Panobinostat in Treating Patients With Relapsed or Refractory Non-Hodgkin Lymphoma

Sponsor
Mayo Clinic (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01261247
Collaborator
National Cancer Institute (NCI) (NIH)
41
Enrollment
2
Locations
1
Arm
143.4
Anticipated Duration (Months)
20.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Panobinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. This phase II trial is studying how well panobinostat works in treating patients with relapsed or refractory non-Hodgkin lymphoma

Detailed Description

PRIMARY OBJECTIVES: I. To evaluate the proportion of confirmed response of LBH589 in patients with relapsed or refractory non-Hodgkin lymphoma. SECONDARY OBJECTIVES: I. To describe the toxicities associated with LBH589 in patients with NHL. II. To evaluate overall survival, progression-free survival, and duration of response in patients treated with LBH589. TERTIARY OBJECTIVES: I. To evaluate the pharmacokinetics of LBH589. II. To assess the correlation between clinical (toxicity and/or tumor response or activity) effects with the pharmacologic (pharmacokinetic/pharmacodynamic) parameters, and/or biologic (correlative laboratory) results. OUTLINE: Patients receive oral panobinostat 3 times weekly. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for up to 2 years.

Study Design

Study Type:
Interventional
Actual Enrollment :
41 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study of the Histone Deacetylase (HDAC) Inhibitor LBH589 (Panobinostat) in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma
Actual Study Start Date :
Jan 17, 2011
Actual Primary Completion Date :
May 9, 2016
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: Arm I

Patients receive oral panobinostat 3 times weekly. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Drug: panobinostat
Given orally
Other Names:
  • Faridak
  • HDAC inhibitor LBH589
  • histone deacetylase inhibitor LBH589
  • LBH589
  • Other: laboratory biomarker analysis
    Correlative studies

    Genetic: western blotting
    Correlative studies
    Other Names:
  • Blotting, Western
  • Western Blot
  • Genetic: DNA analysis
    Correlative studies

    Other: flow cytometry
    Correlative studies

    Other: pharmacological study
    Correlative studies
    Other Names:
  • pharmacological studies
  • Other: immunohistochemistry staining method
    Optional correlative studies
    Other Names:
  • immunohistochemistry
  • Outcome Measures

    Primary Outcome Measures

    1. Proportion of Confirmed Responses Defined to be a CR or PR Noted as the Objective Status [Every 28 days for up to 2 years]

      The primary endpoint of this phase II trial is the proportion of confirmed responses (complete response (CR) or partial response (PR)) noted as the objective status and will be considered synonymous with "success" for this study.Response will be evaluated using all cycles of treatment. A CR is defined using the Cheson et al. Revised Response Criteria for Malignant Lymphoma as Disappearance of all evidence of disease. A PR is defined as Regression of measurable disease and no new sites with ≥50% decrease in SPD of up to 6 largest dominant masses; no increase in size of other nodes. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients.

    Secondary Outcome Measures

    1. Median Overall Survival Time [Every 6 months for up to 2 years]

      The median overall survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.

    2. Median Progression-free Survival Time [Every 6 months for up to 2 years]

      The median progression-free survival time is defined as the time from registration to progression or death due to any cause. The distribution of progression-free survival will be estimated using the method of Kaplan-Meier. Progression is defined using the Cheson et al. Revised Response Criteria for Malignant Lymphoma as: Any new lesion or increase by ≥50% of previously involved sites from nadir, Appearance of a new lesion(s) > 1.5 cm in any axis, ≥50% increase from nadir in SPD of more than one node, or ≥50% increase in longest diameter of a previously identified node > 1 cm in short axis, Lesions PET positive if FDG-avid lymphoma or PET positive prior to therapy, > 50% increase from nadir in the SPD of any previous lesions, New or recurrent involvement.

    3. Duration of Response [Every 6 months for up to 2 years]

      Duration of response is defined for all evaluable patients who have achieved a confirmed response as the date at which the patient's objective status is first noted to be a CR or PR to the earliest date progression (PD) is documented. The distribution of duration of response will be estimated using the method of Kaplan-Meier. (CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites, PD: Any new lesion or increase by ≥50% of previously involved sites from nadir).

    Other Outcome Measures

    1. Pharmacokinetic/Pharmacodynamic of LBH589 and Correlation With Clinical Effects as Assessed by Immunoblotting, SNPs Analysis, Serum Cytokine Assays, and Flow Cytometry for Suppressive Monocytes (Correlative Studies) [At baseline and day 1 of courses 3, 5, 7 and every three courses thereafter for up to 2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria

    • Biopsy-proven relapsed or refractory non-Hodgkin lymphoma requiring treatment, who have failed, unable to tolerate, or refused other available active therapies; patients should not have other treatment options considered curative (NOTE: for patients with lymphoma without CNS involvement, a re-biopsy is necessary unless the patient has had a previous biopsy =< 6 months prior to treatment on this protocol if there has been no intervening treatment; patients with biopsy-proven CNS lymphoma at any time are not required to have a rebiopsy to be eligible for this study); NOTE: relapsed NHL is defined as NHL that relapses after at least one prior therapy and does not have available curative therapy; refractory NHL is defined as NHL that has progressed or not responded to most recent therapy and has had at least one prior therapy and have no available curative therapies

    • Measurable disease by CT or MRI or the CT portion of the PET/CT: must have at least one lesion that has a single diameter of >= 2 cm or tumor cells in the blood >= 5 x 10^9/L; skin lesions can be used if the area is >= 2 cm in at least one diameter and photographed with a ruler

    • The following disease types are eligible: transformed lymphomas: diffuse large B cell lymphoma, mantle cell lymphoma, follicular lymphoma grade III; precursor B lymphoblastic leukemia/lymphoma; mediastinal (thymic) large B-cell lymphoma; Burkitt lymphoma/leukemia; precursor T-lymphoblastic leukemia/lymphoma; primary cutaneous anaplastic large cell lymphoma; anaplastic large cell lymphoma - primary systemic type; small lymphocytic lymphoma/chronic lymphocytic leukemia; follicular lymphoma, grades 1, 2; extranodal marginal zone B-cell lymphoma of MALT type; nodal marginal zone B-cell lymphoma; splenic marginal zone B-cell lymphoma; peripheral T cell lymphoma, unspecified; anaplastic large cell lymphoma (T and null cell type); lymphoplasmacytic lymphoma (Waldenstrom Macroglobulinemia); CNS lymphoma; post transplant lymphoproliferative disorders; mycosis fungoides/Sezary syndrome; primary effusion lymphoma; blastic NK-cell lymphoma; adult T-cell leukemia/lymphoma; extranodal NK/T-cell lymphoma, nasal type; enteropathy-type T-cell lymphoma; hepatosplenic T-cell lymphoma; subcutaneous panniculitis-like T-cell lymphoma; angioimmunoblastic T-cell lymphoma; anaplastic large cell lymphoma - primary cutaneous type

    • For lymphoplasmacytic lymphoma patients without measurable lymphadenopathy, measurable disease can be defined by both of the following criteria: bone marrow lymphoplasmacytosis with > 10% lymphoplasmacytic cells or aggregates, sheets, lymphocytes, plasma cells, or lymphoplasmacytic cells on bone marrow biopsy and quantitative IgM monoclonal protein > 1,000 mg/dL

    • ANC >= 1000/uL

    • Hgb >= 9 g/dl

    • PLT >= 75,000/uL

    • Total bilirubin =< 1.5 x upper limit of normal (ULN) or if total bilirubin is > 1.5 x ULN the direct bilirubin must be normal

    • AST =< 3 x ULN

    • Albumin > 3.0 g/dl

    • Creatinine =< 2.5 x ULN

    • Serum potassium, magnesium and phosphorus >= LLN and =< 1.2 x ULN

    • Total serum calcium [corrected for serum albumin] or ionized calcium >= LLN

    • Clinically euthyroid; patients are permitted to receive thyroid hormone supplements to treat underlying hypothyroidism

    • Baseline MUGA or ECHO must demonstrate LVEF >= the lower limit of the institutional normal

    • Ability to understand and the willingness to sign a written informed consent document

    • Willingness to return to Mayo Clinic

    • Life expectancy >= 12 weeks

    • Willingness to provide blood and tissues samples for research studies as required by the protocol

    • Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only

    • ECOG performance status (PS) 0, 1 or 2

    Exclusion Criteria

    • Prior HDAC, DAC, HSP90 inhibitors or valproic acid for the treatment of cancer

    • Patients who will need valproic acid for any medical condition during the study or within 5 days prior to first panobinostat treatment

    • Candidate for known standard therapy for the patient's disease that is potentially curative

    • Uncontrolled infection requiring ongoing antibiotics

    • Any prior therapy for lymphoma within the previous 2 weeks for standard treatments and within 4 weeks for experimental therapies unless the patient has recovered from the nadir of the previous treatment to a level that meets the inclusion criteria

    • Receiving corticosteroids > 20mg of prednisone per day (or equivalent)

    • Persistent toxicities >= grade 2 from prior chemotherapy or biological therapy regardless of interval since last treatment

    • Patients with congenital long QT syndrome

    • History or presence of sustained ventricular tachyarrhythmia (patients with a history of atrial arrhythmia are eligible but should be discussed with the study PI prior to enrollment)

    • Any history of ventricular fibrillation or torsade de pointes

    • Bradycardia defined as HR < 50 bpm; patients with pacemakers are eligible if HR >= 50 bpm

    • Screening ECG with a QTcFredericia (QTcF) > 450 msec

    • Right bundle branch block + left anterior hemiblock (bifascicular block)

    • Patients with myocardial infarction or unstable angina =< 6 months prior registration

    • Other clinically significant heart disease (e.g. CHF NY Heart Association class III or IV, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen)

    • Pregnant women or women of reproductive ability who are unwilling to use effective contraception during the study and for 3 months after stopping treatment

    • Nursing women

    • Men who are unwilling to use a condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking the drug and for 3 months after stopping treatment

    • Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-FDA-approved indication and in the context of a research investigation); patients should have recovered from any immunotherapy, chemotherapy, or radiation therapy related toxicities

    • Known positivity for human immunodeficiency virus (HIV) or hepatitis C with uncontrolled disease; baseline testing for HIV and hepatitis C is not required

    • Active other malignancy requiring treatment that would interfere with the assessments of response of the lymphoma to protocol treatment

    • Inability to swallow or impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of the drugs (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea > CTCAE Grade 2, malabsorption syndrome or small bowel resection) that would preclude use of oral medications

    • Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months

    • Any severe and/or uncontrolled medical conditions or other conditions that, in the treating physician's opinion, could adversely impact their ability to participate in the study; patients on chronic oxygen therapy, those with liver disease such as cirrhosis, chronic hepatitis or chronic persistent hepatitis, or uncontrolled infections will be excluded

    • Concomitant use of strong or moderate CYP3A4 inhibitors

    • Using medications that have a relative risk of prolonging the QT interval or inducing torsade de pointes if treatment cannot be discontinued or switched to a different medication prior to starting study drug

    • Active bleeding tendency. NOTE: Patients on therapeutic anticoagulation should be monitored carefully to maintain therapeutic level of anticoagulation to avoid increased risk of bleeding due to concurrent drug induced thrombocytopenia. It is suggested that patients who require anticoagulation therapy while on therapy use low molecular weight heparin (LMWH).

    • Major surgery =< 4 weeks prior to registration or have not recovered from side effects of such therapy

    • History of other prior malignancies except for properly treated basal cell or squamous cell carcinoma of skin, in situ cervical cancer, in situ breast cancer or early stage prostate cancer

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Mayo Clinic in ArizonaScottsdaleArizonaUnited States
    2Mayo ClinicRochesterMinnesotaUnited States55905

    Sponsors and Collaborators

    • Mayo Clinic
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Patrick Johnston, M.D., Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT01261247
    Other Study ID Numbers:
    • MC0986
    • NCI-2010-02326
    • 10-004705
    • CLBH589BUS59T
    • MC0986
    First Posted:
    Dec 16, 2010
    Last Update Posted:
    Feb 10, 2022
    Last Verified:
    Feb 1, 2022

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group TitleArm I (LBH589)
    Arm/Group DescriptionPatients receive oral 40 mg panobinostat 3 times weekly. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
    Period Title: Overall Study
    STARTED41
    COMPLETED39
    NOT COMPLETED2

    Baseline Characteristics

    Arm/Group TitleArm I (LBH589)
    Arm/Group DescriptionPatients receive oral 40 mg panobinostat 3 times weekly. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
    Overall Participants39
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    61.0
    Sex: Female, Male (Count of Participants)
    Female
    12
    30.8%
    Male
    27
    69.2%
    Region of Enrollment (Count of Participants)
    United States
    39
    100%

    Outcome Measures

    1. Primary Outcome
    TitleProportion of Confirmed Responses Defined to be a CR or PR Noted as the Objective Status
    DescriptionThe primary endpoint of this phase II trial is the proportion of confirmed responses (complete response (CR) or partial response (PR)) noted as the objective status and will be considered synonymous with "success" for this study.Response will be evaluated using all cycles of treatment. A CR is defined using the Cheson et al. Revised Response Criteria for Malignant Lymphoma as Disappearance of all evidence of disease. A PR is defined as Regression of measurable disease and no new sites with ≥50% decrease in SPD of up to 6 largest dominant masses; no increase in size of other nodes. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients.
    Time FrameEvery 28 days for up to 2 years

    Outcome Measure Data

    Analysis Population Description
    Patients who completed the study were evaluable for the primary outcome. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response.
    Arm/Group TitleArm I (LBH589)
    Arm/Group DescriptionPatients receive oral 40 mg panobinostat 3 times weekly. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
    Measure Participants39
    Number (95% Confidence Interval) [proportion of CR or PR patients]
    0.21
    2. Secondary Outcome
    TitleMedian Overall Survival Time
    DescriptionThe median overall survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.
    Time FrameEvery 6 months for up to 2 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleArm I (LBH589)
    Arm/Group DescriptionPatients receive oral 40 mg panobinostat 3 times weekly. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
    Measure Participants39
    Median (95% Confidence Interval) [months]
    14.9
    3. Secondary Outcome
    TitleMedian Progression-free Survival Time
    DescriptionThe median progression-free survival time is defined as the time from registration to progression or death due to any cause. The distribution of progression-free survival will be estimated using the method of Kaplan-Meier. Progression is defined using the Cheson et al. Revised Response Criteria for Malignant Lymphoma as: Any new lesion or increase by ≥50% of previously involved sites from nadir, Appearance of a new lesion(s) > 1.5 cm in any axis, ≥50% increase from nadir in SPD of more than one node, or ≥50% increase in longest diameter of a previously identified node > 1 cm in short axis, Lesions PET positive if FDG-avid lymphoma or PET positive prior to therapy, > 50% increase from nadir in the SPD of any previous lesions, New or recurrent involvement.
    Time FrameEvery 6 months for up to 2 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleArm I (LBH589)
    Arm/Group DescriptionPatients receive oral 40 mg panobinostat 3 times weekly. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
    Measure Participants39
    Median (95% Confidence Interval) [months]
    3.1
    4. Secondary Outcome
    TitleDuration of Response
    DescriptionDuration of response is defined for all evaluable patients who have achieved a confirmed response as the date at which the patient's objective status is first noted to be a CR or PR to the earliest date progression (PD) is documented. The distribution of duration of response will be estimated using the method of Kaplan-Meier. (CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites, PD: Any new lesion or increase by ≥50% of previously involved sites from nadir).
    Time FrameEvery 6 months for up to 2 years

    Outcome Measure Data

    Analysis Population Description
    Patients who achieved a confirmed response were included in this analysis.
    Arm/Group TitleArm I (LBH589)
    Arm/Group DescriptionPatients receive oral 40 mg panobinostat 3 times weekly. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
    Measure Participants8
    Median (95% Confidence Interval) [months]
    19.7
    5. Other Pre-specified Outcome
    TitlePharmacokinetic/Pharmacodynamic of LBH589 and Correlation With Clinical Effects as Assessed by Immunoblotting, SNPs Analysis, Serum Cytokine Assays, and Flow Cytometry for Suppressive Monocytes (Correlative Studies)
    Description
    Time FrameAt baseline and day 1 of courses 3, 5, 7 and every three courses thereafter for up to 2 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description

    Adverse Events

    Time FrameUp to 25 months
    Adverse Event Reporting Description CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
    Arm/Group TitleArm I (LBH589)
    Arm/Group DescriptionPatients receive oral 40 mg panobinostat 3 times weekly. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
    All Cause Mortality
    Arm I (LBH589)
    Affected / at Risk (%)# Events
    Total0/41 (0%)
    Serious Adverse Events
    Arm I (LBH589)
    Affected / at Risk (%)# Events
    Total34/41 (82.9%)
    Blood and lymphatic system disorders
    Anemia6/41 (14.6%) 9
    Febrile neutropenia1/41 (2.4%) 1
    Cardiac disorders
    Atrial fibrillation1/41 (2.4%) 1
    Gastrointestinal disorders
    Abdominal pain1/41 (2.4%) 1
    Diarrhea2/41 (4.9%) 2
    Intra-abdominal hemorrhage1/41 (2.4%) 1
    General disorders
    Fatigue4/41 (9.8%) 4
    Fever1/41 (2.4%) 2
    Infections and infestations
    Enterocolitis infectious1/41 (2.4%) 2
    Lung infection3/41 (7.3%) 7
    Skin infection1/41 (2.4%) 1
    Upper respiratory infection2/41 (4.9%) 2
    Injury, poisoning and procedural complications
    Postoperative hemorrhage1/41 (2.4%) 1
    Investigations
    Electrocardiogram QT corrected interval prolonged1/41 (2.4%) 1
    INR increased1/41 (2.4%) 1
    Lymphocyte count decreased3/41 (7.3%) 3
    Neutrophil count decreased12/41 (29.3%) 18
    Platelet count decreased33/41 (80.5%) 46
    Serum amylase increased1/41 (2.4%) 1
    White blood cell decreased8/41 (19.5%) 10
    Metabolism and nutrition disorders
    Dehydration1/41 (2.4%) 1
    Hypertriglyceridemia1/41 (2.4%) 2
    Hyponatremia1/41 (2.4%) 2
    Hypophosphatemia2/41 (4.9%) 2
    Renal and urinary disorders
    Renal calculi1/41 (2.4%) 2
    Respiratory, thoracic and mediastinal disorders
    Dyspnea1/41 (2.4%) 1
    Vascular disorders
    Hypertension1/41 (2.4%) 1
    Hypotension2/41 (4.9%) 2
    Other (Not Including Serious) Adverse Events
    Arm I (LBH589)
    Affected / at Risk (%)# Events
    Total38/41 (92.7%)
    Blood and lymphatic system disorders
    Anemia11/41 (26.8%) 20
    Gastrointestinal disorders
    Abdominal pain1/41 (2.4%) 1
    Constipation1/41 (2.4%) 1
    Diarrhea31/41 (75.6%) 98
    Dyspepsia2/41 (4.9%) 4
    Nausea29/41 (70.7%) 63
    Vomiting15/41 (36.6%) 20
    General disorders
    Edema limbs1/41 (2.4%) 1
    Fatigue35/41 (85.4%) 159
    Infections and infestations
    Lung infection2/41 (4.9%) 3
    Sinusitis1/41 (2.4%) 1
    Upper respiratory infection1/41 (2.4%) 7
    Investigations
    Alkaline phosphatase increased1/41 (2.4%) 1
    CD4 lymphocytes decreased2/41 (4.9%) 2
    CPK increased1/41 (2.4%) 1
    Creatinine increased1/41 (2.4%) 7
    Lymphocyte count decreased6/41 (14.6%) 8
    Neutrophil count decreased17/41 (41.5%) 83
    Platelet count decreased19/41 (46.3%) 61
    Weight loss2/41 (4.9%) 3
    White blood cell decreased15/41 (36.6%) 47
    Metabolism and nutrition disorders
    Anorexia8/41 (19.5%) 9
    Dehydration1/41 (2.4%) 1
    Hyperglycemia3/41 (7.3%) 3
    Hypertriglyceridemia5/41 (12.2%) 18
    Hypoalbuminemia1/41 (2.4%) 1
    Hypoglycemia1/41 (2.4%) 1
    Hypophosphatemia4/41 (9.8%) 5
    Nervous system disorders
    Dysgeusia4/41 (9.8%) 15
    Headache1/41 (2.4%) 1
    Renal and urinary disorders
    Chronic kidney disease1/41 (2.4%) 4
    Vascular disorders
    Hypertension1/41 (2.4%) 2

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/TitlePatrick Johnston, MD, PhD
    OrganizationMayo Clinic Cancer Center
    Phone507-284-2511
    Emailjohnston.patrick@mayo.edu
    Responsible Party:
    Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT01261247
    Other Study ID Numbers:
    • MC0986
    • NCI-2010-02326
    • 10-004705
    • CLBH589BUS59T
    • MC0986
    First Posted:
    Dec 16, 2010
    Last Update Posted:
    Feb 10, 2022
    Last Verified:
    Feb 1, 2022