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CompletedNCT00840177Updated May 3, 2023Results posted

S0919 Idarubicin, Cytarabine, and Pravastatin in Treating Patients With Relapsed Acute Myeloid Leukemia

A Phase 2 interventional study of cytarabine and idarubicin in Leukemia, sponsored by SWOG Cancer Research Network. Completed at 185 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-03.

Sponsored by SWOG Cancer Research Network · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
115
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

RATIONALE: Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Pravastatin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Pravastatin may also help idarubicin and cytarabine work better by making cancer cells more sensitive to the drugs. Giving idarubicin and cytarabine together with pravastatin may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving idarubicin and cytarabine together with pravastatin works in treating patients with relapsed acute myeloid leukemia (AML).

ADDITIONAL BACKGROUND: S0919 was initially designed for patients with relapsed acute myeloid leukemia (AML), where the patient's preceding remission had lasted ≥ 3 months. The null response rate was 30%. The study closed to accrual on Nov 1, 2012 after meeting the defined criterion for a positive study; and the results are being submitted to the American Society of Clinical Oncology meeting. Based on the promising results from this trial, the trial has now been amended to evaluate this therapeutic regimen in poor-risk patients (patients with newly diagnosed acute myeloid leukemia (AML) arising out of myelodysplastic syndrome (MDS), primary refractory acute myeloid leukemia (AML), and relapsed acute myeloid leukemia (AML) with the patient's preceding remission lasting \< 6 months).

Read the detailed description

COHORTS:

Cohort 1 (Initial cohort: Relapsed AML with previous remission ≥ 3 months), Cohort 2 (Poor-risk cohort: MDS transformed to AML), Cohort 3 (Poor-risk cohort: Refractory or relapsed AML with previous remission \< 6 months)

OBJECTIVES:

  • To test whether the complete remission (CR) rate (including CR with incomplete recovery) in patients with relapsed acute myeloid leukemia (AML) treated with idarubicin and cytarabine in combination with pravastatin is sufficiently high to warrant a phase III investigation.
  • To estimate relapse-free survival and overall survival rates in these patients.
  • To estimate the frequency and severity of toxicities of this regimen in these patients.
  • To evaluate, in a preliminary manner, whether pre-study cytogenetic features correlate with response in these patients.

OUTLINE: This is a multicenter study.

  • Induction therapy: Patients receive oral pravastatin once daily on days 1-8, idarubicin IV over 10-15 minutes on days 4-6, and cytarabine IV continuously on days 4-7. Patients achieving complete remission proceed to consolidation therapy.
  • Consolidation therapy: Beginning 30-60 days after the start of induction therapy, patients receive oral pravastatin once daily on days 1-6 and idarubicin IV over 10-15 minutes and cytarabine IV continuously on days 4 and 5. Treatment repeats approximately every 5 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 5 years.

02

Conditions studied

  • Leukemia

Keywords

  • recurrent adult acute myeloid leukemia
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • adult acute myeloid leukemia with inv(16)(p13;q22)
  • adult acute myeloid leukemia with t(15;17)(q22;q12)
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • adult acute myeloid leukemia with t(8;21)(q22;q22)
03

In context

Leukemia

5,475 studies on the registry are indexed under Leukemia; 629 are open to participants now.

This study's enrollment of 115 is above the median of 38 across 4,268 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

SWOG Cancer Research Network is the lead sponsor of 339 studies on the registry; 37 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.

Browse SWOG Cancer Research Network studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Cohort 1 (Initial cohort: Relapsed AML with previous remission >/= 3 months) is permanently closed to accrual DISEASE CHARACTERISTICS

  • Patients must have a previous morphologically confirmed diagnosis of acute myeloid leukemia (AML). Note: This protocol uses the World Health Organization (WHO) diagnostic criteria for acute myeloid leukemia (AML) (see Section 4.1). Patients with acute promyelocytic leukemia (APL, FAB, M3) or blastic transformation of chronic myelogenous leukemia (CMML) are not eligible.
  • Patients must have received at least one prior chemotherapy regimen for their acute myeloid leukemia (AML) and they may have received any type of chemotherapy. They must have achieved complete remission (CR), lasting at least three months with their last induction regimen and they must have relapsed after the last regimen. Relapse must be documented by a bone marrow examination demonstrating > 5% blasts in the bone marrow not attributable to another cause. Refractory patients and patients who have received autologous or allogeneic stem cell transplantation are not eligible. Administration of hydroxyurea to control high white blood cell (WBC) count prior to, during and after registration is permitted.
  • Patients must not have symptomatic congestive heart failure, coronary artery disease, cardiomyopathy, or uncontrolled arrhythmias. Either an echocardiogram or multiple-gated acquisition (MUGA) scan with an ejection fraction ≥ 45% must be obtained within 28 days prior to registration. (Either method for measuring cardiac function is acceptable, however, the same scan must be used throughout treatment and follow-up to monitor the patient for cardiac toxicity.) If patient has symptoms suggestive of ischemia or congestive heart failure after that cardiac evaluation was done, a repeat study must be obtained prior to registration.
  • Patients must have a serum creatinine \< 2.0 mg/dl within 14 days prior to registration.
  • Patients must have a total bilirubin ≤ 2.0 x Institutional Upper Limit of Normal (IULN) within 14 days prior to registration, unless the elevation is due primarily to elevated unconjugated hyperbilirubinemia secondary to Gilbert's syndrome or hemolysis and not to liver dysfunction.
  • Patients must have SGOT (AST) ≤ 3.0 x IULN and SGPT (ALT) ≤ 3.0 x IULN within 14 days prior to registration. Treatment may begin with SGOT/SGPT above those limits, if the abnormalities are thought to be due to the patient's leukemia.
  • Patients must have Zubrod performance status of 0-2 (see Section 10.8).
  • Patients must be ≥ 18 years of age.
  • Patients must not have clinical evidence of leptomeningeal disease (a spinal tap does not need to be performed).

  • Patients not known to be HIV+ must be tested for HIV infection (the human immunodeficiency virus) within 14 days prior to registration (see Section 2.0 for justification). Patients who are HIV+ may be eligible providing they meet all of the following additional criteria within 14 days prior to registration:

    1. Patient must have no history of AIDS defining events.
    2. CD4 cells ≥ 500/mm3.
    3. Viral load of \< 50 copies HIV mRNA/mm3 if on cART or \< 25,000 copies HIV mRNA if not on cART.
    4. No zidovudine or stavudine as part of cART. Patients who are HIV+ and do not meet all of these criteria will not be eligible for this study.
  • Patients with prior malignancy (other than AML) are eligible. However, the patient must be in remission from the prior malignancy and have completed all chemotherapy and radiotherapy at least 6 months prior to registration and all treatment related toxicities must have been resolved. NOTE: For patients with prior history of malignancy who have received anthracyclines or mediastinal/pericardial radiation in the past, the risk versus benefit of therapy should be weighed, particularly in the setting of receiving consolidation therapy.
  • Patients must not have a systemic fungal, bacterial, viral or other infection that is not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
  • Southwest Oncology Group patients must be registered on SWOG-9007 ("Cytogenetic Studies in Leukemia Patients"). Collection of pretreatment marrow specimens must be completed within 28 days prior to registration. Pretreatment specimens of bone marrow (or peripheral blood if the marrow aspirate is a dry tap) must be submitted to an approved Southwest Oncology Group Cytogenetics Laboratory for cytogenetics analysis. Note that protocol SWOG-9007 also requires submission of specimens at additional timepoints.
  • Southwest Oncology Group patients must be offered participation in S9910 ("Leukemia Centralized Reference Laboratories and Tissue Repositories Ancillary"). If consent is given, collection of pretreatment blood and/or marrow specimens must be completed within 28 days prior to registration. If the patient consents to participate in S9910, pretreatment specimens of marrow and/or peripheral blood must be submitted to the Southwest Oncology Group Myeloid Repository at the University of New Mexico for cellular and molecular studies. Note that protocol S9910 also requests submission of specimens at additional timepoints.
  • Women of reproductive potential must have a negative pregnancy test within 14 days prior to registration. Patients must not be pregnant or nursing because of the teratogenic potential of the drugs used in this study. Women/men of reproductive potential must have agreed to use an effective contraceptive method.
  • All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
  • At the time of patient registration, the treating institution's name and ID number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base.

Cohort 2 (MDS transformed to AML) is permanently closed to accrual AND Cohort 3 (relapsed/refractory AML) is permanently closed to accrual

DISEASE CHARACTERISTICS:

  • For patients registered to relapsed/refractory (Cohort 3), morphologically confirmed diagnosis of acute myeloid leukemia (AML)
  • Patient registered to the myelodysplastic syndrome (MDS) transformed to acute myeloid leukemia (AML) cohort (Cohort 2) patients must have a previous morphologically confirmed diagnosis of myelodysplastic syndrome/chronic myelomonocytic leukemia (MDS/CMML). Patients may have received previous non-intensive therapy (such as: azacitidine, decitabine, low-dose cytarabine, lenalidomide) given treatment of myelodysplastic syndrome/chronic myelomonocytic leukemia (MDS/CMML) (with up to 20% blasts). At time of registration, patient must have morphologically confirmed diagnosis of acute myeloid leukemia (AML).
  • Patients with acute promyelocytic leukemia (i.e., APL, FAB M3) or blastic transformation of chronic myelogenous leukemia are not eligible
  • Patients must not have received autologous or allogeneic stem cell transplant.

  • Patients in the relapsed/refractory acute myeloid leukemia (AML) cohort (Cohort 3) must:

    • Have received ≥ 1 prior chemotherapy regimen for acute myeloid leukemia (AML)

      • Any type of prior chemotherapy allowed
      • Administration of hydroxyurea to control high white blood cell (WBC) prior to, during, and after registration is permitted
    • Relapse must be documented by a bone marrow examination demonstrating > 5% blasts in the bone marrow not attributable to another cause
    • Patient must not have received chemo within 14 days prior to registration
  • Primary refractory patients eligible if, on Day 14 of previous chemo regimen, they have significant residual disease. Patients who received only hypomethylating agent or low dose therapy for Induction are not considered primary refractory for this study and are not eligible.
  • Relapsed patients must have achieved a complete remission (CR) or CR with incomplete blood count recovery that lasted \< 6 months after the last induction regimen
  • No clinical evidence of leptomeningeal disease
  • Pretreatment (collected within 28 days of registration) cytogenetics must be performed on all patients.
  • Patients must have complete history and physical exam within 28 days prior to registration.

PATIENT CHARACTERISTICS:

  • No symptomatic congestive heart failure, coronary artery disease, cardiomyopathy, or uncontrolled arrhythmias

    • Ejection fraction ≥ 45% by echocardiogram or MUGA scan within 28 days prior to registration (or within 14 days prior to registration if the patient has received anthracycline in the 28 day window)
  • Zubrod performance status 0-2
  • Serum creatinine ≤ 2.0 times upper limit of normal (ULN)
  • Total bilirubin ≤ 2.0 times ULN (unless elevation is primarily due to elevated unconjugated hyperbilirubinemia secondary to Gilbert's syndrome or hemolysis AND not due to liver dysfunction)
  • AST and ALT ≤ 3.0 times ULN
  • Not pregnant or nursing and negative pregnancy test within 14 days prior to registration. Females of child-bearing potential must agree to use effective contraception

  • No HIV positivity unless the following criteria are met:

    • No history of AIDS-defining events
    • CD4 count ≥ 500/mm³
    • Viral load \< 25,000 copies (\< 50 copies if on combination antiretroviral therapy)
    • Not receiving zidovudine or stavudine as part of combination antiretroviral therapy
  • No uncontrolled systemic fungal, bacterial, viral, or other infection, defined as exhibiting ongoing signs/symptoms related to the infection with no improvement despite appropriate antibiotics or other treatment
  • Patients with prior malignancy (other than AML and MDS/CMML) eligible provided patient is in remission from that malignancy at least 6 months prior to registration. Except for acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) treatment, all treatment related toxicities must have been resolved.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
115 participants (actual)

Study arms

  • Experimental
    treatment

    Induction (1 cycle): pravastatin 1280 mg/d PO D 1-8 idarubicin 12 mg/m2/d IV D 4-6 cytarabine 1.5 g/m2/d continuous IV D 4-7 Consolidation (up to 2 cycles): pravastatin 1280 mg/d PO D 1-6 idarubicin 12 mg/m2/d IV D 4-5 cytarabine 1.5 g/m2/d continuous IV D 4-5

    Drug: cytarabine · Drug: idarubicin · Drug: pravastatin sodium

Interventions

  • Drugcytarabine

    1.5 g/m2/day given by continuous IV on days 4-7

  • Drugidarubicin

    12 mg/m2/day given intravenously over 10-15 minutes on days 4-6

  • Drugpravastatin sodium

    1,280 mg/day given orally on days 1-8

06

What researchers measure

Primary outcomes

  1. Complete Remission (CR) Rate (Including CR With Incomplete Recovery)

    Participants who achieved morphological complete remission with or without incomplete blood count recovery. Per the Revised Recommendations of the International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia, morphologic complete remission requires that the patient achieve the morphologic leukemia-free state and have an absolute neutrophil count of more than 1,000/μL and platelets of ≥ 100,000/μL.

    Time frame: Up to 5 years after registration

Secondary outcomes

  1. Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0

    Number of patients with Grade 3-5 adverse events that were possibly, probably or definitely related to study drug are reported by given type of adverse event

    Time frame: Up to 5 years post registration

Other outcomes

  1. Correlation Between Pre-study Cytogenetic Features and Response

    Time frame: 5 years

  2. Overall Survival (OS)

    OS is calculated for all participants from the date of initial registration on study until death from any cause. Observations for participants last known to be alive were censored.

    Time frame: OS assessed for up to 5 years, median OS reported

  3. Relapse-free Survival (RFS)

    RFS is calculated for participants who have achieved a complete response (CR) or CR with incomplete blood count recovery (CRi). RFS will be measured from the date of CR or CRi until relapse from CR or CRi for death from any cause. Observation is censored at the date of last follow-up for patients last known to be alive without report of relapse. Per the Revised Recommendations of the International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia, morphologic complete remission requires that the patient achieve the morphologic leukemia-free state and have an absolute neutrophil count of more than 1,000/μL and platelets of ≥ 100,000/μL.

    Time frame: RFS assessed for up to 5 years, median RFS reported

07

Results

Posted Jan 13, 2020

Participant flow

Participant flow — Overall Study
MilestoneInitial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthPoor-risk Cohort: MDS Transformed to AMLPoor-risk Cohort: Refractory/Relapsed AML, < 6 Mths Remission
Started362950
Treated362946
Assessed for aes352946
Completed182039
Not completed18911
Withdrew: Adverse event511
Withdrew: Refusal unrelated to adverse events101
Withdrew: Progression/relapse200
Withdrew: Death455
Withdrew: Not protocol specified630
Withdrew: Ineligible003
Withdrew: Did not start treatment001

Outcome measures

PrimaryComplete Remission (CR) Rate (Including CR With Incomplete Recovery)

Participants who achieved morphological complete remission with or without incomplete blood count recovery. Per the Revised Recommendations of the International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia, morphologic complete remission requires that the patient achieve the morphologic leukemia-free state and have an absolute neutrophil count of more than 1,000/μL and platelets of ≥ 100,000/μL.

Time frame:
Up to 5 years after registration
Reported as:
Count of participants · Participants
Complete Remission (CR) Rate (Including CR With Incomplete Recovery)
ParticipantsInitial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthPoor-risk Cohort: MDS Transformed to AMLPoor-risk Cohort: Refractory/Relapsed AML, < 6 Mths Remission
Complete Remission (CR) Rate (Including CR With Incomplete Recovery)271414
SecondaryFrequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0

Number of patients with Grade 3-5 adverse events that were possibly, probably or definitely related to study drug are reported by given type of adverse event

Time frame:
Up to 5 years post registration
Reported as:
Number · Participants
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
ParticipantsInitial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthPoor-risk Cohort: MDS Transformed to AMLPoor-risk Cohort: Refractory/Relapsed AML, < 6 Mths Remission
ALT, SGPT (serum glutamic pyruvic transaminase)022
AST, SGOT031
Acidosis (metabolic or respiratory)010
Albumin, serum-low (hypoalbuminemia)136
Alkaline phosphatase001
Alkalosis (metabolic or respiratory)010
Anorexia110
Bilirubin (hyperbilirubinemia)220
Blood/Bone Marrow-Other (Specify)210
Bone marrow cellularity100
Calcium, serum-low (hypocalcemia)253
Carbon monoxide diffusion capacity (DL(co))141
Cardiac General-Other (Specify)100
Cardiac-ischemia/infarction010
Colitis, infectious (e.g., Clostridium difficile)011
Conduction abnormality - Asystole100
Confusion100
Constitutional Symptoms-Other (Specify)020
Creatinine032
Diarrhea348
Distention/bloating, abdominal020
Dry mouth/salivary gland (xerostomia)010
Dyspnea (shortness of breath)212
Edema: limb020
Esophagitis100
Fatigue (asthenia, lethargy, malaise)322
Febrile neutropenia201832
Glucose, serum-high (hyperglycemia)120
Hemoglobin111421
Hemorrhage, GI - Duodenum010
Hemorrhage, GU - Vagina100
Hemorrhage, pulmo/upper resp- Bronchopulmonary NOS001
Hemorrhage, pulmonary/upper respiratory - Nose001
Hemorrhage/Bleeding-Other (Specify)100
Hypertension100
Hypotension121
Hypoxia123
Ileus, GI (functional obstruction of bowel)120
Inf (clin/microbio) w/Gr 3-4 neuts - Blood447
Inf (clin/microbio) w/Gr 3-4 neuts - Bronchus101
Inf (clin/microbio) w/Gr 3-4 neuts - Kidney001
Inf (clin/microbio) w/Gr 3-4 neuts - Lung526
Inf (clin/microbio) w/Gr 3-4 neuts - Meninges001
Inf (clin/microbio) w/Gr 3-4 neuts - Sinus100
Inf (clin/microbio) w/Gr 3-4 neuts - Skin010
Inf (clin/microbio) w/Gr 3-4 neuts - Small bowel100
Inf (clin/microbio) w/Gr 3-4 neuts - Stomach001
Infection with unknown ANC - Blood124
Infection with unknown ANC - Lung (pneumonia)010
Infection with unknown ANC - Mucosa001
Infection with unknown ANC - Sinus100
Infection with unknown ANC - Small bowel NOS010
Infection-Other (Specify)110
Left ventricular diastolic dysfunction200
Leukocytes (total WBC)161117
Lipase100
Lymphopenia659
Magnesium, serum-high (hypermagnesemia)010
Mental status100
Mucositis/stomatitis (clinical exam) - Oral cavity001
Mucositis/stomatitis (clinical exam) - Pharynx001
Mucositis/stomatitis (functional/symp) - Oral cav101
Musculoskeletal/Soft Tissue-Other (Specify)010
Nausea213
Necrosis, GI - Small bowel NOS010
Neutrophils/granulocytes (ANC/AGC)141516
Obstruction, GI - Small bowel NOS010
Ocular/Visual-Other (Specify)100
Opportunistic inf associated w/gt=Gr 2 lymphopenia002
Pain - Abdomen NOS130
Pain - Bone001
Pain - Esophagus001
Pain - Extremity-limb001
Pain - Oral cavity003
Pain - Peritoneum010
Phosphate, serum-low (hypophosphatemia)242
Platelets171619
Pleural effusion (non-malignant)010
Potassium, serum-high (hyperkalemia)020
Potassium, serum-low (hypokalemia)633
Pulmonary hypertension100
Pulmonary/Upper Respiratory-Other (Specify)010
Rash/desquamation001
Renal failure002
Renal/Genitourinary-Other (Specify)010
SVT and nodal arrhythmia - Atrial fibrillation110
SVT and nodal arrhythmia - Atrial flutter100
Sodium, serum-high (hypernatremia)100
Sodium, serum-low (hyponatremia)101
Syncope (fainting)100
Typhlitis (cecal inflammation)001
Ulcer, GI - Duodenum010
Ulceration001
Vomiting220
Weight loss002
Other pre-specifiedCorrelation Between Pre-study Cytogenetic Features and Response
Time frame:
5 years

Results for this outcome have not been posted.

Other pre-specifiedOverall Survival (OS)

OS is calculated for all participants from the date of initial registration on study until death from any cause. Observations for participants last known to be alive were censored.

Time frame:
OS assessed for up to 5 years, median OS reported
Reported as:
Median · months
Overall Survival (OS)
monthsInitial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthPoor-risk Cohort: MDS Transformed to AMLPoor-risk Cohort: Refractory/Relapsed AML, < 6 Mths Remission
Overall Survival (OS)10 (7 to 12)10 (4 to 18)4 (3 to 6)
Other pre-specifiedRelapse-free Survival (RFS)

RFS is calculated for participants who have achieved a complete response (CR) or CR with incomplete blood count recovery (CRi). RFS will be measured from the date of CR or CRi until relapse from CR or CRi for death from any cause. Observation is censored at the date of last follow-up for patients last known to be alive without report of relapse. Per the Revised Recommendations of the International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia, morphologic complete remission requires that the patient achieve the morphologic leukemia-free state and have an absolute neutrophil count of more than 1,000/μL and platelets of ≥ 100,000/μL.

Time frame:
RFS assessed for up to 5 years, median RFS reported
Reported as:
Median · months
Relapse-free Survival (RFS)
monthsInitial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthPoor-risk Cohort: MDS Transformed to AMLPoor-risk Cohort: Refractory/Relapsed AML, < 6 Mths Remission
Relapse-free Survival (RFS)9 (5 to 20)19.4 (4.3 to NA)2.7 (0.3 to 18.9)

Adverse events

Collected over Up to 5 years post registration. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 Mnths27/36 (75%)5/35 (14.3%)34/35 (97.1%)
Poor-risk Cohort: MDS Transformed to AML20/29 (69%)8/29 (27.6%)28/29 (96.6%)
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths Remission41/46 (89.1%)10/46 (21.7%)45/46 (97.8%)
Most frequent serious events
Showing 10 of 24
Most frequent serious events
EventInitial Cohort: Relapsed AML With Previous Remission ≥ 3 MnthsPoor-risk Cohort: MDS Transformed to AMLPoor-risk Cohort: Refractory/Relapsed AML, < 6 Mths Remission
Carbon monoxide diffusion capacity (DL(co))Investigations1/354/291/46
Carbon monoxide diffusion capacity (DL(co))Respiratory, thoracic and mediastinal disorders1/354/291/46
Infection with unknown ANC - BloodInfections and infestations1/352/295/46
HypotensionVascular disorders0/352/291/46
Death not associated with CTCAE term - Death NOSGeneral disorders1/350/293/46
Cardiac General-OtherCardiac disorders1/351/290/46
Cardiac-ischemia/infarctionCardiac disorders0/351/290/46
SVT and nodal arrhythmia - Atrial fibrillationCardiac disorders1/351/290/46
Ileus, GI (functional obstruction of bowel)Gastrointestinal disorders0/351/290/46
Inf (clin/microbio) w/Gr 3-4 neuts - BloodInfections and infestations0/351/290/46
Most frequent other events
Showing 10 of 125
Most frequent other events
EventInitial Cohort: Relapsed AML With Previous Remission ≥ 3 MnthsPoor-risk Cohort: MDS Transformed to AMLPoor-risk Cohort: Refractory/Relapsed AML, < 6 Mths Remission
DiarrheaGastrointestinal disorders22/3525/2934/46
Febrile neutropeniaBlood and lymphatic system disorders21/3522/2933/46
NauseaGastrointestinal disorders20/3522/2924/46
HemoglobinBlood and lymphatic system disorders13/3521/2923/46
Albumin, serum-low (hypoalbuminemia)Metabolism and nutrition disorders6/3520/2919/46
Potassium, serum-low (hypokalemia)Metabolism and nutrition disorders12/3520/2924/46
PlateletsInvestigations18/3519/2920/46
Calcium, serum-low (hypocalcemia)Metabolism and nutrition disorders9/3519/2916/46
Fatigue (asthenia, lethargy, malaise)General disorders14/3518/2918/46
Neutrophils/granulocytes (ANC/AGC)Investigations14/3518/2918/46

Baseline characteristics

Eligible patients who started treatment

Age, Continuous
Age, Continuous(years)Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthPoor-risk Cohort: MDS Transformed to AMLPoor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionTotal
Median58.6 (23.2 to 78.2)64.9 (21.8 to 77.1)57.3 (23.1 to 74.9)60.7 (21.8 to 78.2)
Sex: Female, Male
Sex: Female, Male(Participants)Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthPoor-risk Cohort: MDS Transformed to AMLPoor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionTotal
Female19132254
Male17162457
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthPoor-risk Cohort: MDS Transformed to AMLPoor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionTotal
Hispanic or Latino5049
Not Hispanic or Latino29283895
Unknown or Not Reported2147
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Initial Cohort: Relapsed AML With Previous Remission ≥ 3 MonthPoor-risk Cohort: MDS Transformed to AMLPoor-risk Cohort: Refractory/Relapsed AML, < 6 Mths RemissionTotal
American Indian or Alaska Native0000
Asian0066
Native Hawaiian or Other Pacific Islander1001
Black or African American3126
White30283593
More than one race0033
Unknown or Not Reported2002
08

Study locations

185 sites
  • University of Alabama at Birmingham Cancer Center
    Birmingham, Alabama 35233, United States
  • University of Arkansas for Medical Sciences
    Little Rock, Arkansas 72205, United States
  • Stanford Cancer Institute
    Palo Alto, California 94304, United States
  • University of Colorado Cancer Center - Anschutz Cancer Pavilion
    Aurora, Colorado 80045, United States
  • Smilow Cancer Hospital Care Center at Saint Francis
    Hartford, Connecticut 06105, United States
  • Moffitt Cancer Center
    Tampa, Florida 33612, United States
  • Saint Alphonsus Cancer Care Center-Boise
    Boise, Idaho 83706, United States
  • Saint Alphonsus Cancer Care Center-Caldwell
    Caldwell, Idaho 83605, United States
  • Kootenai Medical Center
    Coeur d'Alene, Idaho 83814, United States
  • Walter Knox Memorial Hospital
    Emmett, Idaho 83617, United States
  • Idaho Urologic Institute-Meridian
    Meridian, Idaho 83642, United States
  • Saint Alphonsus Medical Center-Nampa
    Nampa, Idaho 83686, United States
  • Kootenai Cancer Center
    Post Falls, Idaho 83854, United States
  • Kootenai Cancer Clinic
    Sandpoint, Idaho 83864, United States
  • Saint Joseph Medical Center
    Bloomington, Illinois 61701, United States
  • Illinois CancerCare-Bloomington
    Bloomington, Illinois 61704, United States
  • Illinois CancerCare-Canton
    Canton, Illinois 61520, United States
  • Memorial Hospital of Carbondale
    Carbondale, Illinois 62902, United States
  • SIH Cancer Institute
    Carterville, Illinois 62918, United States
  • Illinois CancerCare-Carthage
    Carthage, Illinois 62321, United States
  • Centralia Oncology Clinic
    Centralia, Illinois 62801, United States
  • Cancer Care Center of Decatur
    Decatur, Illinois 62526, United States
  • Decatur Memorial Hospital
    Decatur, Illinois 62526, United States
  • Crossroads Cancer Center
    Effingham, Illinois 62401, United States
  • Illinois CancerCare-Eureka
    Eureka, Illinois 61530, United States
  • Illinois CancerCare-Galesburg
    Galesburg, Illinois 61401, United States
  • Western Illinois Cancer Treatment Center
    Galesburg, Illinois 61401, United States
  • Illinois CancerCare-Kewanee Clinic
    Kewanee, Illinois 61443, United States
  • Illinois CancerCare-Macomb
    Macomb, Illinois 61455, United States
  • Loyola University Medical Center
    Maywood, Illinois 60153, United States
  • Illinois CancerCare-Ottawa Clinic
    Ottawa, Illinois 61350, United States
  • Radiation Oncology of Northern Illinois
    Ottawa, Illinois 61350, United States
  • Illinois CancerCare-Pekin
    Pekin, Illinois 61554, United States
  • OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
    Pekin, Illinois 61554, United States
  • Methodist Medical Center of Illinois
    Peoria, Illinois 61603, United States
  • Illinois CancerCare-Peoria
    Peoria, Illinois 61615, United States
  • OSF Saint Francis Radiation Oncology at Peoria Cancer Center
    Peoria, Illinois 61615, United States
  • OSF Saint Francis Medical Center
    Peoria, Illinois 61637, United States
  • Illinois CancerCare-Peru
    Peru, Illinois 61354, United States
  • Valley Radiation Oncology
    Peru, Illinois 61354, United States
  • Illinois CancerCare-Princeton
    Princeton, Illinois 61356, United States
  • Central Illinois Hematology Oncology Center
    Springfield, Illinois 62702, United States
  • Southern Illinois University School of Medicine
    Springfield, Illinois 62702, United States
  • Springfield Clinic
    Springfield, Illinois 62702, United States
  • Memorial Medical Center
    Springfield, Illinois 62781, United States
  • Cancer Care Specialists of Illinois-Swansea
    Swansea, Illinois 62226, United States
  • Memorial and Saint Elizabeth's Health Care Services LLP
    Swansea, Illinois 62226, United States
  • Hospital District Sixth of Harper County
    Anthony, Kansas 67003, United States
  • Cancer Center of Kansas - Chanute
    Chanute, Kansas 66720, United States
  • Cancer Center of Kansas - Dodge City
    Dodge City, Kansas 67801, United States
  • Cancer Center of Kansas - El Dorado
    El Dorado, Kansas 67042, United States
  • Cancer Center of Kansas - Fort Scott
    Fort Scott, Kansas 66701, United States
  • Cancer Center of Kansas-Independence
    Independence, Kansas 67301, United States
  • Cancer Center of Kansas-Kingman
    Kingman, Kansas 67068, United States
  • Lawrence Memorial Hospital
    Lawrence, Kansas 66044, United States
  • Cancer Center of Kansas-Liberal
    Liberal, Kansas 67905, United States
  • Cancer Center of Kansas-Manhattan
    Manhattan, Kansas 66502, United States
  • Cancer Center of Kansas - McPherson
    McPherson, Kansas 67460, United States
  • Cancer Center of Kansas - Newton
    Newton, Kansas 67114, United States
  • Cancer Center of Kansas - Parsons
    Parsons, Kansas 67357, United States
  • Cancer Center of Kansas - Pratt
    Pratt, Kansas 67124, United States
  • Cancer Center of Kansas - Salina
    Salina, Kansas 67401, United States
  • Cancer Center of Kansas - Wellington
    Wellington, Kansas 67152, United States
  • Associates In Womens Health
    Wichita, Kansas 67208, United States
  • Cancer Center of Kansas-Wichita Medical Arts Tower
    Wichita, Kansas 67208, United States
  • Cancer Center of Kansas - Wichita
    Wichita, Kansas 67214, United States
  • Via Christi Regional Medical Center
    Wichita, Kansas 67214, United States
  • Wesley Medical Center
    Wichita, Kansas 67214, United States
  • Wichita NCI Community Oncology Research Program
    Wichita, Kansas 67214, United States
  • Cancer Center of Kansas - Winfield
    Winfield, Kansas 67156, United States
  • Hematology/Oncology Clinic LLP
    Baton Rouge, Louisiana 70809, United States
  • Tulane University Health Sciences Center
    New Orleans, Louisiana 70112, United States
  • Louisiana State University Health Sciences Center Shreveport
    Shreveport, Louisiana 71103, United States
  • Saint Joseph Mercy Hospital
    Ann Arbor, Michigan 48106-0995, United States
  • Michigan Cancer Research Consortium NCORP
    Ann Arbor, Michigan 48106, United States
  • IHA Hematology Oncology Consultants-Brighton
    Brighton, Michigan 48114, United States
  • Saint Joseph Mercy Brighton
    Brighton, Michigan 48114, United States
  • IHA Hematology Oncology Consultants-Canton
    Canton, Michigan 48188, United States
  • Saint Joseph Mercy Canton Health Center
    Canton, Michigan 48188, United States
  • Caro Cancer Center
    Caro, Michigan 48723, United States
  • IHA Hematology Oncology Consultants-Chelsea
    Chelsea, Michigan 48118, United States
  • Saint Joseph Mercy Chelsea
    Chelsea, Michigan 48118, United States
  • Hematology Oncology Consultants-Clarkston
    Clarkston, Michigan 48346, United States
  • Newland Medical Associates-Clarkston
    Clarkston, Michigan 48346, United States
  • Beaumont Hospital-Dearborn
    Dearborn, Michigan 48124, United States
  • Saint John Hospital and Medical Center
    Detroit, Michigan 48236, United States
  • Great Lakes Cancer Management Specialists-Doctors Park
    East China Township, Michigan 48054, United States
  • Hurley Medical Center
    Flint, Michigan 48502, United States
  • Genesee Cancer and Blood Disease Treatment Center
    Flint, Michigan 48503, United States
  • Genesee Hematology Oncology PC
    Flint, Michigan 48503, United States
  • Genesys Hurley Cancer Institute
    Flint, Michigan 48503, United States
  • Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
    Grosse Pointe Woods, Michigan 48236, United States
  • Lymphoma Clinic of Michigan
    Grosse Pointe Woods, Michigan 48236, United States
  • Michigan Breast Specialists-Grosse Pointe Woods
    Grosse Pointe Woods, Michigan 48236, United States
  • Allegiance Health
    Jackson, Michigan 49201, United States
  • Sparrow Hospital
    Lansing, Michigan 48912, United States
  • Hope Cancer Clinic
    Livonia, Michigan 48154, United States
  • Saint Mary Mercy Hospital
    Livonia, Michigan 48154, United States
  • Hematology Oncology Associates East PC
    Macomb, Michigan 48044, United States
  • Michigan Breast Specialists-Macomb Township
    Macomb, Michigan 48044, United States

Showing the first 100 of 185 sites.

09

References and documents

Publications

  • Statler A, Othus M, Erba HP, Chauncey TR, Radich JP, Coutre S, Advani A, Nand S, Ravandi F, Mukherjee S, Sekeres MA. Comparable outcomes of patients eligible vs ineligible for SWOG leukemia studies. Blood. 2018 Jun 21;131(25):2782-2788. doi: 10.1182/blood-2018-01-826693. Epub 2018 Apr 4. PubMed 29618479 ↗

Study documents

  • Protocol, analysis plan and consent form · Sep 12, 2016

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00840177
Lead sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Feb 10, 2009
Start date
Dec 10, 2009
Primary completion
Dec 2018
Completion
Oct 21, 2021
Results posted
Jan 13, 2020
Last update
May 3, 2023

Study contacts

Anjali Advani, MD
study chair · The Cleveland Clinic

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Cytarabine · Idarubicin · Pravastatin

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Leukemia →

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SWOG Cancer Research Network →

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