[U-13C]glucose for Leukemia, Lymphocytic, Chronic, B-Cell

Phase-Based Estimates
1
Effectiveness
1
Safety
University of Wisconsin, Madison, WI
+3 More
[U-13C]glucose - Other
Eligibility
18+
All Sexes
Eligible conditions
Leukemia, Lymphocytic, Chronic, B-Cell

Study Summary

In Vivo Metabolic Profiling of CLL (Chronic Lymphocytic Leukemia)

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Eligible Conditions

  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia
  • Leukemia, Lymphoid
  • Chronic Lymphocytic Leukemia (CLL)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether [U-13C]glucose will improve 2 primary outcomes and 1 other outcome in patients with Leukemia, Lymphocytic, Chronic, B-Cell. Measurement will happen over the course of 10 minutes.

10 minutes
Validate ex vivo labeling model to assay metabolism
Hour 2
Amount of [U-13C15N]L-glutamine incorporation into metabolites in normal and leukemic lymphocytes: LCMS pharmacokinetic analysis
Amount of [U-13C]glucose incorporation into metabolites in normal and leukemic lymphocytes: Liquid chromatography-mass spectrometry (LCMS) pharmacokinetic analysis

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

4 Treatment Groups

Group A: Healthy volunteers
Group B subset-2: Treatment naïve CLL patients with low disease burden

This trial requires 16 total participants across 4 different treatment groups

This trial involves 4 different treatments. [U-13C]glucose 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 < 1 and are in the first stage of evaluation with people.

Group B subset-2: Treatment naïve CLL patients with low disease burden
Other
Participants with low disease burden CLL (Chronic Lymphocytic Leukemia) defined as confined to Rai stage 0.
Group B subset-1: Treatment naïve CLL(Chronic Lymphocytic Leukemia) patients with low disease burden
Other
Participants with low disease burden CLL (Chronic Lymphocytic Leukemia) defined as confined to Rai stage 0.
Group C:Treatment naïve CLL patients with high systemic disease burden
Other
Treatment naïve CLL patients with high systemic disease burden
Group A: Healthy volunteers
Other
Healthy volunteers are defined as people without a history of cancer

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 hours (± 5 minutes)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 2 hours (± 5 minutes) for reporting.

Closest Location

University of Wisconsin - Madison, WI

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Group A
Adult (18 years of age or older)
No previous history of cancer
Routine history of normal blood counts and vital signs
Documented Informed Consent
Group B
Diagnosis of CLL with low disease burden defined as Rai stage 0 ((Lymphocytosis; no enlargement of the lymph nodes, spleen, or liver; red blood cell and platelet counts are near normal.)
Treatment naïve
Group C
Diagnosis of CLL with high systemic disease burden defined as infiltration of bone marrow causing cytopenia

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 is leukemia, lymphocytic, chronic, b-cell?

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The most commonly encountered leukemias, in an area representative of the adult population in Northern Europe, are B-cell non-accelerated chronic and acute lymphocytic leukemias. Chronic lymphocytic leukaemias occur slightly more often than previously reported (2:1-3) and, in a small minority of patients, acute lymphoproliferative or myeloproliferative leukemias can also occur. Chronic lymphocytic leukaemias are characterized by a very long survival (median 3 years at diagnosis). Results from a recent paper confirms previous research suggesting that chronic lymphocytic leukaemia in children is a distinct, less aggressive disease than acute B-cell leukaemias.

Unverified Answer

How many people get leukemia, lymphocytic, chronic, b-cell a year in the United States?

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The incidence of lymphocytic, chronic, B-cell leukemia is increasing among men, ages 45-49, whites, and in a number of states. [Age at diagnosis is also increasing] A similar trend in incidence was not observed in other geographic areas, suggesting a different etiology of disease of the leukemia in states in which the incidence is increasing. However, it is still unknown at what age the increasing trend starts. Further evaluation of this problem is warranted.

Unverified Answer

What are common treatments for leukemia, lymphocytic, chronic, b-cell?

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There are many treatments for individuals with leukemia, lymphocytic, chronic, or B-cell, which include chemotherapy for all patients; in addition, many therapeutic options are available for patients with certain subtypes of leukemia, lymphocytic, chronic, or C-cell. Patients with C-cell leukemia, lymphocytic, chronic, or C-cell may benefit from treatments that are targeted toward the affected cells; treatment of individuals with these types of leukemia is an area of active research and clinical trials. Treatment of leukemia is often accomplished with the use of multiple drug combinations.

Unverified Answer

Can leukemia, lymphocytic, chronic, b-cell be cured?

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Findings from a recent study of patients treated with modern conventional therapy for leukemia, lymphocytic, and chronic B-cell disorders, a satisfactory clinical management of all patients was achieved and long-term survivals can be expected for most patients.

Unverified Answer

What are the signs of leukemia, lymphocytic, chronic, b-cell?

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Symptoms may vary in size, frequency of symptom presentation, and presentation itself. Most often, symptoms are vague, and diagnosis may be delayed. Leukemia (particularly [chronic lymphocytic leukemia](https://www.withpower.com/clinical-trials/chronic-lymphocytic-leukemia) [CLL]) often follows an insidious course over the course of several years. Patients with B cell lymphomas often present with symptoms of fatigue, weight loss, and shortness of breath. Because of the delay in diagnosis, patients may receive inappropriate treatment for years if symptoms are unrecognized, and symptom severity may need to be measured and reassessed frequently. In both chronic lymphocytic leukemia [CLL] and B cell lymphomas, symptoms generally resolve after treatment with standard doses of corticosteroids, which should be continued indefinitely.

Unverified Answer

What causes leukemia, lymphocytic, chronic, b-cell?

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In lymphoid leukemia, two separate subgroups-acute lymphoblastic leukemia and chronic lymphocytic leukemia are well documented-are defined by distinct pathophysiologic abnormalities and by different clinical presentations and courses. Genetic abnormalities in acute lymphoblastic leukemia are quite common (>40%), and a subset of these patients have the t(14;18)(q22;q21) translocation [t(14;18)(q22;q21)] associated with c-MYC rearrangement. The role of MYC as a leukemogenic factor has been debated for a long time.

Unverified Answer

How quickly does leukemia, lymphocytic, chronic, b-cell spread?

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For the time it took the leukemia to spread, our patients had a worse overall outcome (p = 0.095) which was the endpoint of our study. However, the disease remained stable or even decreased in some patients, resulting from treatment.

Unverified Answer

What is the survival rate for leukemia, lymphocytic, chronic, b-cell?

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In summary, the survival rate for leukemia, lymphocytic, chronic, b-cell is 74% at 3 and 12 months, and 75% is 30 months for ALL and 50% for AML. It's important to recognize that the survival rate for ALL and AML increases when the person is treated correctly in clinical trials.

Unverified Answer

Does [13c5]glutamine improve quality of life for those with leukemia, lymphocytic, chronic, b-cell?

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Contrary to study 1, neither [13c5]galnor [13c5]-D-L-glutamine improves chemotherapy-induced symptoms in the short term, however, they have a significant positive impact on QOL during a 4-week observation period.

Unverified Answer

Is [13c5]glutamine safe for people?

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The clinical response rate was high and was similar to that observed with MMF. There were no deaths reported due to toxicity. Glx is an effective chemotherapy drug for treating SLL.

Unverified Answer

Is [13c5]glutamine typically used in combination with any other treatments?

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When used in combination with chemotherapy or radiation, (13)C5GN is typically used in low to average doses. In studies with high dose (15)C6ARG, toxicity was observed in about 2/3 of patients who received a dose of>30 Gy, with nausea reported in 2/6 and emesis in 2/4 patients receiving high dose.

Unverified Answer

What is the latest research for leukemia, lymphocytic, chronic, b-cell?

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There are a few leukemias that are new and interesting; however, there are still many open research questions that remain unanswered. [Figure 3] show several research topics for future leukemias.

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