Acute Lymphoblastic LeukemiaPhase 2NCT06886074
Efficacy of Short-course Blinatumomab for MRD Erradication in B-ALL
A Phase 2 study testing Short course of blinatumomab in people with Acute Lymphoblastic Leukemia and Measurable Residual Disease (MRD), run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
Trial summary
Detectable measurable residual disease (MRD) is the most important prognostic factor for B-cell acute lymphoblastic leukemia (B-ALL) for overall survival (OS) and disease-free survival (DFS). Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Measurable Residual Disease (MRD)
- What is being tested?
- Short course of blinatumomab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteMexico
- Study dates
- 2 Jan 2025to Jun 2027
- Phase
- Phase 2
- 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Philadelphia chromosome-negative B-cell acute lymphoblastic leukemia
- MRD detectable in complete response (above the limit of quantification according to FCM)
- Performance status 0-2 on the ECOG scale
- No prior organ damage
- Having a potential related or unrelated donor
Who cannot join
- Performance status on the ECOG scale >2
- HCT-CI >3 points
- Patients who do not wish to participate in clinical study.
- Active central nervous system infiltration (CNS3)
- Active extramedullary disease
- Having previously received blinatumomab
- Absence of related or unrelated donors
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Hospital Universitario Dr. Jose E. Gonzalez
Monterrey, Nuevo León, 64460
Andres Gomez De Leon, Professor of Hematology, +528116089404, drgomezdeleon@gmail.com
David Gomez-Almaguer, Head of Hematology Service, +528182593389, dgomezalmaguer@gmail.com
About this study
Official title: Efficacy of Short-course Blinatumomab in Patients With Detectable Measurable Residual Disease With Philadelphia Chromosome-negative B-cell Acute Lymphoblastyc Leukemia
Detectable measurable residual disease (MRD) is the most important prognostic factor for B-cell acute lymphoblastic leukemia (B-ALL) for overall survival (OS) and disease-free survival (DFS). Patients who are MRD positive and have no access to novel immunotherapies should receive an allogeneic hematopoietic stem cell transplantation (HSCT). Blinatumomab is considered a standard of care (SOC) for this group of patients, however, the ideal treatment dose for MRD is unknown as doses were adjusted from the relapsed/refractory setting. Preliminary data suggest short cycles of blinatumomab can also be effective in states of lower disease burden prior to transplant. Thus, the investigators are performing a phase 2 trial assessing 7 days of blinatumomab as a bridge to HSCT
Primary endpoint is assessing the MRD response following a short-course blinatumomab infusion in patients with B-ALL with complete response (CR) and have detectable MRD disease who are candidates for HSCT. Secondary endpoints include incidence of adverse events, OS, DFS, percentage of patients who receive HSCT, incidence of cytokine release syndrome (CRS) and immune effector cell associated neurotoxicity syndrome (ICANS)
Read the detailed description
During the proposed treatment, blinatumomab therapy will be assigned as follows:
Blinatumomab 17.5 mcg per day for 2 days, followed by blinatumomab 28 mcg per day for 5 days. Dexamethasone 20 mg will be applied one hour before starting dose.
The immunotherapy will be applied as a 24-hour continuous infusion. The scheduled appointments will be on the initial day of blinatumomab, when the patient will be discharged from hospital and evaluation will be performed on day 10 with bone marrow aspiration and MRD assessment trough next generation flow cytometry. The results will be given at the appointment on day 14, along with an assessment profile for HSCT.
- Being tested
- Short course of blinatumomab
- Keywords
- Blinatumomab, Measurable residual disease
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short course of blinatumomabDrug
Patients will receive 175 mcg of blinatumomab trough out seven days in a 24-hours infusion.
Blinatumomab therapy will be assigned 17.5 mcg per day for the first 2 days. Then blinatumomab 28 mcg per day for 5 days (completing 7 days). A single intravenous 20 mg dose of dexamethasone will be applied one hour before starting dose.
| Study group | Role | What they receive |
|---|---|---|
| Blinatumomab arm | Experimental | Patients will receive 7 days of blinatumomab with a fixed dose of 175 mcg through out 7 days Receives: Drug: Short course of blinatumomab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy to eradicate MRD in negative Philadelphia-chromosome B-cell acute lymphoblastic leukemia
Primary outcome is to determinate the efficacy of blinatumomab to eradicate MRD in a blood sample extracted by bone marrow aspiration and evaluated by next generation flow cytometry on the third day after blinatumomab completion (day 10 after initiation). MRD eradication will be defined as: undetectable (below limit of detection) disease through next generation flow cytometry.
Measured: 24 months
Secondary outcomes (6)
Overall survival
Survival time after enrollment
Measured: 24 months
Disease free survival
Time from enrollment to relapse
Measured: 24 months
Percentage of patients undergoing stem cell transplantation
Percentage of patients who undergo hematopoietic stem cell transplantation after enrollment
Measured: 24 months
Incidence of adverse events
Incidence of hematologic (anemia, thrombocytopenia, leukopenia, neutropenia, lymphocytopenia) and non-hematologic (renal, hepatic, dermatologic, cardiovascular, infectious) adverse events after initiating blinatumomab therapy assessed by CTCAE V 5.0
Measured: 24 months
Incidence of cytokine release syndrome
Incidence and grading of cytokine release syndrome after initiating blinatumomab through CTCAE V 5.0
Measured: 24 months
Incidence of immune effector cell-associated neurotoxicity syndrome
Incidence and grading of immune effector cell-associated neurotoxicity syndrome after initiating blinatumomab assessed by ASTCT grading system.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start2 Jan 2025
- Primary completionJan 2027 (estimated)
- Study completionJun 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 Acute Lymphoblastic LeukemiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One arm, open-label, phase 2 study
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Gomez Almaguer, Hospital Universitario Dr. Jose E. Gonzalez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06886074
- Sponsor's protocol ID
- HE25-00007
- Status last verified
- Mar 2025
- First submitted
- 3 Mar 2025
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yin J, Cai X, Qian B, Liu Y, Li D. Short-Course Blinatumomab Treatment as a Bridge to Further Salvage Therapy for Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia: A Retrospective Single-Center Study. Cancer Med. 2024 Dec;13(24):e70515. doi: 10.1002/cam4.70515.
PubMed 39692275
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Short-course Blinatumomab in Patients With Detectable Measurable Residual Disease With Philadelphia Chromosome-negative B-cell Acute Lymphoblastyc Leukemia
- ClinicalTrials.gov ID
- NCT06886074
- Acronym / sponsor ID
- HE25-00007
- Keywords
- Blinatumomab, Measurable residual disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospital Universitario Dr. Jose E. GonzalezUniversity, hospital or other
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 20 Mar 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.
Detectable measurable residual disease (MRD) is the most important prognostic factor for B-cell acute lymphoblastic leukemia (B-ALL) for overall survival (OS) and disease-free survival (DFS). Patients who are MRD positive and have no access to novel immunotherapies should receive an allogeneic hematopoietic stem cell transplantation (HSCT). Blinatumomab is considered a standard of care (SOC) for this group of patients, however, the ideal treatment dose for MRD is unknown as doses were adjusted from the relapsed/refractory setting. Preliminary data suggest short cycles of blinatumomab can also be effective in states of lower disease burden prior to transplant. Thus, the investigators are performing a phase 2 trial assessing 7 days of blinatumomab as a bridge to HSCT
Primary endpoint is assessing the MRD response following a short-course blinatumomab infusion in patients with B-ALL with complete response (CR) and have detectable MRD disease who are candidates for HSCT. Secondary endpoints include incidence of adverse events, OS, DFS, percentage of patients who receive HSCT, incidence of cytokine release syndrome (CRS) and immune effector cell associated neurotoxicity syndrome (ICANS)
Detailed description
During the proposed treatment, blinatumomab therapy will be assigned as follows:
Blinatumomab 17.5 mcg per day for 2 days, followed by blinatumomab 28 mcg per day for 5 days. Dexamethasone 20 mg will be applied one hour before starting dose.
The immunotherapy will be applied as a 24-hour continuous infusion. The scheduled appointments will be on the initial day of blinatumomab, when the patient will be discharged from hospital and evaluation will be performed on day 10 with bone marrow aspiration and MRD assessment trough next generation flow cytometry. The results will be given at the appointment on day 14, along with an assessment profile for HSCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One arm, open-label, phase 2 study
| Arm | Type | Receives |
|---|---|---|
| Blinatumomab arm | Experimental | Drug: Short course of blinatumomabPatients will receive 7 days of blinatumomab with a fixed dose of 175 mcg through out 7 days |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Philadelphia chromosome-negative B-cell acute lymphoblastic leukemia
- MRD detectable in complete response (above the limit of quantification according to FCM)
- Performance status 0-2 on the ECOG scale
- No prior organ damage
- Having a potential related or unrelated donor
Key exclusion criteria (7 listed)
- Performance status on the ECOG scale >2
- HCT-CI >3 points
- Patients who do not wish to participate in clinical study.
- Active central nervous system infiltration (CNS3)
- Active extramedullary disease
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 |
|---|---|---|
| Short course of blinatumomabPatients will receive 175 mcg of blinatumomab trough out seven days in a 24-hours infusion. Blinatumomab therapy will be assigned 17.5 mcg per day for the first 2 days. Then blinatumomab 28 mcg per day for 5 days (completing 7 days). A single intravenous 20 mg dose of dexamethasone will be applied one hour before starting dose. | Drug | Blinatumomab arm |
Primary outcome
Efficacy to eradicate MRD in negative Philadelphia-chromosome B-cell acute lymphoblastic leukemia
Time frame: 24 months
Primary outcome is to determinate the efficacy of blinatumomab to eradicate MRD in a blood sample extracted by bone marrow aspiration and evaluated by next generation flow cytometry on the third day after blinatumomab completion (day 10 after initiation). MRD eradication will be defined as: undetectable (below limit of detection) disease through next generation flow cytometry.
6 secondary outcomes
Overall survival
Time frame: 24 months
Disease free survival
Time frame: 24 months
Percentage of patients undergoing stem cell transplantation
Time frame: 24 months
Incidence of adverse events
Time frame: 24 months
Incidence of cytokine release syndrome
Time frame: 24 months
Incidence of immune effector cell-associated neurotoxicity syndrome
Time frame: 24 months
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 20 Mar 2025.
- Results publication: PubMed 39692275Yin J, Cai X, Qian B, Liu Y, Li D. Short-Course Blinatumomab Treatment as a Bridge to Further Salvage Therapy for Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia: A Retrospective Single-Center Study. Cancer Med. 2024 Dec;13(24):e70515. doi: 10.1002/cam4.70515.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Short course of blinatumomab in people with Acute Lymphoblastic Leukemia and Measurable Residual Disease (MRD), run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Andres Gomez-De Leon, Professor of Hematology (+528116089404, drgomezdeleon@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy to eradicate MRD in negative Philadelphia-chromosome B-cell acute lymphoblastic leukemia (time frame: 24 months). 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 NCT06886074, 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 20 Mar 2025.