BLINCYTO (Blinatumomab) for Leukemia

Phase-Based Estimates
1
Effectiveness
2
Safety
Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore, MD
Leukemia+2 More
BLINCYTO (Blinatumomab) - Drug
Eligibility
18+
All Sexes
Eligible conditions
Leukemia

Study Summary

This study is evaluating whether a drug called blinatumomab is effective for treating patients with relapsed or refractory (R/R) or measurable residual disease (MRD) CD19-positive mixed phenotypic acute leukemia (MP

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Eligible Conditions

  • Leukemia
  • Mixed Phenotype Acute Leukemia (MPAL)
  • Measurable Residual Disease (MRD)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether BLINCYTO (Blinatumomab) will improve 2 primary outcomes, 2 secondary outcomes, and 5 other outcomes in patients with Leukemia. Measurement will happen over the course of From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.

Month 100
Cohort A survival
Cohort B survival
Year 1
CD 19 measurement
CD3-positive measurement
Cohort A response rate
Cohort B response rate
Leukemic blasts evaluation
Subject response evaluation
leukemic blasts evaluation

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

3 Treatment Groups

No Control Group
Subjects with CD19-positive MPAL in CR/CRh/CRi/CRp and detectable MRD

This trial requires 30 total participants across 3 different treatment groups

This trial involves 3 different treatments. BLINCYTO (Blinatumomab) is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Subjects with CD19-positive MPAL in CR/CRh/CRi/CRp and detectable MRD
Drug
Cohort B: Evaluate the efficacy of blinatumomab to achieve MRD-negativity in subjects with CD19-positive MPAL in CR, or CRh, or CRi or CRp after receiving at least one chemotherapy block of standard ALL or AML treatment with MRD-positivity at a level of ≥ 0.1% using an assay with a minimum sensitivity of 0.01% The treatment of blinatumomab consists of induction, consolidation and maintenance therapy Subject will receive study drug blinatumomab by continuous IV infusion (CIV) Each treatment cycle consists of 28 days of blinatumomab CIV followed by a 14±3 days treatment-free interval for induction, 28±3 days treatment-free interval for consolidation, and 56±3 days treatment-free interval for maintenance. The dose of blinatumomab is 28 mcg/day
Subjects with R/R CD19-positive MPAL
Drug
Cohort A: Evaluate the efficacy of blinatumomab to achieve the best morphologic response after the first two cycles of therapy in subjects with morphologic R/R CD19-positive MPAL The treatment of blinatumomab consists of induction, consolidation and maintenance therapy Subject will receive study drug blinatumomab by continuous IV infusion (CIV) Each treatment cycle consists of 28 days of blinatumomab CIV followed by a 14±3 days treatment-free interval for induction, 28±3 days treatment-free interval for consolidation, and 56±3 days treatment-free interval for maintenance The initial dose of blinatumomab is 9 mcg/day for 7 days. The target dose for rest of treatment is 28 mcg/day
Subjects with CD19-positive MPAL in complete remission and detectable MRD
Drug
Cohort B: Evaluate the efficacy of blinatumomab to achieve MRD-negativity in subjects with CD19-positive MPAL in CR, or CRh, or CRi or CRp after receiving at least one chemotherapy block of standard ALL or AML treatment with MRD-positivity at a level of ≥ 0.1% using an assay with a minimum sensitivity of 0.01%

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly through study completion, an average of 1 year for reporting.

Closest Location

Greenebaum Cancer Center at University of Maryland Medical Center - Baltimore, MD

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Leukemia or one of the other 2 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Subjects must have histologically or cytologically confirmed R/R CD19-positive MPAL based on the WHO criteria, OR CD19-positive MPAL in CR/CRh/CRi/CRp after at least one chemotherapy block of standard ALL or AML therapy with detectable MRD ≥ 0.1% show original
Age 18 years and older
Previous cytotoxic chemotherapy (except for hydroxyurea) must have been completed at least 2 weeks prior to day 1 of treatment on the study. Subjects with hematologic malignancies are expected to have hematologic abnormalities at study entry.
ECOG performance status < 3
Direct bilirubin ≤ 2.5 mg/dL
AST/ALT/Alkaline phosphatase ≤ 5 X institutional upper limit of normal
You have a serum creatinine of less than 3 mg/dL. show original
Subjects who have undergone allo-HSCT are eligible if they are ≥ 4 weeks post stem cell infusion, have no evidence of GVHD > Grade 2, and are at least ≥ 1 week off all immunosuppressive therapy. show original
Subjects with a history of CNS leukemia must be clinically stable with a flow cytometric clear CSF in the 2 weeks prior to day 1 of blinatumomab administration. show original
Female subjects of childbearing potential must have a negative pregnancy test

Patient Q&A Section

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

Is blincyto (blinatumomab) safe for people?

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This preliminary study provides preliminary evidence that blincyto in combination with other chemotherapeutic regimens is safe in this population. This was a Phase 2b trial and no long-term data are available to support conclusions of safety or efficacy\n

Unverified Answer

What are the chances of developing leukemia?

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In the US, the overall risk of developing leukemia is 6-times higher in the United States than in Western Europe. The incidence rate of ALL increases with age to a peak in the fifth decade but afterwards it declines. CLL has a lower lifetime risk compared to ALL by approximately 30%; however, this has a lower incidence rate and more pronounced age and sex dependency.

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What is leukemia?

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Leukemia is defined as any type of blood cancer in which cells fail to undergo cell division properly and is the result of the development of acquired genetic abnormalities. These genetic abnormalities arise from errors in DNA repair and programmed cell death. There are three types of leukemia: myeloid, lymphoid, and acute. These are categorized based on the type of blood cell affected, cell origin, cause, and the ability of the disease to spread to other areas of the body. The word lymphangioma refers to a tumor composed of lymph tissue that has grown outside the confines of its lymph channels and filled the lymph system with nodules.

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What causes leukemia?

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There are many different types of leukemia and causes that can be linked to the type or location of cancer. Most cancers have a strong genetic basis, but all types of leukemia can have more than one factor that can worsen the chances of developing the disease.\n

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What are common treatments for leukemia?

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This case illustrates the commonality of leukemia therapy and highlights the role of personalized medicine in cancer therapy. It highlights the value of clinical trials, particularly for patients with refractory disease.

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Can leukemia be cured?

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The prognosis of acute leukemia does depend on the level of immunosuppression at diagnosis, its duration, and treatment with other types of chemotherapy and the relapse schedule. These factors strongly influence the rate of remission in patients with acute leukemia. However, these effects are too weak to justify any talk about curing leukemia.

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How many people get leukemia a year in the United States?

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The American Cancer Society reports a 20 percent decrease in new cases of leukemia and myeloid leukemia over the past 25 years. This decline in the disease incidence is attributed to increased use of chemoradiation. The number of new cases of lymphoid leukemia or multiple myeloma has remained stable since 1995. Rates of AML have more than doubled since 1987 and now equal rates of ALL since 1987 have increased fourfold.

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What are the signs of leukemia?

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Signs of leukemia may be experienced by many people without leukemia. Individuals may be unaware of symptoms for a long time. Certain symptoms, such as fever and night sweats, are more suggestive of leukemia than others. Symptoms of leukemia are often present (or at least felt) in these people. The most common signs of leukemia are headaches and loss of appetite. Signs of leukemia can be debilitating. Many people with leukemia, especially those who are very young or very old, may feel their symptoms are not as severe.\n

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What is the survival rate for leukemia?

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For patients with ALL the relative 5 year survival rate is 92.2%, 95.7% and 94.2% for 2-stage 2, 2-stage 3 trials respectively, with relapse only affecting 15.9% of patients, regardless of trial stage. For most ALL children, 5 year survival remains near 90%, irrespective of treatment. In contrast, for CLL the relative 5 year survival rate is 73%, regardless of treatment. For CML, survival rates between trials and treatment levels are less clear, and the relative survivals remain fairly constant. Nevertheless, overall survival of CML patients is around 72% 5 year survival, and CEL patients have around 68%.

Unverified Answer

What is the average age someone gets leukemia?

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The majority of people diagnosed with ALL before 20-25 years of age, this is probably because leukemia is usually the first presentation of malignancy in the youth. This statistic should be used in designing and evaluating diagnostic screening programs in the pediatric population. When leukemia is diagnosed in the adult population, age is rarely used as a diagnostic criterion for this disease.

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Has blincyto (blinatumomab) proven to be more effective than a placebo?

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Blincyto provided a small but nonsignificant improvement over a placebo in improving disease-free survival and achieving remission in patients with previously treated chronic lymphocytic leukemia.

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Who should consider clinical trials for leukemia?

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With our present knowledge it is possible to predict a good prognosis in a sizeable proportion of ALL case; however, it has to be emphasized that these good prognoses are often not achieved by ALL patients unless they enter a phase of complete treatment. It is necessary to guarantee that ALL patients are going to get adequate treatment and that the treatment is free of toxicity.

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