Adult Acute Lymphoblastic Leukemia in Complete RemissionPhase 2NCT02458014
Blinatumomab in Treating Patients With B-cell Acute Lymphoblastic Leukemia With Minimal Residual Disease
A Phase 2 study testing Blinatumomab and TKI in people with Adult Acute Lymphoblastic Leukemia in Complete Remission and B Acute Lymphoblastic Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This phase II trial studies how well blinatumomab works in treating patients with B-cell acute lymphoblastic leukemia whose disease is in remission (causes no symptoms or signs) but is still present in a small number of cells in the body (minimal residual disease). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Acute Lymphoblastic Leukemia in Complete Remission, B Acute Lymphoblastic Leukemia, Minimal Residual Disease
- What is being tested?
- Blinatumomab and TKI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2015to 16 Sep 2025
- Phase
- Phase 2
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 with B-lineage acute lymphocytic leukemia (ALL) in hematologic complete remission (CR) with molecular failure (i.e., had never achieved an MRD-negativity status before blinatumomab) or had a molecular relapse (i.e., became MRD positive after having been MRD negative) starting at any time point after 3 months of frontline therapy; molecular disease or minimal residual disease is defined by a value of at least of 1 x 10^-4 (0.01%) by multicolor flow cytometry and/or by next generation sequencing (NGS)
- Patients with B-lineage ALL in hematologic complete remission (CR) with molecular failure (i.e., had never achieved an MRD-negativity status before blinatumomab) or had a molecular relapse (i.e., became MRD positive after having been MRD negative) starting at any time point after 3 months of frontline therapy; molecular disease or minimal residual disease is defined by a value of at least of 1 x 10-4 (0.01%) by multicolor flow cytometry and/or by next generation sequencing (NGS)
- Performance status of 0, 1, or 2
- Creatinine clearance >= 30 ml/minute
- Bilirubin less than or equal to 3.0 mg/dL
- No active or co-existing malignancy with life expectancy less than 12 months
- Patients with Philadelphia chromosome positive (Ph+) ALL can be enrolled in CR1 or CR2 and beyond; a tyrosine kinase inhibitor (TKI) will be added at the discretion of the treating physician; MRD for these patients will be defined by PCR of 0.1% and above (International Scale)
Who cannot join
- Pregnant or nursing women
- Known to be human immunodeficiency virus positive (HIV+)
- Active and uncontrolled disease/infection as judged by the treating physician
- Unable or unwilling to sign the consent form
- Active central nervous system (CNS) or extramedullary disease
- Monoclonal antibodies therapy within 2 weeks before study entry
- Radiotherapy and cancer chemotherapy (except for intrathecal prophylaxis and/or low-dose maintenance therapy such as vinca alkaloids, mercaptopurine, methotrexate, steroids) or any investigational drug within 2 weeks before study entry
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Blinatumomab in Patients With B-Cell Lineage Acute Lymphocytic Leukemia With Positive Minimal Residual Disease
This phase II trial studies how well blinatumomab works in treating patients with B-cell acute lymphoblastic leukemia whose disease is in remission (causes no symptoms or signs) but is still present in a small number of cells in the body (minimal residual disease). Immunotherapy with monoclonal antibodies, such as blinatumomab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the clinical efficacy of blinatumomab in patients B-cell acute lymphoblastic leukemia in complete morphologic remission with positive minimal residual disease (MRD) in terms of relapse-free survival (RFS).
SECONDARY OBJECTIVES:
- To evaluate other efficacy endpoints such as overall survival and MRD negativity rate by flow cytometry and/or polymerase chain reaction (PCR) overall and after the first cycle, as well as safety of blinatumomab in this setting.
OUTLINE:
Patients receive blinatumomab intravenously (IV) continuously on days 1-28. Treatment repeats every 6 weeks for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Patients who do not proceed with stem cell transplantation may receive blinatumomab IV maintenance therapy with one cycle every 3 months for up to 4 cycles. Patients who remain in MRD remission for 3 months and then become MRD positive again can be retreated following the same treatment plan previously received.
After completion of study treatment, patients are followed up every 6 months.
- Conditions
- Adult Acute Lymphoblastic Leukemia in Complete Remission, B Acute Lymphoblastic Leukemia, Minimal Residual Disease, Philadelphia Chromosome Positive
- Being tested
- Blinatumomab, TKI
- Medical subject headings
- Burkitt Lymphoma, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlinatumomabBiological
Also called Anti-CD19 x Anti-CD3 Bispecific Monoclonal Antibody, Anti-CD19/Anti-CD3 Recombinant Bispecific Monoclonal Antibody MT103, Blincyto, MEDI-538
Given IV
TKIOther
A TKI will be added at the discretion of the treating physician.
| Study group | Role | What they receive |
|---|---|---|
| Treatment (blinatumomab) | Experimental | Patients receive blinatumomab IV continuously on days 1-28. Treatment repeats every 6 weeks for up to 5 courses in the absence of disease progression or unacceptable toxicity. Patients who do not proceed with stem cell transplantation may receive blinatumomab IV maintenance therapy with one cycle every 3 months for up to 4 cycles. Patients who remain in MRD remission for 3 months and then become MRD positive again can be retreated following the same treatment plan previously received. Receives: Biological: Blinatumomab |
| Treatment (blinatumomab + TKI) | Experimental | Patients receive blinatumomab IV continuously on days 1-28. Treatment repeats every 6 weeks for up to 5 courses in the absence of disease progression or unacceptable toxicity. Patients who do not proceed with stem cell transplantation may receive blinatumomab IV maintenance therapy with one cycle every 3 months for up to 4 cycles. Patients who remain in MRD remission for 3 months and then become MRD positive again can be retreated following the same treatment plan previously received. A TKI will be added at the discretion of the treating physician. Receives: Biological: Blinatumomab; Other: TKI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse-free Survival (RFS)
RFS is relapse-free survival, which is defined as the time interval from date of treatment start until the date of death or hematologic or extramedullary disease relapse. Patients who are alive and relapsefree at the last follow-up date will be censored at that time. In addition, patients who drop off the study due to receiving allogeneic stem cell transplantation will be censored at the time off study.
Measured: From the date of treatment start until the date of death, relapse or discontinuation due to receiving allogeneic stem cell transplantation, assessed up to 112 months.
Secondary outcomes (3)
Overall Survival (OS)
Time from date of treatment start until date of death due to any cause.
Measured: From treatment start to the date of death or last follow-up, whichever occurred first, Up to 10 years, and 1 day
Number of Patients MRD Negative Overall
MRD negativity is defined as undetectable MRD by flow cytometry with a sensitivity of at least 10^-4. For patients with Ph+ ALL, MRD negativity is defined as undetectable MRD by flow cytometry with a sensitivity of at least 10^-4 AND absence of a quantifiable PCR for BCR-ABL1 by PCR with a sensitivity of at least 10^-4 or a ratio of BCR-ABL1 to ABL1 by PCR of < 0.01% according to the International Scale for patients with p210 transcript or a ratio of BCR-ABL1 to ABL1 by PCR of < 0.01% for patients with non-p210 transcripts
Measured: Up to 10 years and 1 day
Number of Participants Who Were MRD Negative After Course 1
MRD negativity is defined as undetectable MRD by flow cytometry with a sensitivity of at least 10^-4. For patients with Ph+ ALL, MRD negativity is defined as undetectable MRD by flow cytometry with a sensitivity of at least 10^-4 AND absence of a quantifiable PCR for BCR-ABL1 by PCR with a sensitivity of at least 10^-4 or a ratio of BCR-ABL1 to ABL1 by PCR of < 0.01% according to the International Scale for patients with p210 transcript or a ratio of BCR-ABL1 to ABL1 by PCR of < 0.01% for patients with non-p210 transcripts
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2015 (estimated)
- Study start14 Sep 2015
- Primary completion16 Sep 2025
- Study completion16 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Adult Acute Lymphoblastic Leukemia in Complete RemissionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Elias Jabbour, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02458014
- Sponsor's protocol ID
- 2014-0844
- Other IDs
- NCI-2015-01547, 2014-0844
- Status last verified
- Sep 2026
- First submitted
- 26 May 2015
- Last updated
- 25 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Jabbour EJ, Short NJ, Jain N, Jammal N, Jorgensen J, Wang S, Wang X, Ohanian M, Alvarado Y, Kadia T, Sasaki K, Garris R, Garcia-Manero G, Ravandi F, Kantarjian HM. Blinatumomab is associated with favorable outcomes in patients with B-cell lineage acute lymphoblastic leukemia and positive measurable residual disease at a threshold of 10-4 and higher. Am J Hematol. 2022 Sep;97(9):1135-1141. doi: 10.1002/ajh.26634. Epub 2022 Jun 24.
PubMed 35713551Shi Z, Zhu Y, Zhang J, Chen B. Monoclonal antibodies: new chance in the management of B-cell acute lymphoblastic leukemia. Hematology. 2022 Dec;27(1):642-652. doi: 10.1080/16078454.2022.2074704.
PubMed 35622074