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B-cell Acute Lymphoblastic LeukemiaPhase 2NCT04448834

Blincyto Amgen Acrotech BioPharma PH2 Blincyto Marqibo R/R Philadelphi CD19+ ALL

A Phase 2 study testing Blinatumomab in people with B-cell Acute Lymphoblastic Leukemia, run by Dorothy Sipkins, MD, PhD at 3 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Hypotheses: The Investigator hypothesizes that targeting ALL cells with 2 different modalities, ie liposomal vincristine sulfate as a microtubule inhibitor and blinatumomab as a BITE immuno-oncology therapy, will have at least additive benefits and allow an effective, safe therapeutic option for patients. 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
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
3 sitesUnited States
Study dates
Jan 2022to 1 Jun 2023
Phase
Phase 2
Are there results?
None posted in the registry

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 Ph-, CD19+ ALL, with any of the following:
  • Relapsed or refractory to at least 2 prior regimens ≥ 5% blasts in the bone marrow or peripheral blood or persistent extranodal/marrow site (such as skin).
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Age ≥ 18 years of age, at the time of informed consent.
  • Subject has provided informed consent. Those unable to provide consent for themselves will not be eligible.
  • Pts may have been exposed to either agent in the past if they had at least 6 months of response from start of therapy AND it has been at least 6 months since their last dose of either agent.

Who cannot join

  • History of malignancy other than ALL within 3 years prior to start of protocol-required therapy with the exception of:
  • Malignancy treated with curative intent and with no known active disease present for 2 years before enrollment and felt to be at low risk for recurrence by the treating physician
  • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
  • Adequately treated cervical carcinoma in situ without evidence of disease
  • Adequately treated breast ductal carcinoma in situ without evidence of disease
  • Prostatic cancer without evidence of progression for 1 year.
Show all 25Show fewer
  • History or presence of clinically relevant CNS pathology as adult seizures, recent stroke (within 1 year), severe brain injuries, Parkinson's disease, psychosis
  • With the exception of CNS leukemia that is well controlled with therapy prior to enrolling on this study. A negative CNS evaluation for active disease is required within 3 months of enrollment in those with prior history within one year of active CNS disease .
  • Current severe autoimmune disease or history of autoimmune disease with potential CNS involvement such as lupus, sjogren's, psoriasis, multiple sclerosis, wegener's granulomatosis.
  • Allogeneic HSCT within 12 weeks prior to start of blinatumomab/marqibo
  • Any active acute Graft-versus-Host Disease (GvHD) grade 2 to grade 4 according to the Glucksberg criteria or active chronic GvHD requiring systemic treatment of more than 10 mg prednisone daily (or equivalent)
  • Cancer chemotherapy or immunotherapy within 2 weeks prior to start of blinatumomab/marqibo. Administration of dexamethasone and hydrea permitted within the 21 day screening period.
  • Subject received prior anti-CD19 therapy ARE eligible however if they received prior blinatumomab, however they are ineligible if they did not have a response to it lasting at least 6 months; also they are ineligible if they had exposure to blinatumomab within 6 months of starting therapy on this study.
  • Abnormal screening laboratory values as defined below:
  • AST (SGOT) and/or ALT (SGPT) and/or alkaline phosphatase ≥ 5 x upper limit of normal (ULN)
  • Total bilirubin ≥ 3 x ULN (unless related to Gilbert´s or Meulengracht disease)
  • Creatinine ≥ 3 ULN or creatinine clearance < 40 mL/min (calculated)
  • Known infection with human immunodeficiency virus (HIV) or chronic active infection with hepatitis B virus (PCR positive) or hepatitis C virus (PCR positive).
  • Subject is pregnant or breast feeding
  • Woman of childbearing potential and is not willing to use 2 highly effective methods of contraception while receiving blinatumomab/marqibo and for an additional 3 months after the last dose of protocol-specified therapy
  • Male who has a female partner of childbearing potential, and is not willing to use 2 highly effective forms of contraception for at least an additional 3 months after the last dose of protocol-specified therapy
  • Male who has a pregnant partner, and is not willing to use a condom during sexual activity for 3 months after the last dose of protocol-specified therapy
  • Currently receiving treatment in another investigational device or drug study or less than 30 days since ending treatment on another investigational device or drug study(s). The 30 days is calculated from day 1 of blinatumomab treatment.
  • Subject has known severe sensitivity to immunoglobulins or any of the products or components to be administered during dosing.
  • History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the Investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Duke University

    Durham, North Carolina, 27705

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Novant Health Cancer Institute and Innovation Center

    Winston-Salem, North Carolina, 27101

Other trials in United States

About this study

Official title: A Phase 2 Single Arm, Multicenter Trial to Evaluate the Efficacy of the BiTE® Antibody Blinatumomab (Blincyto) and Vincristine Sulfate Liposomal Injection (Marqibo) in Adult Subjects With Relapsed/Refractory Philadelphia Negative CD19+ Acute Lymphoblastic Leukemia

Hypotheses: The Investigator hypothesizes that targeting ALL cells with 2 different modalities, ie liposomal vincristine sulfate as a microtubule inhibitor and blinatumomab as a BITE immuno-oncology therapy, will have at least additive benefits and allow an effective, safe therapeutic option for patients. Further, the Investigator hypothesizes that the combination will result in a high rate of response and thus allow enhanced immunologic recovery.

Primary Objectives To evaluate whether the combination will result in a median progression-free survival (PFS) of at least 1 year.

To evaluate if the complete remission/complete remission with incomplete hematological recovery (CR/CRi*) rate is ≧ 75% following 2 cycles in adult subjects with R/R Ph- ALL and duration of remission Secondary Objectives To evaluate the rate of Minimal Residual Disease (MRD) and duration To evaluate the proportion of patients who are able to progress to allogeneic transplantation To evaluate the safety of blinatumomab and liposomal vincristine sulfate in combination To evaluate the effect of the combination and response on measures of immune reconstitution

Being tested
Blinatumomab
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

    Also called liposomal vincristine

    liposomal vincristine 2.25 mg/m2 weekly x 3 per cycle (weeks 3-5 in cycle 1 and 2-4 in subsequent cycles)

Study groups in NCT04448834
Study groupRoleWhat they receive
TreatmentExperimentalA single cycle of blinatumomab which includes 4 weeks of CIVI of blinatumomab followed by a 2 week treatment free interval
Receives: Drug: Blinatumomab

What is being measured

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

  1. Progression-free survival (PFS)

    patient report

    Measured: At 1 year

  2. Complete remission/complete remission with incomplete hematological recovery (CR/CRi*) rate

    lab reports

    Measured: End of Cycle 2 (1 cycle is 6 weeks in duration)

Secondary outcomes (5)

  1. Minimal Residual Disease (MRD) and duration

    Flow Measurement

    Measured: End of Cycle 2 (1 cycle is 6 weeks in duration)

  2. Minimal Residual Disease (MRD) and duration

    Flow Measurement

    Measured: End of Therapy (up to 58 weeks)

  3. Proportion of patients able to progress to allogeneic transplantation

    Investigator reported

    Measured: End of study (up to 58 weeks)

  4. Safety of blinatumomab and liposomal vincristine sulfate in combination, as measured by rate of toxicity

    Investigator report of toxicities

    Measured: Through all cycles of therapy (up to 58 weeks)

  5. Immune reconstitution, as measured by the immune reconstitution panel

    immune reconstitution panel

    Measured: End of study (up to 58 weeks)

Timeline

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

  1. First posted26 Jun 2020
  2. Study startJan 2022 (estimated)
  3. Primary completion1 Jun 2023 (estimated)
  4. Study completion1 Jun 2023 (estimated)

Why it stopped: Study not moving forward

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04448834
Sponsor's protocol ID
Pro00104913
Status last verified
Feb 2022
First submitted
22 Jun 2020
Last updated
2 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Blinatumomab in people with B-cell Acute Lymphoblastic Leukemia, run by Dorothy Sipkins, MD, PhD at 3 sites 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 6 inclusion and 25 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: withdrawn, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Progression-free survival (PFS) (time frame: At 1 year). The study lists 2 primary outcomes in all. 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 NCT04448834.

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 2 Mar 2022.

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