Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Syndrome

Leukemia

Leukemia, Lymphoid

Lymphoma

Leukemia, Lymphocytic, Chronic, B-Cell

Tumor Lysis Syndrome

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Lymphosarcoma

Chronic Lymphocytic Leukemia

Chromosome 17p Deletion

Antineoplastic Agents

All Drugs and Chemicals

Venetoclax

Obinutuzumab

Bendamustine Hydrochloride

Antineoplastic Agents, Alkylating

Alkylating Agents

Antineoplastic Agents, Immunological

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.

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.

Bendamustine

The venetoclax dose was administered according to a weekly ramp-up schedule over 5 weeks to the recommended daily dose of 400 mg. 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.

ABBVIE INC.

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.

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.

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 3b 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

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.

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.

Complete response 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 by physical examination
* 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.

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.

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.

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.

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.

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.

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 ).

AbbVie

Participants who received obinutuzumab during the debulking regimen period

Obinutuzumab_Debulk

Participants who received obinutuzumab and bendamustine during the debulking regimen period

Obinutuzumab_Bendamustine_Debulk

Participants who received obinutuzumab and venetoclax during the post debulking period

Obinutuzumab_Venetoclax_Postdebulk

Participants who received venetoclax monotherapy during the post debulking period; safety data were collected starting 30 days after the last dose of obinutuzumab

Venetoclax_MONO_Postdebulk

Obinutuzumab/Bendamustine

Total

Age, Continuous

Sex: Female, Male

White

Black or African American

Asian

American Indian/Alaska Native

Native Hawaiian or Other Pacific Islander

Other

Missing

Race/Ethnicity, Customized

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

Global Medical Services

From Baseline to the End of Cycle 2

From Baseline to the End of Cycle 4

From Baseline to the End of Cycle 6

Participants who completed debulking and were subsequently treated with venetoclax with available data

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

All treated participants who received at least 1 dose of any study drug

Complete Response Rate

Overall Response Rate (ORR)

All treated participants who received at least 1 dose of any study drug and who had a record of first response (CR, CRi, PR, or nPR)

Duration of Response (DoR)

Progression-Free Survival (PFS)

Time to Progression (TTP)

Overall Survival (OS)

At Week 38

At Week 65

Undetectable Minimal Residual Disease (UMRD) Rate

Overall Study

Central Nervous System Depressants

Anesthetics

Patients will be operated gynecologic cancers and have American Society of Anesthesia score 1 or 2. Subjects will walk during one hour with average speed 3 km/hour 12 hour before surgery.

Patients will be operated gynecologic cancers and have American Society of Anesthesia score 1 or 2. Subjects will not walk preoperatively.

walking

Preoperative walking's effect of postoperative bowel functions ASA 1 or 2 in patient with gynecologic cancers.

walking preoperatively not walking preoperatively

Doctor who evaluate bowel function will not know whether patients walked or not

Preoperatively Walking's Effect of Postoperative Bowel Functions in Patient With Gynecologic Cancer.

Jinekolojik Kanserler Nedeni Ile Opere Edilen Hastalarda Preoperatif yürümenin Postoperatif Barsak fonksiyonlarına Etkisi

Doctor will detect the time with auscultation

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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	NCT03406156	Chronic Lymphoc... Small Lymphocyt...	Obinutuzumab Bendamustine Venetoclax	18 Years - 99 Years	AbbVie
Preoperatively Walking's Effect of Postoperative Bowel Functions in Patient With Gynecologic Cancer.	NCT03553121	Postoperative B...	walking	18 Years - 80 Years	Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Spots Global Cancer Trial Database for debulking

Every month we try and update this database with for debulking cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for debulking

Every month we try and update this database with for debulking cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for debulking cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.