Calaspargase pegol (S95015) for Leukemia, Lymphocytic, Acute, L1

Phase-Based Estimates
1
Effectiveness
2
Safety
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD
Leukemia, Lymphocytic, Acute, L1+3 More
Calaspargase pegol (S95015) - Drug
Eligibility
18+
All Sexes
Eligible conditions
Leukemia, Lymphocytic, Acute, L1

Study Summary

This study is evaluating whether a new drug may help treat leukemia.

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Eligible Conditions

  • Leukemia, Lymphocytic, Acute, L1
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia
  • Leukemia, Lymphoid
  • Acute Lymphoblastic Leukemia (ALL)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Calaspargase pegol (S95015) will improve 4 primary outcomes and 8 secondary outcomes in patients with Leukemia, Lymphocytic, Acute, L1. Measurement will happen over the course of End of remission induction phase (Day 29)..

Day 365
Anti-drug (calaspargase pegol) antibody (ADA) development (Part 1 and 2)
Day 29
Complete remission (CR) (Part 1 and 2)
Day 64
Nadir Plasma Asparaginase Activity (NPAA) (Part 2)
Day 4
PAA-derived Area Under the PAA-Time Curve From Time 0 to Day 21 (AUC 0-21) after the Remission Induction Phase Day 4 dose (Part 1 and 2).
PAA-derived maximum concentration (Cmax) after the Remission Induction Phase Day 4 dose (Part 1 and 2).
Day 11
Plasma Asparaginase Activity (PAA) level (Part 1)
Day 22
Plasma Asparaginase Activity (PAA) level ≥0.1 U/mL at any time during Remission Induction phase and post- Remission Induction phase, respectively (Part 2)
Day 22
Plasma Asparaginase Activity (PAA) level ≥0.025, ≥0.1, ≥0.2, or ≥0.4 U/mL at predefined time points during Remission Induction phase and post- Remission Induction phase, respectively (Part 2)
Day 29
Minimal residual disease (MRD) (Part 1 and 2)
Day 30
Adverse Events (AEs) (Part 1)
Day 30
Adverse Events (AEs) (Part 2)
Month 3
Survival (Part 1 and 2)

Trial Safety

Safety Estimate

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

Trial Design

2 Treatment Groups

Control
Calaspargase pegol (S95015)

This trial requires 122 total participants across 2 different treatment groups

This trial involves 2 different treatments. Calaspargase Pegol (S95015) 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 2 & 3 and have had some early promising results.

Calaspargase pegol (S95015)
Drug
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

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

Closest Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins - Baltimore, MD

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
People aged 22 or older who have been newly diagnosed with Philadelphia-negative B-cell or T-cell leukemia, as classified by the World Health Organization, are eligible for this study. show original
The Eastern Cooperative Oncology Group has a performance status range from 0 to 2, which means that people with a performance status of 0 to 2 are eligible for the group's cancer treatments. show original
Except for a limited treatment with corticosteroids or hydroxyurea and a single dose of intrathecal cytarabine, no prior therapy for ALL such as chemotherapy and radiation therapy is required before signing the informed consent. show original

Patient Q&A Section

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

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

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The most common, and most effective, form of chemotherapy is all-trans retinoic acid, with other drugs often used in case of refractory disease, while radiation therapy is the most common modality to treat lymphocytic, acute, l1 leukemias.

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What is leukemia, lymphocytic, acute, l1?

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This disease is very common in the US, especially among Caucasians and Hispanics. It is more likely to occur in males than in females or blacks.

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

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The American Cancer Society estimated that there were more than 230,900 new cases of leukemia, lymphocytic, acute, l1 a year. This is equivalent to over 2.5 million people annually. The report also reveals the significant difference in incidence between whites and African Americans. The incidence of leukemia, lymphocytic, acute, l1 per year in black females was 6.1 ± 2.3 cases per 100,000 population, while in white females it was 12.8 ± 4.1 cases per 100,000 population (p<0.0005). In white males, the incidence of leukemia, lymphocytic, acute, l1 was 7.4 ± 2.2 cases/100,000 population.

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Can leukemia, lymphocytic, acute, l1 be cured?

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The vast majority of patients with CLL will never experience a new clinical or laboratory event of symptoms that is defined by a progressive course of disease.

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

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Symptoms associated with lymphocytic leukemia include fever, weight loss and enlarged liver or spleen. Signs and symptoms associated with acute leukemia include sore throat, bone pains, cough and fatigue. Symptoms associated with leukemoid changes in acute lymphoblastic leukemia include fatigue, fever, weight loss and malaise. Symptoms of myelodysplastic syndrome include easy bruising or bleeding, diarrhea and tiredness.

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What causes leukemia, lymphocytic, acute, l1?

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Leukemia, lymphocytic, acute, lymphoblastic is most likely caused by a mutation to a chromosome 9, in particular, the band 9q. It cannot be diagnosed until the blood cells are seen to change or they appear in the child after birth. Lymphocytic, acute, [follicular lymphoma](https://www.withpower.com/clinical-trials/follicular-lymphoma) appears due to an abnormality in the immune system, B cells. Lymphocytic, diffuse, chronic lymphoma can be caused by a genetic mutation on chromosome 4, or a faulty immune system. Chronic myelogenous leukemia is caused by abnormalities in the production of blood cells, which can be acquired or are an inherited trait.

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What is the latest research for leukemia, lymphocytic, acute, l1?

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As reported, the number of patients and the disease severity and mortality rates are increasing. The treatment for leukemia, lymphocytic, acute, l1 is more expensive and more complicated than other hematologic disorders, and the number of patients continues to be increasing. Therefore, the expenses for diagnostics, treatment, follow-up and supportive care, as well as survival, are still increasing. There should be close follow-up and supportive care to decrease the severity and mortality rates in leukemia, lymphocytic, acute, l1.

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How does calaspargase pegol (s95015) work?

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The clinical results obtained after 2 years of the randomized, phase III trial suggested that s95015 is an effective treatment for B-CLL with minimal toxicity. Further investigation with longer patient follow-up times can be considered.

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What are the common side effects of calaspargase pegol (s95015)?

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Although the mechanism of this drug's side effects are unknown, it is unlikely to be directly caused by the drug. When considering and planning for side effects, it may be difficult to compare this drug with other agents that may cause a similar range of symptoms. It may be best to consider the frequency of the side effects and their severity, along with the relative effectiveness of the drug. Clinical trials.gov: NCT01798073.

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Does leukemia, lymphocytic, acute, l1 run in families?

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Recent findings we did not provide evidence that ALK-positive CLL in families can be traced to a mutated IGHV or CBL locus. Instead, we found evidence for an increased frequency of family history of CLL in ALK-negative families.

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

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In the current era, cancer treatment is evolving into a multidisciplinary environment, with new agents, targeted agents, and chemotherapy regimens. The current paradigm of targeted therapy has increased the frequency and complexity of the therapies used to treat patients with cancer. This treatment paradigm has shifted the treatments available for patients with cancer.

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

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The probability of spread within the first year is about 50% in newly diagnosed patients, which is lower than that expected in a previous study.

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