TriangleNCT02242942 · CITED IN SOURCE DOCUMENTS
Comparison of the Treatments of Obinutuzumab + Venetoclax Versus Obinutuzumab + Chlorambucil in Patients With Chronic Lymphocytic Leukemia
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2025-11-06
This open-label, multicenter, randomized Phase III study is designed to compare the efficacy and safety of a combined regimen of obinutuzumab and venetoclax versus obinutuzumab + chlorambucil in participants with chronic lymphocytic leukemia (CLL) and coexisting medical conditions. The time on study treatment was approximately one year and the follow-up period will be up to 9 years
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Progression Free Survival (PFS) Based on Institutional Review Committee (IRC)-Assessments According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria
Progression Free Survival (PFS) Based on Investigator Assessment According to IWCLL Criteria
Percentage of Participants With an Overall Response (OR) at Completion of Treatment, as Determined by the Investigator According to IWCLL Criteria
Percentage of Participants With a Complete Response Rate (CRR) at the Completion of Treatment Assessment as Determined by the Investigator According to IWCLL Criteria
Percentage of Participants With Minimal Residual Disease (MRD) Negativity in Peripheral Blood as Measured by Allele-Specific Oligonucleotide Polymerase Chain Reaction (ASO-PCR) at Completion of Treatment
Percentage of Participants With MRD Negativity in Bone Marrow as Measured by ASO-PCR at Completion of Treatment
Overall Survival (OS)
Percentage of Participants With MRD Negativity in Peripheral Blood as Measured by ASO-PCR at Completion of Combination Treatment Assessment
Percentage of Participants With MRD Negativity in Bone Marrow as Measured by ASO-PCR at Completion of Combination Treatment Assessment
Percentage of Participants With OR at Completion of Combination Treatment Response Assessment
Duration of Objective Response (DOR)
Percentage of Participants By Best Response Achieved (CR, CRi, PR, Stable Disease (SD), or PD)
Event-Free Survival
Time to Next Anti-Leukemic Treatment
Number of Participants With Adverse Events (AEs)
Percentage of Participants With CD19 + /CD5+ B Cells or CD14+ Monocytes
Percentage of Participants With Human-Anti-Human Antibodies
Percentage of Participants Recorded as Premature Study Withdrawals
Plasma Concentrations of Venetoclax
Serum Concentrations of Obinutuzumab
Change From Baseline in M.D. Anderson Symptom Inventory-CLL (MDASI-CLL) Score
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQC30)
Change From Baseline in EuroQol 5 Dimension Questionnaire (EQ-5D-3L)
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion Criteria: * Documented previously untreated CLL according to the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria * CLL requiring treatment according to IWCLL criteria * Total Cumulative Illness Rating Scale (CIRS score) greater than (\>) 6 * Adequate marrow function independent of growth factor or transfusion support within 2 weeks of screening as per protocol, unless cytopenia is due to marrow involvement of CLL * Adequate liver function * Life expectancy \> 6 months * Agreement to use highly effective contraceptive methods per protocol Exclusion Criteria: * Transformation of CLL to aggressive Non-Hodgkin's lymphoma (Richter's transformation or pro-lymphocytic leukemia) * Known central nervous system involvement * Participants with a history of confirmed progressive multifocal leukoencephalopathy (PML) * An individual organ/ system impairment score of 4 as assessed by the CIRS definition limiting the ability to receive the treatment regimen of this trial with the exception of eyes, ears, nose, throat organ system * Participants with uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia * Inadequate renal function * History of prior malignancy, except for conditions as listed in the protocol if participants have recovered from the acute side effects incurred as a result of previous therapy * Use of investigational agents or concurrent anti-cancer treatment within the last 4 weeks of registration * Participants with active bacterial, viral, or fungal infection requiring systemic treatment within the last two months prior to registration * History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products * Hypersensitivity to chlorambucil, obinutuzumab, or venetoclax or to any of the excipients * Pregnant women and nursing mothers * Positive test results for chronic hepatitis B virus (HBV) infection (defined as positive hepatitis B surface antigen \[HBsAg\] serology) or positive test result for hepatitis C (hepatitis C virus \[HCV\] antibody serology testing) * Participants with known infection with human immunodeficiency virus (HIV) or human T-cell leukemia virus-1 (HTLV-1) * Requires the use of warfarin, marcumar, or phenprocoumon * Received agents known to be strong and moderate Cytochrome P450 3A inhibitors or inducers within 7 days prior to the first dose of study drug
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Subjects received obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles comprised of 28 days.
- intervention Names
- Drug: Venetoclax
- Drug: Obinutuzumab
- label
- Safety Run-in Obinutuzumab + Venetoclax
- type
- EXPERIMENTAL
- description
- Participants will receive obinutuzumab for 6 cycles and chlorambucil for 12 cycles. Cycles will comprise 28 days.
- intervention Names
- Drug: Chlorambucil
- Drug: Obinutuzumab
- label
- Obinutuzumab + Chlorambucil
- type
- EXPERIMENTAL
- description
- Participants will receive obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles will comprise 28 days.
- intervention Names
- Drug: Venetoclax
- Drug: Obinutuzumab
- label
- Obinutuzumab + Venetoclax
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Obinutuzumab + Chlorambucil
- description
- Chlorambucil 0.5 milligrams per kilogram (mg/kg) orally at Day 1 and Day 15 at of each 28 day cycle for 12 cycles.
- name
- Chlorambucil
- type
- DRUG
- arm Group Labels
- Obinutuzumab + Venetoclax
- Safety Run-in Obinutuzumab + Venetoclax
- description
- Venetoclax, oral tablet: 20 mg daily during Cycle 1, Day 22-28; 50 mg daily during Cycle 2, Day 1-7; 100 mg daily during Cycle 2, Day 8-14; 200 mg daily during Cycle 2, Day 15-21; 400 mg daily during Cycle 2, Day 22-28 and on Day 1-28 for all subsequent cycles until the end of Cycle 12.
- name
- Venetoclax
- other Names
- ABT-0199, GDC-0199
- type
- DRUG
- arm Group Labels
- Obinutuzumab + Chlorambucil
- Obinutuzumab + Venetoclax
- Safety Run-in Obinutuzumab + Venetoclax
- description
- Obinutuzumab, IV infusion: 100 mg or 1000 mg, depending on splitting rules, at Cycle 1, Day 1 (if 100 mg was received on Day 1, 900 mg will be administered on Cycle 1, Day 2); 1000 mg at Cycle 1, Day 8 and Day 15; 1000 mg at Day 1 for all subsequent cycles until the end of Cycle 6
- name
- Obinutuzumab
- other Names
- GA-101; Gazyva
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 445
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- PFS was determined according to IWCLL 2008 criteria and defined as the time from randomization to the first occurrence of PD or death from any cause. Disease progression was characterized by at least one of the following: 1) \>/= 50% increase in the absolute number of circulating lymphocytes to at least 5\*10\^9/L, 2) Appearance of new palpable lymph nodes (\> 15 mm in longest diameter) or any new extra-nodal lesion; 3) \>/= 50% increase in the longest diameter of any previous site of lymphadenopathy; 4) \>/= 50% increase in the enlargement of the liver and/or spleen; 5) Transformation to a more aggressive histology.
- measure
- Progression Free Survival (PFS) Based on Investigator Assessment According to IWCLL Criteria
- time Frame
- Baseline until disease progression or death up to approximately 3.75 years
- secondary Outcomes
- description
- PFS was determined according to IWCLL 2008 criteria and defined as the time from randomization to the first occurrence of progressive disease (PD) or death from any cause. Disease progression was characterized by at least one of the following: 1) \>/= 50% increase in the absolute number of circulating lymphocytes to at least 5\*10\^9/L, 2) Appearance of new palpable lymph nodes (\> 15 mm in longest diameter) or any new extra-nodal lesion; 3) \>/= 50% increase in the longest diameter of any previous site of lymphadenopathy; 4) \>/= 50% increase in the enlargement of the liver and/or spleen; 5) Transformation to a more aggressive histology.
- measure
- Progression Free Survival (PFS) Based on Institutional Review Committee (IRC)-Assessments According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria
- time Frame
- Baseline until disease progression or death up to approximately 3.75 years
- description
- OR was defined as complete response (CR), CR with incomplete bone marrow recovery (CRi), or partial response (PR) according to IWCLL 2008 criteria. CR requires all of the following: peripheral blood lymphocytes below 4x10\^9/L, absence of lymphadenopathy by physical examination and computed tomography (CT) scan, no hepatomegaly or splenomegaly, absence of disease or constitutional symptoms, blood counts of neutrophils \>1.5\*10\^9/L, platelets \>100\*10\^9/L and hemoglobin \>110 g/L, bone marrow at least normocellular for age without clonal infiltrate (except for Cri). PR: two of the following features for at least 2 months: \>/= 50% decrease in peripheral blood lymphocyte count from the pretreatment value, \>/=50% reduction in lymphadenopathy, \>/=50% reduction of liver and/or spleen enlargement, and at least one of the following blood counts: neutrophils \>1.5\*10\^9/L, platelets \>100\*10\^9/L and hemoglobin \>110 g/L.
- measure
- Percentage of Participants With an Overall Response (OR) at Completion of Treatment, as Determined by the Investigator According to IWCLL Criteria
- time Frame
- At the completion of treatment assessment 3 months after treatment completion (at approximately 15 months)
- description
- CRR was defined as the rate of a clinical response of CR or CRi according to IWCLL 2008 criteria. CR requires all of the following: peripheral blood lymphocytes below 4x10\^9/L, absence of lymphadenopathy by physical examination and CT scan, no hepatomegaly or splenomegaly, absence of disease or constitutional symptoms, blood counts of neutrophils \>1.5\*10\^9/L, platelets \>100\*10\^9/L and hemoglobin \>110 g/L, bone marrow at least normocellular for age without clonal infiltrate (except for Cri).
- measure
- Percentage of Participants With a Complete Response Rate (CRR) at the Completion of Treatment Assessment as Determined by the Investigator According to IWCLL Criteria
- time Frame
- At the completion of treatment assessment 3 months after treatment completion (at approximately 15 months)
- description
- MRD negativity was defined as having \< 1 CLL cell per 10,000 leucocytes in peripheral blood.
- measure
- Percentage of Participants With Minimal Residual Disease (MRD) Negativity in Peripheral Blood as Measured by Allele-Specific Oligonucleotide Polymerase Chain Reaction (ASO-PCR) at Completion of Treatment
- time Frame
- At the completion of treatment assessment 3 months after treatment completion (at approximately 15 months)
- description
- MRD negativity was defined as having \< 1 CLL cell per 10,000 leucocytes in bone marrow.
- measure
- Percentage of Participants With MRD Negativity in Bone Marrow as Measured by ASO-PCR at Completion of Treatment
- time Frame
- At the completion of treatment assessment 3 months after treatment completion (at approximately 15 months)
- description
- OS was defined as the time between the date of randomization and the date of death due to any cause.
- measure
- Overall Survival (OS)
- time Frame
- Baseline until death, up to approximately 10.75 years
- description
- MRD negativity was defined as having \< 1 CLL cell per 10,000 leucocytes in peripheral blood.
- measure
- Percentage of Participants With MRD Negativity in Peripheral Blood as Measured by ASO-PCR at Completion of Combination Treatment Assessment
- time Frame
- Day 1 Cycle 9 or 3 months after last IV infusion, approximately 9 months
- description
- MRD negativity was defined as having \< 1 CLL cell per 10,000 leucocytes in bone marrow.
- measure
- Percentage of Participants With MRD Negativity in Bone Marrow as Measured by ASO-PCR at Completion of Combination Treatment Assessment
- time Frame
- Day 1 Cycle 9 or 3 months after last IV infusion at approximately 9 months
- description
- OR was defined as CR, CRi or PR according to IWCLL 2008 criteria. CR required all of the following: peripheral blood lymphocytes below 4x10\^9/L, absence of lymphadenopathy by physical examination, no hepatomegaly or splenomegaly, absence of disease or constitutional symptoms, blood counts of neutrophils \>1.5\*10\^9/L, platelets \>100\*10\^9/L and hemoglobin \>110 g/L. PR: two of the following features for at least 2 months: \>/= 50% decrease in peripheral blood lymphocyte count from the pretreatment value, \>/=50% reduction in lymphadenopathy, \>/=50% reduction of liver and/or spleen enlargement, and at least one of the following blood counts: neutrophils \>1.5\*10\^9/L, platelets \>100\*10\^9/L and hemoglobin \>110 g/L.
- measure
- Percentage of Participants With OR at Completion of Combination Treatment Response Assessment
- time Frame
- Day 1 Cycle 7 or 28 days after last IV infusion, approximately 6 months
- description
- PD was defined as lymphadenopathy, \>=50% increase in liver or spleen size, \>=50% increase in lymphocyte count, transformation to a more aggressive histology or occurrence of cytopenia.
- measure
- Duration of Objective Response (DOR)
- time Frame
- Time from the first occurrence of a documented objective response to the time of PD as determined by the investigator or death from any cause, up to approximately 10.75 years
- description
- CR: peripheral blood lymphocytes below 4x10\^9/L, absence of lymphadenopathy by physical examination and CT scan, no hepatomegaly or splenomegaly, absence of disease or constitutional symptoms, blood counts of neutrophils \>1.5\*10\^9/L, platelets \>100\*10\^9/L and hemoglobin \>110 g/L, bone marrow at least normocellular for age without clonal infiltrate (except for Cri). PR: any two for at least 2 months: \>/= 50% decrease in peripheral blood lymphocyte count from the pretreatment value, \>/=50% reduction in lymphadenopathy, \>/=50% reduction of liver and/or spleen enlargement, and at least one of the following blood counts: neutrophils \>1.5\*10\^9/L, platelets \>100\*10\^9/L and hemoglobin \>110 g/L. PD: lymphadenopathy, \>=50% increase in liver or spleen size, \>=50% increase in lymphocyte count, transformation to a more aggressive histology or occurrence of cytopenia. SD: a non-response and used to characterize participants who did not achieve a CR or a PR, and who have not exhibited PD.
- measure
- Percentage of Participants By Best Response Achieved (CR, CRi, PR, Stable Disease (SD), or PD)
- time Frame
- Baseline up to the completion of treatment assessment 3 months after treatment completion (up to approximately 15 months)
- measure
- Event-Free Survival
- time Frame
- Time between date of randomization and the date of disease progression/relapse on the basis of investigator-assessment, death, or start of a new anti-leukemic therapy, up to 10.75 years
Full study description
- brief Summary
- This open-label, multicenter, randomized Phase III study is designed to compare the efficacy and safety of a combined regimen of obinutuzumab and venetoclax versus obinutuzumab + chlorambucil in participants with chronic lymphocytic leukemia (CLL) and coexisting medical conditions. The time on study treatment was approximately one year and the follow-up period will be up to 9 years
Source references
- references
- citation
- Munir T, Martinez-Calle N, Xu S, Yang K, Ge X, Ali AK, Mohseninejad L, Dobi B, Rakonczai P, Ma H, Williams R, Aldairy W, Lamanna N. Indirect Comparisons of the Efficacy and Safety of Zanubrutinib versus Venetoclax plus Obinutuzumab in Treatment-Naive Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma. Oncol Ther. 2025 Dec;13(4):1055-1070. doi: 10.1007/s40487-025-00380-0. Epub 2025 Sep 13.
- pmid
- 40944848
- type
- DERIVED
- citation
- Al-Sawaf O, Robrecht S, Zhang C, Olivieri S, Chang YM, Fink AM, Tausch E, Schneider C, Ritgen M, Kreuzer KA, Sivchev L, Niemann CU, Schwarer A, Loscertales J, Weinkove R, Strumberg D, Kilfoyle A, Manzoor BS, Jawaid D, Emechebe N, Devine J, Boyer M, Runkel ED, Eichhorst B, Stilgenbauer S, Jiang Y, Hallek M, Fischer K. Venetoclax-obinutuzumab for previously untreated chronic lymphocytic leukemia: 6-year results of the randomized phase 3 CLL14 study. Blood. 2024 Oct 31;144(18):1924-1935. doi: 10.1182/blood.2024024631.
- pmid
- 39082668
- type
- DERIVED
- citation
- Langerbeins P, Giza A, Robrecht S, Cramer P, von Tresckow J, Al-Sawaf O, Fink AM, Furstenau M, Kutsch N, Simon F, Goede V, Hoechstetter M, Niemann CU, da Cunha-Bang C, Kater A, Dubois J, Gregor M, Staber PB, Tausch E, Schneider C, Stilgenbauer S, Eichhorst B, Fischer K, Hallek M. Reassessing the chronic lymphocytic leukemia International Prognostic Index in the era of targeted therapies. Blood. 2024 Jun 20;143(25):2588-2598. doi: 10.1182/blood.2023022564.
- pmid
- 38620092
- type
- DERIVED
- citation
- Al-Sawaf O, Zhang C, Jin HY, Robrecht S, Choi Y, Balasubramanian S, Kotak A, Chang YM, Fink AM, Tausch E, Schneider C, Ritgen M, Kreuzer KA, Chyla B, Paulson JN, Pallasch CP, Frenzel LP, Peifer M, Eichhorst B, Stilgenbauer S, Jiang Y, Hallek M, Fischer K. Transcriptomic profiles and 5-year results from the randomized CLL14 study of venetoclax plus obinutuzumab versus chlorambucil plus obinutuzumab in chronic lymphocytic leukemia. Nat Commun. 2023 Apr 18;14(1):2147. doi: 10.1038/s41467-023-37648-w.
- pmid
- 37072421
- type
- DERIVED
- citation
- Badawi M, Chen X, Marroum P, Suleiman AA, Mensing S, Koenigsdorfer A, Schiele JT, Palenski T, Samineni D, Hoffman D, Menon R, Salem AH. Bioavailability Evaluation of Venetoclax Lower-Strength Tablets and Oral Powder Formulations to Establish Interchangeability with the 100 mg Tablet. Clin Drug Investig. 2022 Aug;42(8):657-668. doi: 10.1007/s40261-022-01172-4. Epub 2022 Jul 13.
- pmid
- 35829925
- type
- DERIVED
- citation
- Samineni D, Gibiansky L, Wang B, Vadhavkar S, Rajwanshi R, Tandon M, Sinha A, Al-Sawaf O, Fischer K, Hallek M, Salem AH, Li C, Miles D. Pharmacokinetics and Exposure-Response Analysis of Venetoclax + Obinutuzumab in Chronic Lymphocytic Leukemia: Phase 1b Study and Phase 3 CLL14 Trial. Adv Ther. 2022 Aug;39(8):3635-3653. doi: 10.1007/s12325-022-02170-w. Epub 2022 Jun 16.
- pmid
- 35708885
- type
- DERIVED
- citation
- Al-Sawaf O, Zhang C, Lu T, Liao MZ, Panchal A, Robrecht S, Ching T, Tandon M, Fink AM, Tausch E, Schneider C, Ritgen M, Bottcher S, Kreuzer KA, Chyla B, Miles D, Wendtner CM, Eichhorst B, Stilgenbauer S, Jiang Y, Hallek M, Fischer K. Minimal Residual Disease Dynamics after Venetoclax-Obinutuzumab Treatment: Extended Off-Treatment Follow-up From the Randomized CLL14 Study. J Clin Oncol. 2021 Dec 20;39(36):4049-4060. doi: 10.1200/JCO.21.01181. Epub 2021 Oct 28.
- pmid
- 34709929
- type
- DERIVED
- citation
- Al-Sawaf O, Zhang C, Tandon M, Sinha A, Fink AM, Robrecht S, Samoylova O, Liberati AM, Pinilla-Ibarz J, Opat S, Sivcheva L, Le Du K, Fogliatto LM, Niemann CU, Weinkove R, Robinson S, Kipps TJ, Tausch E, Schary W, Ritgen M, Wendtner CM, Kreuzer KA, Eichhorst B, Stilgenbauer S, Hallek M, Fischer K. Venetoclax plus obinutuzumab versus chlorambucil plus obinutuzumab for previously untreated chronic lymphocytic leukaemia (CLL14): follow-up results from a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2020 Sep;21(9):1188-1200. doi: 10.1016/S1470-2045(20)30443-5.
- pmid
- 32888452
- type
- DERIVED
- citation
- Fischer K, Al-Sawaf O, Bahlo J, Fink AM, Tandon M, Dixon M, Robrecht S, Warburton S, Humphrey K, Samoylova O, Liberati AM, Pinilla-Ibarz J, Opat S, Sivcheva L, Le Du K, Fogliatto LM, Niemann CU, Weinkove R, Robinson S, Kipps TJ, Boettcher S, Tausch E, Humerickhouse R, Eichhorst B, Wendtner CM, Langerak AW, Kreuzer KA, Ritgen M, Goede V, Stilgenbauer S, Mobasher M, Hallek M. Venetoclax and Obinutuzumab in Patients with CLL and Coexisting Conditions. N Engl J Med. 2019 Jun 6;380(23):2225-2236. doi: 10.1056/NEJMoa1815281. Epub 2019 Jun 4.
- pmid
- 31166681
- type
- DERIVED
Source notices and limitations
Discovery and provenance
- release id
- ctgov-registry-7ad944f6deaf1f5cd6122126
- edge id
- nct-edge-03d942e1ef18533e4be8
- requested nct id
- NCT02242942
- primary nct id
- NCT02242942
- source kind
- nci_explicit_reference_or_link
- source record id
- Source null
- source file sha256
- a3c282d86c06355bc19b65dd6c0f0500e049a33f7bc5ec60898c1ab86f549b67
- payload sha256
- 8e52a3f8253596706789dc47cc61d25a2322020a914904cdbe75fe364bd06152
- payload
- clinical indication matching status
- not_inferred
- end exclusive
- true
- id
- nct-edge-03d942e1ef18533e4be8
- link basis
- explicit_NCT_identifier_in_acquired_source
- nct id
- NCT02242942
- occurrences
- context exact
- plus obinutuzumab vs. chlorambucil plus obinutuzumab):</p> <div class="pdq-content-list"><ol id="_1136"><li>The prospective <a href="/clinicaltrials/NCT02242942">CLL14</a> trial (NCT02242942) included 432 previously untreated patients with significant medical comorbidities (6 or higher on the Cumulative Illness Rating
- end
- 131450
- exact text
- NCT02242942
- start
- 131439
- context exact
- bucil plus obinutuzumab):</p> <div class="pdq-content-list"><ol id="_1136"><li>The prospective <a href="/clinicaltrials/NCT02242942">CLL14</a> trial (NCT02242942) included 432 previously untreated patients with significant medical comorbidities (6 or higher on the Cumulative Illness Rating Scale; median age, 72 years).
- end
- 131480
- exact text
- NCT02242942
- start
- 131469
- offset unit
- unicode_code_points
- source file
- /tmp/cancer-full-research/nci/raw/94021c3589cde88db0.html
- source file sha256
- a3c282d86c06355bc19b65dd6c0f0500e049a33f7bc5ec60898c1ab86f549b67
- source json pointer
- Source null
- source kind
- nci_explicit_reference_or_link
- source record id
- Source null
- source retrieved at
- 2026-09-09T23:21:54.948146+00:00
- source string basis
- UTF-8_text_with_universal_newline_translation
- source string sha256
- f211024171a6098ccb55e7b80f789a026b07c66361c52977ba3a3a06e9639511
- source title
- Chronic Lymphocytic Leukemia Treatment (PDQ®)–Health Professional Version
- source update dates
- context
- Updated: April 25, 2025
- datetime
- 2025-04-25T12:00:00Z
- display
- April 25, 2025
- release id
- ctgov-registry-7ad944f6deaf1f5cd6122126
- edge id
- nct-edge-a3b9b5fc0db6c14c9e35
- requested nct id
- NCT02242942
- primary nct id
- NCT02242942
- source kind
- fda_spl_label
- source record id
- 5d893369-497c-46ee-9b64-ee737fab4225
- source file sha256
- bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
- payload sha256
- f7d9178756ad10c3be59ac44b81134d7dc15e26c2a37c68ba842cfd84f7421a2
- payload
- application numbers
- NDA208573
- clinical indication matching status
- not_inferred
- end exclusive
- true
- id
- nct-edge-a3b9b5fc0db6c14c9e35
- link basis
- explicit_NCT_identifier_in_acquired_source
- nct id
- NCT02242942
- occurrences
- context exact
- EN+A arm and 42 in the FCR/BR arm. In Combination with Obinutuzumab CLL14 (BO25323) was a randomized (1:1), multicenter, open-label, actively controlled trial (NCT02242942) that evaluated the efficacy and safety of VENCLEXTA in combination with obinutuzumab (VEN+G) versus obinutuzumab in combination with chlorambucil (GClb) for p
- end
- 4361
- exact text
- NCT02242942
- start
- 4350
- offset unit
- unicode_code_points
- source file
- /tmp/cancer-full-research/indications/raw/labels-00300.json
- source file sha256
- bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
- source json pointer
- /results/98/clinical_studies/0
- source kind
- fda_spl_label
- source record id
- 5d893369-497c-46ee-9b64-ee737fab4225
- source string basis
- parsed_JSON_string_unmodified
- source string sha256
- e029d66014882009f1241859331c828e89c4363a558a3916f4f5f0b6a4c1e22b
- spl effective time
- 20260520
- spl set id
- b118a40d-6b56-cee3-10f6-ded821a97018
Preserved source evidence · Not medical advice