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Ibrutinib, Rituximab, Venetoclax, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma

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ClinicalTrials.gov Identifier: NCT03710772
Recruitment Status : Recruiting
First Posted : October 18, 2018
Last Update Posted : September 6, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date  ICMJE October 15, 2018
First Posted Date  ICMJE October 18, 2018
Last Update Posted Date September 6, 2019
Actual Study Start Date  ICMJE May 1, 2019
Estimated Primary Completion Date April 22, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
Efficacy of ibrutinib plus rituximab combination followed by venetoclax [ Time Frame: Up to course 12 ]
Determined by complete response (CR). The complete response after 4 cycles of venetoclax combined with ibrutinib plus rituximab and toxicity within first cycle of venetoclax combination will be monitored simultaneously using the Bayesian stopping boundaries calculated based on beta-binomial distributions. The prior probabilities of response and toxicity are modeled by beta distributions. Complete response and its 95% confidence interval will be calculated. Logistic regression will be utilized to assess the effect of patient prognostic factors on the CR rate and the toxicity rate.
Original Primary Outcome Measures  ICMJE
 (submitted: October 17, 2018)
Efficacy of ibrutinib plus rituximab combination followed by venetoclax as determined by complete response (CR) [ Time Frame: After 12, 28 day cycles ]
The complete response after 4 cycles of venetoclax combined with ibrutinib plus rituximab and toxicity within first cycle of venetoclax combination will be monitored simultaneously using the Bayesian stopping boundaries calculated based on beta-binomial distributions. The prior probabilities of response and toxicity are modeled by beta distributions. Complete response and its 95% confidence interval will be calculated. Logistic regression will be utilized to assess the effect of patient prognostic factors on the CR rate and the toxicity rate.
Change History Complete list of historical versions of study NCT03710772 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
  • Incidence of adverse events [ Time Frame: Up to 5 years ]
    Graded according to Common Terminology Criteria for Adverse Events (CTCAE). The safety is measured by toxicity which is defined as grade 3-4 non-hematologic toxicities within first cycle treatment of venetoclax combined with ibrutinib plus rituximab. Toxicity data by type and severity will be summarized by frequency tables. Logistic regression will be utilized to assess the effect of patient prognostic factors on the CR rate and the toxicity rate.
  • Progression-free survival (PFS) [ Time Frame: Up to 5 years ]
    The distribution of PFS will be estimated using the method of Kaplan and Meier. Comparison of PFS by important subgroups will be made using the log-rank test.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2018)
  • Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) [ Time Frame: Up to 5 years ]
    The safety is measured by toxicity which is defined as grade 3-4 non-hematologic toxicities within first cycle treatment of venetoclax combined with ibrutinib plus rituximab. Toxicity data by type and severity will be summarized by frequency tables. Logistic regression will be utilized to assess the effect of patient prognostic factors on the CR rate and the toxicity rate.
  • Progression-free survival (PFS) [ Time Frame: Up to 5 years ]
    The distribution of PFS will be estimated using the method of Kaplan and Meier. Comparison of PFS by important subgroups will be made using the log-rank test.
Current Other Pre-specified Outcome Measures
 (submitted: October 17, 2018)
Circulating tumor deoxyribonucleic acid (ctDNA) levels [ Time Frame: Up to 5 years ]
Descriptive statistics will be used to summarize the ctDNA levels. Longitudinal analysis will be applied to evaluate the change of over time for each detected variant using mixed-effects model. Dynamic prediction modeling with time-dependent covariate in survival analysis for PFS will be explored based on ctDNA levels and clinical covariates.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Ibrutinib, Rituximab, Venetoclax, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma
Official Title  ICMJE A Phase II Study of Ibrutinib Plus Rituximab Followed by Venetoclax and Hyper-CVAD Consolidation in Newly Diagnosed Young Patients With Mantle Cell Lymphoma: Window II Protocol
Brief Summary This phase II trial studies how well ibrutinib and rituximab given together with venetoclax and combination chemotherapy work in treating patients with newly diagnosed mantle cell lymphoma. Ibrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as rituximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy such as, venetoclax, cyclophosphamide, vincristine, doxorubicin, and dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ibrutinib, rituximab, and venetoclax together with combination chemotherapy may work better in treating patients with mantle cell lymphoma.
Detailed Description

PRIMARY OBJECTIVES:

I. To determine the complete response rate of the ibrutinib plus rituximab combination followed by venetoclax in newly diagnosed young mantle cell lymphoma (MCL) patients.

SECONDARY OBJECTIVES:

I. To determine the safety profile of the ibrutinib plus rituximab combination followed by venetoclax in newly diagnosed young MCL patients.

II. To evaluate the progression-free survival and overall survival time of the ibrutinib plus rituximab combination followed by venetoclax and hyper-fractionated cyclophosphamide, vincristine, doxorubicin hydrochloride, and dexamethasone (hyper-CVAD) in newly diagnosed young MCL patients.

EXPLORATORY OBJECTIVES:

I. Developing a novel minimal residual disease (MRD) assay using circulating tumor deoxyribonucleic acid (DNA) (ctDNA) from patients' plasma samples collected in this trial.

OUTLINE:

PART I: Patients receive ibrutinib orally (PO) once daily (QD) on days 1-28 and receive rituximab intravenously (IV) over 4-8 hours on days 1, 8, 15, and 22 of course 1 and on day 1 of courses 3-12. Patients also receive venetoclax PO QD on days 1-28 of courses 5-12. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

PART II: Patients are assigned to 1 of 3 groups depending on risk status.

GROUP I:

COMBINATION CHEMOTHERAPY: Patients receive rituximab IV over 6 hours on day 1, dexamethasone PO or IV on days 1-4, cyclophosphamide IV over 3 hours twice daily (BID) on days 2-4, and doxorubicin hydrochloride IV over 24 hours and vincristine IV over 15-30 minutes on day 5 of odd-numbered courses (1, 3, 5, and 7). Patients also receive rituximab IV over 6 hours on day 1, methotrexate IV over 24 hours on day 2, and cytarabine IV over 2 hours BID on days 3-4 of even-numbered courses (2, 4, 6, and 8). Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Patients receive ibrutinib and venetoclax PO QD on days 1-28, and rituximab IV over 4-8 hours on day 1 of every other month. Courses repeat every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.

GROUP II: Patients receive combination chemotherapy as in group I. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patience also receive maintenance therapy as in group I.

GROUP III: Patients receive maintenance therapy as in group I.

After completion of study treatment, patients are followed up at 30 days, every 4 months for 2 years, every 6 months for 2 years, and then annually for up to 5 years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • CD20 Positive
  • Mantle Cell Lymphoma
Intervention  ICMJE
  • Drug: Cyclophosphamide
    Given IV
    Other Names:
    • (-)-Cyclophosphamide
    • 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
    • Carloxan
    • Ciclofosfamida
    • Ciclofosfamide
    • Cicloxal
    • Clafen
    • Claphene
    • CP monohydrate
    • CTX
    • CYCLO-cell
    • Cycloblastin
    • Cycloblastine
    • Cyclophospham
    • Cyclophosphamid monohydrate
    • Cyclophosphamidum
    • Cyclophosphan
    • Cyclophosphane
    • Cyclophosphanum
    • Cyclostin
    • Cyclostine
    • Cytophosphan
    • Cytophosphane
    • Cytoxan
    • Fosfaseron
    • Genoxal
    • Genuxal
    • Ledoxina
    • Mitoxan
    • Neosar
    • Revimmune
    • Syklofosfamid
    • WR- 138719
  • Drug: Cytarabine
    Given IV
    Other Names:
    • .beta.-Cytosine arabinoside
    • 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone
    • 1-.beta.-D-Arabinofuranosylcytosine
    • 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone
    • 1-Beta-D-arabinofuranosylcytosine
    • 1.beta.-D-Arabinofuranosylcytosine
    • 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-
    • 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-
    • Alexan
    • Ara-C
    • ARA-cell
    • Arabine
    • Arabinofuranosylcytosine
    • Arabinosylcytosine
    • Aracytidine
    • Aracytin
    • Aracytine
    • Beta-cytosine Arabinoside
    • CHX-3311
    • Cytarabinum
    • Cytarbel
    • Cytosar
    • Cytosine Arabinoside
    • Cytosine-.beta.-arabinoside
    • Cytosine-beta-arabinoside
    • Erpalfa
    • Starasid
    • Tarabine PFS
    • U 19920
    • U-19920
    • Udicil
    • WR-28453
  • Drug: Dexamethasone
    Given PO or IV
    Other Names:
    • Aacidexam
    • Adexone
    • Aknichthol Dexa
    • Alba-Dex
    • Alin
    • Alin Depot
    • Alin Oftalmico
    • Amplidermis
    • Anemul mono
    • Auricularum
    • Auxiloson
    • Baycuten
    • Baycuten N
    • Cortidexason
    • Cortisumman
    • Decacort
    • Decadrol
    • Decadron
    • Decalix
    • Decameth
    • Decasone R.p.
    • Dectancyl
    • Dekacort
    • Deltafluorene
    • Deronil
    • Desamethasone
    • Desameton
    • Dexa-Mamallet
    • Dexa-Rhinosan
    • Dexa-Scheroson
    • Dexa-sine
    • Dexacortal
    • Dexacortin
    • Dexafarma
    • Dexafluorene
    • Dexalocal
    • Dexamecortin
    • Dexameth
    • Dexamethasonum
    • Dexamonozon
    • Dexapos
    • Dexinoral
    • Dexone
    • Dinormon
    • Fluorodelta
    • Fortecortin
    • Gammacorten
    • Hexadecadrol
    • Hexadrol
    • Lokalison-F
    • Loverine
    • Methylfluorprednisolone
    • Millicorten
    • Mymethasone
    • Orgadrone
    • Spersadex
    • Visumetazone
  • Drug: Doxorubicin Hydrochloride
    Given IV
    Other Names:
    • 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)
    • ADM
    • Adriacin
    • Adriamycin
    • Adriamycin Hydrochloride
    • Adriamycin PFS
    • Adriamycin RDF
    • ADRIAMYCIN, HYDROCHLORIDE
    • Adriamycine
    • Adriblastina
    • Adriblastine
    • Adrimedac
    • Chloridrato de Doxorrubicina
    • DOX
    • DOXO-CELL
    • Doxolem
    • Doxorubicin.HCl
    • Doxorubin
    • Farmiblastina
    • FI 106
    • FI-106
    • hydroxydaunorubicin
    • Rubex
  • Drug: Ibrutinib
    Given PO
    Other Names:
    • BTK Inhibitor PCI-32765
    • CRA-032765
    • Imbruvica
    • PCI-32765
  • Drug: Methotrexate
    Given IV
    Other Names:
    • Abitrexate
    • Alpha-Methopterin
    • Amethopterin
    • Brimexate
    • CL 14377
    • CL-14377
    • Emtexate
    • Emthexat
    • Emthexate
    • Farmitrexat
    • Fauldexato
    • Folex
    • Folex PFS
    • Lantarel
    • Ledertrexate
    • Lumexon
    • Maxtrex
    • Medsatrexate
    • Metex
    • Methoblastin
    • Methotrexate LPF
    • Methotrexate Methylaminopterin
    • Methotrexatum
    • Metotrexato
    • Metrotex
    • Mexate
    • Mexate-AQ
    • MTX
    • Novatrex
    • Rheumatrex
    • Texate
    • Tremetex
    • Trexeron
    • Trixilem
    • WR-19039
  • Biological: Rituximab
    Given IV
    Other Names:
    • ABP 798
    • BI 695500
    • C2B8 Monoclonal Antibody
    • Chimeric Anti-CD20 Antibody
    • CT-P10
    • IDEC-102
    • IDEC-C2B8
    • IDEC-C2B8 Monoclonal Antibody
    • MabThera
    • Monoclonal Antibody IDEC-C2B8
    • PF-05280586
    • Rituxan
    • Rituximab Biosimilar ABP 798
    • Rituximab Biosimilar BI 695500
    • Rituximab Biosimilar CT-P10
    • Rituximab Biosimilar GB241
    • Rituximab Biosimilar IBI301
    • Rituximab Biosimilar PF-05280586
    • Rituximab Biosimilar RTXM83
    • Rituximab Biosimilar SAIT101
    • RTXM83
  • Drug: Venetoclax
    Given PO
    Other Names:
    • ABT-0199
    • ABT-199
    • ABT199
    • GDC-0199
    • RG7601
    • Venclexta
  • Drug: Vincristine
    Given IV
    Other Names:
    • LEUROCRISTINE
    • VCR
    • Vincrystine
Study Arms  ICMJE
  • Experimental: Group I (ibrutinib, rituximab, venetoclax, chemotherapy)

    Patients receive ibrutinib, rituximab, and venetoclax as described in part I.

    COMBINATION CHEMOTHERAPY: Patients receive rituximab IV over 6 hours on day 1, dexamethasone PO or IV on days 1-4, cyclophosphamide IV over 3 hours twice daily (BID) on days 2-4, and doxorubicin hydrochloride IV over 24 hours and vincristine IV over 15-30 minutes on day 5 of odd-numbered courses (1, 3, 5, and 7). Patients also receive rituximab IV over 6 hours on day 1, methotrexate IV over 24 hours on day 2, and cytarabine IV over 2 hours BID on days 3-4 of even-numbered courses (2, 4, 6, and 8). Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.

    MAINTENANCE THERAPY: Patients receive ibrutinib and venetoclax PO QD on days 1-28, and rituximab IV over 4-8 hours on day 1 of every other month. Courses repeat every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.

    Interventions:
    • Drug: Cyclophosphamide
    • Drug: Cytarabine
    • Drug: Dexamethasone
    • Drug: Doxorubicin Hydrochloride
    • Drug: Ibrutinib
    • Drug: Methotrexate
    • Biological: Rituximab
    • Drug: Venetoclax
    • Drug: Vincristine
  • Experimental: Group II (ibrutinib, rituximab, venetoclax, chemotherapy)

    Patients receive ibrutinib, rituximab, and venetoclax as in part I.

    Patients receive combination chemotherapy as in group I. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patience also receive maintenance therapy as in group I.

    Interventions:
    • Drug: Cyclophosphamide
    • Drug: Cytarabine
    • Drug: Dexamethasone
    • Drug: Doxorubicin Hydrochloride
    • Drug: Ibrutinib
    • Drug: Methotrexate
    • Biological: Rituximab
    • Drug: Venetoclax
    • Drug: Vincristine
  • Experimental: Group III (ibrutinib, rituximab, venetoclax)
    Patients receive ibrutinib, rituximab, venetoclax as in part I. Patients then receive maintenance therapy as in group I.
    Interventions:
    • Drug: Ibrutinib
    • Biological: Rituximab
    • Drug: Venetoclax
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 17, 2018)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 18, 2023
Estimated Primary Completion Date April 22, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Confirmed diagnosis of mantle cell lymphoma with CD20 positivity in tissue biopsy
  • MCL must be symptomatic and need immediate therapy. Symptoms and nature of MCL include any of the following: a) B-symptoms, b) Mantle Cell Lymphoma International Prognostic Index (MIPI) larger than 3, c) Ki 67 larger than or equal to 30%, d) bulky tumors larger than 10cm or in case of larger than or equal to 2 tumors, each larger than or equal to 5cm in diameter, e) disease threatening organ function, f) elevated lactate dehydrogenase (LDH), g) peripheral blood (PB) white blood cell (WBC) larger than 50,000, h) pancytopenia due to bone marrow MCL, i) patient's choice due to anxiety; j) pain due to lymphoma; k) somatic mutations in the TP53, c-MYC or NOTCH genes; l) size of spleen larger than or equal to 20 cm
  • Newly diagnosed MCL with no prior therapy
  • Sign (or their legally-acceptable representatives must sign) an informed consent document indicating that they understand the purpose of and procedures required for the study, including biomarkers, and are willing to participate in the study
  • Bi-dimensional measurable disease using both computed tomography (CT) scan and/or positron emission tomography (PET)-CT gastrointestinal, bone marrow or spleen only patients are allowable
  • Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
  • Absolute neutrophil count (ANC) larger than or equal to 1000/mm^3 independent of growth factor support
  • Platelets larger than or equal to 100,000/mm^3 or larger than or equal to 50,000/mm^3 if bone marrow involvement without necessitating transfusion
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 3 x upper limit of normal (ULN)
  • Total bilirubin less than or equal to 1.5 x ULN unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin
  • Creatinine clearance (CLcr) larger than 50 mL/min
  • Cardiac ejection fraction larger than or equal to 50% by echocardiogram (ECHO) or multigated acquisition (MUGA)
  • Disease free of prior malignancies with exception of currently treated basal cell, squamous cell carcinoma of the skin, carcinoma "in situ" of the cervix or breast, or other malignancies in remission (including prostate cancer patients in remission from radiation therapy, surgery or brachytherapy), not actively being treated with life expectancy of larger than 3 years. Principal investigator (PI) can use clinical judgement in the best interest of patients
  • Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test (within 30 days of initiation of protocol therapy) and must be willing to use acceptable methods of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials. Men must agree to use a latex condom during sexual contact with a female of childbearing potential even if they have had a successful vasectomy. Men must agree to not donate sperm during and after the study. For females, these restrictions apply for 1 month after the last dose of study drug. For males, these restrictions apply for 3 months after the last dose of study drug

Exclusion Criteria:

  • Any serious medical condition including but not limited to, uncontrolled hypertension, uncontrolled diabetes mellitus, active/symptomatic coronary artery disease, chronic obstructive pulmonary disease (COPD), renal failure, active hemorrhage, laboratory abnormality, or psychiatric illness that, in the investigators opinion, places the patient at unacceptable risk or would prevent the subject from signing the informed consent form.
  • Pregnant or breast-feeding females
  • Known human immunodeficiency virus (HIV) infection (HIV testing is not required)
  • Evidence of other clinically significant uncontrolled condition(s) including, but not limited to: a. Uncontrolled and/or active systemic infection (viral, bacterial or fungal) b. Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface (HBs) antigen negative-, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) may participate
  • Treatment with any of the following within 7 days prior to the first dose of study drug:

    • Steroid therapy for anti-neoplastic intent
    • Moderate or strong cytochrome P450 3A (CYP3A) inhibitors
    • Moderate or strong CYP3A inducers
  • Administration or consumption of any of the following within 3 days prior to the first dose of study drug:

    • Grapefruit or grapefruit products
    • Seville oranges (including marmalade containing Seville oranges)
    • Star fruit
  • Patients with active hepatitis B infection (not including patients with prior hepatitis B vaccination; or positive serum hepatitis B antibody). Known hepatitis C infection is allowed as long as there is no active disease and is cleared by gastrointestinal (GI) consultation
  • Central nervous system with mantle cell lymphoma
  • Significant neuropathy (grades 3 to 4, or grade 2 with pain) within 14 days prior to enrollment
  • Contraindication to any of the required concomitant drugs or supportive treatments or intolerance to hydration due to preexisting pulmonary or cardiac impairment including pleural effusion requiring thoracentesis or ascites requiring paracentesis unless due to lymphoma
  • Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction, or any other gastrointestinal condition that could interfere with the absorption and metabolism of ibrutinib
  • Major surgery within 4 weeks of initiation of therapy or a wound that has not fully healed within 4 weeks of randomization. Clearance letter from primary physician required
  • Requires anticoagulation with warfarin or equivalent vitamin K antagonist
  • Requires chronic treatment with strong CYP3A inhibitors
  • Patients with New York Health Association (NYHA) Class III and IV heart failure, myocardial infarction in the preceding 6 months, and significant conduction abnormalities, including but not limited to left bundle branch block, 2nd degree atrioventricular (AV) block type II, 3rd degree block, QT prolongation (corrected QT [QTc] larger than 500 msec), sick sinus syndrome, ventricular tachycardia, symptomatic bradycardia (heart rate less than 50 bpm), hypotension, light headedness and syncope, persistent and uncontrolled atrial fibrillation
  • Recent placement of a stent and by recommendation of their cardiologist need to stay on anticoagulants such as warfarin or equivalent vitamin K antagonist
  • Acute infection requiring treatment (IV antibiotics, antivirals, or antifungals) within 14 days prior to initiation of therapy
  • Child-Pugh class B or C are excluded
  • Vaccinated with live, attenuated vaccines within 4 weeks of randomization
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Luhua(Michael) Wang 713-792-2860 miwang@mdanderson.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03710772
Other Study ID Numbers  ICMJE 2018-0447
NCI-2018-02137 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2018-0447 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Luhua (Michael) Wang M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP