M-CHOP in Richter´s Syndrome (GELLC-9Richter)

July 23, 2024 updated by: GELLC (Grupo Español de Leucemia Linfocítica Crónica)

CHOP Plus Mosunetuzumab as First Line in Patients With Richter´s Syndrome: a Phase II Study of the Spanish CLL Group

The purpose of the study is to assess the efficacy, safety and tolerability of mosunetuzumab combined with CHOP in patients with untreated DLBCL-RS syndrome, identifying biological factors to address the probability of response.

In addition, efficacy and tolerability of maintenance with mosunetuzumab in patients not receiving an allo-SCT will be ascertained.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The primary study objective and associated endpoint is to evaluate the efficacy of mosunetuzumab combined with CHOP (M-CHOP) after the end of induction (EoI) in patients with RS who have never received therapy.

Primary endpoint will be complete remission (CR) evaluated by an independent review committee according to modified Lugano classification using PET/CT scan after the EoI visit. CR is defined as a score of 1, 2 or 3 for lymph nodes and extra-lymphatic sites at PET without new lesions and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. All PET evaluable in patients with at least one dose of mosunetuzumab will be included in the efficacy population.

The secondary study objectives and associated endpoints are:

  • To evaluate the efficacy of mosunetuzumab combined with CHOP (M-CHOP) after the end of induction (EoI) and maintenance (EoM) in patients with therapy naive RS.
  • Overall response rate (ORR), defined as the proportion of participants with a complete response (CR) or partial response (PR) at the end of induction (EoI) and maintenance (EoM), as determined by local and independent review committee according to modified Lugano classification using PET/CT scan and IWCLL criteria (Hallek 2018).
  • Complete remission (CR) at the EoM will be defined as a score of 1, 2 or 3 (no uptake above background) for lymph nodes and extralymphatic sites at PET without new lesions and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. In addition, patients need to have a normal blood count with normal/immunohistochemistry (IHC)-negative bone marrow morphology as per iwCLL criteria (Hallek 2018). All PET evaluable patients with at least one dose of mosunetuzumab will be included in the efficacy population.
  • Best overall response: the best response is defined as the achievement of a PET score of 1-3 associated with a normal blood count with normal/immunohistochemistry (IHC)-negative bone marrow morphology as per iwCLL criteria, or a PET score of 1-3 associated with incomplete recovery in blood and normal/immunohistochemistry (IHC)-negative bone marrow morphology evaluated at any time during the treatment induction or maintenance, whichever occurs first.
  • Minimal residual disease (MRD) response rate determined by the proportion of patients with MRD-negativity (defined as < 1 CLL cell in 10,000 leukocytes), assessed by flow cytometry in responders (CR/PR) in peripheral blood (PB) and/or bone marrow (BM) after the EoI and EoM.
  • Progression free survival (PFS), defined as the time from the first study treatment to the first occurrence of disease progression or death from any cause, whichever occurs first. PFS will be assessed by the investigator, using the Lugano criteria.
  • Overall survival (OS), defined as the time from first dose to death from any cause.
  • Duration of response (DoR), defined as the time from best overall response (the first occurrence of a documented objective response) to disease progression by Lugano criteria or death from any cause, whichever occurs first.

To determine the incidence and severity of adverse events

  • Incidence of adverse events (AEs): number and percentage of patients with 1 or more AE.
  • Severity of AEs according to NCI CTCAE v5.0. For events of CSR, severity will be determined by ASTCT CSR consensus grading criteria. For events of TLS, the presence of laboratory and/or clinical TLS will be determined according to Howard criteria.

To evaluate the study treatment exposure:

  • Treatment duration
  • Total dose received
  • Number of cycles and dose modifications
  • Treatment interruptions and discontinuations

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Spain
      • Barcelona, Spain
        • Not yet recruiting
        • H. Vall d'Hebron
        • Contact:
          • Pau Abrisqueta
      • Barcelona, Spain
        • Recruiting
        • H. Clínic i Provincial
        • Contact:
          • Pablo Mozas
      • Barcelona, Spain
        • Recruiting
        • ICO Duran i Reynals
        • Contact:
          • Ana Oliveira
      • Las Palmas De Gran Canaria, Spain
        • Recruiting
        • C. H. U. de Gran Canaria Dr. Negrín
        • Contact:
          • Alexia Suárez Cabrera
      • Madrid, Spain
        • Recruiting
        • H. U. 12 de Octubre
        • Contact:
          • Javier de la Serna
      • Madrid, Spain
        • Recruiting
        • H. U. La Princesa
        • Contact:
          • Luis Miguel Juárez
      • Marbella, Spain
        • Recruiting
        • H. Costa del Sol
        • Contact:
          • María Ángeles Medina
      • Murcia, Spain
        • Recruiting
        • H. G. U. Morales Meseguer
        • Contact:
          • Dolores García Malo
      • Oviedo, Spain
        • Not yet recruiting
        • H. U. Central de Asturias
        • Contact:
          • Ángel Ramírez Páyer
      • Salamanca, Spain, 37007
        • Recruiting
        • H. U. de Salamanca
        • Contact:
          • Almudena Navarro Bailón
      • San Sebastián, Spain
        • Recruiting
        • H. U. de Donostia
        • Contact:
          • Izaskun Zeberio Echechipia
      • Santander, Spain
        • Recruiting
        • H. U. Marqués de Valdecilla
        • Contact:
      • Santiago De Compostela, Spain
        • Recruiting
        • C. H. U. de Santiago
        • Contact:
          • Adrián Mosquera
      • Sevilla, Spain
        • Recruiting
        • H. U. Virgen del Rocío
        • Contact:
          • Fátima de la Cruz
      • Valencia, Spain
        • Recruiting
        • H. C. U. de Valencia
        • Contact:
          • Mª José Terol
      • Zaragoza, Spain
        • Not yet recruiting
        • H. Lozano Blesa
        • Contact:
          • Teresa Olave

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients meeting all the following inclusion criteria will be eligible for participation in the study:

    1. Capable of giving signed informed consent as described in Section 13.2, which includes compliance with the requirements and restrictions listed in the Informed Consent Form and this protocol.
    2. Aged between 18 and 79 years at the time of signing the Informed Consent Form
    3. Ability to comply with the study protocol and procedures and required hospitalizations, in the investigator's judgement.
    4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤2.
    5. Adult patients with previously untreated, histologically proven Richter's syndrome, diffuse large B cell variants, following WHO 2008 criteria (Swerdlow SH, 2008).
    6. Screening flow cytometry or immunohistochemistry (IHC) evidence of CD20 positive disease as per central review (dim expression of CD20 is acceptable)

    7. Adequate BM function independent of growth factor or transfusion at screening as follows unless cytopenia is clearly due to marrow involvement of CLL:

      1. Platelet count ≥75 x 109/L; in cases of thrombocytopenia clearly due to marrow involvement of CLL (per the discretion of the investigator), platelet count should be ≥ 30 x 109/L.
      2. ANC ≥1 x 109/L unless neutropenia is clearly due to marrow involvement of CLL (per the discretion of the investigator)
      3. Total hemoglobin ≥ 9 g/dL unless anemia is due to marrow involvement of CLL (per the discretion of the investigator)
    8. Measured or estimated creatinine clearance ≥ 45 mL/min by institutional standard method.
    9. Life expectancy > 3 months

    10. For women of childbearing potential (WOCBP): agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year, and agreement to refrain from donating eggs, during the treatment period and for at least 3 months after the last dose of mosunetuzumab and 3 months after the last dose of tocilizumab (if applicable).

      1. It is recommended to remain abstinent or use contraception for 12 months after the final dose of cyclophosphamide, doxorubicin, or vincristine.
      2. A woman is considered to be of childbearing potential (WOCBP) if she is postmenarchal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis). The definition of childbearing potential may be adapted for alignment with local guidelines or regulations.

Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.

Exclusion Criteria:

  1. Pregnant or breastfeeding or intending to become pregnant during the study or within 3 months after the final dose of mosunetuzumab.

    a) WOCBP must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment. If a serum pregnancy test has not been performed within 14 days prior to receiving first study treatment, a negative urine pregnancy test result (performed within 7 days prior to study treatment) must be available.

  2. Participants who have received any of the following treatments prior to study entry:

    a) Treatment with mosunetuzumab or other CD20/CD3-directed bispecific antibodies.

  3. Participants who have received any of the following treatments, whether investigational or approved, given to treat RS, within the respective time periods prior to initiation of study treatment:

    1. Autologous SCT within 100 days prior to first mosunetuzumab administration.
    2. Allogeneic stem cell transplant for CLL
    3. CAR T-cell therapy for CLL within 100 days before first study treatment
    4. Systemic corticosteroid treatment ≤ 20 mg/day prednisone or equivalent to control symptoms related to disease progression for a maximum of 5 days before starting C1D1 and inhaled corticosteroids are permitted.
  4. Central nervous system (CNS) involvement as documented by spinal fluid cytology or imaging.
  5. Transformation of CLL to prolymphocytic leukemia.

  6. History of prior malignancy, except for conditions as listed below if patients have recovered from the acute side effects incurred as a result of previous therapy:

    1. Malignancies treated with curative intent and with no known active disease present for ≥ 2 years before enrollment.
    2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
    3. Adequately treated cervical carcinoma in situ without evidence of disease.
    4. Surgically/adequately treated low grade, early stage, localized prostate cancer without evidence of disease.

  7. Any of the following laboratory abnormalities:

    1. Calculated creatinine Clearance < 45 mL/min (by institutional standard method.).
    2. Absolute neutrophil count (ANC) < 1.0 x 109/L, unless secondary to bone marrow involvement by CLL.
    3. Platelet count <75 x 109/L except if thrombocytopenia is clearly due to marrow involvement of CLL (per the discretion of the investigator) for which exclusion criteria would be platelet count < 30 x 109/L.
    4. Serum aspartate aminotransferase (AST)/serum glutamic-oxaloacetictransaminase (SGOT) or alanine transaminase (ALT)/serum glutamate pyruvate transaminase (SGPT) >2.5 x upper limit of normal (ULN).
    5. Serum total bilirubin > 1.5 x ULN, except in cases of Gilbert's syndrome.
  8. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
  9. Contraindication to tocilizumab.

  10. Presence of any autoimmune disorder including autoimmune hemolytic anemia or autoimmune thrombocytopenia active at the moment of first dose of therapy.

    a) Participants with a history of disease-related immune thrombocytopenic purpura or autoimmune hemolytic anemia may be eligible.

  11. History of autoimmune disease, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. Exceptions include the following:

    1. Participants with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible.
    2. Participants with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.
    3. Participants with a remote history of, or well-controlled autoimmune disease, with a treatment-free interval from immunosuppressive therapy for 12 months may be eligible after review and discussion with the Coordinators.
  12. History of solid organ transplantation
  13. 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.
  14. History of confirmed progressive multifocal leukoencephalopathy (PML)
  15. Positive serologic HIV test at screening
  16. Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen [HBsAg] serology). Participants with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HBsAg) may be included if hepatitis B virus (HBV) DNA is undetectable at the time of screening. These participants must be willing to undergo monthly DNA testing and appropriate prophylactic antiviral therapy as indicated.
  17. Acute or chronic hepatitis C virus (HCV) infection. Participants who are positive for HCV antibody must be negative for HCV by polymerase chain reaction (PCR) to be eligible for study participation.
  18. Known or suspected chronic active Epstein Barr Virus infection (CAEBV).
  19. Patients with history of macrophage activation syndrome (MAS)/hemophagocytic lymphohistiocytosis (HLH)
  20. Received a live, attenuated vaccine within 4 weeks before first dose of study treatment, or in whom it is anticipated that such a live attenuated vaccine will be required during the study period or within 5 months after the final dose of study treatment.
  21. Left ventricular ejection fraction (LVEF) <50% by multiple-gated acquisition (MUGA) scan or echocardiogram.

  22. Evidence of any significant, concomitant disease that could affect compliance with the protocol or interpretation of results, including, but not limited to:

    1. significant cardiovascular disease (e.g., New York Heart Association Class III or IV cardiac disease, myocardial infarction within the previous 3 months, unstable arrhythmia, or unstable angina)
    2. significant pulmonary disease (such as obstructive pulmonary disease or history of bronchospasm)
    3. clinically significant history of liver disease, including viral or other hepatitis, or cirrhosis.
    4. current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease.
    5. Participants with a history of stroke who have not experienced a stroke or transient ischemic attack in the past year and have no residual neurologic deficits as judged by the investigator are allowed.
    6. 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.
  23. Recent major surgery within 4 weeks prior to first study treatment administration, with the exception of protocol-mandated procedures (e.g., tumor biopsies and bone marrow biopsies)
  24. Participants who are in dependence to the Sponsor or an investigator.
  25. Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes an individual's safe participation in and completion of the study.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: M-CHOP (Mosunetuzumab combined with CHOP)

M-CHOP (Mosunetuzumab IV combined with CHOP)

Investigational medicinal product (IMP) for this study is mosunetuzumab which will be provided by the Sponsor

CHOP regimen, dexamethasone, rasburicase, acetaminophen/paracetamol, diphenhydramine methylprednisolone, allopurinol and tocilizumab are considered non-investigational medicinal products (NIMPs).
Biological: Mosunetuzumab

Cycle 1: d8, 1 mg; d15, 2 mg

Cycle 2 and beyond: 30 mg

Drug: CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone)

Cyclophosphamide will be administered at a dose of 750 mg/ m2 IV on Day 1 of Cycle 1-6, every 21 days.

Doxorubicin will be administered at a dose of 50 mg/m2 IV on Day 1 of Cycle 1-6, during induction treatment.

Vincristine will be administered at a dose of 1.4 mg/m2 (maximum 2 mg) IV infusion in 50 ml sodium chloride 0.9% over 10 minutes on Day 1 of Cycle 1-6, every 21 days.

Methylprednisolone will be administered at fixed dose of dose 80 mg IV on Day 1 of Cycle 1-6, every 21 days.

Prednisone will be administered at a dose of 60 mg/m2 orally on Days 2-5 of Cycle 1-6, every 21 days.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Complete remission (CR)
Time Frame: 8-12 weeks after the end of induction

The number and percentage of patients with CR will be analyzed at 8-12 weeks after the end of induction (as primary endpoint by Lugano criteria) and at the end of maintenance (as secondary endpoint by Lugano and iwCLL criteria).

CR is defined as a score of 1, 2 or 3 (no uptake above background) for lymph nodes and extra-lymphatic sites at PET/CT without new lesions and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. In addition, to evaluate CR as per iwCLL criteria at the end of maintenance, patients need to have a normal blood count with normal/immunohistochemistry (IHC)-negative bone marrow morphology.
8-12 weeks after the end of induction
Overall Response Rate (ORR)
Time Frame: 8-12 weeks after the end of induction
The number and percentage of patients with a CR or PR will be analyzed 3 weeks after the end of induction (EoI) and 8-12 weeks the end of maintenance (EoM). The analysis will be performed in the ITT population
8-12 weeks after the end of induction
Minimal-residual disease (MRD)
Time Frame: 8-12 weeks after the end of induction

The number and percentage of patients with MRD-negativity (defined as < 1 CLL cell in 10,000 leukocytes), assessed by flow cytometry in responders (CR/PR) in PB and/or BM at 3 weeks after the EoI and 8-12 weeks after the EoM.

Response endpoints will be summarized using descriptive statistics along with 2-sided 95% CIs for proportions (CR, ORR, MRD) using the Clopper-Pearson exact method
8-12 weeks after the end of induction

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: Up to 10 months
The time from the first dose of study treatment to the first occurrence of disease progression (assessed by the local investigator per Lugano criteria (PET) or death from any cause, whichever occurs first).
Up to 10 months
Overall Survival (OS)
Time Frame: Up to 21 months
OS is defined as the time from first dose to death from any cause. Participants who do not die during the study will be censored at the last follow-up. This analysis will be performed in the ITT population
Up to 21 months
Duration of Response (DoR)
Time Frame: Up to 4 years
DOR, defined as the time from best overall response (the first occurrence of a documented objective response) to disease progression (by Lugano) or death from any cause, whichever occurs first. Participants who do not experience disease progression, relapse, or die during the study will be censored at the date of their last tumor assessment. Only patients with a CR or PR will be included in the analysis.
Up to 4 years

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GELLC (Grupo Español de Leucemia Linfocítica Crónica)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 26, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 15, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 26, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GELLC-9-Richter

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

Yes

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.

Clinical Trials on Chronic Lymphocytic Leukemia

Clinical Trials on Mosunetuzumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings