BlinatumomabPhase 1NCT07283640
A Phase IB Trial of Subcutaneous Blinatumomab in Combination With Revumenib for Patients With KMT2A-rearranged Acute Lymphoblastic Leukemia
A Phase 1 study testing Revumenib and Blinatumomab in people with Blinatumomab and Revumenib, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To learn about the safety and effects of revumenib in combination with blinatumomab in patients with newly diagnosed or relapsed/refractory Ph-negative ALL with a KMT2A rearrangement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blinatumomab, Revumenib, Lymphoblastic Leukemia
- What is being tested?
- Revumenib and Blinatumomab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2026to 31 Aug 2031
- Phase
- Phase 1
- 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
None listed.
Who cannot join
- Active serious infection not controlled by oral or IV antibiotics
- Active secondary malignancy other than skin cancer (basal cell carcinoma or squamous cell carcinoma) that in the investigator's opinion will shorten survival to less than 1 year
- Participants with psychiatric illness that would limit compliance with study requirements
- Untreated CNS disease. Participants with controlled CNS disease may be included (as defined by being asymptomatic and having CNS cleared of leukemic involvement)
- Detectable HIV viral load within the previous 6 months. Participants with a known history of HIV must have viral load testing prior to study enrollment.
- Any of the following within 6 months prior to study entry: myocardial infarction, congestive heart failure New York Heart Association Classification Class > II, life-threatening, uncontrolled arrhythmia, cerebrovascular accident, or transient ischemic attack
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- QTc using Friderica's correction (QTcF) >450 msec
- Personal of family history of long QT syndrome
- Cirrhosis with a Child Pugh score of B or C
- Participants with active hepatitis B (defined as Hepatitis B surface antigen with detectable Hepatitis B virus DNA by PCR) or hepatitis C infection (defined as presence of detectable Hepatitis C virus RNA by PCR)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
MD Anderson Cancer
Houston, Texas, 77030
Elias J Jabbour, MD, 713-792-4764, ejabbour@mdanderson.org
Elias J Jabbour, MD
About this study
To learn about the safety and effects of revumenib in combination with blinatumomab in patients with newly diagnosed or relapsed/refractory Ph-negative ALL with a KMT2A rearrangement.
Read the detailed description
Primary Objectives
- To determine the safety of recommended dose by 20 participants including 10 relapsed/refractory participants (cohort 1) and 10 newly diagnosed participants (cohort 2).
- To evaluate the overall response rate (combination of complete remission [CR] + complete remission with incomplete count recovery [CRi) + complete remission with incomplete hematologic recovery [CRh]) of the combination of SC blinatumomab and revumenib in cohort 1 and cohort 2 (participants with MRD-only disease will not be included towards the overall response rate)
- To evaluate event-free survival (EFS, defined as the time from treatment initiation to relapse, death, or documented treatment failure) in cohort 2
Secondary Objectives
- To evaluate overall survival (OS, defined as the time from treatment initiation to death from any cause)
- To summarize the safety of the combination of revumenib and SC blinatumomab at all revumenib doses tested
- To evaluate measurable residual disease (MRD) negativity by flow cytometry (sensitivity of 10-4) and ClonoSeq NGS (sensitivity of 10-6)
- To characterize the frequency of lineage switch after treatment with the combination of revumenib and SC blinatumomab
- Conditions
- Blinatumomab, Revumenib, Lymphoblastic Leukemia, KMT2A-rearranged
- Being tested
- Revumenib, Blinatumomab
- 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.
RevumenibDrug
Given by po
BlinatumomabDrug
Given by IV
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Treatment with SC Blinatumomab + Revumenib in R/R ALL Receives: Drug: Revumenib; Drug: Blinatumomab |
| Cohort 2 | Experimental | Treatment with SC Blinatumomab + Revumenib in Newly Diagnosed ALL Receives: Drug: Revumenib; Drug: Blinatumomab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted16 Dec 2025
- Study start18 Nov 2026 (estimated)
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BlinatumomabStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen, Syndax Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Elias J Jabbour, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07283640
- Sponsor's protocol ID
- 2025-0932
- Other IDs
- NCI-2025-09116
- Status last verified
- Aug 2026
- First submitted
- 4 Dec 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IB Trial of Subcutaneous Blinatumomab in Combination With Revumenib for Patients With KMT2A-rearranged Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT07283640
- Acronym / sponsor ID
- 2025-0932
- Conditions
- Blinatumomab, Revumenib, Lymphoblastic Leukemia, KMT2A-rearranged
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Amgen, Syndax Pharmaceuticals
- Study start
- 18 Nov 2026 (estimated)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2031 (estimated)
- First posted
- 16 Dec 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.
To learn about the safety and effects of revumenib in combination with blinatumomab in patients with newly diagnosed or relapsed/refractory Ph-negative ALL with a KMT2A rearrangement.
Detailed description
Primary Objectives
- To determine the safety of recommended dose by 20 participants including 10 relapsed/refractory participants (cohort 1) and 10 newly diagnosed participants (cohort 2).
- To evaluate the overall response rate (combination of complete remission [CR] + complete remission with incomplete count recovery [CRi) + complete remission with incomplete hematologic recovery [CRh]) of the combination of SC blinatumomab and revumenib in cohort 1 and cohort 2 (participants with MRD-only disease will not be included towards the overall response rate)
- To evaluate event-free survival (EFS, defined as the time from treatment initiation to relapse, death, or documented treatment failure) in cohort 2
Secondary Objectives
- To evaluate overall survival (OS, defined as the time from treatment initiation to death from any cause)
- To summarize the safety of the combination of revumenib and SC blinatumomab at all revumenib doses tested
- To evaluate measurable residual disease (MRD) negativity by flow cytometry (sensitivity of 10-4) and ClonoSeq NGS (sensitivity of 10-6)
- To characterize the frequency of lineage switch after treatment with the combination of revumenib and SC blinatumomab
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Revumenib, Drug: BlinatumomabTreatment with SC Blinatumomab + Revumenib in R/R ALL |
| Cohort 2 | Experimental | Drug: Revumenib, Drug: BlinatumomabTreatment with SC Blinatumomab + Revumenib in Newly Diagnosed ALL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- Active serious infection not controlled by oral or IV antibiotics
- Active secondary malignancy other than skin cancer (basal cell carcinoma or squamous cell carcinoma) that in the investigator's opinion will shorten survival to less than 1 year
- Participants with psychiatric illness that would limit compliance with study requirements
- Untreated CNS disease. Participants with controlled CNS disease may be included (as defined by being asymptomatic and having CNS cleared of leukemic involvement)
- Detectable HIV viral load within the previous 6 months. Participants with a known history of HIV must have viral load testing prior to study enrollment.
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 |
|---|---|---|
| RevumenibGiven by po | Drug | Cohort 1, Cohort 2 |
| BlinatumomabGiven by IV | Drug | Cohort 1, Cohort 2 |
Primary outcome
Safety and adverse events (AEs).
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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 12 Aug 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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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.
Elias J Jabbour, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Revumenib and Blinatumomab in people with Blinatumomab and Revumenib, 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 0 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: opening soon, as of the sponsor's last update on 12 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 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?
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 Elias J Jabbour, MD (713-792-4764, ejabbour@mdanderson.org), or a site near the patient. 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?
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 12 Aug 2026.