system or extramedullary involvement at the time of diagnosis;
- Patients participating in other clinical studies simultaneously;
- Accompanying diseases that, in the judgment of the investigator, pose a serious risk to patient safety or affect the patient's ability to complete the study;
- A history of definite neurological or psychiatric disorders, including epilepsy or dementia;
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 |
|---|---|---|
| BlinatumomabAlso: Combination chemotherapy with multiple drugs., preventive intrathecal injectionsThe 14-day blinatumomab combined with reduced-dose chemotherapy is used for the induction treatment of newly diagnosed Ph-chromosome negative acute B-lymphoblastic leukemia. | Drug | Reduced-dose chemotherapy followed by blinatumomab induction treatment group |
Primary outcome
The overall response rate
Time frame: At the end of induction treatment from day 28 to day 35
The overall response rate after induction therapy = Complete Remission (CR) + CR with partial hematologic recovery (CRh) + CR with incomplete hematologic recovery (Cri).
Minimal Residual Disease (MRD) negativity rate after induction therapy
Time frame: At the end of induction treatment from day 28 to day 35
MRD negativity refers to a flow cytometry test result where MRD is less than 0.01%.
4 secondary outcomes
Complete molecular remission rate.
Time frame: At the end of induction treatment from day 28 to day 35
One-year overall survival rate.
Time frame: From diagnosis of the disease to the end of the first year
One-year event-free survival rate
Time frame: From diagnosis of the disease to the end of the first year
Safety
Time frame: From enrollment until withdrawal from the study or the end of follow-up up to two years
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 18 Oct 2024.
- Derived from this study: PubMed 41671463Davis KL, Yao CC, Zimmerman JAO, Rau RE. Immunotherapy in B-Cell Acute Lymphoblastic Leukemia. J Natl Compr Canc Netw. 2025 Dec;23(12):e257067. doi: 10.6004/jnccn.2025.7067.
- Individual participant dataSharing planned: Undecided
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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.
Chunyan Ji, Doctor principal investigator
Qilu Hospital of Shandong University
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia, Lymphocytic, Acute, Adult, run by Shandong University.
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 6 inclusion and 13 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 18 Oct 2024. 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.
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 Yanping Sun (18560089133, syp215920@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The overall response rate (time frame: At the end of induction treatment from day 28 to day 35). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06649422, which also lists 1 linked publication.
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 18 Oct 2024.