Comparing the Effectiveness of the Immunotherapy Agents Rituximab or Mosunetuzumab in Patients With Nodular Lymphocyte-Predominant Hodgkin Lymphoma

April 18, 2024 updated by: National Cancer Institute (NCI)

NORM: Nodular Lymphocyte-Predominant Hodgkin Lymphoma Patients Treated in a Randomized Phase 2 Trial With Either Rituximab or Mosunetuzumab

This phase II trial compares mosunetuzumab to the usual treatment (rituximab) for improving survival in patients with nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL). Rituximab and mosunetuzumab are monoclonal antibodies. They bind to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Mosunetuzumab may be more effective at extending survival in patients with NLPHL than the usual approach with rituximab.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. To compare the progression-free survival (PFS) of mosunetuzumab versus rituximab in NLPHL patients.

SECONDARY OBJECTIVES:

I. To compare the safety and antitumor activity of NLPHL patients treated with mosunetuzumab versus rituximab.

II. To evaluate the molecular effects of mosunetuzumab and rituximab on tumor cells and the immune response and identify biomarkers of response or resistance with ribonucleic acid sequencing (RNAseq), whole exome sequencing (WES), immunohistochemistry (IHC) CD20, PD-1, PD-L1, PD-L2.

III. To evaluate tumor microenvironment and peripheral immune status with single-cell ribonucleic acid sequencing (scRNA-seq).

EXPLORATORY OBJECTIVES:

I. To evaluate CD20 expression and correlate with response. II. To evaluate the dynamic molecular response of NLPHL patients treated with rituximab or mosunetuzumab with circulating tumor deoxyribonucleic acid (ctDNA).

III. To evaluate the safety and efficacy (including tumor response, immune response, and overall survival) of the crossover patients.

IV. To assess the association of baseline fludeoxyglucose F-18 (FDG)-positron emission tomography/computed tomography (PET/CT) measurements including metabolic tumor volume (MTV) and maximum standardized uptake value (SUVmax), in combination with other risk factors, with PFS and overall survival (OS) in patients with lymphocyte-predominant Hodgkin lymphoma treated with mosunetuzumab or rituximab.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive mosunetuzumab subcutaneously (SC) on days 1, 8, and 15 of cycle 1 and day 1 of subsequent cycles. Treatment repeats every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients who experience progressive disease (PD) will be permitted to crossover to arm II at week 12. Patients also receive FDG and undergo PET/CT at baseline and end of treatment. Patients who are positive at pre-treatment bone marrow biopsy also receive FDG and undergo PET/CT on study. Patients also undergo bone marrow biopsy and tissue biopsy at baseline and end of treatment, and blood sample collection throughout the trial.

ARM II: Patients receive rituximab intravenously (IV) on day 1 and rituximab and hyaluronidase human SC on days 8, 15, and 22 of each cycle. Cycles repeat every 28 days for up to 2 cycles 8 weeks apart in the absence of disease progression or unacceptable toxicity. Patients may receive rituximab IV on days 8, 15, and 22 of each cycle if rituximab and hyaluronidase human is not available. Patients who experience PD will be permitted to crossover to arm I at week 12. Patients also receive FDG and undergo PET/CT at baseline and end of treatment. Patients who are positive at pre-treatment bone marrow biopsy also receive FDG and undergo PET/CT on study. Patients also undergo bone marrow biopsy and tissue biopsy at baseline and end of treatment, and blood sample collection throughout the trial.

After completion of study treatment, patients are followed up every 3 months for the first year, every 4 months for the second year, and every 6 months for 3 years.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Alex F. Herrera
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Cancer Center
        • Principal Investigator:
          • Marc S. Hoffmann
        • Contact:
      • Overland Park, Kansas, United States, 66210
        • Recruiting
        • University of Kansas Cancer Center-Overland Park
        • Principal Investigator:
          • Marc S. Hoffmann
        • Contact:
      • Westwood, Kansas, United States, 66205
        • Recruiting
        • University of Kansas Hospital-Westwood Cancer Center
        • Principal Investigator:
          • Marc S. Hoffmann
        • Contact:
    • Missouri
      • Kansas City, Missouri, United States, 64154
        • Recruiting
        • University of Kansas Cancer Center - North
        • Principal Investigator:
          • Marc S. Hoffmann
        • Contact:
      • Lee's Summit, Missouri, United States, 64064
        • Recruiting
        • University of Kansas Cancer Center - Lee's Summit
        • Principal Investigator:
          • Marc S. Hoffmann
        • Contact:
      • North Kansas City, Missouri, United States, 64116
        • Recruiting
        • University of Kansas Cancer Center at North Kansas City Hospital
        • Principal Investigator:
          • Marc S. Hoffmann
        • Contact:
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan Kettering Basking Ridge
        • Principal Investigator:
          • Raphael E. Steiner
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering Monmouth
        • Principal Investigator:
          • Raphael E. Steiner
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • Memorial Sloan Kettering Bergen
        • Principal Investigator:
          • Raphael E. Steiner
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
    • New York
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering Commack
        • Principal Investigator:
          • Raphael E. Steiner
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering Westchester
        • Principal Investigator:
          • Raphael E. Steiner
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Principal Investigator:
          • Raphael E. Steiner
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
      • Uniondale, New York, United States, 11553
        • Recruiting
        • Memorial Sloan Kettering Nassau
        • Principal Investigator:
          • Raphael E. Steiner
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center
        • Principal Investigator:
          • Sami Ibrahimi
        • Contact:
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • University of Pittsburgh Cancer Institute (UPCI)
        • Contact:
          • Site Public Contact
          • Phone Number: 412-647-8073
        • Principal Investigator:
          • Natalie Galanina
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Principal Investigator:
          • Dai Chihara
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Huntsman Cancer Institute/University of Utah
        • Contact:
        • Principal Investigator:
          • Allison Bock

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histopathologically confirmed diagnosis of NLPHL as confirmed by local pathologist's expert review.

    • Untreated NLPHL: stage IB to IV according to Cotswolds. The proportion of patients with stages I or II treated with consolidative radiotherapy will be capped at 40%.
    • Previously treated NLPHL, any stage.
    • According to the treating physician, the patient should not be observed and needs therapy, notably because of B-symptoms (unexplained fever [temperature > 38 degrees Celsius (> 100.4 degrees Fahrenheit)], weight loss [unexplained loss of > 10 percent of body weight over the past six months], or drenching night sweats), symptomatic nodal or extranodal disease, or patient preferences.
  • Patients must have measurable disease according to the Lugano/Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) classification.
  • Age >= 18 years. Because no dosing or adverse event (AE) data are currently available on the use of mosunetuzumab in patients < 18 years of age, children are excluded from this study.
  • Eastern Cooperative Oncology Group performance status =< 2 (Karnofsky >= 60%).
  • Absolute neutrophil count >= 1,000/mcL.
  • Platelets >= 100,000/mcL.
  • Total bilirubin =< 1.5 institutional upper limit of normal (ULN), except in patients with Gilbert's syndrome as defined by > 80% unconjugated bilirubin.
  • Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase [SGOT])/alanine transaminase (ALT)(serum glutamic-pyruvic transaminase [SGPT]) =< 3 x institutional ULN.
  • Glomerular filtration rate (GFR) >= 40mL /min= GFR (mL/Min/1.73 m^2) * body surface area (BSA)/1.73.
  • Human immunodeficiency virus-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.
  • The effects of mosunetuzumab on the developing human fetus are unknown. For this reason and because other therapeutic agents used in this trial are known to be teratogenic, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men and women treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 3 months after completion of mosunetuzumab administration and 12 months after completion of rituximab administration.
  • Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.

Exclusion Criteria:

  • Classical Hodgkin lymphoma (cHL) or composite lymphoma.
  • Transformed NLPHL, concerns of the treating physician of an occult transformation or concerns of the treating physician that the patient needs cytotoxic therapy.
  • Previous therapy with rituximab.
  • Patients who have not recovered from AEs due to prior anticancer therapy (i.e., have residual toxicities > grade 1) with the exception of alopecia.
  • Patients who are receiving any other investigational agents.
  • Patients with central nervous system (CNS) involvement as a result of lymphoma.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to mosunetuzumab or rituximab.
  • Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous.
  • Pregnant women are excluded from this study because there is an unknown but potential risk for AEs in nursing infants secondary to treatment of the mother with mosunetuzumab; breastfeeding should be discontinued if the mother is treated with mosunetuzumab or rituximab. These potential risks may also apply to other agents used in this study.
  • Prior allogeneic stem cell or solid organ transplantation.
  • Participants who have received a live, attenuated vaccine within 4 weeks before first dose of study treatment or anticipation that such a live, attenuated vaccine will be required during the study. Participants must not receive live, attenuated vaccines (e.g., FluMist [registered trademark]) while receiving study treatment and after the last dose until B-cell recovery to the normal ranges. Killed vaccines or toxoids should be given at least 4 weeks prior to the first dose of study treatment to allow development of sufficient immunity.
  • Any other anti-cancer therapy, whether investigational or approved, including but not limited to chemotherapy, within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to initiation of study treatment.

  • Evidence of any significant, concomitant disease that could affect compliance with the protocol or interpretation of results as judged by the investigator, including, but not limited to:

    • Significant cardiovascular disease (e.g., New York Heart Association class III or IV cardiac disease, myocardial infarction within the previous 6 months, unstable arrhythmia, or unstable angina).
    • Significant pulmonary disease (such as obstructive pulmonary disease or history of bronchospasm).
    • Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease.
    • Participants with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 1 year and have no residual neurologic deficits as judged by the investigator are allowed.
    • Participants with a history of epilepsy who have had no seizures in the past 2 years with or without anti-epileptic medications can be eligible only for the expansion cohort.
    • History of confirmed progressive multifocal leukoencephalopathy (PML).
  • Participants with infections requiring IV treatment with antibiotics or hospitalization (grade 3 or 4) within the last 4 weeks prior to enrollment or known active bacterial, viral (including SARS-CoV-2), fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment.
  • Systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 2 weeks prior to first dose of study treatment.
  • Known or suspected chronic active Epstein-Barr virus (EBV) or cytomegalovirus (CMV) infection.
  • Known or suspected history of hemophagocytic lymphohistiocytosis (HLH).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I (Mosunetuzumab)
Patients receive mosunetuzumab SC on days 1, 8, and 15 of cycle 1 and day 1 of subsequent cycles. Treatment repeats every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients who experience PD will be permitted to crossover to arm II at week 12. Patients also receive FDG and undergo PET/CT at baseline and end of treatment. Patients who are positive at pre-treatment bone marrow biopsy also receive FDG and undergo PET/CT on study. Patients also undergo bone marrow biopsy and tissue biopsy at baseline and end of treatment, and blood sample collection throughout the trial.
Procedure: Biospecimen Collection
Undergo blood sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Procedure: Computed Tomography
Undergo PET/CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
  • Computerized axial tomography (procedure)
  • Computerized Tomography (CT) scan
Procedure: Positron Emission Tomography
Undergo PET/CT
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging
  • PT
  • Positron emission tomography (procedure)
Procedure: Biopsy
Undergo tissue biopsy
Other Names:
  • Bx
  • BIOPSY_TYPE
Procedure: Bone Marrow Biopsy
Undergo bone marrow biopsy
Other Names:
  • Biopsy of Bone Marrow
  • Biopsy, Bone Marrow
Biological: Mosunetuzumab
Given SC
Other Names:
  • RO7030816
  • BTCT4465A
  • Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody BTCT4465A
  • BTCT 4465A
  • BTCT-4465A
  • CD20/CD3 BiMAb BTCT4465A
  • RG 7828
  • RG-7828
  • RG7828
  • Lunsumio
  • Mosunetuzumab-axgb
Other: Fludeoxyglucose F-18
Receive FDG
Other Names:
  • 18FDG
  • FDG
  • fludeoxyglucose F 18
  • Fludeoxyglucose (18F)
  • Fludeoxyglucose F18
  • Fluorine-18 2-Fluoro-2-deoxy-D-Glucose
  • Fluorodeoxyglucose F18
Active Comparator: Arm II (Rituximab, Rituximab and hyaluronidase human)
Patients receive rituximab IV on day 1 and rituximab and hyaluronidase human SC on days 8, 15, and 22 of each cycle. Cycles repeat every 28 days for up to 2 cycles 8 weeks apart in the absence of disease progression or unacceptable toxicity. Patients may receive rituximab IV on days 8, 15, and 22 of each cycle if rituximab and hyaluronidase human is not available. Patients who experience PD will be permitted to crossover to arm I at week 12. Patients also receive FDG and undergo PET/CT at baseline and end of treatment. Patients who are positive at pre-treatment bone marrow biopsy also receive FDG and undergo PET/CT on study. Patients also undergo bone marrow biopsy and tissue biopsy at baseline and end of treatment, and blood sample collection throughout the trial.
Procedure: Biospecimen Collection
Undergo blood sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Biological: Rituximab
Given IV
Other Names:
  • Rituxan
  • MabThera
  • ABP 798
  • BI 695500
  • C2B8 Monoclonal Antibody
  • Chimeric Anti-CD20 Antibody
  • CT-P10
  • IDEC-102
  • IDEC-C2B8
  • IDEC-C2B8 Monoclonal Antibody
  • Monoclonal Antibody IDEC-C2B8
  • PF-05280586
  • Riabni
  • Rituximab ABBS
  • Rituximab ARRX
  • Rituximab Biosimilar ABP 798
  • Rituximab Biosimilar BI 695500
  • Rituximab Biosimilar CT-P10
  • Rituximab Biosimilar GB241
  • Rituximab Biosimilar IBI301
  • Rituximab Biosimilar JHL1101
  • Rituximab Biosimilar PF-05280586
  • Rituximab Biosimilar RTXM83
  • Rituximab Biosimilar SAIT101
  • Rituximab Biosimilar SIBP-02
  • rituximab biosimilar TQB2303
  • Rituximab PVVR
  • Rituximab-arrx
  • Rituximab-pvvr
  • RTXM83
  • Ruxience
  • Truxima
  • Ikgdar
  • Mabtas
  • Rituximab-abbs
Biological: Rituximab and Hyaluronidase Human
Given SC
Other Names:
  • Rituxan Hycela
  • Rituximab Plus Hyaluronidase
  • Rituximab/Hyaluronidase
  • Rituximab/Hyaluronidase Human
Procedure: Computed Tomography
Undergo PET/CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
  • Computerized axial tomography (procedure)
  • Computerized Tomography (CT) scan
Procedure: Positron Emission Tomography
Undergo PET/CT
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging
  • PT
  • Positron emission tomography (procedure)
Procedure: Biopsy
Undergo tissue biopsy
Other Names:
  • Bx
  • BIOPSY_TYPE
Procedure: Bone Marrow Biopsy
Undergo bone marrow biopsy
Other Names:
  • Biopsy of Bone Marrow
  • Biopsy, Bone Marrow
Other: Fludeoxyglucose F-18
Receive FDG
Other Names:
  • 18FDG
  • FDG
  • fludeoxyglucose F 18
  • Fludeoxyglucose (18F)
  • Fludeoxyglucose F18
  • Fluorine-18 2-Fluoro-2-deoxy-D-Glucose
  • Fluorodeoxyglucose F18

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS) time
Time Frame: Time from the date of randomization to the first objective documentation of disease progression or death due to any cause, assessed up to 5 years
Will be assessed according to the Lugano/Lymphoma Response to Immunomodulatory Therapy Criteria classification. The overall PFS curve will be displayed by treatment arm using the Kaplan-Meier (KM) method, and statistical comparisons will be performed by a log-rank test.
Time from the date of randomization to the first objective documentation of disease progression or death due to any cause, assessed up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response
Time Frame: At week 12 and end of treatment
The count and incidence rate of the response categories will be summarized for the overall population and by each treatment arm with a 95% exact confidence intervals (CIs). Comparison between treatment arms will be performed by a chi-squared test.
At week 12 and end of treatment
Duration of response
Time Frame: Time from the first date of partial or complete response until death or the assessment date of disease progression, assessed up to 5 years
Will be displayed by treatment arm using the KM method, and statistical comparisons will be performed by a log-rank test.
Time from the first date of partial or complete response until death or the assessment date of disease progression, assessed up to 5 years
Overall survival (OS)
Time Frame: Time from the date of randomization to death due to any cause, assessed up to 5 years
Will be displayed by randomized treatment arm using the KM method, and statistical comparisons will be performed by a log-rank test.
Time from the date of randomization to death due to any cause, assessed up to 5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
CD20 expression
Time Frame: Assessed up to 5 years
CD20 expression will be evaluated and correlated with overall response rate, complete remission rate at end of treatment, and 2-year progression free survival.
Assessed up to 5 years
Molecular effects of mosunetuzumab and rituximab on tumor cells and the immune response
Time Frame: Assessed up to 5 years
Will assess the molecular effects of mosunetuzumab and rituximab on tumor cells and the immune response and identify biomarkers of response or resistance (objective response rate, complete remission rate at end of treatment, and 2-year PFS) with ribonucleic acid sequencing, whole exome sequencing, immunohistochemistry CD20, PD-1, PD-L1, and PD-L2.
Assessed up to 5 years
Tumor microenvironment and peripheral immune status
Time Frame: Assessed up to 5 years
Will be assessed by single-cell ribonucleic acid sequencing.
Assessed up to 5 years
Incidence of adverse events
Time Frame: Assessed up to 5 years
Will be assessed by tumor response, immune response, and overall survival of the crossover patients.
Assessed up to 5 years
Fludeoxyglucose F-18 positron emission tomography/computed tomography (FDG-PET/CT) measurements
Time Frame: At baseline
Will assess the association of FDG-PET/CT measurements, including metabolic tumor volume and maximum standardized uptake value, in combination with other risk factors, with PFS and OS in patients with lymphocyte-predominant Hodgkin lymphoma treated with mosunetuzumab or rituximab.
At baseline
Dynamic molecular response of nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL) patients
Time Frame: During the first 7 weeks of treatment and at the end of treatment
Will evaluate the dynamic molecular response of NLPHL patients treated with rituximab or mosunetuzumab with circulating tumor deoxyribonucleic acid.
During the first 7 weeks of treatment and at the end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Raphael E Steiner, University of Texas MD Anderson Cancer Center LAO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2024

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

June 1, 2023

First Submitted That Met QC Criteria

June 1, 2023

First Posted (Actual)

June 2, 2023

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2023-04108 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • UM1CA186691 (U.S. NIH Grant/Contract)
  • 10590 (Other Identifier: CTEP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

"NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page."

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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