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Lymphoma, Non-HodgkinPhase 1/2NCT02055820

A Study Evaluating the Safety, Efficacy and Pharmacokinetics of Venetoclax Combined With Chemotherapy in Participants With B-Cell Non-Hodgkin's Lymphoma (NHL) and DLBCL

A Phase 1/2 study testing Venetoclax, Cyclophosphamide and Obinutuzumab in people with Lymphoma, Non-Hodgkin, run by Hoffmann-La Roche at 52 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a multicenter, open-label, dose-finding study of venetoclax administered orally in combination with rituximab (R) or obinutuzumab (G) and standard doses of cyclophosphamide, doxorubicin, vincristine and oral prednisone (CHOP) in participants with Non-Hodgkin's Lymphoma (NHL). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma, Non-Hodgkin
What is being tested?
Venetoclax, Cyclophosphamide and Obinutuzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
267 participants
Where
52 sitesin 10 countries
Study dates
17 Nov 2013to 28 Jun 2019
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • General Inclusion Criteria:
  • At least one bi-dimensionally measurable lymphoma lesion on CT scan defined as > 1.5 cm in its longest dimension, which is also FDG avid by screening PET scan.
  • Confirmed availability of archival or freshly biopsied tumor tissue prior to study enrollment
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
  • Adequate hematologic function
  • For female participants of childbearing potential, agreement to use highly effective forms of contraception
Show all 12Show fewer
  • Dose-Escalation Portion of the Study:
  • Participants must have histologically confirmed B-cell NHL, except MCL or SLL
  • Participants must have never received previous R-CHOP treatment
  • Any relapsed/refractory participants that are enrolled during the dose escalation should have received only a single previous treatment regimen
  • Expansion Portion of the Study:
  • Participants must have previously untreated CD20-positive DLBCL and IPI score must be 2-5

Who cannot join

  • General Exclusion Criteria:
  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
  • Contraindication to receive any of the individual components of CHOP, rituximab or obinutuzumab
  • Prior anthracycline therapy
  • Participants with ongoing corticosteroid use >30 mg per day of prednisone or equivalent
  • CNS lymphoma or primary mediastinal DLBCL
Show all 22Show fewer
  • Vaccination with live vaccines within 28 days prior to randomization
  • Chemotherapy or other investigational therapy within 28 days prior to the start of Cycle 1
  • History of other malignancy that could affect compliance with the protocol or interpretation of results
  • Evidence of significant, uncontrolled concomitant disease
  • Significant cardiovascular disease or significant pulmonary disease
  • Left ventricular ejection fraction less than (<) 50% as defined by multiple-gated acquisition (MUGA)
  • Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks prior to Cycle 1 Day 1
  • Received the following agents within 7 days prior to the first dose of venetoclax: steroid therapy for anti-neoplastic intent; strong and moderate cytochrome P450 (CYP) 3A4 inhibitors or inducers; grapefruit/grapefruit products, seville oranges or star fruit within 3 days prior to the first dose of venetoclax
  • Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
  • Recent major surgery
  • Women who are pregnant or lactating
  • Dose-Escalation Portion of the Study:
  • Participants with confirmed mantle cell lymphoma (MCL) or small lymphocytic lymphoma (SLL)
  • Expansion Portion of the Study:
  • Participants with transformed lymphoma (participants with discordant bone marrow involvement (i.e., low grade histology in bone marrow) may be considered after discussion with the Medical Monitor)
  • Prior therapy for NHL

Trial locations and contacts

52 sites in 10 countries.

52 sites in 10 countries

France11 sites

  • Hopital Henri Mondor, Unite Hemopathies lymphoides

    Créteil, 94010

  • Centre Hospitalier Départemental Les Oudairies

    La Roche-sur-Yon, 85025

  • Clinique Victor Hugo; Pharmacie

    Le Mans, 72015

  • Hopital Claude Huriez - CHU Lille

    Lille, 59037

  • Hopital Saint Eloi

    Montpellier, 34295

  • CHU Nantes - Hôtel Dieu; Service Assistance Medicale à la Procreation

    Nantes, 44093

  • Hôpital Saint-Louis

    Paris, 75475

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • CHU Rennes - Hopital Pontchaillou

    Rennes, 35033

  • Centre Henri Becquerel; Hematologie

    Rouen, 76038

  • Hôpital de Brabois Adultes

    Vandœuvre-lès-Nancy, 54511

Other trials in France

United States9 sites

  • San Juan Oncology Associates

    Farmington, New Mexico, 87401

  • St. Jude Heritage Healthcare

    Fullerton, California, 92835

  • Hackensack University Medical Center; WFAN - Imus Pediatric Center

    Hackensack, New Jersey, 07601

  • UCLA Jonsson Comprehensive Cancer Center

    Los Angeles, California, 90095

  • Tennessee Oncology

    Nashville, Tennessee, 37203

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • Uni of Rochester Medical Center; Wilmot Cancer Center, Pharmacy Department

    Rochester, New York, 14642

  • Central Coast Medical Oncology

    Santa Maria, California, 93454

  • The West Clinici

    St Louis, Missouri, 63129

Other trials in United States

Spain6 sites

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • ICO l´Hospitalet - Hospital Duran i Reynals; Hematology

    Barcelona, 08907

  • Hospital Universitario La Paz

    Madrid, 280146

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario de Salamanca

    Salamanca, 37007

Other trials in Spain

Canada5 sites

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • BC Cancer Agency, CSI

    Kelowna, British Columbia, V1Y 5L3

  • Jewish General Hospital; Research Unit

    Montreal, Quebec, H3T 1E2

  • CHU de Quebec - Hôpital de l' Enfant Jésus

    Québec, G1J 1Z4

  • BC Cancer Agency Vancouver Centre - PARENT; BC Cancer Agency

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Italy5 sites

  • Azienda Ospedaliero Universitaria San Martino

    Genoa, Liguria, 16132

  • Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale

    Naples, Campania, 80131

  • Azienda Ospedaliera Vincenzo Cervello

    Palermo, Sicily, 90127

  • Azienda Ospedaliero Universitaria Pisana; U.O. Farmaceutica

    Pisa, Tuscany, 56100

  • Azienda Ospedaliera Città della Salute e della Scienza di Torino

    Turin, Piedmont, 10126

Other trials in Italy

Australia4 sites

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • Peter MacCallum Cancer Centre-East Melbourne

    Melbourne, Victoria, 3000

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Czechia4 sites

  • Fakultni nemocnice Brno

    Brno, 613 00

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

  • Fakultni nemocnice Ostrava

    Ostrava - Poruba, 708 52

  • Vseobecna Fakultni Nemocnice v Praze, I. Interni Klinika - Klinika Hematoonkologie VFN a 1. LF UK

    Prague, 128 08

Other trials in Czechia

Hungary3 sites

  • Semmelweis Egyetem

    Budapest, 1083

  • Orszagos Onkologiai Intezet

    Budapest, 1122

  • Debreceni Egyetem; Belgyogyaszati Klinika Hematologiai Tanszek

    Debrecen, 4032

Other trials in Hungary

Netherlands3 sites

  • Amsterdam UMC Location VUMC

    Amsterdam, 1081 HV

  • Erasmus Medisch Centrum

    Rotterdam, 3015 GD

  • UMC Utrecht

    Utrecht, 3508 GA

Other trials in Netherlands

Austria2 sites

  • LKH - Universitätsklinikum der PMU Salzburg

    Salzburg, 5020

  • Medizinische Universität Wien

    Vienna, 1090

Other trials in Austria

About this study

Official title: A Phase Ib/II, Open-Label Study Evaluating the Safety, Efficacy and Pharmacokinetics of GDC-0199 (ABT-199) in Combination With Rituximab (R) or Obinutuzumab (G) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Patients With B-Cell Non-Hodgkin's Lymphoma (NHL) and DLBCL

This is a multicenter, open-label, dose-finding study of venetoclax administered orally in combination with rituximab (R) or obinutuzumab (G) and standard doses of cyclophosphamide, doxorubicin, vincristine and oral prednisone (CHOP) in participants with Non-Hodgkin's Lymphoma (NHL). The study consisted of 2 stages: a dose-finding Phase Ib stage and a Phase II expansion stage. In the Phase I portion of the study, participants were randomized to one of 2 treatment arms venetoclax in combination with R-CHOP (Arm A) and venetoclax in combination with G-CHOP (Arm B) and explored the doses of venetoclax in combination with R-CHOP and G-CHOP. The maximum tolerated dose (MTD) of venetoclax in combination with R-CHOP and G-CHOP was determined during the dose-finding stage. For the Phase II portion of the study, the venetoclax dose for venetoclax + R-CHOP was on a non-continuous dosing schedule as determined by the Phase Ib portion of the study based on safety and tolerability observed in participants treated in the dose escalation portion of the study. On 17 July 2016, Roche/Genentech as the sponsor of Study BO21005 (Goya study), a Phase III study that evaluated G CHOP versus R-CHOP in 1L DLBCL, informed through a press release that the primary endpoint of investigator-assessed PFS was not met. Given these results, Arm B (venetoclax + G-CHOP) was not expanded in Phase II in patients who are first-line with DLBCL.

Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VenetoclaxDrug

    Also called GDC-0199, ABT-199

    Venetoclax 200 to 800 milligrams (mg) tablets will be administered orally once daily (QD) on Days 4-10 of Cycle 1 and Days 1-10 of Cycles 2-8 during Phase I and MTD will be administered according to the same schedule during Phase II.

  • CyclophosphamideDrug

    Cyclophosphamide 750 milligrams per square meter (mg/m^2) administered intravenously (IV) on Day 1 of each 21-day cycle up to Cycle 6.

  • ObinutuzumabDrug

    Obinutuzumab will be administered by IV infusion as an absolute dose of 1000 mg on Days 1, 8, 15 of Cycle 1 and Day 1 of Cycles 2-8 (cycle length = 21 days).

  • RituximabDrug

    Also called MabThera/Rituxan

    Rituximab 375 mg/m^2 dose will be administered IV on Day 1 of every 21-day cycle.

  • DoxorubicinDrug

    Doxorubicin 50 mg/m^2 administered IV on Day 1 of each 21-day cycle up to Cycle 6.

  • VincristineDrug

    Vincristine 1.4 mg/m^2 (maximum 2 mg) administered IV on Day 1 of each 21-day cycle up to Cycle 6.

  • PrednisoneDrug

    Prednisone 100 mg per day orally on Days 1-5 of each 21-day cycle up to Cycle 6.

Study groups in NCT02055820
Study groupRoleWhat they receive
Venetoclax + G-CHOP ArmExperimentalPhase I: Participants will receive 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle will consist of 21 days. Phase II: Participants will receive 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + obinutuzumab. Each cycle will consist of 21 days. For both phase I and II, participants with ongoing response without excessive toxicity may receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
Receives: Drug: Venetoclax; Drug: Cyclophosphamide; Drug: Obinutuzumab; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone
Venetoclax + R-CHOP ArmExperimentalPhase I: Participants will receive 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle will consist of 21 days. Phase II: Participants will receive 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + rituximab. Each cycle will consist of 21 days. For both phase I and II, participants with ongoing response without excessive toxicity may receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
Receives: Drug: Venetoclax; Drug: Cyclophosphamide; Drug: Rituximab; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety: Number of Participants With Dose-Limiting Toxicities (DLTs)

    DLTs were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0). Decrease in B cells, lymphopenia, and leukopenia caused by lymphopenia were not considered DLTs but instead were expected outcomes of study treatment. Any Grade >/= 3 adverse event, that was attributed to having a reasonable possibility of being related to the combined administration of venetoclax plus R-CHOP or G-CHOP, that could not be attributed by the investigator to an alternative, clearly identifiable cause such as tumor progression, concurrent illness or medical condition, or concomitant medication and that occurred during the DLT observation period (start of venetoclax treatment through end of Cycle 2) was considered a DLT for dose-escalation purposes. Grade 3 or 4 neutropenia or thrombocytopenia identified on Day 1 of Cycle 2 or 3, resulting in dose delay were considered DLTs.

    Measured: Start of venetoclax administration (Cycle 1 Day 4 or 3 days after first CHOP dose) up to end of Cycle 2 (cycle length = 21 days)

  2. Percentage of Previously Untreated DLBCL Participants With Complete Response (CR) Defined by Positron Emission Tomography-Computed Tomography (PET/CT) Scan Using the Modified Lugano Classification Assessed by Independent Review Committee (IRC)

    CR was defined as follows according to modified Lugano classification for PET/CT-based response: Lymph nodes and extra-lymphatic sites with score 1, 2, or 3 with or without a residual mass on 5-point scale with 1) no uptake above background; 2) uptake </= mediastinum; 3) uptake < mediastinum but </= liver. No evidence of fluorodeoxyglucose (FDG)-uptake disease in marrow. If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy

    Measured: Baseline up to end of treatment (up to approximately 6 months)

  3. Percentage of Participants With CR Defined by PET/CT Scan in Previously Untreated DLBCL Co-Expressing Both Bcl-2 and c-Myc Proteins (DE-DLBCL) Participants Assessed by IRC

    CR was defined as follows according to modified Lugano classification for PET/CT-based response: Lymph nodes and extra-lymphatic sites with score 1, 2, or 3 with or without a residual mass on 5-point scale with 1) no uptake above background; 2) uptake </= mediastinum; 3) uptake < mediastinum but </= liver. No evidence of fluorodeoxyglucose (FDG)-uptake disease in marrow. If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy.

    Measured: Baseline up to end of treatment (up to approximately 6 months)

Secondary outcomes (19)

  1. Venetoclax Plasma PK: Area Under the Plasma Concentration-Time Curve (AUC)

    AUC was calculated based on measurement of venetoclax concentration in plasma over time. Venetoclax exposure was pooled across Phase I and II for the R-CHOP 800 mg cohorts.

    Data are reported as hour*micrograms per milliliter (hr*mcg/mL)

    Measured: Predose (within 30 minutes) & 2, 4, 6, 8 hours (Hr) postdose on Cycle 1 Day 4 (cycle length = 21 days)

  2. Venetoclax Plasma PK: Time to Maximum Observed Plasma Concentration (Tmax)

    Tmax was determined based on measurement of venetoclax concentrations in plasma over time. Venetoclax exposure was pooled across Phase I and II for the R-CHOP 800 mg cohorts.

    Measured: Predose (within 30 minutes) & 2, 4, 6, 8 Hr postdose on Cycle 1 Day 4 (cycle length = 21 days)

  3. Venetoclax Plasma PK: Maximum Observed Plasma Concentration (Cmax)

    Cmax was determined based on measurement of venetoclax concentrations in plasma over time. Venetoclax exposure was pooled across Phase I and II for the R-CHOP 800 mg cohorts.

    Data are reported as micrograms per milliliter

    Measured: Predose (within 30 minutes) & 2, 4, 6, 8 Hr postdose on Cycle 1 Day 4 (cycle length = 21 days)

  4. Venetoclax Plasma PK: Minimum Plasma Concentration (Cmin) Within the Dosing Interval

    Cmin was determined based on measurement of venetoclax concentrations in plasma over time. Venetoclax exposure was pooled across Phase I and II for the R-CHOP 800 mg cohorts.

    Measured: Predose (within 30 minutes) & 2, 4, 6, 8 Hr postdose on Cycle 1 Day 4 (cycle length = 21 days)

  5. Prednisone Plasma PK: AUC

    AUC was determined based on measurement of Predisone concentrations in plasma over time.

    Measured: Predose (within 30 minutes) and 0.5, 1, 2, 4, 6 Hr after prednisone dose on Day 1 of Cycle 1 and 2 (cycle length = 21 days)

  6. Prednisone Plasma PK: Tmax

    Tmax was determined based on measurement of Predisone concentrations in plasma over time.

    Measured: Predose (within 30 minutes) and 0.5, 1, 2, 4, 6 Hr after prednisone dose on Day 1 of Cycle 1 and 2 (cycle length = 21 days)

  7. Prednisone Plasma PK: Cmax

    Cmax was determined based on measurement of Predisone concentrations in plasma over time.

    Measured: Predose (within 30 minutes) and 0.5, 1, 2, 4, 6 Hr after prednisone dose on Day 1 of Cycle 1 and 2 (cycle length = 21 days)

  8. Rituximab PK: Cmax

    Cmax was determined using the post-dose rituximab plasma concentrations at the 800 mg Venetoclax Dose using the end of infusion time point on Cycle 1 Day 1.

    Measured: End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)

  9. Rituximab PK: Cmin Within the Dosing Interval

    Cmin was determined using the pre-dose rituximab plasma concentrations at the 800 mg Venetoclax Dose on Day 1 of Cycle 2.

    Measured: Pre-dose on Cycle 2 Day 1 (cycle length = 21 days)

  10. Obinutuzumab PK: Cmax

    Cmax was determined using the post-dose obinutuzumab plasma concentrations at the 800 mg Venetoclax Dose using the end of infusion time point on Cycle 1 Day 1.

    Measured: End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)

  11. Cyclophosphamide PK: Cmax

    Cmax was determined using the post-dose Cyclophosphamide plasma concentrations on Cycle 1 Day 1.

    Measured: End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)

  12. Doxorubicin PK: Cmax

    Cmax was determined using the post-dose Doxorubicin plasma concentrations.

    Measured: End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)

  13. Vincristine PK: Cmax

    Cmax was determined using the post-dose Vincristine plasma concentrations.

    Measured: End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)

  14. Percentage of Participants With Objective Response Defined as Partial Response (PR) or Complete Response (CR) Defined by Positron Emission Tomography-Computed Tomography (PET/CT) Using the Modified Lugano Classification Assessed by IRC

    Objective Response defined as PR (partial response) or CR (complete response) at end of treatment.

    CR: Lymph nodes and extra-lymphatic sites with score 1, 2 or 3 on a 5-point scale (with a higher score being a worse outcome). No evidence of fluorodeoxyglucose (FDG)-uptake disease in marrow. If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy.

    PR: Lymph nodes and extralymphatic sites with score of 4 or 5 on the 5-point scale with reduced uptake compared with baseline and residual mass(es) of any size. CT-based response criteria for PR must also be met. No new lesions. In bone marrow residual uptake could be higher than in normal marrow but must be reduced compared with baseline; persistent focal changes in the marrow to be considered for further evaluation with magnetic resonance imaging (MRI) or biopsy or an interval scan. OR=PR+CR

    Measured: Baseline to end of treatment (up to approximately 6 months)

  15. Percentage of Participants Who Are Alive and Without Disease Progression at Month 12

    Progressive disease (PD) was determined using the modified Lugano classification criteria. For PET-CT-based PD: Score 4 (uptake moderately > liver) or 5 (uptake markedly higher than liver and/or new lesions) with an increase in intensity of uptake from baseline in target nodes and nodal lesions, new FDG-uptake foci of extranodal lesions consistent with lymphoma at interim or end-of-treatment assessment, no non-measured lesions, new FDG-uptake foci consistent with lymphoma, new or recurrent FDG-uptake foci in bone marrow. For CT-based PD: >/= 50% decrease in SPD of up to 6 target measureable nodes and extranodal sites; non-measured lesion should be absent/normal, have regressed, but not increased; no new lesions.

    Measured: Month 12

  16. Percentage of Participants With CR Defined by Computed Tomography (CT) Scan Using the Modified Lugano Classification

    CR was defined as follows according to modified Lugano classification for CT-based response: Target nodes/nodal masses must have regressed to </= 1.5 cm in longest transverse diameter of a lesion (LDi), no extra-lymphatic sites of disease, absence of non-measured lesions, organ enlargement must have regressed to normal, no new lesions, and if the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy.

    Measured: Baseline up to end of treatment (approx. 6 months)

  17. Safety: Percentage of Participants With Adverse Events

    An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

    Measured: Baseline up to approximately 36 months

  18. Safety: Percentage of Participants Maintaining Relative Dose Intensity of CHOP Chemotherapy

    Maintenance of relative dose intensity was defined as a dose intensity of >/= 90%.

    Measured: Baseline up to Cycle 6 (cycle length = 21 days)

  19. Relative Dose Intensity of Venetoclax

    Dose intensity was categorized as < 80%, 80% to < 85%, 85% to < 90%, or >/= 90%.

    Measured: Baseline up to Cycle 6 (cycle length = 21 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2014 (estimated)
  2. Study start17 Nov 2013
  3. Primary completion28 Jun 2017
  4. Study completion28 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
267 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02055820
Sponsor's protocol ID
GO27878
Other IDs
2013-003749-40
Status last verified
May 2020
First submitted
4 Feb 2014
Last updated
11 Jun 2020
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Zelenetz AD, Salles G, Mason KD, Casulo C, Le Gouill S, Sehn LH, Tilly H, Cartron G, Chamuleau MED, Goy A, Tam CS, Lugtenburg PJ, Petrich AM, Sinha A, Samineni D, Herter S, Ingalla E, Szafer-Glusman E, Klein C, Sampath D, Kornacker M, Mobasher M, Morschhauser F. Venetoclax plus R- or G-CHOP in non-Hodgkin lymphoma: results from the CAVALLI phase 1b trial. Blood. 2019 May 2;133(18):1964-1976. doi: 10.1182/blood-2018-11-880526. Epub 2019 Mar 8.

    PubMed 30850381

  • Samineni D, Huang W, Gibiansky L, Ding H, Zhang R, Li C, Sinha A, Rajwanshi R, Humphrey K, Bazeos A, Salem AH, Miles D. Population Pharmacokinetics and Exposure-Response Analyses for Venetoclax in Combination with R-CHOP in Relapsed/Refractory and Previously Untreated Patients with Diffuse Large B Cell Lymphoma. Adv Ther. 2022 Jan;39(1):598-618. doi: 10.1007/s12325-021-01919-z. Epub 2021 Nov 25.

    PubMed 34822104

  • Morschhauser F, Feugier P, Flinn IW, Gasiorowski R, Greil R, Illes A, Johnson NA, Larouche JF, Lugtenburg PJ, Patti C, Salles GA, Trneny M, de Vos S, Mir F, Samineni D, Kim SY, Jiang Y, Punnoose E, Sinha A, Clark E, Spielewoy N, Humphrey K, Bazeos A, Zelenetz AD. A phase 2 study of venetoclax plus R-CHOP as first-line treatment for patients with diffuse large B-cell lymphoma. Blood. 2021 Feb 4;137(5):600-609. doi: 10.1182/blood.2020006578.

    PubMed 33538797

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Venetoclax, Cyclophosphamide and Obinutuzumab in people with Lymphoma, Non-Hodgkin, run by Hoffmann-La Roche at 52 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in France, United States, Spain, Canada, Italy and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety: Number of Participants With Dose-Limiting Toxicities (DLTs) (time frame: Start of venetoclax administration (Cycle 1 Day 4 or 3 days after first CHOP dose) up to end of Cycle 2 (cycle length = 21 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02055820, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.

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