Study of the Use of Venetoclax in Participants With Chronic Lymphocytic Leukemia (CLL) Under Real-Life Setting (VeRVe)

December 2, 2025 updated by: AbbVie

Observational Study of the Use of Venetoclax in Patients With Chronic Lymphocytic Leukemia (CLL) Under Real-Life Setting in Austria, Germany and Switzerland

An observational study to assess the effectiveness, health economic-relevant costs and participant reported outcomes in participants with Chronic lymphocytic leukemia (CLL) receiving venetoclax as a monotherapy or in combination with rituximab, obinutuzumab, ibrutinib, or acalabrutinib as prescribed at the discretion of the physician and in accordance with local clinical practice and label.

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.

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.
Observational

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.
500

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

  • Austria
      • Salzburg, Austria, 5020
        • Active, not recruiting
        • Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 221153
      • Vienna, Austria, 1140
        • Completed
        • Hanusch Krankenhaus /ID# 221151
    • Lower Austria
      • Sankt Pölten, Lower Austria, Austria, 3100
        • Recruiting
        • Universitaetsklinikum St. Poelten /ID# 221152
    • Styria
      • Graz, Styria, Austria, 8010
        • Completed
        • Medizinische Universitaet Graz /ID# 221155
  • Germany
      • Bad Mergentheim, Germany, 97980
        • Completed
        • Caritas-Krankenhaus gGmbH /ID# 243212
      • Baden-Baden, Germany, 76532
        • Completed
        • MVZ Klinikum Mittelbaden GmbH /ID# 206207
      • Berlin, Germany, 10715
        • Completed
        • Praxis am Volkspark /ID# 243195
      • Berlin, Germany, 10117
        • Completed
        • Praxis für Hämatologie und Onkologie /ID# 241763
      • Berlin, Germany, 10707
        • Completed
        • Onkologische Schwerpunktpraxis /ID# 200953
      • Berlin, Germany, 12487
        • Completed
        • Onkologie am Segelfliegerdamm /ID# 202603
      • Cologne, Germany, 50674
        • Completed
        • Pioh Dres. Draube & Partner /ID# 239507
      • Dresden, Germany, 01307
        • Active, not recruiting
        • Praxis Dres. Prange-Krex/Mohm /ID# 210049
      • Eisenach, Germany, 99817
        • Completed
        • St. Georg Klinikum Eisenach gemeinnützige GmbH (GKE) /ID# 250200
      • Freiburg im Breisgau, Germany, 79110
        • Active, not recruiting
        • Praxis fuer interdisziplinaere Onkolologie und Haematologie /ID# 206999
      • Hagen, Germany, 58095
        • Completed
        • MVZ Onkologie GmbH /ID# 212376
      • Halle, Germany, 06110
        • Completed
        • onkomedic GbR /ID# 218354
      • Hamburg, Germany, 22081
        • Active, not recruiting
        • OncoResearch Lerchenfeld GmbH /ID# 205237
      • Hamburg, Germany, 22767
        • Active, not recruiting
        • Onkologische Gemeinschaftspraxis /ID# 205239
      • Hamm, Germany, 59063
        • Active, not recruiting
        • Evangelisches Krankenhaus Hamm /ID# 206703
      • Hanover, Germany, 30161
        • Completed
        • Studienzentrum am Raschplatz /ID# 250180
      • Hanover, Germany, 30625
        • Completed
        • Studienbüro Kamal und Dorn GBR /ID# 234105
      • Idar-Oberstein, Germany, 55743
        • Active, not recruiting
        • Klinikum Idar-Oberstein GmbH /ID# 210046
      • Langenhessen, Germany, 63225
        • Completed
        • Praxis Fuchs/Koehler /ID# 243215
      • Paderborn, Germany, 33098
        • Completed
        • Bruederkrankenhaus St. Josef Paderborn /ID# 202600
      • Porta Westfalica, Germany, 32457
        • Active, not recruiting
        • Onkologische Praxis GbR /ID# 206705
      • Rostock, Germany, 18057
        • Active, not recruiting
        • Praxis Dres. Decker/Lakner/Leithäuser /ID# 206208
      • Schwetzingen, Germany, 68723
        • Completed
        • MVZ am Schlossgarten GmbH /ID# 210043
      • Schwäbisch Hall, Germany, 74523
        • Active, not recruiting
        • Diakonieklinikum Schwaebisch Hall /ID# 206205
    • Baden-Wurttemberg
      • Mutlangen, Baden-Wurttemberg, Germany, 73557
        • Completed
        • Stauferklinikum Schwaebisch Gmuend /ID# 201518
      • Stuttgart, Baden-Wurttemberg, Germany, 70174
        • Completed
        • Onkologische Praxis /ID# 201545
      • Villingen-Schwenningen, Baden-Wurttemberg, Germany, 78052
        • Active, not recruiting
        • Schwarzwald-Baar-Klinikum /ID# 208176
    • Bavaria
      • Aschaffenburg, Bavaria, Germany, 63739
        • Active, not recruiting
        • MVZ am Klinikum Aschaffenburg Onkologie /ID# 201548
      • Aschaffenburg, Bavaria, Germany, 63739
        • Active, not recruiting
        • Studienzentrum Aschaffenburg /ID# 204125
      • Augsburg, Bavaria, Germany, 86150
        • Completed
        • Gemeinschaftspraxis Dr. Heinrich und Prof. Bangerter /ID# 200950
      • Bad Reichenhall, Bavaria, Germany, 83435
        • Completed
        • Drs. Tanzer, Chirca, Stoeberl /ID# 202613
      • Erlangen, Bavaria, Germany, 91052
        • Completed
        • Internistische Schwerpunktpraxen, Erlangen /ID# 200949
      • Hof, Bavaria, Germany, 95028
        • Completed
        • Onkologie Hof /ID# 201531
      • Kronach, Bavaria, Germany, 96317
        • Active, not recruiting
        • Praxis Dr. Stauch /ID# 202611
      • Landshut, Bavaria, Germany, 84036
        • Active, not recruiting
        • VK&K Studien GbR /ID# 202614
      • Munich, Bavaria, Germany, 81241
        • Active, not recruiting
        • Haemato-Onkologie /ID# 205236
    • Brandenburg
      • Bad Liebenwerda, Brandenburg, Germany, 04924
        • Active, not recruiting
        • Praxis Dr. Kreher /ID# 202604
      • Frankfurt (Oder), Brandenburg, Germany, 15236
        • Completed
        • Praxis Dres. Kiehl/Stein /ID# 210052
      • Potsdam, Brandenburg, Germany, 14467
        • Active, not recruiting
        • MVZ f. Blut- u.Krebserkrankungen /ID# 206704
    • City state Bremen
      • Bremerhaven, City state Bremen, Germany, 27576
        • Completed
        • Ambulantes Tumorzentrum Bremerhaven /ID# 224353
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60389
        • Active, not recruiting
        • Centrum fuer Haematologie und Onkologie Bethanien /ID# 206701
      • Frankfurt am Main, Hesse, Germany, 60596
        • Active, not recruiting
        • MVZ Dres. Cordes & Partner /ID# 202598
      • Frankfurt am Main, Hesse, Germany, 65929
        • Completed
        • Klinikum Frankfurt Hoechst /ID# 210048
      • Kassel, Hesse, Germany, 34125
        • Active, not recruiting
        • Praxis Dres. Tebbe/Mayer /ID# 206730
    • Lower Saxony
      • Goslar, Lower Saxony, Germany, 38642
        • Active, not recruiting
        • Onkologische Kooperation Harz /ID# 201550
      • Hanover, Lower Saxony, Germany, 30171
        • Active, not recruiting
        • OAZ Hannover /ID# 201538
      • Oldenburg, Lower Saxony, Germany, 26121
        • Active, not recruiting
        • Onkolologische Praxis Oldenburg /ID# 202607
      • Osnabrück, Lower Saxony, Germany, 49076
        • Completed
        • MVZ der Paracelsus-Klinik /ID# 201541
      • Westerstede, Lower Saxony, Germany, 26655
        • Completed
        • Med. Studiengesellschaft Nord West GmbH /ID# 201535
    • North Rhine-Westphalia
      • Neuss, North Rhine-Westphalia, Germany, 41462
        • Active, not recruiting
        • Praxis Dres. Plewe/Losem /ID# 202606
    • Rhineland-Palatinate
      • Kaiserslautern, Rhineland-Palatinate, Germany, 67655
        • Active, not recruiting
        • Hämatologie und Onkologie /ID# 205247
    • Saarland
      • Neunkirchen, Saarland, Germany, 66538
        • Completed
        • Praxis Dr. Klaproth/Cura /ID# 216413
    • Saxony
      • Dresden, Saxony, Germany, 01127
        • Active, not recruiting
        • Onkozentrum Dresden /ID# 202599
      • Dresden, Saxony, Germany, 01307
        • Completed
        • BAG Freiberg-Richter, Jacobasch, Illmer, Wolf /ID# 201532
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23562
        • Completed
        • Luebecker Oncology Practice /ID# 200952
      • Neumünster, Schleswig-Holstein, Germany, 24534
        • Active, not recruiting
        • Friedrich-Ebert-Krankenhaus GmbH /ID# 206206
    • State of Berlin
      • Regensburg, State of Berlin, Germany, 93053
        • Active, not recruiting
        • Praxis Dres. Krober/Stosiek /ID# 206729
  • Switzerland
      • Bern, Switzerland, 3010
        • Completed
        • Inselspital, Universitaetsspital Bern /ID# 210031
    • Canton Ticino
      • Bellinzona, Canton Ticino, Switzerland, 6500
        • Completed
        • EOC Ospedale Regionale di Bellinzona e Valli /ID# 208782
    • Canton of Aargau
      • Aarau, Canton of Aargau, Switzerland, 5001
        • Completed
        • Kantonsspital Aarau AG /ID# 210034
    • Canton of Bern
      • Thun, Canton of Bern, Switzerland, 3600
        • Completed
        • Spital Thun /ID# 233714
    • Canton of Lucerne
      • Lucerne, Canton of Lucerne, Switzerland, 6000
        • Completed
        • Luzerner Kantonsspital /ID# 210029
    • Canton of Neuchâtel
      • Neuchâtel, Canton of Neuchâtel, Switzerland, 2000
        • Recruiting
        • Réseau Hospitalier Neuchâtelois /ID# 227865
    • Canton of St. Gallen
      • Sankt Gallen, Canton of St. Gallen, Switzerland, 9007
        • Completed
        • Kantonsspital St. Gallen /ID# 223037
    • Canton of Zurich
      • Winterthur, Canton of Zurich, Switzerland, 8400
        • Completed
        • KSW Kantonsspital Winterthur /ID# 211068
    • Thurgau
      • Münsterlingen, Thurgau, Switzerland, 8596
        • Completed
        • Kantonsspital Münsterlingen /ID# 210035

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants with chronic lymphocytic leukemia (CLL) administering venetoclax per the local label.

Description

Inclusion Criteria:

- Participant with chronic lymphocytic leukemia (CLL) who start venetoclax therapy can be included in the study if treated as specified in the local label for any specific line of treatment.

Exclusion Criteria:

- None

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Participants Receiving Venetoclax
Participants with Chronic Lymphocytic Leukemia (CLL) receiving venetoclax.
Participants Receiving Venetoclax + Rituximab
Participants with CLL receiving venetoclax in combination with rituximab.
Participants Receiving Venetoclax + Obinutuzumab
Participants with CLL receiving venetoclax in combination with obinutuzumab.
Participants Receiving Venetoclax + Ibrutinib
Participants with CLL receiving venetoclax in combination with ibrutinib.
Participants Receiving Venetoclax + Acalabrutinib
Participants with CLL receiving venetoclax in combination with acalabrutinib.

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
Percentage of Participants Achieving Best Overall Response Rate (ORR)
Time Frame: Up to 12 months
ORR is defined as the percentage of participants achieving partial response (PR) and complete response with incomplete regeneration of bone marrow (CRi) and complete response (CR) according to physician's assessment to therapy with venetoclax.
Up to 12 months

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
Percentage of Participants Still on Venetoclax Monotherapy
Time Frame: Up to 24 months
Percentage of participants still on venetoclax monotherapy throughout the study.
Up to 24 months
Percentage of Participants Still on Venetoclax in Combination with Rituximab
Time Frame: Up to 24 months
Percentage of participants still on venetoclax in combination with rituximab throughout the study.
Up to 24 months
Percentage of Participants Receiving Venetoclax Monotherapy with Disease Progression
Time Frame: Up to 24 months
Disease progression as defined in the study protocol in participants receiving venetoclax monotherapy.
Up to 24 months
Percentage of Participants Receiving Venetoclax in Combination with Obinutuzumab with Disease Progression
Time Frame: Up to 24 months
Disease progression as defined in the study protocol in participants receiving venetoclax in combination with obinutuzumab.
Up to 24 months
Percentage of Participants Receiving Venetoclax in Combination with Rituximab with Disease Progression
Time Frame: Up to 36 months
Disease progression as defined in the study protocol in participants receiving venetoclax in combination with rituximab.
Up to 36 months
Overall Survival (OS) Rate in Participants Receiving Venetoclax Monotherapy
Time Frame: Up to 24 months
Percentage of participants with OS where OS is defined as the number of days from the date of entry in the study to the date of death.
Up to 24 months
Overall Survival (OS) Rate in Participants Receiving Venetoclax in Combination with Obinutuzumab
Time Frame: Up to 24 months
Percentage of participants with OS where OS is defined as the number of days from the date of entry in the study to the date of death.
Up to 24 months
Overall Survival (OS) Rate in Participants Receiving Venetoclax in Combination with Rituximab
Time Frame: Up to 36 months
Percentage of participants with OS where OS is defined as the number of days from the date of entry in the study to the date of death.
Up to 36 months
Progression-Free Survival (PFS) Rate in Participants Receiving Venetoclax Monotherapy
Time Frame: Up to 24 months
Percentage of participants with PFS where PFS is defined as the number of days from the date of entry in the study to the date of the first documented disease progression, start of a subsequent treatment regimen, or death due to any cause, whichever occurs first.
Up to 24 months
Progression-Free Survival (PFS) Rate in Participants Receiving Venetoclax in Combination with Obinutuzumab
Time Frame: Up to 24 months
Percentage of participants with PFS where PFS is defined as the number of days from the date of entry in the study to the date of the first documented disease progression, start of a subsequent treatment regimen, or death due to any cause, whichever occurs first.
Up to 24 months
Progression-Free Survival (PFS) Rate in Participants Receiving Venetoclax in Combination with Rituximab
Time Frame: Up to 36 months
Percentage of participants with PFS where PFS is defined as the number of days from the date of entry in the study to the date of the first documented disease progression, start of a subsequent treatment regimen, or death due to any cause, whichever occurs first.
Up to 36 months
Minimal Residual Disease (MRD) measurement on plasma circulating tumor Deoxyribo nucleic acid (DNA) (Switzerland Only)
Time Frame: Up to 24 months
MRD is defined as less than 1 clonal lymphocyte per 10000 leukocytes in peripheral blood or bone marrow.
Up to 24 months
Percentage of Participants Receiving Venetoclax Monotherapy and Achieving Complete Response (CR)
Time Frame: Up to 24 months
Complete Response as defined in the study protocol.
Up to 24 months
Percentage of Participants Receiving Venetoclax in Combination with Obinutuzumab and Achieving Complete Response (CR)
Time Frame: Up to 24 months
Complete Response as defined in the study protocol.
Up to 24 months
Percentage of Participants Receiving Venetoclax in Combination with Rituximab and Achieving Complete Response (CR)
Time Frame: Up to 36 months
Complete Response as defined in the study protocol.
Up to 36 months
Percentage of Participants Receiving Venetoclax Monotherapy and Achieving Complete Response with Incomplete Regeneration of Bone Marrow (CRi)
Time Frame: Up 24 months
Incomplete regeneration of bone marrow (CRi) as defined in the study protocol.
Up 24 months
Percentage of Participants Receiving Venetoclax Combination with Obinutuzumab and Achieving Complete Response with Incomplete Regeneration of Bone Marrow (CRi)
Time Frame: Up 24 months
Incomplete regeneration of bone marrow (CRi) as defined in the study protocol.
Up 24 months
Percentage of Participants Receiving Venetoclax Combination with Rituximab and Achieving Complete Response with Incomplete Regeneration of Bone Marrow (CRi)
Time Frame: Up 36 months
Incomplete regeneration of bone marrow (CRi) as defined in the study protocol.
Up 36 months
Percentage of Participants Receiving Venetoclax Monotherapy and Achieving Partial Response (PR)
Time Frame: Up to 24 months
Partial response as defined in the study protocol.
Up to 24 months
Percentage of Participants Receiving Venetoclax Combination with Obinutuzumab and Achieving Partial Response (PR)
Time Frame: Up to 24 months
Partial response as defined in the study protocol.
Up to 24 months
Percentage of Participants Receiving Venetoclax Combination with Rituximab and Achieving Partial Response (PR)
Time Frame: Up to 36 months
Partial response as defined in the study protocol.
Up to 36 months
Percentage of Participants Receiving Venetoclax Monotherapy with Progressive Disease
Time Frame: Up to 24 months
Progressive disease as defined in the study protocol.
Up to 24 months
Percentage of Participants Receiving Venetoclax Combination with Obinutuzumab with Progressive Disease
Time Frame: Up to 24 months
Progressive disease as defined in the study protocol.
Up to 24 months
Percentage of Participants Receiving Venetoclax Combination with Rituximab with Progressive Disease
Time Frame: Up to 36 months
Progressive disease as defined in the study protocol.
Up to 36 months
Percentage of Participants Receiving Venetoclax Monotherapy with Stable Disease (SD)
Time Frame: Up to 24 months
SD is defined as percentage of all participants not having PD, but who do not meet the criteria for PR or CR.
Up to 24 months
Percentage of Participants Receiving Venetoclax Combination with Obinutuzumab with Stable Disease (SD)
Time Frame: Up to 24 months
SD is defined as percentage of all participants not having PD, but who do not meet the criteria for PR or CR.
Up to 24 months
Percentage of Participants Receiving Venetoclax Combination with Rituximab with Stable Disease (SD)
Time Frame: Up to 36 months
SD is defined as percentage of all participants not having PD, but who do not meet the criteria for PR or CR.
Up to 36 months
Quality of Life using EORTC QLQ-C30 Scores
Time Frame: Up to 104 weeks
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire (QLQ) developed to assess the quality of life of cancer patients. and is based on multi-item and single-item scales. The core questionnaire contains 5 functional scales, 3 symptom scales, 1 global health status scale, as well as 6 single-item measures.
Up to 104 weeks
QLQ-CLL 16/17 Scores
Time Frame: Up to 104 weeks
Quality of Life Questionnaire - Chronic Lymphocytic Leukemia (QLQ-CLL)16/17 is designed for participants with stage 0 to stage 4 chronic lymphocytic leukemia. It is used to assess 5 domains of health-related quality of life important in CLL: fatigue, side effects and symptoms of disease, infection and social activities or future illness-related concerns.
Up to 104 weeks
European Quality of Life 5 Dimensions (EQ-5D-5L) including visual analogue scale (VAS)
Time Frame: Up 24 months
The EQ-5D-5L is a standardized non-disease specific instrument for describing and valuing health-related quality of life. EQ-5D-5L questionnaire consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-5L questionnaire plus a VAS will be used to assess general health in 5 dimensions (mobility, self-care, usual activities, pain/discomfort anxiety/depression).
Up 24 months
Management of Venetoclax Therapy
Time Frame: Up to 24 Months
Management of venetoclax therapy includes time from blood sampling to laboratory result availability, changes in laboratory values, occurence of tumor lysis syndrome and possible interventions, length and reason for hospitalizations, duration of IV hydration, therapy modifications, supportive therapies other criteria described in the protocol.
Up to 24 Months
Health Resource Utilization (HRU) per year
Time Frame: Up to 24 Months
Health Resource Utilization (HRU) per year will be assessed.
Up to 24 Months
Clonal evolution and eradication of Tumor Protein p53 (TP53) mutated clones associated with treatment in relation to MRD negativity (Switzerland Only)
Time Frame: Up to 24 months
Clonal evolution and eradication of TP53 mutated clones associated with treatment in relation to MRD negativity is evaluated
Up to 24 months
Value of MRD Assessment
Time Frame: Up to 24 Months
Value of MRD assessment by flow cytometry compared to comprehensive MRD assessment including flow cytometry plus NGS in peripheral blood as described in Annex II (Switzerland only).
Up to 24 Months

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.
AbbVie

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: ABBVIE INC., AbbVie

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.
December 4, 2017

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.
December 1, 2030

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.
December 1, 2030

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).
November 10, 2017

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.
November 10, 2017

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.
November 14, 2017

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.
December 8, 2025

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.
December 2, 2025

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.
December 1, 2025

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.
  • P17-132

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

No

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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