Tyrosine Kinase Inhibitor for Leukemia, Myeloid, Chronic-Phase

Phase-Based Estimates
1
Effectiveness
2
Safety
University of Illinois, Chicago, IL
Leukemia, Myeloid, Chronic-Phase+4 More
Tyrosine Kinase Inhibitor - Drug
Eligibility
< 65
All Sexes
Eligible conditions
Leukemia, Myeloid, Chronic-Phase

Study Summary

This study is evaluating whether stopping tyrosine kinase inhibitors will help patients with chronic myeloid leukemia in chronic phase continue or re-achieve molecular remission.

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Eligible Conditions

  • Leukemia, Myeloid, Chronic-Phase
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia
  • Leukemia, Myeloid
  • Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Tyrosine Kinase Inhibitor will improve 2 primary outcomes and 1 secondary outcome in patients with Leukemia, Myeloid, Chronic-Phase. Measurement will happen over the course of Up to 36 months.

Year 2
Treatment-free remission (TFR)
Up to 1 year
Major molecular remission (MMR/MR3)
Up to 36 months
Clinical factors and laboratory correlates affecting persistence of MMR

Trial Safety

Safety Estimate

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

Trial Design

2 Treatment Groups

Control
Basic Science (stop taking TKI, biospecimen collection)

This trial requires 110 total participants across 2 different treatment groups

This trial involves 2 different treatments. Tyrosine Kinase Inhibitor 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 and have already been tested with other people.

Basic Science (stop taking TKI, biospecimen collection)Patients stop taking TKI medication within 10 days after enrollment. Patients undergo peripheral blood collection to monitor loss of MMR every 4 weeks in year 1, every 6 weeks in year 2, and every 12 weeks in year 3. Patients who lose their molecular remission may restart TKI medication and are monitored every 4 weeks in year 1, every 6 weeks in year 2, and every 12 weeks in year 3.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 1
~250

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from date of tki discontinuation to the date of the first event (molecular recurrence, hematologic relapse, cytogenetic relapse, re-initiation of tki therapy, second malignant neoplasm, or death) or censoring, assessed up to 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from date of tki discontinuation to the date of the first event (molecular recurrence, hematologic relapse, cytogenetic relapse, re-initiation of tki therapy, second malignant neoplasm, or death) or censoring, assessed up to 2 years for reporting.

Closest Location

University of Illinois - Chicago, IL

Eligibility Criteria

This trial is for patients born any sex aged 65 and younger. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
REGULATORY REQUIREMENTS
All patients and/or their parents or legal guardians must sign a written informed consent
Please note: The lab evaluating disease status and molecular response for this study must be College of American Pathology (CAP) and/or Clinical Laboratory Improvement Amendments (CLIA) certified (United States [US] only), sites in other countries must be certified by their accredited authorities. All labs must use the International Scale guidelines with a sensitivity of detection assay =< 0.01% BCR-ABL1 and be able to report results in =< 2 weeks
Patient agrees to discontinue TKI therapy
All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Age >= 8 years at the time of enrollment
Patient must have been diagnosed with CML-CP at < 18 years of age.
Patient must have histologic verification of CML-CP at original diagnosis
Patient must be in molecular remission (MR) with a BCR-ABL1 level of =< 0.01% BCR-ABL1 as measured using the International Scale (IS) by RQ-PCR for >= 2 consecutive years at the time of enrollment
Patient must have received any TKI for a minimum of 3 consecutive years at time of enrollment

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 causes leukemia, myeloid, chronic-phase?

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Although a single cause or environmental factor might be implicated in the development of many forms of leukemia, it appears that a large portion of cases are multifactorial and represent a spectrum of disease states.

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What are the signs of leukemia, myeloid, chronic-phase?

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It is important to keep in mind that leukemia can present with a variety of clinical signs, so a thorough physical exam, comprehensive laboratory studies, and complete medical history are warranted and often required to support an initial diagnosis and subsequent management. There are no specific clinical signs other than the presence or absence of a marrow aplasia (as is seen in this case).

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What is leukemia, myeloid, chronic-phase?

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The most common cancer in Africa is acute lymphocytic leukemia (ALL), and the second most common malignancy. The current study found that the prevalence of ALL among children and adolescents is 9%, and that it affects mainly males (male: male ratio, 3:1). We found that ALL has a prevalence of 9% for all leukemias in Cameroon, compared to the incidence of 4.4% for ALL and 3.3% for AML. We also found that the incidence of ALL was relatively higher than the WHO/FAO guidelines of 4.5%, and this was due to under-reporting.

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What are common treatments for leukemia, myeloid, chronic-phase?

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What are common treatments for leukemia, myeloid, chronic-phase? Patients with leukemia who are treated with cytotoxic chemotherapy do well, but with an increased risk of opportunistic infections. Patients who are treated with monoclonal antibody agents are in the long-term remission and have a low risk of infection. Patients who are treated with non-chemotherapy agents are at higher risk of infection. A small number of patients have a prolonged remission with immunomodulatory agents or T cell depletion. Patients younger and older patients tend to have a poor prognosis.

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Can leukemia, myeloid, chronic-phase be cured?

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It is possible to cure chronic leukemia. Most instances are with complete remission after intensive therapy with anthracyclines combined with corticosteroids. In many cases, even after complete remissions, the disease recurs and the patient dies within a few years.

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How many people get leukemia, myeloid, chronic-phase a year in the United States?

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The incidence of leukemic diseases is relatively low in the United States (< 1 case per 10,000 person-years for all B-Cell cancers,< 1 case per 10,000 person-years for CML,< 5 cases per 10,000 person-years for ALL,< 1 case per 10,000 person-years for AML) relative to a number of other global reference sites and are similar to incidence in the Netherlands and Northern Europe, USA.

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How quickly does leukemia, myeloid, chronic-phase spread?

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While leukemia in patients with AML has a tendency towards high proliferation of the disease, a significant proportion of these blasts are located close to normal tissue. It is therefore quite difficult to determine the time of spread of AML to the rest of the body. In addition, it is almost impossible to predict whether or not patients with AML will develop myeloid or chronic phase disease.

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Has tyrosine kinase inhibitor proven to be more effective than a placebo?

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Data from a recent study of this study support the hypothesis that TKIs can produce a measurable benefit to patients with CML during the CML-induction phase of treatment as evidenced by reductions in disease progression during treatment with imatinib, and a reduction in relapse rate compared to a placebo.

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What is the survival rate for leukemia, myeloid, chronic-phase?

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The data in this study showed that patients with ALL who are treated as a subgroup of the acute phase of LMP exhibited better treatment results than patients whose disease progression was treated as ALL, not as LMP. In MOP, the disease progression also was associated with a better treatment response when patients were treated as a subgroup of the chronic phase of LMP. Prospective clinical trials should continue to evaluate the treatment for ALL, MOP, and chronic phase subgroups of LMP, as well as the treatment algorithms for ALL and MOP.

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What is the latest research for leukemia, myeloid, chronic-phase?

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This article reviews recent advances in the treatment of acute myeloid leukemia (AML), myelodysplastic/myeloproliferative disorders (MDS/PPD), and chronic myeloid leukemia (CML). All treatments have shown significant improvement in patient outcome, though there is still no cure for these diseases. Clinical trials may provide a valid benchmark for estimating their efficacy. However, clinical trials can easily be confounded by bias such as the placebo effect, reporting bias, and heterogeneity. Clinical trials, therefore, must be regarded as important, but their interpretation and comparison needs to remember that any treatment has a possible effect of its own.

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What is the average age someone gets leukemia, myeloid, chronic-phase?

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The number of new cases of leukemia and myeloid, chronic-phase was highest overall in males and was low in females throughout Finland. In females, those who developed leukemia before the age of 20 (myeloid, chronic phase) and those who had been pregnant were at significantly larger risk.

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What does tyrosine kinase inhibitor usually treat?

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The overall response rate to imatinib in this study was 40%. However, there were some patients who achieved partial responses and those who remained free of disease for up to 18 mo. Therefore, even though imatinib seems useful in the first 6-12 mo and has been commonly used since that time, further studies are required to see if it remains effective in maintaining remission long-term. If the duration and type of treatment (imatinib/stirrup regimens) has more important role in determining response rates, these findings have clinical implications.

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