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High Dose Cyclophosphamide, Tacrolimus, and Mycophenolate Mofetil in Preventing Graft Versus Host Disease in Patients With Hematological Malignancies Undergoing Myeloablative or Reduced Intensity Donor Stem Cell Transplant

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ClinicalTrials.gov Identifier: NCT03128359
Recruitment Status : Recruiting
First Posted : April 25, 2017
Last Update Posted : June 4, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

Tracking Information
First Submitted Date  ICMJE March 24, 2017
First Posted Date  ICMJE April 25, 2017
Last Update Posted Date June 4, 2019
Actual Study Start Date  ICMJE May 30, 2017
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2017)
GRFS [ Time Frame: From stem cell infusion to grade 3-4 acute graft versus host disease (GVHD), moderate-severe chronic GVHD, relapse, progression or death (from any cause), whichever occurs first, assessed for up to 2 years ]
Estimates will be calculated using the Kaplan-Meier method, Greenwood formula will be used to calculate standard error (SE), and log-log transformation method will be used to construct 95% confidence intervals. Graft versus host disease (GVHD, acute and chronic), disease status and vital status will be monitored per clinical standard operating procedure. For this endpoint failure is defined as the first occurrence of grade 3 or 4 acute GVHD, or moderate/severe chronic GVHD, or disease relapse (for patients in complete remission at the start of conditioning) or disease progression (for patients with active disease at the start of conditioning) or death (from any cause). Patients not experiencing any of these will be censored at his/her date of last contact.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03128359 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2017)
  • Acute graft versus host disease (aGVHD) of grades 2-4 and 3-4 graded according to the Consensus Grading [ Time Frame: Up to 100 days post-stem cell infusion ]
    The first day of aGVHD onset at a certain grade will be used to calculate cumulative incidence curves for that GVHD grade. Relapse/death prior to onset will be considered competing events.
  • Change in quality of life as assessed by SF-36, Functional Assessment of Cancer Therapy Bone Marrow Transplant questionnaire [ Time Frame: Baseline up to 2 years ]
  • Change in quality of life as assessed by the MD Anderson Symptom Inventory questionnaire [ Time Frame: Baseline up to 2 years ]
  • Change in quality of life as assessed by the PedsQL Stem Cell Transplant module [ Time Frame: Baseline up to 2 years ]
  • Chronic graft versus host disease (cGVHD) graded according to the National Institutes of Health Consensus Staging [ Time Frame: Day 100 post-stem cell infusion up to 2 years ]
    The first day of cGVHD onset at a certain grade will be used to calculate cumulative incidence curves. Relapse/death prior to onset will be considered competing events.
  • Cumulative incidence of relapse/progression [ Time Frame: From start of protocol therapy, assessed for up to 2 years ]
    Will be calculated as competing risks using the Gray method.
  • Incidence of adverse events graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 Toxicity Scale [ Time Frame: Up to 100 days post-stem cell infusion ]
    Will include the type, severity, and the probable association with the study regimen. Tables will be constructed to summarize the observed incidence by severity and type of toxicity.
  • Incidence of adverse events graded using the Berman Toxicity Scale [ Time Frame: Up to 100 days post-stem cell infusion ]
    Will include the type and severity. Tables will be constructed to summarize the observed incidence by type of toxicity.
  • Microbiologically documented infections [ Time Frame: Up to 100 days post-stem cell infusion ]
    Will be reported by site of disease, date of onset, severity and resolution.
  • Non-relapse Mortality (NRM) [ Time Frame: From start of protocol therapy until non-disease related death, or last follow-up, whichever comes first, assessed for up to 2 years ]
    Will be calculated as competing risks using the Gray method.
  • Overall Survival (OS) [ Time Frame: From start of protocol therapy to death, or last follow up, whichever occurs first, assessed for up to 2 years ]
    Estimates will be calculated using the Kaplan-Meier method, Greenwood formula will be used to calculate SE, and log-log transformation method will be used to construct 95% confidence intervals. Each patient's vital status will be monitored per clinical standard operating procedure. For this endpoint failure is defined as death (from any cause). Patients not experiencing a death event will be censored at his/her date of last contact.
  • Progression Free Survival (PFS) [ Time Frame: From start of protocol therapy to death, relapse/progression, or last follow up, whichever occurs first, assessed for up to 2 years ]
    Estimates will be calculated using the Kaplan-Meier method, Greenwood formula will be used to calculate SE, and log-log transformation method will be used to construct 95% confidence intervals. Disease status and vital status will be monitored per clinical standard operating procedure. For this endpoint failure is defined as disease relapse (for patients in complete remission at the start of conditioning) or disease progression (for patients with active disease at the start of conditioning) or death (from any cause). Patients not experiencing any of these will be censored at his/her date of last contact.
  • Time to hematological recovery in terms of neutrophil (absolute neutrophil count >= 500/ul, 1.0 x 10^3/ul) and platelet (20 x 10^3/ul and 100 x 10^3/ul) engraftment time [ Time Frame: Up to 2 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2017)
  • Acute graft versus host disease (aGVHD) of grades 2-4 and 3-4 graded according to the Consensus Grading [ Time Frame: Up to 100 days post-stem cell infusion ]
    The first day of aGVHD onset at a certain grade will be used to calculate cumulative incidence curves for that GVHD grade. Relapse/death prior to onset will be considered competing events.
  • Change in quality of life as assessed by SF-36, Functional Assessment of Cancer Therapy Bone Marrow Transplant questionnaire [ Time Frame: Baseline up to 2 years ]
  • Change in quality of life as assessed by the MD Anderson Symptom Inventory questionnaire [ Time Frame: Baseline up to 2 years ]
  • Chronic graft versus host disease (cGVHD) graded according to the National Institutes of Health Consensus Staging [ Time Frame: Day 100 post-stem cell infusion up to 2 years ]
    The first day of cGVHD onset at a certain grade will be used to calculate cumulative incidence curves. Relapse/death prior to onset will be considered competing events.
  • Cumulative incidence of relapse/progression [ Time Frame: From start of protocol therapy, assessed for up to 2 years ]
    Will be calculated as competing risks using the Gray method.
  • Incidence of adverse events graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 Toxicity Scale [ Time Frame: Up to 100 days post-stem cell infusion ]
    Will include the type, severity, and the probable association with the study regimen. Tables will be constructed to summarize the observed incidence by severity and type of toxicity.
  • Incidence of adverse events graded using the Berman Toxicity Scale [ Time Frame: Up to 100 days post-stem cell infusion ]
    Will include the type and severity. Tables will be constructed to summarize the observed incidence by type of toxicity.
  • Microbiologically documented infections [ Time Frame: Up to 100 days post-stem cell infusion ]
  • Non-relapse Mortality (NRM) [ Time Frame: From start of protocol therapy until non-disease related death, or last follow-up, whichever comes first, assessed for up to 2 years ]
    Will be calculated as competing risks using the Gray method.
  • Overall Survival (OS) [ Time Frame: From start of protocol therapy to death, or last follow up, whichever occurs first, assessed for up to 2 years ]
    Estimates will be calculated using the Kaplan-Meier method, Greenwood formula will be used to calculate SE, and log-log transformation method will be used to construct 95% confidence intervals. Each patient's vital status will be monitored per clinical standard operating procedure. For this endpoint failure is defined as death (from any cause). Patients not experiencing a death event will be censored at his/her date of last contact.
  • Progression Free Survival (PFS) [ Time Frame: From start of protocol therapy to death, relapse/progression, or last follow up, whichever occurs first, assessed for up to 2 years ]
    Estimates will be calculated using the Kaplan-Meier method, Greenwood formula will be used to calculate SE, and log-log transformation method will be used to construct 95% confidence intervals. Disease status and vital status will be monitored per clinical standard operating procedure. For this endpoint failure is defined as disease relapse (for patients in complete remission at the start of conditioning) or disease progression (for patients with active disease at the start of conditioning) or death (from any cause). Patients not experiencing any of these will be censored at his/her date of last contact.
  • Time to hematological recovery in terms of neutrophil (absolute neutrophil count >= 500/ul, 1.0 x 10^3/ul) and platelet (20 x 10^3/ul and 100 x 10^3/ul) engraftment time [ Time Frame: Up to 2 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE High Dose Cyclophosphamide, Tacrolimus, and Mycophenolate Mofetil in Preventing Graft Versus Host Disease in Patients With Hematological Malignancies Undergoing Myeloablative or Reduced Intensity Donor Stem Cell Transplant
Official Title  ICMJE A Pilot Study of Post-transplant High Dose Cyclophosphamide (PTCY) as Part of Graft-Versus-Host Disease (GVHD) Prophylaxis in T-Cell Replete HLA-Mismatched Unrelated Donor (MMUD) Ablative and Reduced Intensity Hematopoietic Cell Transplantation (HCT) for Hematological Malignancies
Brief Summary This pilot phase II trial studies how well high dose cyclophosphamide, tacrolimus, and mycophenolate mofetil work in preventing graft versus host disease in patients with hematological malignancies undergoing myeloablative or reduced intensity donor stem cell transplant. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft versus host disease). Giving high dose cyclophosphamide, tacrolimus, and mycophenolate mofetil after the transplant may stop this from happening.
Detailed Description

PRIMARY OBJECTIVES:

I. To estimate the graft versus host disease (GVHD)-free relapse/progression-free survival (GRFS) at one-year post hematopoietic cell transplantation (HCT) and to evaluate the clinical activity of post-transplant high dose cyclophosphamide (PTCy).

SECONDARY OBJECTIVES:

I. To summarize toxicities/complications/infections including type, frequency, severity, attribution, time course and duration through 100 days post-transplant.

II. To estimate the cumulative incidence (CI) of acute and chronic GVHD. III. To characterize the time course of neutrophil and platelet recovery/engraftment.

IV. To estimate overall survival (OS), progression-free survival (PFS), CI of relapse/progression and non-relapse mortality (NRM) at 100 days, 1 year and 2 years.

V. To describe quality of life at 100 days, 6 months, 1 and 2 years. VI. To characterize immune cell reconstitution and T cell repertoire post high dose cyclophosphamide in mismatched donor HCT.

VII. To characterize quality of life.

OUTLINE:

CONDITIONING REGIMEN: Patients are assigned to 1 of 3 conditioning regimens at the discretion of the attending physician and principal investigator.

REGIMEN A (REDUCED INTENSITY CONDITIONING): Patients receive fludarabine phosphate intravenously (IV) over 60 minutes on days -7 to -3 and melphalan hydrochloride IV over 20 minutes on day -2.

REGIMEN B (MYELOABLATIVE CONDITIONING [MAC]): Patients receive fludarabine phosphate IV over 1-3 hours and busulfan IV over 3 hour on days -5 to -2.

REGIMEN C (MAC): Patients receive fludarabine phosphate IV over 60 minutes on days -7 to -5 and total body irradiation (TBI) twice daily (BID) on days -4 to -1.

TRANSPLANT: Patients undergo peripheral blood stem cell (PBSC) hematopoietic cell transplantation (HCT) on day 0.

GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4, mycophenolate mofetil IV or orally (PO) thrice daily (TID) beginning on day 5 and stopping on day 35 if no severe GVHD is present, and tacrolimus IV continuously on days 5-180 with a taper beginning on day 90 in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up twice weekly for 100 days, twice monthly for 6 months, monthly until no evidence of GVHD, and then yearly for up to 2 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: Supportive Care
Condition  ICMJE
  • Acute Leukemia
  • Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
  • Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Diffuse Large B-Cell Lymphoma
  • Follicular Lymphoma
  • Graft Versus Host Disease
  • Hodgkin Lymphoma
  • Mantle Cell Lymphoma
  • Marginal Zone Lymphoma
  • Myelodysplastic Syndrome
  • Myeloproliferative Neoplasm
  • Recurrent Acute Myeloid Leukemia With Myelodysplasia-Related Changes
  • Recurrent Plasma Cell Myeloma
  • Refractory Plasma Cell Myeloma
  • Secondary Myelodysplastic Syndrome
Intervention  ICMJE
  • Drug: Busulfan
    Given IV
    Other Names:
    • 1, 4-Bis[methanesulfonoxy]butane
    • BUS
    • Bussulfam
    • Busulfanum
    • Busulfex
    • Busulphan
    • CB 2041
    • CB-2041
    • Glyzophrol
    • GT 41
    • GT-41
    • Joacamine
    • Methanesulfonic Acid Tetramethylene Ester
    • Methanesulfonic acid, tetramethylene ester
    • Mielucin
    • Misulban
    • Misulfan
    • Mitosan
    • Myeleukon
    • Myeloleukon
    • Myelosan
    • Mylecytan
    • Myleran
    • Sulfabutin
    • Tetramethylene Bis(methanesulfonate)
    • Tetramethylene bis[methanesulfonate]
    • WR-19508
  • 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: Fludarabine Phosphate
    Given IV
    Other Names:
    • 2-F-ara-AMP
    • 9H-Purin-6-amine, 2-fluoro-9-(5-O-phosphono-.beta.-D-arabinofuranosyl)-
    • Beneflur
    • Fludara
    • SH T 586
  • Procedure: Hematopoietic Cell Transplantation
    Undergo PBSC HCT
    Other Names:
    • HCT
    • Hematopoietic Stem Cell Transplantation
    • HSCT
    • stem cell transplantation
  • Other: Laboratory Biomarker Analysis
    Correlative studies
  • Drug: Melphalan Hydrochloride
    Given IV
    Other Names:
    • Alkeran
    • Alkerana
    • Evomela
  • Drug: Mycophenolate Mofetil
    Given IV or PO
    Other Names:
    • Cellcept
    • MMF
  • Procedure: Peripheral Blood Stem Cell Transplantation
    Undergo PBSC HCT
    Other Names:
    • PBPC transplantation
    • Peripheral Blood Progenitor Cell Transplantation
    • Peripheral Stem Cell Support
    • Peripheral Stem Cell Transplant
    • Peripheral Stem Cell Transplantation
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Name: Quality of Life Assessment
  • Drug: Tacrolimus
    Given IV
    Other Names:
    • FK 506
    • Fujimycin
    • Hecoria
    • Prograf
    • Protopic
  • Radiation: Total-Body Irradiation
    Undergo TBI
    Other Names:
    • TOTAL BODY IRRADIATION
    • Whole-Body Irradiation
Study Arms  ICMJE
  • Experimental: Regimen A (fludarabine, melphalan, PBSC HCT, GVHD prophylaxis)

    Patients receive fludarabine phosphate IV over 60 minutes on days -7 to -3 and melphalan hydrochloride IV over 20 minutes on day -2.

    Patients undergo PBSC HCT on day 0.

    Patients receive cyclophosphamide IV over 1-2 hours on days 3-4, mycophenolate mofetil IV or PO TID beginning on days 5 and stopping on day 35 if no severe GVHD is present-35, and tacrolimus IV continuously on days 5-180 with a taper beginning on day 90 in the absence of disease progression or unacceptable toxicity.

    Interventions:
    • Drug: Cyclophosphamide
    • Drug: Fludarabine Phosphate
    • Procedure: Hematopoietic Cell Transplantation
    • Other: Laboratory Biomarker Analysis
    • Drug: Melphalan Hydrochloride
    • Drug: Mycophenolate Mofetil
    • Procedure: Peripheral Blood Stem Cell Transplantation
    • Other: Quality-of-Life Assessment
    • Drug: Tacrolimus
  • Experimental: Regimen B (fludarabine, busulfan, PBSC HCT, GVHD prophylaxis)

    Patients receive fludarabine phosphate IV over 1-3 hours and busulfan IV over 3 hour on days -5 to -2.

    Patients undergo PBSC HCT on day 0.

    Patients receive cyclophosphamide IV over 1-2 hours on days 3-4, mycophenolate mofetil IV or PO TID beginning on days 5 and stopping on day 35 if no severe GVHD is present-35, and tacrolimus IV continuously on days 5-180 with a taper beginning on day 90 in the absence of disease progression or unacceptable toxicity.

    Interventions:
    • Drug: Busulfan
    • Drug: Cyclophosphamide
    • Drug: Fludarabine Phosphate
    • Procedure: Hematopoietic Cell Transplantation
    • Other: Laboratory Biomarker Analysis
    • Drug: Mycophenolate Mofetil
    • Procedure: Peripheral Blood Stem Cell Transplantation
    • Other: Quality-of-Life Assessment
    • Drug: Tacrolimus
  • Experimental: Regimen C (fludarabine, TBI, PBSC HCT, GVHD prophylaxis)

    Patients receive fludarabine phosphate IV over 60 minutes on days -7 to -5 and TBI BID on days -4 to -1.

    Patients undergo PBSC HCT on day 0.

    Patients receive cyclophosphamide IV over 1-2 hours on days 3-4, mycophenolate mofetil IV or PO TID beginning on days 5 and stopping on day 35 if no severe GVHD is present-35, and tacrolimus IV continuously on days 5-180 with a taper beginning on day 90 in the absence of disease progression or unacceptable toxicity.

    Interventions:
    • Drug: Cyclophosphamide
    • Drug: Fludarabine Phosphate
    • Procedure: Hematopoietic Cell Transplantation
    • Other: Laboratory Biomarker Analysis
    • Drug: Mycophenolate Mofetil
    • Procedure: Peripheral Blood Stem Cell Transplantation
    • Other: Quality-of-Life Assessment
    • Drug: Tacrolimus
    • Radiation: Total-Body Irradiation
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: April 20, 2017)
38
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with acute leukemia or chronic myelogenous leukemia with no circulating blasts and with less than 10% blasts in the bone marrow
  • Patients with myelodysplastic syndrome (MDS) with intermediate-2 or high risk per International Prognostic Scoring System (IPSS) (or intermediate, high, very high risk by Revised International Prognostic Scoring System [IPSS-R]) or myeloproliferative neoplasm; primary or secondary if high-risk features or refractory disease
  • Patients with chronic lymphocytic leukemia/small lymphocytic lymphoma, follicular, marginal zone, diffuse large B-cell, Hodgkin lymphoma, or mantle cell lymphoma with chemosensitive disease at time of transplantation; all types of lymphoma are eligible
  • High risk, or refractory and relapsed multiple myeloma
  • No available human leukocyte antigen (HLA)-matched related donor
  • Available matched unrelated donor
  • Ejection fraction at rest >= 50%
  • Karnofsky performance status (KPS) >= 70
  • Measured creatinine clearance more than 60 mL/min. The updated Schwartz formula should be used for pediatric patients (>=5 to 12 years old)
  • Carbon monoxide diffusing capability test (DLCO) >= 50% (adjusted for hemoglobin) and forced expiratory volume in 1 second (FEV1) >= 50%
  • Total bilirubin < 1.5 x the upper limit of normal; patients who have been diagnosed with Gilbert's disease are allowed to exceed the defined bilirubin value of 1.5 x the upper limit of normal
  • Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) < 2.5 x the upper limit of normal
  • Alkaline phosphatase < 2.5 x the upper limit of normal
  • Female subjects (unless postmenopausal for at least 1 year before the screening visit, or surgically sterilized), agree to practice two (2) effective methods of contraception at the same time, or agree to completely abstain from heterosexual intercourse, from the time of signing of the informed consent through 12 months post-transplant
  • Male subjects (even if surgically sterilized), of partners of women of childbearing potential must agree to one of the following: practice effective barrier contraception, or abstain from heterosexual intercourse from the time of signing the informed consent through 12 months post-transplant
  • All subjects must have the ability to understand and the willingness to sign a written informed consent document

DONOR INCLUSION CRITERIA

  • 7 out of 8 at high resolution using deoxyribonucleic acid (DNA)-based typing with either antigen or allele mismatched HLA (-A, -B, -C, and -DR) or 8/8 HLA-mismatched with either double DQ mismatch (10/12) or combined DQ and DP mismatch
  • Donor must be willing to donate peripheral blood stem cells
  • Suitable donor
  • Medically cleared to donate per National Marrow Donor Program (NMDP)
  • Absence of donor-specific antibodies (DSA) to the mismatched HLA-locus
  • Donor choices per matched unrelated donor (MUD) committee according to center standard operating procedure (SOP)

Exclusion Criteria:

  • Prior allogeneic transplant
  • Active central nervous system (CNS) involvement by malignant cells
  • Patients with uncontrolled bacterial, viral or fungal infections (currently taking medication and with progression or no clinical improvement) at time of enrollment
  • Patients with transformed lymphoma (e.g., Richter's transformation arising in follicular lymphoma or chronic lymphocytic leukemia)
  • Patients seropositive for the human immunodeficiency virus (HIV)
  • Patients with active hepatitis B or C determined by polymerase chain reaction (PCR)
  • Myocardial infarction within 6 months prior to enrollment or New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities; prior to study entry, any electrocardiography (ECG) abnormality at screening must be documented by the investigator as not medically relevant
  • Female patients who are lactating or pregnant
  • Patients with a serious medical or psychiatric illness likely to interfere with participation in this clinical study
  • History of another primary malignancy that has not been in remission for at least 3 years (the following are exempt from the 3-year limit: non-melanoma skin cancer, fully excised melanoma in situ [Stage 0], curatively treated localized prostate cancer, and cervical or breast carcinoma in situ on biopsy or a squamous intraepithelial lesion on PAP smear)
  • Psychosocial issues: no appropriate caregivers identified, or non-compliant to medications
  • Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03128359
Other Study ID Numbers  ICMJE 16419
NCI-2017-00480 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
16419 ( Other Identifier: City of Hope Medical Center )
Has Data Monitoring Committee Yes
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 City of Hope Medical Center
Study Sponsor  ICMJE City of Hope Medical Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Monzr Al Malki, MD City of Hope Medical Center
PRS Account City of Hope Medical Center
Verification Date June 2019

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