AzTrials
AzTrials

B-cell Acute Lymphoblastic LeukemiaPhase 1/2NCT07153796

A Phase 1b/2 Study to Assess the Safety and Efficacy of Subcutaneous Blinatumomab in Combination With Low Intensity Chemotherapy in Older Patients With Newly Diagnosed B-Cell Acute Lymphoblastic Leukemia

A Phase 1/2 study testing Blinatumomab, Mini-CVD and MTX/ARA-C in people with B-cell Acute Lymphoblastic Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This is a single arm open-label phase 2 trial to study the safety and efficacy of SC Blinatumomab in combination with low-intensity chemotherapy for older or unfit patients with B-ALL. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
B-cell Acute Lymphoblastic Leukemia
What is being tested?
Blinatumomab, Mini-CVD and MTX/ARA-C
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteUnited States
Study dates
30 Jan 2026to 30 Sep 2033
Phase
Phase 1/2
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients 60 years or older with previously untreated Ph-negative B-ALL. Patients may have received minimal prior therapy before (up to 2 cycles of previous therapy)
  • Patients 18 to 59 years of age with previously untreated Ph-negative B-ALL who are deemed medically unfit for intensive chemotherapy. Patients may have received minimal prior therapy (up to 2 cycles of previous therapy)
  • Unfit patients are defined as having at least one of the below comorbidities:
  • COG >2
  • Severe cardiac disorder (e.g., congestive heart failure requiring treatment, ejection fraction <50%, or chronic stable angina)
  • Severe pulmonary disorder (e.g., DLCO <65% or FEV1 <65%)
Show all 17Show fewer
  • Hepatic disorder with total bilirubin 1.5 x upper limit of normal
  • ECOG Performance status of 0, 1, or 2.
  • Adequate organ function with estimated creatinine clearance of > 50 mg/min/1.73m2, bilirubin less than or equal to 3.5 mg, ALT and/or AST less than or equal to 5 times institutional upper limit of normal.
  • The effects of blinatumomab on the developing human fetus are unknown. For this reason and because Class C agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:
  • Postmenopausal (no menses in greater than or equal to 12 consecutive months).
  • History of hysterectomy or bilateral salpingo-oophorectomy.
  • Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
  • History of bilateral tubal ligation or another surgical sterilization procedure.
  • Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
  • Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of blinatumomab administration.
  • Ability to understand and the willingness to sign a written informed consent document.

Who cannot join

  • Pregnant women are excluded from this study because blinatumomab is a Class C agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with blinatumomab, breastfeeding should be discontinued if the mother is treated with blinatumomab These potential risks may also apply to other agents used in this study.
  • Women of child-bearing potential (WOCBP) must have negative pregnancy test. WOCBP defined as not post-menopausal for 12 months or no previous surgical sterilization.
  • Female subjects of childbearing potential unwilling/unable to use highly effective method of contraception during treatment and for an additional 4 months after the last dose of SC blinatumomab
  • Prior history of therapy with SC Blinatumomab
  • Philadelphia positive (+) B-ALL
  • Known HIV-positive patients
Show all 16Show fewer
  • Patients with active inflammatory or infectious hepatitis. Patients with evidence of chronic hepatitis B infection must have undetectable HBV viral load on suppressive therapy. For patients with a history of Hepatitis C, infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
  • Active and uncontrolled disease/infection as judged by the treating physician
  • Patients with a cardiac ejection fraction as measured by MUGA or TTE <40%
  • Unable/unwilling to sign informed consent form
  • No other investigational therapy within the past 14 days
  • Symptomatic CNS disease at the time of enrollment.
  • History or presence of clinically relevant 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 or severe (> or = grade 3) CNS events including ICANS from prior CART or other T cell engager therapies.
  • No other concurrent anti-leukemia therapy will be allowed, except for BCR::ABL1 tyrosine kinase inhibitors in patients with Ph-like ALL where tyrosine kinase inhibitors have been shown to be effective.
  • Current uncontrolled autoimmune disease or history of autoimmune disease with potential CNS involvement.
  • Patients with psychiatric illness/social situations that would limit compliance with study requirements.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The University of Texas M. D. Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

This is a single arm open-label phase 2 trial to study the safety and efficacy of SC Blinatumomab in combination with low-intensity chemotherapy for older or unfit patients with B-ALL.

Read the detailed description

Primary Objective:

  1. To evaluate event-free survival (EFS, time from treatment initiation to relapse or death) of SC Blinatumomab in combination with low-intensity chemotherapy in older and unfit patients with newly diagnosed Ph-negative B-cell ALL

Secondary Objectives:

  1. Determine efficacy of SC Blinatumomab in combination with low-intensity chemotherapy in older and unfit patients with newly diagnosed Ph-negative B-cell ALL through the overall response rate (complete remission [CR] + complete remission with incomplete count recovery [CRi])
  2. Determine overall survival (OS, time from treatment start to death from any cause)
  3. Determine rates of MRD negativity by flow cytometry (sensitivity of 10-4) and ClonoSeq NGS (sensitivity of 10-6)
  4. Determine the safety of the combination of SC Blinatumomab with low intensity chemotherapy

Exploratory Objective:

  1. Pending exploratory objectives, single cell analysis and correlation with secondary AML/MDS
Being tested
Blinatumomab, Mini-CVD, MTX/ARA-C
Medical subject headings
Burkitt Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BlinatumomabDrug

    Given by IV

  • Mini-CVDDrug

    Given by IV

  • MTX/ARA-CDrug

    Given by IV

Study groups in NCT07153796
Study groupRoleWhat they receive
Age 18-59 years or 60-70 years: Mini-CVD + MTX/ARA-C + BlinatumomabExperimentalParticipants who are 60-70 years of age or 18-59 years of age and unfit for intensive chemotherapy will receive a total of 8 cycles of induction-consolidation cycles.
Receives: Drug: Blinatumomab; Drug: Mini-CVD; Drug: MTX/ARA-C
Age>70 years: Mini-CVD + BlinatumomabExperimentalParticipants older than 70 years of age will receive 1 cycle of mini-CVD in combination with SC Blinatumomab followed by SC Blinatumomab alone for 7 cycles for a total of 8 cycles of treatment.
Receives: Drug: Blinatumomab; Drug: Mini-CVD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and Adverse Events (AEs)

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

    Measured: Through study completion; an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2025
  2. Study start30 Jan 2026
  3. Primary completion30 Sep 2031 (estimated)
  4. Study completion30 Sep 2033 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07153796
Sponsor's protocol ID
2025-0935
Other IDs
NCI-2025-06510
Status last verified
Aug 2026
First submitted
3 Sep 2025
Last updated
18 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Blinatumomab, Mini-CVD and MTX/ARA-C in people with B-cell Acute Lymphoblastic Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.

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 16 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: under way, not looking for participants, as of the sponsor's last update on 18 Aug 2026. 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 United States. 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 combined 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.

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?

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?

Safety and Adverse Events (AEs) (time frame: Through study completion; an average of 1 year). 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 NCT07153796.

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 Aug 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in