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RecruitingNCT04870944Updated Sep 11, 2026

CBL0137 for the Treatment of Relapsed or Refractory Solid Tumors, Including CNS Tumors and Lymphoma

A Phase 1/2 interventional study of Biospecimen Collection and Bone Marrow Aspirate in Diffuse Midline Glioma, H3 K27-Altered, Metastatic Malignant Neoplasm in the Central Nervous System and Recurrent Diffuse Intrinsic Pontine Glioma, sponsored by Children's Oncology Group. Recruiting at 35 sites in 2 countries. Open to participants aged 12 Months to 21 Years. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by Children's Oncology Group · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
63
Allocation
Not applicable
Ages
12 Months to 21 Years
Sex
All
01

Study summary

This phase I/II trial evaluates the best dose, side effects and possible benefit of CBL0137 in treating patients with solid tumors, including central nervous system (CNS) tumors or lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Drugs, such as CBL0137, block signals passed from one molecule to another inside a cell. Blocking these signals can affect many functions of the cell, including cell division and cell death, and may kill cancer cells.

Read the detailed description

PRIMARY OBJECTIVES:

I. To estimate the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of Facilitates Chromatin Transcription (FACT) complex-targeting curaxin CBL0137 (CBL0137) administered via infusion on Day 1 and Day 8 of a 21-day cycle to children with recurrent or refractory solid tumors, including CNS tumors and lymphoma. (Phase 1 Dose Escalation) II. To preliminarily determine the antitumor effects as measured by objective response rate of CBL0137 in children with progressive/recurrent diffuse intrinsic pontine glioma (DIPG) and other H3 K27-altered diffuse midline gliomas (DMG). (Phase 2)

SECONDARY OBJECTIVES:

I. To preliminarily determine the antitumor effects of CBL0137 in children with refractory solid tumors and other CNS tumors, to the extent possible in the context of a Phase 1 study.

II. To define and describe the toxicities of CBL0137 in children with recurrent or refractory solid tumors, including CNS tumors.

III. To characterize the pharmacokinetics of CBL0137 in children with recurrent or refractory solid tumors, including CNS tumors.

EXPLORATORY OBJECTIVES:

I. To measure biologic marker FACT in tumor specimens with potential for correlation with disease response.

II. To evaluate the effect of CBL0137 on immune response by measuring the effects on the interferon response pathway in peripheral blood mononuclear cells.

III. To preliminarily determine the effect of treatment with CBL0137 on overall survival of children with DIPG or other diffuse midline gliomas, H3 K27-altered, in comparison with historical controls.

OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.

Patients receive CBL0137 intravenously (IV) over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity. Patients with pseudoprogression may remain on treatment, as per the treating physician. Patients also undergo echocardiography (ECHO) collection of blood samples throughout the trial. Patients may also undergo bone marrow aspirate and/or biopsy as clinically indicated.

After completion of study treatment, patients are followed up at 3, 6, 9, 12, 18, 24, 36, 48 and 60 months.

02

Conditions studied

  • Diffuse Midline Glioma, H3 K27-Altered
  • Metastatic Malignant Neoplasm in the Central Nervous System
  • Recurrent Diffuse Intrinsic Pontine Glioma
  • Recurrent Diffuse Midline Glioma, H3 K27-Altered
  • Recurrent Lymphoma
  • Recurrent Malignant Solid Neoplasm
  • Recurrent Primary Malignant Central Nervous System Neoplasm
  • Refractory Lymphoma
  • Refractory Malignant Solid Neoplasm
  • Refractory Primary Malignant Central Nervous System Neoplasm
03

Who can participate

Ages eligible
12 Months to 21 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Parts A and B: Patients must be >= 12 months and =\< 21 years of age at the time of study enrollment
  • Patients must have had histologic verification of malignancy at original diagnosis or relapse, except in patients with diffuse intrinsic brain stem tumors, or patients with pineal tumors and elevations of cerebrospinal fluid (CSF) or serum tumor markers, including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG)

    • Part A: Patients with relapsed or refractory solid tumors or lymphoma, including patients with CNS tumors or known CNS metastases (including untreated or progressive) are eligible
    • Part B: Patients with progressive or recurrent DIPG (diagnosed by biopsy or imaging characteristics) and other H3 K27-altered DMG previously treated with radiation therapy
  • Part A: Patients must have either measurable or evaluable disease
  • Part B: Patients must have measurable disease
  • Patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life
  • Patients must have a performance status corresponding to Easter Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients =\< 16 years of age. Patients must have a Karnofsky or Lansky score >= 50%
  • Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment. If after the required timeframe, the numerical eligibility criteria are met, e.g., blood count criteria, the patient is considered to have recovered adequately

    • Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive

      • Solid tumor patients: >= 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea)
    • Anti-cancer agents not known to be myelosuppressive (eg, not associated with reduced platelet or absolute neutrophil count [ANC] counts): >= 7 days after the last dose of agent
    • Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =\< 1
    • Corticosteroids: If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid. Patients with CNS tumors receiving corticosteroids must have been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment
    • Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g., pegfilgrastim) or 7 days for short acting growth factor. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur
    • Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)
    • Stem cell Infusions (with or without total body irradiation [TBI]):

      • Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of graft versus host disease (GVHD)
      • Autologous stem cell infusion including boost infusion: >= 30 days
    • Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g., modified T cells, natural killer [NK] cells, dendritic cells, etc.)
    • Radiation therapy [XRT]/external beam irradiation including protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation
    • Radiopharmaceutical therapy (e.g., radiolabeled antibody, I-131 metaiodobenzylguanidine [131I MIBG]): >= 42 days after systemically administered radiopharmaceutical therapy
    • Patients must not have received prior exposure to CBL0137
  • For patients with solid tumors without known bone marrow involvement:

    • Peripheral absolute neutrophil count (ANC) >= 1000/uL (performed within 7 days prior to enrollment unless otherwise indicated)
    • Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions). These patients will not be evaluable for hematologic toxicity. At least 5 of every cohort of 6 patients must be evaluable for hematologic toxicity for the dose-escalation part of the study. If dose-limiting hematologic toxicity is observed, all subsequent patients enrolled must be evaluable for hematologic toxicity
  • For patients with solid tumors without known bone marrow involvement:

    • Platelet count >= 100,000/uL (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment) (performed within 7 days prior to enrollment unless otherwise indicated)
    • Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions). These patients will not be evaluable for hematologic toxicity. At least 5 of every cohort of 6 patients must be evaluable for hematologic toxicity for the dose-escalation part of the study. If dose-limiting hematologic toxicity is observed, all subsequent patients enrolled must be evaluable for hematologic toxicity
  • Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m\^2 or a creatinine based on age/sex as follows (performed within 7 days prior to enrollment unless otherwise indicated):

    • Age: Maximum serum creatinine (mg/dL)
    • 1 to \< 2 years: 0.6 (male); 0.6 (female)
    • 2 to \< 6 years: 0.8 (male); 0.8 (female)
    • 6 to \< 10 years: 1 (male); 1 (female)
    • 10 to \< 13 years: 1.2 (male); 1.2 (female)
    • 13 to \< 16 years: 1.5 (male); 1.4 (female)
    • >= 16 years: 1.7 (male); 1.4 (female)
  • Patients with solid tumors:

    • Bilirubin (sum of conjugated + unconjugated or total) =\< 1.5 x upper limit of normal (ULN) for age (performed within 7 days prior to enrollment unless otherwise indicated)
  • Patients with solid tumors:

    • Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =\< 135 U/L. For the purpose of this study, the ULN for SGPT is 45 U/L (performed within 7 days prior to enrollment unless otherwise indicated)
  • Shortening fraction of >= 27% by echocardiogram (performed within 7 days prior to enrollment unless otherwise indicated) or
  • Ejection fraction of >= 50% by gated radionuclide study (performed within 7 days prior to enrollment unless otherwise indicated)
  • Corrected QT (QTC) \< 480 msec (performed within 7 days prior to enrollment unless otherwise indicated)
  • Patients with seizure disorder may be enrolled if seizures well controlled without the use of enzyme-inducing anti-convulsant agents. Well controlled is defined by no increase in seizure frequency in the prior 7 days
  • Nervous system disorders (Common Terminology Criteria for Adverse Events [CTCAE] version [v]5) resulting from prior therapy must be =\< grade 2, with the exception of decreased tendon reflex (DTR). Any grade of DTR is eligible
  • Patients have consented to receive a central venous catheter prior to the administration of CBL0137. A central line is required for CBL0137 administration

Exclusion criteria

Exclusion Criteria:

  • Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies, OR because there is yet no available information regarding human fetal or teratogenic toxicities. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use two effective methods of birth control, including a medically accepted barrier or contraceptive method (e.g., male or female condom) for the duration of the study. Abstinence is an acceptable method of birth control
  • Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible. If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
  • Patients who are currently receiving another investigational drug are not eligible
  • Patients who are currently receiving other anti-cancer agents are not eligible (except leukemia patients receiving hydroxyurea, which may be continued until 24 hours prior to start of protocol therapy)
  • Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial
  • Patients who are receiving drugs that are strong inducers or inhibitors of CYP3A4, CYP2B6 (e.g., carbamazepine) and CYP1A2 (e.g., ciprofloxacin, enoxacin, fluvoxamine, smoking) are not eligible. These agents are to be avoided for 7 days prior to the start of CBL0137 and for the duration of the protocol therapy. Sensitive substrates of CYP2D6 (e.g., atomoxetine, desipramine, dextromethorphan, eliglustat, nebivolol, nortriptyline, perphenazine, tolterodine, R-venlafaxine) should also be avoided for the duration protocol therapy
  • Patients who are receiving drugs associated with a known risk of Torsades de Pointes (TdP) are not eligible. Drugs associated with known risk of Torsades de Pointes (TdP) are to be avoided for 7 days prior to the start of CBL0137 and for duration of the protocol therapy
  • Patients with known peripheral vascular disease are excluded
  • Patients with a history of pro-thrombotic disorder are not eligible
  • Patients who have an uncontrolled infection are not eligible
  • Patients who have received a prior solid organ transplantation are not eligible
  • Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
63 participants (estimated)

Study arms

  • Experimental
    Treatment (CBL0137)

    Patients receive CBL0137 IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity. Patients with pseudoprogression may remain on treatment, as per the treating physician. Patients also undergo ECHO collection of blood samples throughout the trial. Patients may also undergo bone marrow aspirate and/or biopsy as clinically indicated.

    Procedure: Biospecimen Collection · Procedure: Bone Marrow Aspirate · Procedure: Bone Marrow Biopsy · Procedure: Echocardiography Test · Drug: FACT Complex-targeting Curaxin CBL0137

Interventions

  • ProcedureBiospecimen Collection

    Undergo collection of blood samples

    Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

  • ProcedureBone Marrow Aspirate

    Undergo bone marrow aspirate

    Also known as: BONE MARROW, LIQUID, Human Bone Marrow Aspirate

  • ProcedureBone Marrow Biopsy

    Undergo bone marrow biopsy

    Also known as: Biopsy of Bone Marrow, Biopsy, Bone Marrow

  • ProcedureEchocardiography Test

    Undergo ECHO

    Also known as: EC, Echocardiography

  • DrugFACT Complex-targeting Curaxin CBL0137

    Given IV

    Also known as: CBL0137

05

What researchers measure

Primary outcomes

  1. Maximum tolerated dose and/or Recommended Phase 2 dose of CBL0137

    Maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of CBL0137 in children with relapsed or refractory solid tumors including central nervous system (CNS) tumors and lymphoma.

    Time frame: Up to 21 days

  2. Frequency of dose limiting toxicities of CBL0137 (Phase I)

    The frequency (%) of patients experiencing a cycle 1 dose limiting toxicity attributable to CBL0137 by study part and dose level.

    Time frame: Up to 21 days

  3. Anti-tumor effect of CBL0137 in children with diffuse intrinsic pontine glioma (DIPG) or other H3 K27-altered diffuse midline gliomas (Phase II)

    Frequency (%) of patients with at least partial response to CBL0137 at the maximum tolerated dose/recommended phase II dose (MTD/RP2D) in children with progressive or recurrent diffuse intrinsic pontine glioma (DIPG).

    Time frame: Up to 4 months

Secondary outcomes

  1. Anti-tumor effect of CBL0137 in children with solid tumors (Phase I)

    Frequency (%) of patients with at least partial response to CBL0137 at the MTD/RP2D in children with refractory solid tumors and other central nervous system (CNS) tumors.

    Time frame: Up to 4 months

  2. Frequency of adverse events attributable to CBL0137

    The frequency (%) of patients experiencing adverse events that are at least possibly attributable to CBL0137 by study part and dose level.

    Time frame: Up to 60 months

  3. Area under the drug concentration curve of CBL0137

    The median (min, max) of the area under the drug concentration curve for CBL0137 by study part and dose level.

    Time frame: Up to 3 days

Other outcomes

  1. FACT in tumor specimens

    A descriptive analysis of biomarkers will assess associations with disease response. The parameters will be summarized with simple summary statistics, including means, medians, ranges, and standard deviations (if numbers and distribution permit). All these analyses will be descriptive and exploratory and hypotheses generating in nature. FACT expression in tumor specimens will be determined by immunohistochemistry.

    Time frame: Up to 60 months

  2. Immune response

    Will measure effects on the interferon response pathway. A descriptive analysis of biomarkers will assess associations with disease response. The parameters will be summarized with simple summary statistics, including means, medians, ranges, and standard deviations (if numbers and distribution permit). All these analyses will be descriptive and exploratory and hypotheses generating in nature. Peripheral blood lymphocytes will be assessed for expression of genes in the interferon response pathway, in order to determine whether treatment with CBL0137 leads to increase gene expression.

    Time frame: Up to 60 months

  3. Overall survival

    Will be compared with historical controls in children with DIPG or other diffuse midline gliomas, H3 K27-altered.

    Time frame: Up to 60 months

  4. Progression-free survival

    An exploratory analysis of progression-free survival using Kaplan-Meier curves and the log-rank test statistic will compare overall time-to-disease progression (or death) versus historical cohort for the DIPG cohort.

    Time frame: Up to 60 months

06

Study locations

33 of 35 sites recruiting
  • Children's Hospital of Alabama
    Birmingham, Alabama 35233, United States
    Recruiting
  • Phoenix Childrens Hospital
    Phoenix, Arizona 85016, United States
    • Site Public Contact · Contact · 602-546-0920
    • Alok K. Kothari · Principal investigator
    Recruiting
  • Children's Hospital Los Angeles
    Los Angeles, California 90027, United States
    • Site Public Contact · Contact · 323-361-4110
    • Fariba Navid · Principal investigator
    Recruiting
  • Children's Hospital of Orange County
    Orange, California 92868, United States
    • Site Public Contact · Contact · oncresearch@choc.org · 714-509-8646
    • Elyssa M. Rubin · Principal investigator
    Recruiting
  • UCSF Medical Center-Mission Bay
    San Francisco, California 94158, United States
    • Site Public Contact · Contact · cancertrials@ucsf.edu · 877-827-3222
    • Kieuhoa T. Vo · Principal investigator
    Recruiting
  • Children's Hospital Colorado
    Aurora, Colorado 80045, United States
    Recruiting
  • Children's National Medical Center
    Washington D.C., District of Columbia 20010, United States
    Recruiting
  • Johns Hopkins All Children's Hospital
    St. Petersburg, Florida 33701, United States
    • Site Public Contact · Contact · Ashley.Repp@jhmi.edu · 727-767-4784
    • Jonathan L. Metts · Principal investigator
    Recruiting
  • Children's Healthcare of Atlanta - Arthur M Blank Hospital
    Atlanta, Georgia 30329, United States
    • Site Public Contact · Contact · Olivia.Floyd@choa.org · 404-785-0232
    • Jason R. Fangusaro · Principal investigator
    Recruiting
  • Lurie Children's Hospital-Chicago
    Chicago, Illinois 60611, United States
    • Site Public Contact · Contact · 773-880-4562
    • Elizabeth A. Sokol · Principal investigator
    Recruiting
  • University of Chicago Comprehensive Cancer Center
    Chicago, Illinois 60637, United States
    Recruiting
  • Riley Hospital for Children
    Indianapolis, Indiana 46202, United States
    • Site Public Contact · Contact · 800-248-1199
    • Brian D. Weiss · Principal investigator
    Recruiting
  • Johns Hopkins University/Sidney Kimmel Cancer Center
    Baltimore, Maryland 21287, United States
    • Site Public Contact · Contact · jhcccro@jhmi.edu · 410-955-8804
    • Christine A. Pratilas · Principal investigator
    Recruiting
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02215, United States
    • Site Public Contact · Contact · 877-442-3324
    • Steven G. DuBois · Principal investigator
    Recruiting
  • C S Mott Children's Hospital
    Ann Arbor, Michigan 48109, United States
    • Site Public Contact · Contact · 800-865-1125
    • Rajen Mody · Principal investigator
    Recruiting
  • University of Minnesota/Masonic Cancer Center
    Minneapolis, Minnesota 55455, United States
    • Site Public Contact · Contact · 612-624-2620
    • Robin L. Williams · Principal investigator
    Recruiting
  • Children's Mercy Hospitals and Clinics
    Kansas City, Missouri 64108, United States
    Recruiting
  • Washington University School of Medicine
    St Louis, Missouri 63110, United States
    • Site Public Contact · Contact · info@siteman.wustl.edu · 800-600-3606
    • Shalini Shenoy · Principal investigator
    Recruiting
  • Roswell Park Cancer Institute
    Buffalo, New York 14263, United States
    Recruiting
  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
    New York, New York 10032, United States
    Recruiting
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10065, United States
    • Site Public Contact · Contact · 212-639-7592
    • Julia L. Glade Bender · Principal investigator
    Recruiting
  • New York Medical College
    Valhalla, New York 10595, United States
    • Site Public Contact · Contact · 914-594-3794
    • Mitchell S. Cairo · Principal investigator
    Recruiting
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
    • Site Public Contact · Contact · 888-275-3853
    • Jessica M. Sun · Principal investigator
    Recruiting
  • Cincinnati Children's Hospital Medical Center
    Cincinnati, Ohio 45229, United States
    • Site Public Contact · Contact · cancer@cchmc.org · 513-636-2799
    • Joseph G. Pressey · Principal investigator
    Recruiting
  • Oregon Health and Science University
    Portland, Oregon 97239, United States
    • Site Public Contact · Contact · trials@ohsu.edu · 503-494-1080
    • Bill H. Chang · Principal investigator
    Recruiting
  • Children's Hospital of Philadelphia
    Philadelphia, Pennsylvania 19104, United States
    Recruiting
  • Children's Hospital of Pittsburgh of UPMC
    Pittsburgh, Pennsylvania 15224, United States
    • Site Public Contact · Contact · jean.tersak@chp.edu · 412-692-8570
    • Andrew Bukowinski · Principal investigator
    Recruiting
  • Saint Jude Children's Research Hospital
    Memphis, Tennessee 38105, United States
    Recruiting
  • UT Southwestern/Simmons Cancer Center-Dallas
    Dallas, Texas 75390, United States
    Recruiting
  • Cook Children's Medical Center
    Fort Worth, Texas 76104, United States
    Recruiting
  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
    Houston, Texas 77030, United States
    • Site Public Contact · Contact · burton@bcm.edu · 713-798-1354
    • Jennifer H. Foster · Principal investigator
    Recruiting
  • Primary Children's Hospital
    Salt Lake City, Utah 84113, United States
    • Site Public Contact · Contact · 801-585-5270
    • Matthew Dietz · Principal investigator
    Recruiting
  • Seattle Children's Hospital
    Seattle, Washington 98105, United States
    Suspended
  • Children's Hospital of Wisconsin
    Milwaukee, Wisconsin 53226, United States
    • Site Public Contact · Contact · MACCCTO@mcw.edu · 414-955-4727
    • Sarah Rumler · Principal investigator
    Recruiting
  • Sydney Children's Hospital
    Randwick, New South Wales 2031, Australia
    Suspended
07

Registry details

Key details

Study ID
NCT04870944
Lead sponsor
Children's Oncology Group
Collaborators
Incuron LLC
Responsible party
Sponsor
First posted
May 4, 2021
Start date
Jan 28, 2022
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Sep 11, 2026

Study contacts

David S Ziegler
principal investigator · Pediatric Early Phase Clinical Trial Network

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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