Higher or Lower Dose Cladribine, Cytarabine, and Mitoxantrone in Treating Medically Less Fit Patients With Newly Diagnosed Acute Myeloid Leukemia or Myeloid Neoplasm
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03012672 |
Recruitment Status :
Active, not recruiting
First Posted : January 6, 2017
Last Update Posted : January 7, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |

Study Type : | Interventional (Clinical Trial) |
Actual 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 |
Actual Primary Completion Date : | December 10, 2020 |
Estimated Study Completion Date : | December 31, 2025 |

Arm | Intervention/treatment |
---|---|
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 |
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 |
- Feasibility defined as proportion of patients willing to be randomized to either intensive or non-intensive induction and post remission chemotherapy [ Time Frame: At end of enrollment ]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.
- Attitude of patients toward randomization [ Time Frame: Up to 12 months ]Will be determined by a patient preference survey. 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 ]Will be measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30. 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 leukostasis, white blood cell (WBC) > 100,000/uL, or acute symptoms felt related to their high-grade myeloid neoplasm can be treated with leukapheresis or may receive up to 1 dose of cytarabine (up to 500 mg/m^2) anytime prior to study day 1
- 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

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
United States, Washington | |
Fred Hutch/University of Washington Cancer Consortium | |
Seattle, Washington, United States, 98109 |
Principal Investigator: | Anna Halpern | Fred Hutch/University of Washington Cancer Consortium |
Responsible Party: | University of Washington |
ClinicalTrials.gov Identifier: | NCT03012672 |
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 ) RG9217016 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium ) |
First Posted: | January 6, 2017 Key Record Dates |
Last Update Posted: | January 7, 2021 |
Last Verified: | January 2021 |
Leukemia Neoplasms Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms by Histologic Type Cytarabine 2-chloro-3'-deoxyadenosine 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 |