Higher or Lower Dose Cladribine, Cytarabine, and Mitoxantrone in Treating Medically Less Fit Patients With Newly Diagnosed Acute Myeloid Leukemia or Myeloid Neoplasm
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| ClinicalTrials.gov Identifier: NCT03012672 |
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Recruitment Status :
Recruiting
First Posted : January 6, 2017
Last Update Posted : May 6, 2019
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Sponsor:
Fred Hutchinson Cancer Research Center
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center
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Brief Summary:
This randomized pilot trial studies how well higher or lower dose cladribine, cytarabine, and mitoxantrone work in treating medically less fit patients with newly diagnosed acute myeloid leukemia or myeloid neoplasm. Drugs used in chemotherapy, such as cladribine, cytarabine, and mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving cladribine, cytarabine, and mitoxantrone at higher or lower dose may work better in treating patients with newly diagnosed acute myeloid leukemia.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Acute Leukemia of Ambiguous Lineage Acute Myeloid Leukemia Myeloid Neoplasm | Drug: Cladribine Drug: Cytarabine Biological: Granulocyte Colony-Stimulating Factor Drug: Mitoxantrone Hydrochloride Other: Quality-of-Life Assessment Other: Questionnaire Administration | Phase 2 |
Show Detailed Description
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 50 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Impact of Treatment Intensity on Survival, Quality of Life, and Resource Utilization in Medically Less Fit Adults With Acute Myeloid Leukemia and Analogous Myeloid Neoplasms: A Randomized Pilot Study |
| Actual Study Start Date : | December 30, 2016 |
| Estimated Primary Completion Date : | July 15, 2020 |
| Estimated Study Completion Date : | July 15, 2020 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Core binding factor acute myeloid leukemia
Cytogenetically normal acute myeloid leukemia
Familial acute myeloid leukemia with mutated CEBPA
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm I (higher-dose)
INDUCTION: Patients receive G-CSF SC on days 0-5, higher dose cladribine IV over 2 hours on days 1-5, higher dose cytarabine IV over 2 hours on days 1-5, and higher dose mitoxantrone IV over 60 minutes on days 1-3. Treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients who achieve CR/CRi with up to 2 courses of Induction receive G-CSF, cladribine, and cytarabine as in Induction. Courses repeat every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. |
Drug: Cladribine
Given IV
Other Names:
Drug: Cytarabine Given IV
Other Names:
Biological: Granulocyte Colony-Stimulating Factor Given SC
Other Names:
Drug: Mitoxantrone Hydrochloride Given IV
Other Names:
Other: Quality-of-Life Assessment Ancillary studies
Other Name: Quality of Life Assessment Other: Questionnaire Administration Ancillary studies |
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Experimental: Arm II (lower-dose)
INDUCTION: Patients receive G-CSF SC on days 0-5, lower dose cladribine IV over 2 hours on days 1-5, lower dose cytarabine IV over 1 hour on days 1-5, and lower dose mitoxantrone IV over 60 minutes on days 1-3. Treatment repeats every 6 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients who achieve CR/CRi with up to 6 courses of Induction receive G-CSF, cladribine, and cytarabine as in Induction. Courses repeat every 6 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity. |
Drug: Cladribine
Given IV
Other Names:
Drug: Cytarabine Given IV
Other Names:
Biological: Granulocyte Colony-Stimulating Factor Given SC
Other Names:
Drug: Mitoxantrone Hydrochloride Given IV
Other Names:
Other: Quality-of-Life Assessment Ancillary studies
Other Name: Quality of Life Assessment Other: Questionnaire Administration Ancillary studies |
Primary Outcome Measures :
- Feasibility defined as proportion of patients willing to be randomized to either intensive or non-intensive induction and post remission chemotherapy [ Time Frame: Up to 5 years ]Randomizing patients to either intensive or non-intensive induction and post remission chemotherapy will be considered feasible if the true proportion of patients willing to be randomized is 60% or higher.
Secondary Outcome Measures :
- Attitude of patients toward randomization as determined by a patient preference survey [ Time Frame: Up to 12 months ]Exploratory, descriptive, and observational methods will be used.
- Care costs [ Time Frame: Up to 5 years ]The costs associated with inpatient and outpatient management will be calculated using electronic billing information from the University of Washington Medical Center (UWMC) and Seattle Cancer Care Alliance (SCCA). Costs will be converted from charges using departmental cost-to-charge ratios. Descriptive information identifying major cost drivers and total/subset costs per phase of treatment will be reported.
- Duration of response [ Time Frame: Up to 5 years ]Will be evaluated.
- Event-free survival [ Time Frame: Up to 5 years ]Will be determined by peripheral blood count and bone marrow evaluation and categorized according to criteria recommended by International Working Groups.
- Fitness for intensive chemotherapy as measured by a treatment-related mortality (TRM) score that includes additional co-morbidity factors [ Time Frame: Up to 12 months ]The ability of physicians and the prediction algorithm(s) to assess the likelihood of early death will be compared.
- Medical complications [ Time Frame: Up to 5 years ]Information on medical complications (e.g. need for intensive care unit (ICU) level care, length of ICU stay, neutropenic fever, documented infections, bleeding, reasons for hospitalization) will be collected from the medical records from the University of Washington Medical Center (UWMC) and Seattle Cancer Care Alliance (SCCA).
- Medical resource utilization [ Time Frame: Up to 5 years ]Information on use of medical resources (e.g. platelet transfusions; days of IV antimicrobial therapy, total hospital length of stay) will be collected from the medical records from the University of Washington Medical Center (UWMC) and Seattle Cancer Care Alliance (SCCA).
- Overall survival [ Time Frame: Up to 5 years ]Will be assessed for all patients. Will be determined by peripheral blood count and bone marrow evaluation and categorized according to criteria recommended by International Working Groups.
- Quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 [ Time Frame: Up to 12 months ]Exploratory, descriptive, and observational methods will be used.
- Relapse-free survival [ Time Frame: Up to 5 years ]Will be determined by peripheral blood count and bone marrow evaluation and categorized according to criteria recommended by International Working Groups.
- Response [ Time Frame: Up to 5 years ]The differences in anti-leukemic efficacy between patients treated with lower-intensity chemotherapy and those treated with higher-intensity chemotherapy will be estimated. Exploratory, descriptive, and observational methods will be used.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of untreated ?high-grade? myeloid neoplasm (>= 10% myeloid blasts by morphology in bone marrow and/or peripheral blood) or AML other than acute promyelocytic leukemia (APL) with t(15;17)(q22;q12) or variants according to the 2016 World Health Organization (WHO) classification; patients with acute leukemias of ambiguous lineage are eligible; outside diagnostic material is acceptable as long as peripheral blood and/or bone marrow slides are reviewed at the study institution and cytogenetic/molecular information is available
- Treatment-related mortality (TRM) score >= 13.1 as calculated with simplified model
- The use of hydroxyurea before enrollment is permitted; hydroxyurea should be discontinued prior to start of study treatment; patients with symptoms/signs of hyperleukocytosis or white blood cell count (WBC) >100,000/uL can be treated with leukapheresis or may receive up to 1 dose of cytarabine (up to 500 mg/m^2) anytime prior to enrollment
- Patients may have received treatment (e.g. azacitidine/decitabine, lenalidomide, growth factors) for antecedent low-grade myeloid neoplasm
- Left ventricular ejection fraction (LVEF) >= 45%, assessed within 3 months prior to registration, e.g. by multigated acquisition (MUGA) scan or echocardiography, or other appropriate diagnostic modality
- Women of childbearing potential and men must agree to use adequate contraception beginning at the signing of the consent until at least 4 weeks after the last dose of study drug
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
- Myeloid blast crisis of chronic myeloid leukemia (CML), unless patient is not considered candidate for tyrosine kinase inhibitor treatment
- Concomitant illness associated with a likely survival of < 1 year
- Active systemic fungal, bacterial, viral, or other infection, unless disease is under treatment with anti-microbials and/or controlled or stable; patients with fever thought to be likely secondary to leukemia are eligible; known hypersensitivity to any study drug
- Known hypersensitivity to any study drug used in this trial
- Pregnancy or lactation
- Concurrent treatment with any other anti-leukemia agent
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03012672
Locations
| United States, Washington | |
| Fred Hutch/University of Washington Cancer Consortium | Recruiting |
| Seattle, Washington, United States, 98109 | |
| Contact: Anna Halpern 206-667-6233 | |
| Principal Investigator: Anna Halpern | |
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Anna Halpern | Fred Hutch/University of Washington Cancer Consortium |
| Responsible Party: | Fred Hutchinson Cancer Research Center |
| ClinicalTrials.gov Identifier: | NCT03012672 History of Changes |
| Other Study ID Numbers: |
9759 NCI-2016-02051 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 9759 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium ) P30CA015704 ( U.S. NIH Grant/Contract ) |
| First Posted: | January 6, 2017 Key Record Dates |
| Last Update Posted: | May 6, 2019 |
| Last Verified: | May 2019 |
Additional relevant MeSH terms:
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Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type Cytarabine Mitoxantrone Cladribine Lenograstim Sargramostim Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |
Antineoplastic Agents Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Adjuvants, Immunologic Analgesics Sensory System Agents Peripheral Nervous System Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |