ClinicalTrials.gg
CompletedNCT03406156Updated Aug 6, 2024Results posted

A Study in Previously Untreated Chronic Lymphocytic Leukemia (CLL) Subjects, Excluding Those With the 17p Deletion, to Evaluate Debulking Regimens Prior to Initiating Venetoclax Combination Therapy

A Phase 3 interventional study of Obinutuzumab and Bendamustine in Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL), sponsored by AbbVie. Completed at 15 sites in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-08-06.

Sponsored by AbbVie · Phase 3, Interventional, and Treatment

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Phase
Phase 3
Study type
Interventional
Enrollment
120
Allocation
Non-randomized
Ages
18 Years to 99 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 69 studies testing venetoclax in Leukemia, Lymphocytic, Chronic, B-Cell — 21 open to participants now, 42 under way, 8 of them phase 3. venetoclax · Leukemia, Lymphocytic, Chronic, B-Cell.

Enrollment
23rd of 69
120 · median 72
Started
2018
with 6 others
Phase 3
15 of 69
3 open now
Registered
22nd of 69
by date
Lead sponsor
11 of 69
AbbVie

Among the 69 studies testing venetoclax in Leukemia, Lymphocytic, Chronic, B-Cell, this one is the 23rd largest by enrollment, is one of 7 that started in 2018, is one of 15 in phase 3, and was the 22nd registered.

Leukemia, Lymphocytic, Chronic, B-Cell

2,036 studies on the registry are indexed under Leukemia, Lymphocytic, Chronic, B-Cell; 237 are open to participants now.

Browse Leukemia, Lymphocytic, Chronic, B-Cell studies →

Open to participants now

21 of the 69 studies testing venetoclax in Leukemia, Lymphocytic, Chronic, B-Cell are open now, in 12 countries. Recruiting first, the newest first:

16 more — sign in →

By country, each count listing its studies:

All 21 open studies →

About venetoclax

venetoclax: first FDA approval 2016 (VENCLEXTA), first EMA approval 2016. What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 188 Leukemia, Lymphocytic, Chronic, B-Cell studies recruiting now, 150 (80%) set no upper age limit and 15 (8%) stop at 75 or younger; 17 take children under 18; 13 take healthy volunteers.

This study: 18 Years to 99 Years · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 69 studies testing venetoclax in Leukemia, Lymphocytic, Chronic, B-Cell, or all of them as a file.
02

Study summary

This is a multi-cohort, open-label study in previously untreated participants with chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), excluding those with the 17p deletion, to evaluate a debulking strategy that would enable all participants to receive subsequent venetoclax as outpatients, with lower risk of tumor lysis syndrome.

Read the detailed description

Safety and efficacy data through 13 October 2021 are included in the interim analysis, which was conducted after all participants completed the post-treatment Week 65 visit or discontinued from the study.

03

Conditions studied

  • Chronic Lymphocytic Leukemia (CLL)
  • Small Lymphocytic Lymphoma (SLL)

Keywords

  • Cancer
  • Chronic Lymphocytic Leukemia
  • 17p Deletion
  • Debulking
  • Obinutuzumab
  • Bendamustine
  • Tumor lysis syndrome
  • Venetoclax
  • Small Lymphocytic Lymphoma
04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adequate hematology, kidney and liver function as described in the protocol
  • Diagnosis of previously untreated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) according to 2008 Modified International Workshop on Chronic Lymphocytic Leukemia National Cancer Institute-sponsored Working Group (IWCLL NCI-WG) criteria
  • (ECOG) performance score of 0 - 1
  • CLL/SLL requires treatment according to the IWCLL criteria
  • Medium tumor burden (any lymph node [LN] 5 to \< 10 cm OR absolute lymphocyte count [ALC] ≥ 25 × 10\^9/L) OR High tumor burden (any LN ≥ 10 cm OR ALC ≥ 25 × 10\^9/L and LN ≥ 5 cm)

Exclusion criteria

Exclusion Criteria:

  • Presence of 17p deletion at Screening
  • Richter's syndrome (transformation of CLL/SLL to aggressive non-Hodgkin's lymphoma or Hodgkin's lymphoma)
  • Prolymphocytic leukemia
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    Obinutuzumab

    Obinutuzumab (100 mg on Day 1 of Cycle 1, 900 mg on Day 2 of Cycle 1, and 1000 mg on Days 8 and 15 of Cycle 1 and Day 1 of Cycle 2; for Cycles 3 - 6 (1000 mg on Day 1) only as needed for participants to achieve low tumor burden) was administered via intravenous infusion during the debulking regimen. After debulking, obinutuzumab (1000 mg) was administered via intravenous infusion on Day 1 of one 5-week and four 4-week cycles during the obinutuzumab/venetoclax combination part of the regimen. Venetoclax was administered according to a weekly ramp-up schedule over 5 weeks to the recommended daily dose of 400 mg.

    Drug: Obinutuzumab · Drug: Venetoclax

  • Experimental
    Obinutuzumab/bendamustine

    Obinutuzumab (100 mg on Day 1 of Cycle 1, 900 mg on Day 2 of Cycle 1, and 1000 mg on Days 8 and 15 of Cycle 1 and Day 1 of Cycle 2; for Cycles 3 - 6 (1000 mg on Day 1) only as needed for participants to achieve low tumor burden) was administered via intravenous infusion during the debulking regimen. Bendamustine (90 mg/m\^2 ) was to be administered to those with nodes or nodal mass \> 10 cm, or with del(11q) and \> 5 cm nodes, or at the discretion of the investigator as above, via intravenous infusion over 10 minutes on Days 1 and 2 (or Days 2 and 3 at the discretion of the investigator during Cycle 1) of each 28-day cycle for up to 6 cycles during the debulking regimen. After debulking, obinutuzumab (1000 mg) was administered via intravenous infusion on Day 1 of one 5-week and four 4-week cycles during the obinutuzumab/venetoclax combination part of the regimen. Venetoclax was administered according to a weekly ramp-up schedule over 5 weeks to the recommended daily dose of 400 mg.

    Drug: Obinutuzumab · Drug: Bendamustine · Drug: Venetoclax

Interventions

  • Administered via intravenous infusion

    Also known as: Gazyva

  • Administered via intravenous infusion

    Also known as: Bendeka

  • The venetoclax dose was administered according to a weekly ramp-up schedule over 5 weeks to the recommended daily dose of 400 mg. Venetoclax was continued for a total duration of up to 53 weeks, including the 5-week ramp-up schedule. Participants were instructed to take venetoclax tablets with a meal and water at approximately the same time each day. Venetoclax tablets were to be swallowed whole and not chewed, crushed, or broken prior to swallowing.

    Also known as: Venclexta, ABT-199, GDC-0199

06

What researchers measure

Primary outcomes

  1. Percentage of Participants Achieving Low Tumor Burden Status With Induction of Obinutuzumab or Obinutuzumab Plus Bendamustine (Debulking Period)

    Low tumor burden is defined as absolute lymphocyte count (ALC) \< 25 × 10\^9 /L and all lymph nodes \< 5 cm per computed tomography (CT) scans.

    Time frame: From Baseline to the end of Cycles 2, 4, and 6, up to approximately 24 weeks after initial dose of study drug

  2. Complete Remission Rate

    Complete remission rate is defined as the percentage of participants achieving complete remission (CR) or complete remission with incomplete marrow recovery (CRi) as their best response based on 2008 Modified International Workshop for Chronic Lymphocytic Leukemia National Cancer Institute-Working Group (IWCLL NCI-WG) criteria. CR required all of the following: * Peripheral blood lymphocytes \<4000/μL * Absence of lymphadenopathy by physical examination and computed tomography scan * No hepatomegaly or splenomegaly * Absence of disease or constitutional symptoms (unexplained fevers \>38°C, drenching night sweats, ≥10% weight loss in last 6 months) * Blood counts above the following: * Neutrophils \>1500/μL * Platelets \>100,000/μL * Hemoglobin \>11.0 g/dL * Bone marrow at least normocellular for age, \<30% lymphocytes CRi was defined as participants with CR who had persistent cytopenia unrelated to CLL but related to drug toxicity.

    Time frame: From first dose of study drug until the last participant completed Week 65 assessments (data cut-off date of 13 October 2021); overall median time on follow-up was up to 787 days

Secondary outcomes

  1. Overall Response Rate (ORR)

    ORR is defined as the percentage of participants who achieved a best response of complete remission (CR), complete remission with incomplete marrow recovery (CRi), nodular partial remission (nPR), or partial remission (PR) based on the 2008 Modified IWCLL NCI-WG criteria at any time during the study as assessed by investigator up through the completion of the 65-week disease response assessment after the start of venetoclax. Participants who did not respond were considered non-responders.

    Time frame: From first dose of study drug until the last participant completed Week 65 assessments (data cut-off date of 13 October 2021); overall median time on follow-up was up to 787 days

  2. Duration of Response (DoR)

    DoR is defined as the number of days from the date of first response (CR, CRi, nPR, or PR per the 2008 Modified IWCLL NCI-WG criteria) to the date of disease progression or death, whichever occurs first. All disease progression was to be included regardless whether the event occurred during or after the participant was taking any study drug (either venetoclax, obinutuzumab, or bendamustine). Duration of response was analyzed by Kaplan-Meier (K-M) methodology.

    Time frame: From first dose of study drug until the last participant completed Week 65 assessments (data cut-off date of 13 October 2021); overall median time on follow-up was up to 787 days

  3. Progression-Free Survival (PFS)

    PFS is defined as the number of days from the date of first dose of any study drug (either venetoclax, obinutuzumab, or bendamustine) to the date of disease progression or death, whichever occurs first. All disease progression was to be included regardless whether the event occurred during or after the participant was taking any study drug. Progression-free survival was analyzed by Kaplan-Meier methodology.

    Time frame: From first dose of study drug until the last participant completed Week 65 assessments (data cut-off date of 13 October 2021); overall median time on follow-up was up to 787 days

  4. Time to Progression (TTP)

    TTP is defined as the number of days from the date of first dose of any study drug (either venetoclax, obinutuzumab, or bendamustine) to date of disease progression. All disease progression was to be included regardless of whether the event occurred during or after the participant was taking any study drug.The distribution of the time to progression was estimated using Kaplan-Meier methodology.

    Time frame: From first dose of study drug until the last participant completed Week 65 assessments (data cut-off date of 13 October 2021); overall median time on follow-up was up to 787 days

  5. Overall Survival (OS)

    OS is defined as number of days from the date of first dose of any study drug (either venetoclax, obinutuzumab, or bendamustine) to the date of death. If a participant had not died, their data was censored at the date when they were last known to be alive prior to the cutoff date.The distribution of OS was estimated using Kaplan-Meier methodology.

    Time frame: From first dose of study drug until the last participant completed Week 65 assessments (data cut-off date of 13 October 2021); overall median time on follow-up was up to 787 days

  6. Undetectable Minimal Residual Disease (UMRD) Rate

    The level of MRD was assessed in the peripheral blood of all participants at 5 months after last dose of obinutuzumab, and at 3 months after last dose of venetoclax/end of treatment (including early study termination) to determine the rate of UMRD. Undetectable Minimal Residual Disease is defined as less than one CLL cell per 10,000 leukocytes (\< 10\^-4 ).

    Time frame: From first dose of study drug until the last participant completed Week 65 assessments (data cut-off date of 13 October 2021)

07

Results

Posted Nov 3, 2022

Participant flow

Participant flow — Overall Study
MilestoneObinutuzumabObinutuzumab/Bendamustine
Started8436
Completed00
Not completed8436
Withdrew: Death93
Withdrew: Withdrawal by subject12
Withdrew: Covid-19 infection10
Withdrew: Non-compliance with study procedures11
Withdrew: Lost to follow-up02
Withdrew: Other, not specified7228

Outcome measures

PrimaryPercentage of Participants Achieving Low Tumor Burden Status With Induction of Obinutuzumab or Obinutuzumab Plus Bendamustine (Debulking Period)

Low tumor burden is defined as absolute lymphocyte count (ALC) \< 25 × 10\^9 /L and all lymph nodes \< 5 cm per computed tomography (CT) scans.

Time frame:
From Baseline to the end of Cycles 2, 4, and 6, up to approximately 24 weeks after initial dose of study drug
Reported as:
Number · percentage of participants
Percentage of Participants Achieving Low Tumor Burden Status With Induction of Obinutuzumab or Obinutuzumab Plus Bendamustine (Debulking Period)
percentage of participantsObinutuzumabObinutuzumab/Bendamustine
From Baseline to the End of Cycle 281.483.9
From Baseline to the End of Cycle 488.387.1
From Baseline to the End of Cycle 695.090.3
PrimaryComplete Remission Rate

Complete remission rate is defined as the percentage of participants achieving complete remission (CR) or complete remission with incomplete marrow recovery (CRi) as their best response based on 2008 Modified International Workshop for Chronic Lymphocytic Leukemia National Cancer Institute-Working Group (IWCLL NCI-WG) criteria. CR required all of the following: * Peripheral blood lymphocytes \<4000/μL * Absence of lymphadenopathy by physical examination and computed tomography scan * No hepatomegaly or splenomegaly * Absence of disease or constitutional symptoms (unexplained fevers \>38°C, drenching night sweats, ≥10% weight loss in last 6 months) * Blood counts above the following: * Neutrophils \>1500/μL * Platelets \>100,000/μL * Hemoglobin \>11.0 g/dL * Bone marrow at least normocellular for age, \<30% lymphocytes CRi was defined as participants with CR who had persistent cytopenia unrelated to CLL but related to drug toxicity.

Time frame:
From first dose of study drug until the last participant completed Week 65 assessments (data cut-off date of 13 October 2021); overall median time on follow-up was up to 787 days
Reported as:
Number · percentage of participants
Complete Remission Rate
percentage of participantsObinutuzumabObinutuzumab/Bendamustine
Complete Remission Rate51.2 (40.0 to 62.3)16.7 (6.4 to 32.8)
SecondaryOverall Response Rate (ORR)

ORR is defined as the percentage of participants who achieved a best response of complete remission (CR), complete remission with incomplete marrow recovery (CRi), nodular partial remission (nPR), or partial remission (PR) based on the 2008 Modified IWCLL NCI-WG criteria at any time during the study as assessed by investigator up through the completion of the 65-week disease response assessment after the start of venetoclax. Participants who did not respond were considered non-responders.

Time frame:
From first dose of study drug until the last participant completed Week 65 assessments (data cut-off date of 13 October 2021); overall median time on follow-up was up to 787 days
Reported as:
Number · percentage of participants
Overall Response Rate (ORR)
percentage of participantsObinutuzumabObinutuzumab/Bendamustine
Overall Response Rate (ORR)94.0 (86.7 to 98.0)88.9 (73.9 to 96.9)
SecondaryDuration of Response (DoR)

DoR is defined as the number of days from the date of first response (CR, CRi, nPR, or PR per the 2008 Modified IWCLL NCI-WG criteria) to the date of disease progression or death, whichever occurs first. All disease progression was to be included regardless whether the event occurred during or after the participant was taking any study drug (either venetoclax, obinutuzumab, or bendamustine). Duration of response was analyzed by Kaplan-Meier (K-M) methodology.

Time frame:
From first dose of study drug until the last participant completed Week 65 assessments (data cut-off date of 13 October 2021); overall median time on follow-up was up to 787 days
Reported as:
Median · months
Duration of Response (DoR)
monthsObinutuzumabObinutuzumab/Bendamustine
Duration of Response (DoR)21.7 (11.8 to NA)NA (NA to NA)
SecondaryProgression-Free Survival (PFS)

PFS is defined as the number of days from the date of first dose of any study drug (either venetoclax, obinutuzumab, or bendamustine) to the date of disease progression or death, whichever occurs first. All disease progression was to be included regardless whether the event occurred during or after the participant was taking any study drug. Progression-free survival was analyzed by Kaplan-Meier methodology.

Time frame:
From first dose of study drug until the last participant completed Week 65 assessments (data cut-off date of 13 October 2021); overall median time on follow-up was up to 787 days
Reported as:
Median · months
Progression-Free Survival (PFS)
monthsObinutuzumabObinutuzumab/Bendamustine
Progression-Free Survival (PFS)23.3 (NA to NA)NA (17.5 to NA)
SecondaryTime to Progression (TTP)

TTP is defined as the number of days from the date of first dose of any study drug (either venetoclax, obinutuzumab, or bendamustine) to date of disease progression. All disease progression was to be included regardless of whether the event occurred during or after the participant was taking any study drug.The distribution of the time to progression was estimated using Kaplan-Meier methodology.

Time frame:
From first dose of study drug until the last participant completed Week 65 assessments (data cut-off date of 13 October 2021); overall median time on follow-up was up to 787 days
Reported as:
Median · months
Time to Progression (TTP)
monthsObinutuzumabObinutuzumab/Bendamustine
Time to Progression (TTP)NA (NA to NA)NA (NA to NA)
SecondaryOverall Survival (OS)

OS is defined as number of days from the date of first dose of any study drug (either venetoclax, obinutuzumab, or bendamustine) to the date of death. If a participant had not died, their data was censored at the date when they were last known to be alive prior to the cutoff date.The distribution of OS was estimated using Kaplan-Meier methodology.

Time frame:
From first dose of study drug until the last participant completed Week 65 assessments (data cut-off date of 13 October 2021); overall median time on follow-up was up to 787 days
Reported as:
Median · months
Overall Survival (OS)
monthsObinutuzumabObinutuzumab/Bendamustine
Overall Survival (OS)NA (NA to NA)NA (NA to NA)
SecondaryUndetectable Minimal Residual Disease (UMRD) Rate

The level of MRD was assessed in the peripheral blood of all participants at 5 months after last dose of obinutuzumab, and at 3 months after last dose of venetoclax/end of treatment (including early study termination) to determine the rate of UMRD. Undetectable Minimal Residual Disease is defined as less than one CLL cell per 10,000 leukocytes (\< 10\^-4 ).

Time frame:
From first dose of study drug until the last participant completed Week 65 assessments (data cut-off date of 13 October 2021)
Reported as:
Number · percentage of participants
Undetectable Minimal Residual Disease (UMRD) Rate
percentage of participantsObinutuzumabObinutuzumab/Bendamustine
At Week 38100 (95.3 to 100)100 (87.7 to 100)
At Week 6595.5 (87.5 to 99.1)100 (83.9 to 100)

Adverse events

Collected over All-cause mortality and adverse event tables include events reported from enrollment to end of study. Median time patients were followed was: 1183.0 days (Obinutuzumab Debulking); 1185.5 days (Obinutuzumab + Bendamustine Debulking); 1114.0 days (Obinutuzumab + Venetoclax Post-debulking); and 992.5 days (Venetoclax Monotherapy Post-debulking).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Obinutuzumab Debulking1/84 (1.2%)7/84 (8.3%)82/84 (97.6%)
Obinutuzumab + Bendamustine Debulking0/36 (0%)3/36 (8.3%)35/36 (97.2%)
Obinutuzumab + Venetoclax Post-debulking1/117 (0.9%)15/117 (12.8%)105/117 (89.7%)
Venetoclax Monotherapy Post-debulking10/114 (8.8%)13/114 (11.4%)90/114 (78.9%)
Most frequent serious events
Showing 10 of 29
Most frequent serious events
EventObinutuzumab DebulkingObinutuzumab + Bendamustine DebulkingObinutuzumab + Venetoclax Post-debulkingVenetoclax Monotherapy Post-debulking
COVID-19 PNEUMONIAInfections and infestations0/840/365/1170/114
NEUTROPENIABlood and lymphatic system disorders0/841/360/1170/114
TUMOUR LYSIS SYNDROMEMetabolism and nutrition disorders2/841/361/1170/114
SQUAMOUS CELL CARCINOMANeoplasms benign, malignant and unspecified (incl cysts and polyps)0/841/361/1170/114
COVID-19Infections and infestations0/840/360/1172/114
PNEUMONIAInfections and infestations0/840/362/1171/114
FEBRILE NEUTROPENIABlood and lymphatic system disorders1/840/360/1170/114
ACUTE MYOCARDIAL INFARCTIONCardiac disorders1/840/361/1170/114
BRONCHITISInfections and infestations1/840/360/1170/114
SKIN INFECTIONInfections and infestations1/840/360/1170/114
Most frequent other events
Showing 10 of 65
Most frequent other events
EventObinutuzumab DebulkingObinutuzumab + Bendamustine DebulkingObinutuzumab + Venetoclax Post-debulkingVenetoclax Monotherapy Post-debulking
INFUSION RELATED REACTIONInjury, poisoning and procedural complications63/8425/363/1170/114
NAUSEAGastrointestinal disorders36/8421/3636/1178/114
FATIGUEGeneral disorders37/8413/3618/11713/114
NEUTROPENIABlood and lymphatic system disorders14/8413/3635/11716/114
DIARRHOEAGastrointestinal disorders17/8411/3636/11722/114
CONSTIPATIONGastrointestinal disorders11/8411/369/1172/114
PYREXIAGeneral disorders10/8410/365/1174/114
HEADACHENervous system disorders22/849/3610/1179/114
HYPERURICAEMIAMetabolism and nutrition disorders4/848/361/1172/114
ARTHRALGIAMusculoskeletal and connective tissue disorders12/848/3614/1175/114

Baseline characteristics

All Treated Participants: all enrolled participants who received at least one dose of any study drug

Age, Continuous
Age, Continuous(years)ObinutuzumabObinutuzumab/BendamustineTotal
Mean64.5 ± 10.0660.7 ± 9.0763.4 ± 9.90
Sex: Female, Male
Sex: Female, Male(Participants)ObinutuzumabObinutuzumab/BendamustineTotal
Female29938
Male552782
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)ObinutuzumabObinutuzumab/BendamustineTotal
White7634110
Black or African American527
Asian000
American Indian/Alaska Native000
Native Hawaiian or Other Pacific Islander000
Other000
Missing303
08

Study locations

15 sites
  • Arizona Oncology Associates, PC-HOPE /ID# 202335
    Tempe, Arizona 85284-1812, United States
  • Rocky Mountain Cancer Centers - Denver Midtown /ID# 202328
    Denver, Colorado 80218, United States
  • MidAmerica Division, Inc. /ID# 201099
    Kansas City, Missouri 64132, United States
  • Oncology Hematology Care, Inc. /ID# 202397
    Cincinnati, Ohio 45236-2725, United States
  • Willamette Valley Cancer Institute and Research Center /ID# 201201
    Eugene, Oregon 97401-6043, United States
  • Prisma Health Cancer Inst - Eastside /ID# 202329
    Greenville, South Carolina 29615, United States
  • Tennessee Oncology - Chattanooga /ID# 202840
    Chattanooga, Tennessee 37404-1108, United States
  • Tennessee Oncology-Nashville Centennial /ID# 201098
    Nashville, Tennessee 37203-1632, United States
  • Texas Oncology - Austin Midtown /ID# 201199
    Austin, Texas 78705, United States
  • Texas Oncology - Beaumont /ID# 202359
    Beaumont, Texas 77701-4691, United States
  • Texas Oncology - Medical City Dallas /ID# 201196
    Dallas, Texas 75230, United States
  • Texas Oncology - McAllen /ID# 202331
    McAllen, Texas 78503, United States
  • Texas Oncology - San Antonio Medical Center /ID# 202332
    San Antonio, Texas 78240-5251, United States
  • Texas Oncology - Northeast Texas /ID# 201211
    Tyler, Texas 75702, United States
  • Northwest Cancer Specialists, P.C. /ID# 201198
    Vancouver, Washington 98684, United States
09

References and documents

Publications

  • Flinn IW, Andorsky D, Melear J, Manda S, Anz B III, Kolibaba K, Yimer H, Burke JM, Fanning S, Courtright J, Islas-Ohlmayer M, Kambhampati S, Vizkelety T, Pesko J, Chyla B, Jiang D, Sharman JP. Debulking Before Initiation of Venetoclax Therapy in Untreated Patients with Chronic Lymphocytic Leukemia: Results from a Phase 3b Study. American Society of Hematology - 63rd Annual Meeting. 2021
  • Sharman J, Andorsky D, Melear J, Manda S, Anz B III, Kolibaba K, Yimer H, Burke J, Fanning S, Courtright J, Islas-Ohlmayer M, Kambhampati S, Jiang D, Pesko D, Vizkelety T, Sharmokh S, Nielsen J, Flinn I. Phase 3b study to evaluate debulking regimens prior to initiating venetoclax therapy in untreated patients with chronic lymphocytic leukemia. Florida Society of Clinical Oncology-2020 Fall Session
  • Flinn I, Andorsky D, Melear J, Manda S, Anz B III, Kolibaba K, Yimer H, Burke J, Fanning S, Courtright J, Islas-Ohlmayer M, Kambhampati S, Jiang D, Pesko D, Vizkelety T, Sharmokh S, Sharman J. Debulking Regimens Prior To Initiating Venetoclax Therapy in Untreated Patients with Chronic Lymphocytic Leukemia: Interim Results from a Phase 3b Study. American Society of Hematology - 62nd Annual Meeting. 2020
  • Sharman J, Andorsky D, Melear J, Manda S, Anz B III, Kolibaba K, Yimer H, Burke J, Fanning S, Courtright J, Islas-Ohlmayer M, Kambhampati S, Jiang D, Pesko J, Vizkelety T, Sharmokh S, Nielsen J, Flinn I. Phase 3b Study to Evaluate Debulking Regimens Prior to Initiating Venetoclax Therapy in Untreated Patients with Chronic Lymphocytic Leukemia. Society of Hematologic Oncology-8th Annual Meeting. 2020
  • Sharman J, Andorsky D. Melear J, Manda S, Anz B II, Kolibaba K, Yimer H, Burke J, Fanning S, Courtright J, Islas-Ohlmayer M, Kambhampati S, Jiang D, Pesko J, Vizkelety T, Sharmkokh S, Nielsen J, Flinn I. Phase 3b study to evaluate debulking regimens prior to initiating venetoclax therapy in untreated patients with chronic lymphocytic leukemia. European Hematology Association-25th Congress. 2020
  • Sharman J, Andorsky D, Melear J, Manda S, Anz B III, Kolibaba K, Yimer H, Burke J, Fanning S, Courtright J, Islas-Ohlmayer M, Kambhampati S, Al Masud A, Zimmerman T, Nielsen J, Vizkelety T, Jiang D, Flinn I. Debulking eliminates need for hospitalization prior to initiating frontline venetoclax therapy in previously untreated CLL patients: a phase 3b study. American Society of Hematology - 61st Annual Meeting. 2019

Related links

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

Time frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

Access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Data sharing details ↗ · vivli.org

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2018 to primary completion in Oct 2021, 38 months.

Results were first posted in Nov 2022, 1 year after primary completion.

Of 57 industry-sponsored phase 3 interventional studies under Leukemia, Lymphocytic, Chronic, B-Cell, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 73. This study's 38 months is below that.

Counting every sponsor, half of 83 studies reached it within 59 months; a quarter within 43 and three quarters within 76.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 16, 2018
First posted
Jan 23, 2018
StartActual
Aug 10, 2018
Primary completionActual
Oct 12, 2021
CompletionActual
Jul 12, 2023
Results first posted
Nov 3, 2022
Last update
Aug 6, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03406156
Lead sponsor
AbbVie
Responsible party
Sponsor
First posted
Jan 23, 2018
Start date
Aug 10, 2018
Primary completion
Oct 12, 2021
Completion
Jul 12, 2023
Results posted
Nov 3, 2022
Last update
Aug 6, 2024

Study contacts

ABBVIE INC.
study director · AbbVie

Oversight

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

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Venetoclax

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