Hybrid Closed Loop System for Leukemia, Lymphocytic, Acute, L1

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Children's Hospital Colorado, Aurora, CO
Leukemia, Lymphocytic, Acute, L1+3 More
Hybrid Closed Loop System - Device
Eligibility
< 65
All Sexes
What conditions do you have?
Select

Study Summary

This study is evaluating whether a closed-loop insulin delivery system is safe and feasible for children and young adults with high risk acute lymphoblastic leukemia.

See full description

Eligible Conditions

  • Leukemia, Lymphocytic, Acute, L1
  • High Risk Acute Lymphoblastic Leukemia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Leukemia, Lymphocytic, Acute, L1

Study Objectives

This trial is evaluating whether Hybrid Closed Loop System will improve 6 primary outcomes and 7 secondary outcomes in patients with Leukemia, Lymphocytic, Acute, L1. Measurement will happen over the course of 35 days.

35 days
CGM Time in hypoglycemia (blood glucose < 70 mg/dL)
Efficacy of glycemic control with HCL insulin delivery assessed by Time in Ranges (TIR)
Efficacy of glycemic control with HCL insulin delivery assessed by mean sensor glucose level
Length of PICU admission in days per patient
Length of hospitalization in days per patient
Need for readmission during the induction phase in percent
Number of episodes of symptomatic hypoglycemia
Rate of bleeding at the CGM insertion site
Rate of bleeding at the HCL insulin infusion site
Rate of infection at the CGM insertion site
Rate of infection at the HCL insulin infusion site
Rate of infection in episodes per patient-days
Rate of remission at the end of induction in percent

Trial Safety

Safety Progress

1 of 3

Other trials for Leukemia, Lymphocytic, Acute, L1

Trial Design

1 Treatment Group

Hybrid Closed-Loop Insulin System During Chemo with Steroid and Asparaginase
1 of 1
Experimental Treatment

This trial requires 20 total participants across 1 different treatment group

This trial involves a single treatment. Hybrid Closed Loop System 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.

Hybrid Closed-Loop Insulin System During Chemo with Steroid and Asparaginase
Device
Subjects will receive insulin via hybrid closed-loop insulin delivery system during the chemotherapy phases that contains steroid and asparaginase. This treatment will be initiated within 4 days of starting induction chemotherapy treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hybrid Closed Loop System
2016
N/A
~90

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 35 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 35 days for reporting.

Closest Location

Children's Hospital Colorado - Aurora, CO

Eligibility Criteria

This trial is for patients born any sex aged 65 and younger. You must have received newly diagnosed for Leukemia, Lymphocytic, Acute, L1 or one of the other 3 conditions listed above. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
should receive prophylactic G-CSF Steroid and asparaginase containing induction chemotherapy regimens should be started with prophylactic G-CSF therapy in order to reduce the incidence of neutropenia. show original
associated with their use A parent or guardian who lives in the home with the participant and also receives training on diabetes, CGM, and HCL therapy, as well as the safety protocols associated with their use. show original
should be vaccinated against HPV People ages 10 years old and older should be vaccinated against HPV. show original
Patients who are newly diagnosed with high-risk acute lymphoblastic leukemia
If the patient is older than 18, they or their parent or guardian must be fluent in reading and speaking English. show original

Patient Q&A Section

How serious can leukemia be?

"The seriousness of leukemia is based largely on the underlying cause of the disease. Patients with AML are generally very seriously sick and often die within 2 years after diagnosis, while patients with CLL are much more manageable and may survive 10 years or more. There are a few rare cancers where almost any patient survives 2 years or more after diagnosis. Cancer patients should always pray hard for their lives when they are in hospital." - Anonymous Online Contributor

Unverified Answer

What does hybrid closed loop system usually treat?

"The hybrid closed loop system is a promising method for treating patients with chronic diseases and operates without external intervention. This approach represents a novel strategy to build intelligent, self-regulating closed systems which have many advantages over conventional closed loop systems. The hybrid closed loop system provides excellent value for money for treatment of patients with chronic disease. This method could be applied to almost any patient, even those who cannot tolerate conventional open-loop techniques. Hybrid closed loop systems operate by using external control methods to regulate the parameters of the system, rather than relying on internal regulation mechanisms. Moreover, they offer a new way to monitor the state of the patient’s health without inserting anything into the body." - Anonymous Online Contributor

Unverified Answer

What are common treatments for leukemia?

"Patients with chronic myeloid leukemia who do not have a stem cell [transplant](https://www.withpower.com/clinical-trials/transplant) may be treated with tyrosine kinase inhibitor drugs. In patients with acute myeloid leukemia, they may receive chemotherapy or bone marrow transplantation. Patients with acute lymphocytic leukemia may be treated with chemotherapy or a bone marrow transplant. Chronic lymphocytic leukemia may be treated with chemotherapy alone or with radiation therapy along with chemotherapy. Patients with multiple myeloma might be treated with chemotherapy or immunotherapy drugs. Patients with myelodysplastic syndromes may be treated with chemotherapy or bone marrow transplantation. Patients with non-Hodgkin's lymphoma may be treated with chemotherapy or biologic therapy." - Anonymous Online Contributor

Unverified Answer

What is the latest research for leukemia?

"The leukemic process is not homogeneous, but rather involves different stages of development. The most common form of leukemia is acute myeloid leukemia (AML). Chronic leukemia is a rarer condition than AML; however, it is more prevalent than ALL. AML and ALL are the most common forms of leukemia and they are often diagnosed together by doctors and patients. A second kind of leukemia is known as lymphoma. There are many types of lymphoma, some of which are much less common than AML and ALL, especially Hodgkin's lymphoma and Non-Hodgkin's lymphoma. These are categorized into categories according to their appearance under the microscope." - Anonymous Online Contributor

Unverified Answer

What is hybrid closed loop system?

"Hybrid CL system reduces the number of infusion times and the amount of chemotherapy drug given per course. It is an effective method for administering low-dose chemotherapy." - Anonymous Online Contributor

Unverified Answer

Is hybrid closed loop system typically used in combination with any other treatments?

"Results from a recent paper suggest that a hybrid closed loop system can significantly affect the effectiveness of chemotherapy treatment. Moreover, we have demonstrated that a hybrid closed loop system may improve the efficiency of chemotherapy treatment by individualizing the drug dosing schedule. Further investigation will be needed to clarify the effects of chemotherapy on the effectiveness of treatment using this innovative device." - Anonymous Online Contributor

Unverified Answer

What are the signs of leukemia?

"A patient complaining about a change in appetite, weight loss, fever, malaise, or feeling tired should be investigated by a medical professional. The case history, physical examination and laboratory tests will help identify the diagnosis. The definitive diagnosis of leukemia is made only after obtaining a complete blood count showing neutrophilia, anaemia, thrombocytopenia or leukocytosis. Image diagnosis of bone marrow aspiration is essential for confirming the diagnosis; bone marrow biopsy has limited use as it does not always give accurate results, and is associated with some risks. An ultrasound scan of the abdomen may aid diagnosis in certain cases." - Anonymous Online Contributor

Unverified Answer

What causes leukemia?

"Most leukemias are caused by genetic mutations. One gene mutation is enough to cause leukemia, and some cases cause leukemia without the presence of a specific gene mutation. Sometimes the same gene mutation can cause multiple types of leukemia. The most common genetic mutations occur in the "TP53" gene." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of leukemia?

"The incidence of congenital errors is much higher than the incidence of acquired errors. That is because most people get their genetic information by inheriting it from both parents, so there is no chance of the child having a change in their DNA.\nHowever, the incidence of acquired errors can increase due to environmental factors. These include radiation, viruses, and chemicals. It is estimated that about 5% of leukemia cases occur as a result of exposure to ionizing radiation. A high risk group is children who were exposed to nuclear explosions during World War II. Acutely, this usually results in a very rapid progression of the leukemia. However, after decades of exposure, even if the leukemia has progressed quickly, it generally remains in remission." - Anonymous Online Contributor

Unverified Answer

Does leukemia run in families?

"Data from a recent study suggest that genetic predisposition does not appear to be responsible for the development of acute myelogenous leukemia (AML) in our family." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for leukemia?

"Survival rates vary greatly between different types of leukemia. Non-Hodgkin's Lymphoma has one of the best cure rates among all non-cancerous illnesses and is also considered curable with current treatments. In contrast, most people diagnosed with chronic myeloid leukemia will die within 5 years from their cancer.\n\nThe orientation of the tumor and its location on the bone marrow plays an important role in determining whether the patient will suffer a relapse of the disease. The type of treatment used and how frequently the patient is treated play a significant role in the prognosis of the patient. Patients who present with acute promyelocytic leukemia have a better prognosis than patients with other subtypes of AML." - Anonymous Online Contributor

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