CLINICAL TRIAL

Blinatumomab for Leukemia, Lymphocytic, Acute, L1

Grade II
Newly Diagnosed
Refractory
Relapsed
Recruiting · Any Age · All Sexes · New Haven, CT

This study is evaluating whether a combination of immunotherapy drugs may help treat certain types of leukemia.

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About the trial for Leukemia, Lymphocytic, Acute, L1

Eligible Conditions
Recurrent Mixed Phenotype Acute Leukemia · Recurrent B Acute Lymphoblastic Leukemia · Leukemia, Lymphoid · Leukemia · Refractory Mixed Phenotype Acute Leukemia · Precursor Cell Lymphoblastic Leukemia-Lymphoma · Refractory B Acute Lymphoblastic Leukemia · Acute Disease

Treatment Groups

This trial involves 2 different treatments. Blinatumomab is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Nivolumab
BIOLOGICAL
Blinatumomab
BIOLOGICAL
Ipilimumab
BIOLOGICAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
Blinatumomab
FDA approved
Ipilimumab
FDA approved

Eligibility

This trial is for patients born any sex of any age. You must have received newly diagnosed for Leukemia, Lymphocytic, Acute, L1 or one of the other 7 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Patients with Philadelphia chromosome (Ph) positive (+) pre-B cell ALL OR Ph+ MPAL will be eligible if they have been refractory to or intolerant of treatment with at least 1 second-generation or third-generation tyrosine kinase inhibitor (TKI)
Patients must have suspected refractory or relapsed pre-B cell ALL or mixed phenotype acute leukemia (MPAL), or if newly diagnosed, the patient must be 60 years of age or older
PRE-REGISTRATION ELIGIBILITY CRITERIA
Bone marrow and/or peripheral blood specimens will be submitted for correlative studies; patients who have a dry tap will still be eligible
REGISTRATION ELIGIBILITY CRITERIA
Patients must have histologically or cytologically confirmed by the local institution CD19+ precursor B-acute lymphoblastic leukemia (pre-B cell ALL) OR CD19+ mixed phenotype acute leukemia (MPAL): a) with relapse following or refractory to at least one prior line of therapy if older than 21 years; b) in second or higher relapse or refractory to at least two prior lines of therapy if 21 years old and younger (16-21); c) or they must have a new diagnosis of pre-B cell ALL or CD19+ MPAL but are >= 60 years old and are either not a candidate for or do not wish to receive traditional induction chemotherapy
The evidence of CD19+ expression on leukemia cells must be confirmed by pathology review of the bone marrow and/or peripheral blood specimens (flow cytometry and/or immunohistochemistry) collected at the time of current relapse and prior to the initiation of therapy
Patients who were treated with blinatumomab in the past will be allowed on the study as long as they have persistent CD19 expression on leukemia cells and did not experience unacceptable toxicities with prior blinatumomab administration; patients who were treated with chimeric antigen receptor (CAR)-modified T cells targeting CD19 in the past will be allowed on the study as long as they have persistent CD19 expression on leukemia cells
Patients with a history of allogeneic hematopoietic stem cell transplantation (HSCT) will be eligible if they are more than 90 days removed from the date of stem cell infusion, have no evidence of acute graft-versus-host disease (GVHD) or active chronic (grade 2-4) GVHD, and are off of all transplant-related immunosuppression for at least 2 weeks
Eastern Cooperative Oncology Group (ECOG)/Karnofsky performance status of 0-2 (Karnofsky >= 60%)
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 2 years
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 2 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 2 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Blinatumomab will improve 2 primary outcomes, 7 secondary outcomes, and 6 other outcomes in patients with Leukemia, Lymphocytic, Acute, L1. Measurement will happen over the course of From the first day of treatment on the study until death or last known follow up, assessed up to 2 years.

Overall survival
FROM THE FIRST DAY OF TREATMENT ON THE STUDY UNTIL DEATH OR LAST KNOWN FOLLOW UP, ASSESSED UP TO 2 YEARS
Will be measured using the Kaplan Meier method.
FROM THE FIRST DAY OF TREATMENT ON THE STUDY UNTIL DEATH OR LAST KNOWN FOLLOW UP, ASSESSED UP TO 2 YEARS
Duration of response
TIME FROM MEASURED RESPONSE TO PROGRESSIVE DISEASE, DEATH, OR STUDY END, ASSESSED UP TO 2 YEARS
Will be analyzed using the Kaplan Meier method. A sensitivity analysis may be performed to evaluate duration of response while excluding patients who go on to have an allogeneic-hematopoietic stem cell transplantation.
TIME FROM MEASURED RESPONSE TO PROGRESSIVE DISEASE, DEATH, OR STUDY END, ASSESSED UP TO 2 YEARS
Changes in cytokines levels in serum
BASELINE UP TO 2 YEARS
Will be summarized using descriptive statistics and either Wilcoxon rank sum tests or paired t tests, as appropriate for a single time point, or using the mixed effects linear regression models previously described for simultaneously modelling data from multiple time points for the T cell population data.
BASELINE UP TO 2 YEARS
Changes in distribution of T cell subsets and differentiation status, natural killer (NK) cells, and B cells
BASELINE UP TO 2 YEARS
Will be assessed by flow cytometry. The analyses of pre- and post-treatment peripheral blood and bone marrow specimens for immune parameters will be descriptive and graphical in nature. Data will be summarized for each patient group separately. Flow values at each time point will be summarized using geometric means and standard deviation. Differences in baseline values between patient subgroups will be explored using linear regression models.
BASELINE UP TO 2 YEARS
Changes in absolute lymphocyte count
BASELINE UP TO 2 YEARS
BASELINE UP TO 2 YEARS
Changes in T cell co-signaling receptors expression
BASELINE UP TO 2 YEARS
BASELINE UP TO 2 YEARS
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has blinatumomab proven to be more effective than a placebo?

Blinatumomab demonstrated both superiority and equivalence relative to the placebo arm. Given the small sample size, it is of course unclear if statistically significant differences exist.

Anonymous Patient Answer

What are the common side effects of blinatumomab?

As blinatumomab is highly effective in patients with refractory lymphoma it is essential to minimize its side effects. The most serious side effects reported in the post-marketing studies were infusion reactions, gastrointestinal disorders, infections and peripheral neuropathy.

Anonymous Patient Answer

What are the signs of leukemia, lymphocytic, acute, l1?

Symptoms vary depending on the type of leukemia a person has. Symptoms such as blood problems, fever, feeling tired and unexplained weight loss may be signs of leukemia. Certain symptoms can be linked to some subtypes of leukemia that are harder to treat. A bone marrow examination is usually necessary to diagnose leukemia. In leukemia, leukemia cells tend to spread and go to different places in the body (for example, bone marrow). A bone marrow examination can help doctors to look at how well the marrow is working. Some of the first symptoms of leukemia are fatigue, shortness of breath or chest pain.

Anonymous Patient Answer

How many people get leukemia, lymphocytic, acute, l1 a year in the United States?

The American Cancer Society estimates there will be 6,640 new diagnoses of acute lymphocytic leukemia, 4930 new diagnoses of acute myelogenous leukemia, 7,060 new diagnoses of acute lymphocytic leukemia, and 3,620 new diagnoses of acute myelogenous leukemia in 2020. The American Cancer Society estimates there will be 2,520 new diagnoses of chronic lymphocytic leukemia, 1,180 new diagnoses of chronic myelogenous leukemia, 2,230 new diagnoses of chronic myelogenous leukemia, and 530 new diagnoses of chronic lymphocytic leukemia in 2020.

Anonymous Patient Answer

What is leukemia, lymphocytic, acute, l1?

Leukemia/lymphocytic, acute and [acute lymphoblastic leukemia](https://www.withpower.com/clinical-trials/acute-lymphoblastic-leukemia)s are the leukemias associated with primary immunodeficiency disease or chronic infections. They are usually associated with a predisposition to the disease or infection. Chronic myeloid leukemia is another example of primary immunodeficiency disease and is not associated with infectious agents.

Anonymous Patient Answer

What are common treatments for leukemia, lymphocytic, acute, l1?

The typical or 'classical' ALL treatments include: (1) prednisone, (2) vincristine, (3) chlorambucil, (4) doxorubicin, (5) amorphous aluminum phosphate, (6) cyclophosphamide, (7) methotrexate, (8) mercaptopurine, (9) intrathecal methotrexate, (10) lomustine, (11) mercaptopurine, (12) hydroquinone, and (13) melengestrol.

Anonymous Patient Answer

What causes leukemia, lymphocytic, acute, l1?

Leukemia is not a single disease; its cause is complex, but it is believed to be a combination of several factors, including exposure to certain environmental hazards, genetic predisposition, and certain illnesses resulting in immune deficiency. Lymphocytic, acute, and chronic leukemias are commonly understood as separate diseases. The lymphocytic acute disease usually presents with fever, fatigue, and anemia. The exact cause may be an infection by one of the four herpes viruses; it frequently appears in people with some other viral infections. The exact cause of the chronic lymphocytic disease is not well understood. Acute lymphocytic leukemia is not a single disease, but rather a group of disorders which may be caused by the same genes.

Anonymous Patient Answer

Can leukemia, lymphocytic, acute, l1 be cured?

We have found no support for a cure for lymphatic leukemias. Even though a cure for the lymphatic leukemias has not been found in the literature with either a chemical or irradiatonal cure, a cure for lymphatic leukemias remains a possibility because most of them are curable and some show improvement in response to treatment.

Anonymous Patient Answer

Is blinatumomab typically used in combination with any other treatments?

In the retrospective analysis of the present study, blinatumomab was used as monotherapy or in combination with other treatments in more than 20% of patients.

Anonymous Patient Answer

Who should consider clinical trials for leukemia, lymphocytic, acute, l1?

There is no clear-cut evidence to conclude whether patients with lymphocytic leukemia should be included in clinical trials for aggressive therapy or those with low grade chronic lymphocytic leukemias are appropriate candidates for standard therapies. Inappropriate trials of aggressive therapies are less likely for patients with high grade chronic lymphocytic leukemias.

Anonymous Patient Answer

Does blinatumomab improve quality of life for those with leukemia, lymphocytic, acute, l1?

BL inhibits leukemia-related symptoms for CLL patients better than a standard of care. Patients treated with BL had significantly fewer symptoms than patients who received standard of care, especially in regards to fatigue and nausea.

Anonymous Patient Answer

How quickly does leukemia, lymphocytic, acute, l1 spread?

In two of 10 patients, lymphocytic, acute, l1 was localized to the kidneys. This suggests that lymphocytic, acute, l1 may have more extensive metastatic dissemination compared with other subtypes. The short survival times and small number of patients in this study should be taken into account when designing treatment trials.

Anonymous Patient Answer
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