Acute Lymphoblastic LeukemiaPhase 1/2NCT03114865

A Study of Blinatumomab in Patients With Pre B-cell ALL and B-cell NHL as Post-allo-HSCT Remission Maintenance

A Phase 1/2 study testing Blinatumomab 9ug, Blinatumomab 28 ug and Blinatumomab in people with Acute Lymphoblastic Leukemia and B-cell Non Hodgkin Lymphoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 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

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Trial summary

The investigators primary objective is to determine the safety and toxicity of incorporating blinatumomab into the post-allogeneic hematopoietic stem cell transplant (HSCT) maintenance setting for patients with CD19+-B-cell malignancies (Acute Lymphoblastic Leukemia [ALL], Non-Hodgkin's Lymphoma [NHL]). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Lymphoblastic Leukemia, B-cell Non Hodgkin Lymphoma, Pre B-Cell Acute Lymphoblastic Leukaemia
What is being tested?: Blinatumomab 9ug, Blinatumomab 28 ug and Blinatumomab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: 1 siteUnited States
Study dates: 5 Sep 2017to 30 Dec 2026
Phase: Phase 1/2

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

Pre-B ALL, low and high grade NHL who underwent an alloHSCT using posttransplant CY GVHD prophylaxis (Pt-Cy alone or combination with MMF/tacrolimus or sirolimus) as follows:
Pre-B ALL patients in CR1 with high-risk features such as adverse cytogenetics including t(9;22) or Ph-like ALL, t(4;11) or other MLL (KMT2A) rearrangements, t(v;14q23)/IgH, complex karyotype (≥5 chromosomal abnormalities), hypodiploidy (<44 chromosomes), low hypodiploidy (30-39 chromosomes)/near triploidy (60-68 chromosomes), intrachromosomal amplification of chromosome 21 (iAMP21), high WBC count at presentation (≥30,000), lack of achievement of complete remission after standard induction chemotherapy (but achieved CR1 following salvage or consolidation), or persistence of detectable disease after induction and consolidation (intensification) or pre-transplant as documented on any of routine clinical tests (morphology, flow cytometry, cytogenetics or molecular studies) OR all Pre-B ALL patients in second and higher CR B. Low and high grade NHL following a nonmyeloablative (reduced-intensity conditioning) transplant irrespective of pre-transplant disease status
Patients should be at least 60 but not more than 180 days from transplant with documented count recovery (ANC >1 x109/L, and non-transfused platelets >30x109/L) and no evidence of disease progression
ECOG performance status 0-2
Ability to give informed consent
In agreement to use an effective barrier method of birth control (hormonal or barrier method of birth control; abstinence) to avoid pregnancy during the study and for a minimum of 30 days after study treatment, for all male and female patients who are fertile
Age ≥18 years
Patients may have received any number of prior regimens to achieve remission. Patients previously treated with blinatumomab will be eligible as long as they did not experience unacceptable toxicities with prior blinatumomab administration. If patient was refractory (no response) to blinatumomab in the past, patient will be eligible if there was no evidence of CD19 loss on leukemia cells.

Who cannot join

Lack of engraftment (less than 85% donor DNA in bone marrow or peripheral blood after allogeneic HSCT).
Active or untreated disease in central nervous system or testes
Patient has received chemotherapy or radiotherapy (with the exception of intrathecal chemotherapy) within 2 weeks of starting blinatumomab. Patient could receive intrathecal prophylactic chemotherapy within a week prior to starting blinatumomab.
Patients with active uncontrolled infection or uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Patients with prior history of severe (grade 3 or 4) acute GVHD or active severe chronic GVHD even if resolved will not be eligible. Patients with history of active acute GVHD (grade 2) and active moderate chronic GVHD who required steroids for the treatment of GVHD will need to be off steroids for at least 4 weeks prior to treatment start. (Topical steroids or physiologic adrenal replacement steroid doses are allowed).
Patients requiring calcineurin inhibitors (i.e. tacrolimus or sirolimus) or other systemic immunosuppressants (cyclosporine (CNI); methotrexate or similar) for GVHD prophylaxis or treatment within 4 weeks prior to treatment start.

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Inadequate end organ function defined as AST, ALT, and alkaline phosphatase > 3X ULN, bilirubin >=1.5X ULN, or creatinine >=2 mg/dL
Patients with Ph-positive ALL who are eligible for post-transplant TKI maintenance based on a demonstrated sensitivity to TKIs pre-transplant (patients with known intolerance or resistance to TKI will be eligible)
Evidence of progressive disease post-transplant
Women who are pregnant or lactating
Known hypersensitivity to blinatumomab
Patients with a concurrent active malignancy for which they are receiving treatment
Concurrent use of any other investigational drugs
Patient who have a history or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, psychosis, or other significant CNS abnormalities. A history of treated CNS leukemia or lymphoma will be allowed if recent imaging and CSF studies confirm the absence of active CNS disease at the time of study entry
Weight <45 kg
Patients receiving other post-transplant maintenance therapies
Infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus or hepatitis C virus (HCV)

Trial locations and contacts

1 site in 1 country.

United States1 site

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287

Other trials in United States

About this study

Official title: A Phase IB/II Study of Blinatumomab in Patients With Pre B-cell Acute Lymphoblastic Leukemia (ALL) and B-cell Non-Hodgkin Lymphoma (NHL) as Post-allogeneic Stem Cell Transplant (Allo-HSCT) Remission Maintenance

Conditions: Acute Lymphoblastic Leukemia, B-cell Non Hodgkin Lymphoma, Pre B-Cell Acute Lymphoblastic Leukaemia
Being tested: Blinatumomab 9ug, Blinatumomab 28 ug, Blinatumomab, Dexamethasone
Keywords: bone marrow, bone marrow transplant, allogeneic, tacrolimus, cyclophosphamide, Blinatumomab
Medical subject headings: Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, B-Cell, Precursor B-Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

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

Blinatumomab 9ugDrug
Also called Blincyto
Cycle 1 - Days 1-7: 9 ug/day IV daily
Blinatumomab 28 ugDrug
Also called Blincyto
Cycle 1 - Days 8-28: 28 ug/day IV daily
BlinatumomabDrug
Also called Blincyto
Cycle 2 - Days 1-28: 28 ug/day IV daily
DexamethasoneDrug
Day 1 of Cycle 1 and 2, prior to a step dose (such as cycle 1 day 8), or when restarting an infusion after an interruption of 4 hours or more: 20 mg IV

Study groups in NCT03114865
Study group	Role	What they receive
Post-alloHSCT Maintenance	Experimental	Blinatumomab will be administered as a continuous intravenous (IV) infusion over four weeks followed by a two-week treatment free interval. It is recommended that patients are hospitalized at least during the first three days of the first cycle and the first two days of the second cycles. Receives: Drug: Blinatumomab 9ug; Drug: Blinatumomab 28 ug; Drug: Blinatumomab; Drug: Dexamethasone

What is being measured

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

Overall survival at two years post first treatment cycle
Percentage of enrolled participants who receive BMT and Blinatumomab and are alive at two years post BMT.
Measured: 2 years

Secondary outcomes (5)

Non-Relapse Mortality
Percentage of participants who experience non-relapse mortality after 2 years.
Measured: 2 years
Progression-free survival
Percentage of participants who experience progression-free survival after 2 years.
Measured: 2 years
Disease-free Survival
Percentage of participants who experience disease-free survival after 2 years.
Measured: 2 years
Overall Survival
Percentage of participants who experience overall survival after 2 years.
Measured: 2 years
Minimal Residual Disease
Percentage of participants who convert from MRD to no MRD after treatment.
Measured: 2 years

Timeline

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

5 Sep 201730 Dec 2026

First posted14 Apr 2017
Study start5 Sep 2017
Primary completion30 Dec 2026 (estimated)
Study completion30 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03114865
Sponsor's protocol ID: J1713
Other IDs: IRB00125679
Status last verified: Oct 2026
First submitted: 11 Apr 2017
Last updated: 22 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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