AzTrials
AzTrials

Chronic Lymphocytic LeukemiaPhase 3NCT01611090

A Study of Ibrutinib in Combination With Bendamustine and Rituximab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

A Phase 3 study testing Ibrutinib, Bendamustine hydrochloride and Rituximab in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Janssen Research & Development, LLC at 155 sites in 21 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

The purpose of this study is to examine the safety and efficacy of Ibrutinib administered in combination with bendamustine and rituximab in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ibrutinib, Bendamustine hydrochloride and Rituximab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
578 participants
Where
155 sitesin 21 countries
Study dates
19 Sep 2012to 23 Jan 2019
Phase
Phase 3
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

  • Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that meets protocol-defined criteria
  • Active disease meeting at least 1 of the International Workshop on Chronic Lymphocytic Leukemia 2008 criteria for requiring treatment
  • Measurable nodal disease by computed tomography
  • Relapsed or refractory CLL or SLL following at least 1 prior line of systemic therapy consisting of at least 2 cycles of a chemotherapy-containing regimen
  • Eastern Cooperative Oncology Group Performance Status score of 0 or 1
  • Hematology and biochemical values within protocol-defined limits
  • Agrees to protocol-defined use of effective contraception
  • Women of childbearing potential must have negative blood or urine pregnancy test at screening

Who cannot join

  • Recent therapeutic interventions within 3 (chemotherapy/radiotherapy) to 10 weeks (immunotherapy)
  • Prior treatment with ibrutinib or other Bruton's tyrosine kinase inhibitors or prior randomization in any other clinical study evaluating ibrutinib
  • The presence of deletion of the short arm of chromosome 17
  • Patients previously treated with a bendamustine-containing regimen who did not achieve a response or who relapsed and required treatment within 24 months of treatment with that regimen
  • Patients for whom the goal of therapy is tumor debulking prior to stem cell transplant
  • Received a hematopoietic stem cell transplant
Show all 15Show fewer
  • Known central nervous system leukemia/lymphoma or Richter's transformation
  • Patients with uncontrolled autoimmune hemolytic anemia or autoimmune thrombocytopenia
  • Chronic use of corticosteroids
  • History of prior malignancy, except: malignancy treated with curative intent and with no known active disease present for >=3 years before randomization; adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; adequately treated cervical carcinoma in situ without evidence of disease
  • History of stroke or intracranial hemorrhage within 6 months prior to randomization; or clinically significant cardiovascular disease
  • Requires anticoagulation with warfarin or equivalent vitamin K antagonists or treatment with strong CYP3A4/5 inhibitors
  • Known history of human immunodeficiency virus or hepatitis C, or active infection with hepatitis B or C
  • Any uncontrolled active systemic infection or any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the patient's safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk
  • A woman who is pregnant or breast feeding, or a man who plans to father a child while enrolled in this study or within 3 months after the last dose of study drug

Trial locations and contacts

155 sites in 21 countries.

155 sites in 21 countries

United States42 sites

  • Study site

    Albuquerque, New Mexico

  • Study site

    Ann Arbor, Michigan

  • Study site

    Atlanta, Georgia

  • Study site

    Baltimore, Maryland

  • Study site

    Battle Creek, Michigan

  • Study site

    Berkeley, California

  • Study site

    Birmingham, Alabama

  • Study site

    Bismarck, North Dakota

  • Study site

    Boca Raton, Florida

  • Study site

    Charleston, South Carolina

  • Study site

    Chicago, Illinois

  • Study site

    Cleveland, Ohio

  • Study site

    Detroit, Michigan

  • Study site

    Duarte, California

  • Study site

    Dunkirk, New York

  • Study site

    Fort Wayne, Indiana

  • Study site

    Goshen, Indiana

  • Study site

    Greenbrae, California

  • Study site

    Hackensack, New Jersey

  • Study site

    Hawthorne, New York

  • Study site

    Indianapolis, Indiana

  • Study site

    Iowa City, Iowa

  • Study site

    Jacksonville, Florida

  • Study site

    Lansing, Michigan

  • Study site

    Lebanon, New Hampshire

  • Study site

    Lincoln, Nebraska

  • Study site

    Louisville, Kentucky

  • Study site

    Marietta, Georgia

  • Study site

    Marrero, Louisiana

  • Study site

    Morgantown, West Virginia

  • Study site

    New York, New York

  • Study site

    Paducah, Kentucky

  • Study site

    Phoenix, Arizona

  • Study site

    Portland, Oregon

  • Study site

    Sioux Falls, South Dakota

  • Study site

    Springfield, Illinois

  • Study site

    St Louis, Missouri

  • Study site

    Stamford, Connecticut

  • Study site

    Temple, Texas

  • Study site

    Washington D.C., District of Columbia

  • Study site

    Westwood, Kansas

  • Study site

    Worcester, Massachusetts

Other trials in United States

Germany22 sites

  • Study site

    Aschaffenburg

  • Study site

    Augsburg

  • Study site

    Cologne

  • Study site

    Dresden

  • Study site

    Erlangen

  • Study site

    Essen

  • Study site

    Frankfurt

  • Study site

    Frechen

  • Study site

    Hamm

  • Study site

    Heidelberg

  • Study site

    Homburg/Saar

  • Study site

    Kassel

  • Study site

    Kiel

  • Study site

    Koblenz

  • Study site

    Kÿln N/a

  • Study site

    Lebach

  • Study site

    Magdeburg

  • Study site

    Mannheim

  • Study site

    Marburg

  • Study site

    Mutlangen

  • Study site

    Ulm

  • Study site

    Würzburg

Other trials in Germany

Russia14 sites

  • Study site

    Arkhangelsk

  • Study site

    Dzerzhinsk

  • Study site

    Krasnodar

  • Study site

    Moscow

  • Study site

    Nizhny Novgorod

  • Study site

    Obninsk

  • Study site

    Perm

  • Study site

    Rostov-on-Don

  • Study site

    Ryazan

  • Study site

    Saint Petersburg

  • Study site

    Samara

  • Study site

    Sochi

  • Study site

    Syktyvkar

  • Study site

    Yekaterinburg

Other trials in Russia

Ukraine8 sites

  • Study site

    Cherkassy

  • Study site

    Dnipro

  • Study site

    Donetsk

  • Study site

    Khakhiv

  • Study site

    Khmelnitskiy

  • Study site

    Kiev

  • Study site

    Lviv

  • Study site

    Vinnitsa

Other trials in Ukraine

Canada7 sites

  • Study site

    Edmonton, Alberta

  • Study site

    Hamilton, Ontario

  • Study site

    London, Ontario

  • Study site

    Montreal, Quebec

  • Study site

    Ottawa, Ontario

  • Study site

    Toronto, Ontario

  • Study site

    Vancouver, British Columbia

Other trials in Canada

France7 sites

  • Study site

    Créteil

  • Study site

    Montpellier

  • Study site

    Paris

  • Study site

    Pessac

  • Study site

    Pierre-Bénite

  • Study site

    Tours

  • Study site

    Villejuif

Other trials in France

Israel7 sites

  • Study site

    Haifa

  • Study site

    Jerusalem

  • Study site

    Nahariya

  • Study site

    Netanya

  • Study site

    Petah Tikva

  • Study site

    Ramat Gan

  • Study site

    Tel Aviv

Other trials in Israel

Belgium5 sites

  • Study site

    Aalst

  • Study site

    Bruges

  • Study site

    Brussels

  • Study site

    Ghent

  • Study site

    Leuven

Other trials in Belgium

Poland5 sites

  • Study site

    Brzozów

  • Study site

    Chorzów

  • Study site

    Krakow

  • Study site

    Opole

  • Study site

    Słupsk

Other trials in Poland

Spain5 sites

  • Study site

    Barcelona

  • Study site

    L'Hospitalet de Llobregat

  • Study site

    Madrid

  • Study site

    Salamanca

  • Study site

    Valencia

Other trials in Spain

United Kingdom5 sites

  • Study site

    Birmingham

  • Study site

    Harrow

  • Study site

    Plymouth

  • Study site

    Sheffield Yorks

  • Study site

    Sutton

Other trials in United Kingdom

Portugal4 sites

  • Study site

    Coimbra

  • Study site

    Lisbon

  • Study site

    Ponta Delgada

  • Study site

    Porto

Other trials in Portugal

Sweden4 sites

  • Study site

    Gothenburg

  • Study site

    Huddinge

  • Study site

    Stockholm

  • Study site

    Umeå

Other trials in Sweden

Turkey (Türkiye)4 sites

  • Study site

    Ankara

  • Study site

    Istanbul

  • Study site

    Izmir

  • Study site

    Kayseri

Other trials in Turkey (Türkiye)

Argentina3 sites

  • Study site

    Buenos Aires

  • Study site

    Ciudad Autonoma Buenos Aires

  • Study site

    Córdoba

Other trials in Argentina

Brazil3 sites

  • Study site

    Rio de Janeiro

  • Study site

    Salvador

  • Study site

    São Paulo

Other trials in Brazil

Mexico3 sites

  • Study site

    México

  • Study site

    Monterrey

  • Study site

    Oaxaca City

Other trials in Mexico

Colombia2 sites

  • Study site

    Bogotá

  • Study site

    Floridablanca

Other trials in Colombia

Czechia2 sites

  • Study site

    Brno

  • Study site

    Prague

Other trials in Czechia

Greece2 sites

  • Study site

    Athens

  • Study site

    Thessalonikis

Other trials in Greece

South Korea1 site

  • Study site

    Seoul

Other trials in South Korea

About this study

Official title: Randomized, Double-blind, Placebo-controlled Phase 3 Study of Ibrutinib, a Bruton's Tyrosine Kinase (BTK) Inhibitor, in Combination With Bendamustine and Rituximab (BR) in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

The purpose of this study is to examine the safety and efficacy of Ibrutinib administered in combination with bendamustine and rituximab in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Read the detailed description

This is a randomized (patients will be assigned by chance to study treatments), double-blind (patients and study personnel will not know the identity of study treatments), placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial)-controlled study to determine the benefits and risks of combining ibrutinib with bendamustine and rituximab (BR) in patients with relapsed or refractory CLL/SLL following at least 1 line of prior systemic therapy. Approximately 580 patients will be randomized in a 1:1 ratio to either treatment arm A (placebo) or treatment arm B (ibrutinib 420 mg).

Study medication will be administered orally once daily on a continuous schedule. All patients will receive BR as the background therapy plus either ibrutinib or placebo for a maximum of 6 cycles, after which treatment with ibrutinib or placebo will continue until disease progression or unacceptable toxicity.

A treatment cycle will be defined as 28 days. The study will include a screening phase, a treatment phase, and a follow-up phase. Study end is defined as when either 80% of the patients have died or 5 years after the last patient is randomized into the study, whichever occurs first.

Patients in treatment arm A (placebo) who complete the treatment phase, with disease progression or (after interim analysis) meet International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria for treatment, may crossover to ibrutinib treatment (as in treatment arm B), at the investigators discretion. This open-label, next-line treatment with ibrutinib will continue until disease progression, unacceptable toxicity, withdrawal from study, or until the study end, whichever occurs earlier. One interim analysis is planned for the study. Efficacy evaluations will include computed tomography scans, laboratory testing, focused physical examinations, bone marrow biopsy and aspirate, and assessment of patient-reported outcomes. In both treatment arms, samples for the development of a population-based pharmacokinetic (PK; study of what the body does to a drug) approach will be collected. Safety will be assessed throughout the study.

Being tested
Ibrutinib, Bendamustine hydrochloride, Rituximab, Placebo
Keywords
Chronic lymphocytic leukemia, Small lymphocytic lymphoma, Relapsed or refractory chronic lymphocytic leukemia, Relapsed or refractory small lymphocytic lymphoma, Ibrutinib, PCI-32765, JNJ-54179060, Bruton's tyrosine kinase inhibitor, Bendamustine, Rituximab
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Recurrence

What participants receive

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

  • IbrutinibDrug

    Type=exact number, unit=mg, number=420 , form=capsule, route=oral use. Capsule is taken once daily continuously.

  • Bendamustine hydrochlorideDrug

    Type=exact number, unit=mg, number=70 mg/m2, route=intravenous use. Administered intravenously on Cycle 1, Days 2-3 and Cycles 2-6, Days 1-2.

  • RituximabDrug

    Type=exact number, unit=mg, number=375 mg/m2 and 500 mg/m2, route=intravenous use. Administered intravenously on Cycle 1, Day 1, and Cycles 2-6, Day 1, respectively.

  • PlaceboDrug

    Form=capsule, route=oral use. Capsule is taken once daily continuously.

Study groups in NCT01611090
Study groupRoleWhat they receive
Ibrutinib + BRExperimentalIbrutinib 420 mg will be administered orally once daily on a continuous schedule. All subjects will receive background therapy with bendamustine and rituximab (BR) for a maximum of 6 cycles (a cycle is defined as 28 days, with the exception of Cycle 1, which will be 29 days to allow for rituximab dosing prior to bendamustine and study medication).
Receives: Drug: Ibrutinib; Drug: Bendamustine hydrochloride; Drug: Rituximab
Placebo + BRPlacebo comparatorMatching placebo will be administered orally once daily on a continuous schedule. All subjects will receive background therapy with BR for a maximum of 6 cycles (a cycle is defined as 28 days, with the exception of Cycle 1, which will be 29 days to allow for rituximab dosing prior to bendamustine and study medication).
Receives: Drug: Bendamustine hydrochloride; Drug: Rituximab; Drug: Placebo

What is being measured

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

  1. Progression-free Survival (PFS)

    PFS was defined as the interval between the date of randomization and the date of disease progression or death, whichever was first reported. IWCLL 2008 criteria for PD: New enlarged nodes >1.5 cm, new hepatomegaly or splenomegaly, or other new organ infiltrates, bone lesion, ascites, or pleural effusion confirmed due to chronic lymphocytic leukemia (CLL); >=50% increase in existing lymph nodes; >=50% increase in enlargement of liver or spleen; >=50% increase from baseline in lymphocyte count (and to >=5*10^9/L) or >=50% increase from nadir count confirmed on >=2 serial assessments if absolute lymphocyte count (ALC) >=30,000 per microliter and lymphocyte doubling time is rapid, unless considered treatment-related lymphocytosis; new cytopenia (Hemoglobin b [Hgb] or platelets) attributable to CLL; and transformation to a more aggressive histology.

    Measured: Up to 5 years

Secondary outcomes (13)

  1. Overall Response Rate (ORR)

    ORR defined as number of participants achieving a complete response (CR), complete response with incomplete marrow recovery (CRi), nodular partial response (nPR) or partial response (PR). IWCLL 2008 criteria: CR- No lymphadenopathy and hepatosplenomegaly, no constitutional symptoms, neutrophils >1.5*10^9/liter (L), platelets >100*10^9/L, Hgb >11 gram per deciliter (g/dL) and absolute lymphocyte count <4000/microliter (mcL); CRi- CR with incomplete recovery of bone marrow; nPR- participants meet criteria for CR, but the bone marrow biopsy shows B-lymphoid nodules, may represent a clonal infiltrate; PR-2 of the following when abnormal at baseline: >=50% decrease in ALC, >=50% decrease in sum products of up to 6 lymph nodes, >=50% decrease in enlargement of spleen or liver; and 1 of the following: neutrophils >1.5*10^9/L, Platelets >100*10^9/L and Hgb>11 g/dL or >=50% improvement over baseline in any of these; no new enlarged nodes or new hepatosplenomegaly.

    Measured: Up to 5 years

  2. Overall Survival (OS)

    OS was defined as the interval between the date of randomization and the date of death from any cause.

    Measured: Up to 5 years

  3. Percentage of Participants With Minimal Residual Disease (MRD)-Negative Response

    MRD-negative response was defined as the percentage of participants who reach MRD negative disease status (less than 1 chronic lymphocytic leukemia [CLL] cell per 10,000 leukocytes) in either bone marrow or peripheral blood. All randomized participants were included in this analysis. Participants with missing MRD data were considered non-responders.

    Measured: Up to 5 years

  4. Percentage of Participants With Sustained Hematologic Improvement

    Sustained hematologic improvement was defined as hematological improvement that was sustained continuously for greater than or equal to (>=) 56 days without blood transfusion or growth factors: 1) Platelet counts greater than (>)100* 109/liter (L) if baseline less than or equal to (<=) 100*109/L or increase >= 50 percent (%) over baseline; 2) Hemoglobin >11 gram per deciliters (g/dL) if baseline <= 11 g/dL or increase >= 2 g/dL over baseline.

    Measured: Up to 5 years

  5. Median Time to Clinically Meaningful Improvement in FACIT-Fatigue Scale

    Time to improvement is defined as the time interval (months) from randomization to the first observation of improvement. FACIT-Fatigue is an instrument for use as a measure of the effect of fatigue in patients with cancer and other chronic diseases. Responses to the 13-item FACIT Fatigue Scale are reported on a 5-point categorical response scale ranging from 0 (not at all) to 4 (very much). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).

    Measured: Up to 2 years

  6. Number of Participants With Clinically Relevant Shifts in Disease-Related Symptoms

    The disease-related symptoms included fatigue, weight loss, fevers, night sweats, abdominal discomfort/splenomegaly and anorexia.

    Measured: From the date of randomization to disease progression (Up to 2 years)

  7. Number of Participants Who Received Subsequent Antineoplastic Therapy

    Number of participants who received subsequent antineoplastic therapy was reported.

    Measured: Up to 5 years

  8. Change From Baseline in Beta2 Microglobulin at End of Treatment (EOT)

    Change from baseline in beta2 microglobulin at end of treatment at time of primary analysis was reported.

    Measured: Baseline to EOT (Up to 2 years)

  9. Change From Baseline in FACIT-Fatigue Scale at End of Treatment

    FACIT-Fatigue is an instrument for use as a measure of the effect of fatigue in patients with cancer and other chronic diseases. Responses to the 13-item FACIT Fatigue Scale are reported on a 5-point categorical response scale ranging from 0 (not at all) to 4 (very much). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).

    Measured: Baseline to EOT (up to 2 years)

  10. Change From Baseline in EORTC QLQ-C30 Physical Functioning Score at End of Treatment

    EORTC QLQ-C30 Physical Functioning Score is a questionnaire to assess quality of life of cancer patients. It is composed of 30 items, multi-item measure (28 items) and 2 single-item measures. For the multiple item measure, 4-point scale is used and the score for each item range from "1 = not at all" to "4 = very much". Higher scores indicate worsening. The 2 single-item measure involves question about the overall health and overall quality of life which was rated on a 7-point scale ranging from "1 = very poor" to "7 = excellent". Lower scores indicate worsening. All scale and item scores were linearly transformed to be in range from 0-100. A higher score represents a higher (better) level of functioning, or a higher (worse) level of symptoms.

    Measured: Baseline to EOT (up to 2 years)

  11. Change From Baseline in EORTC QLQ-CLL 16 Domain Scores at End of Treatment

    The EORTC QLQ-CLL 16 is a 16-item disease specific module that comprises 5 domains of patient-reported health status important in CLL. There are three multi-item scales that include fatigue (2 items), treatment side effects and disease symptoms (8 items), and infection (4 items), and 2 single-item scales on social activities and future health worries. Responses are measured on a 4 point scale ranging from 1 (not at all) to 4 (very much).

    Measured: Baseline to EOT (up to 2 years)

  12. Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) Visual Analog Scale at End of Treatment

    The EQ-5D questionnaire is a brief, generic health-related quality of life assessment (HRQOL) that can also be used to incorporate participant preferences into health economic evaluations. The EQ-5D questionnaire assesses HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a visual analog scale with response options ranging from 0 (worst imaginable health) to 100 (best imaginable health).

    Measured: Baseline to EOT (up to 2 years)

  13. Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) Utility Score Scale at End of Treatment

    The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1. High score indicating a high level of utility.

    Measured: Baseline to EOT (up to 2 years)

Timeline

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

  1. First posted4 Jun 2012 (estimated)
  2. Study start19 Sep 2012
  3. Primary completion23 Jan 2019
  4. Study completion23 Jan 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
578 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01611090
Sponsor's protocol ID
CR100840
Other IDs
PCI-32765CLL3001, 2012-000600-15, U1111-1135-3745
Status last verified
Feb 2020
First submitted
15 May 2012
Last updated
3 Mar 2020
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Abuhelwa AY, Almansour SA, Brown JR, Al-Shamsi HO, Abuhelwa Z, Kharaba Z, Bustanji Y, Semreen MH, Ali S, Alhuraiji A, McKinnon RA, Sorich MJ, Alzoubi KH, Hopkins AM. Statin use and survival in CLL/SLL treated with ibrutinib: pooled analysis of 4 randomized controlled trials. Blood Adv. 2025 Jul 22;9(14):3566-3575. doi: 10.1182/bloodadvances.2024015287.

    PubMed 40266025

  • Fraser GAM, Chanan-Khan A, Demirkan F, Santucci Silva R, Grosicki S, Janssens A, Mayer J, Bartlett NL, Dilhuydy MS, Loscertales J, Avigdor A, Rule S, Samoilova O, Pavlovsky MA, Goy A, Mato A, Hallek M, Salman M, Tamegnon M, Sun S, Connor A, Nottage K, Schuier N, Balasubramanian S, Howes A, Cramer P. Final 5-year findings from the phase 3 HELIOS study of ibrutinib plus bendamustine and rituximab in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma. Leuk Lymphoma. 2020 Dec;61(13):3188-3197. doi: 10.1080/10428194.2020.1795159. Epub 2020 Aug 6.

    PubMed 32762271

  • Lavezzi SM, de Jong J, Neyens M, Cramer P, Demirkan F, Fraser G, Bartlett N, Dilhuydy MS, Loscertales J, Avigdor A, Rule S, Samoilova O, Goy A, Ganguly S, Salman M, Howes A, Mahler M, De Nicolao G, Poggesi I. Systemic Exposure of Rituximab Increased by Ibrutinib: Pharmacokinetic Results and Modeling Based on the HELIOS Trial. Pharm Res. 2019 May 1;36(7):93. doi: 10.1007/s11095-019-2605-8.

    PubMed 31044267

  • Brown JR, Moslehi J, O'Brien S, Ghia P, Hillmen P, Cymbalista F, Shanafelt TD, Fraser G, Rule S, Kipps TJ, Coutre S, Dilhuydy MS, Cramer P, Tedeschi A, Jaeger U, Dreyling M, Byrd JC, Howes A, Todd M, Vermeulen J, James DF, Clow F, Styles L, Valentino R, Wildgust M, Mahler M, Burger JA. Characterization of atrial fibrillation adverse events reported in ibrutinib randomized controlled registration trials. Haematologica. 2017 Oct;102(10):1796-1805. doi: 10.3324/haematol.2017.171041. Epub 2017 Jul 27.

    PubMed 28751558

  • Chanan-Khan A, Cramer P, Demirkan F, Fraser G, Silva RS, Grosicki S, Pristupa A, Janssens A, Mayer J, Bartlett NL, Dilhuydy MS, Pylypenko H, Loscertales J, Avigdor A, Rule S, Villa D, Samoilova O, Panagiotidis P, Goy A, Mato A, Pavlovsky MA, Karlsson C, Mahler M, Salman M, Sun S, Phelps C, Balasubramanian S, Howes A, Hallek M; HELIOS investigators. Ibrutinib combined with bendamustine and rituximab compared with placebo, bendamustine, and rituximab for previously treated chronic lymphocytic leukaemia or small lymphocytic lymphoma (HELIOS): a randomised, double-blind, phase 3 study. Lancet Oncol. 2016 Feb;17(2):200-211. doi: 10.1016/S1470-2045(15)00465-9. Epub 2015 Dec 5.

    PubMed 26655421

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ibrutinib, Bendamustine hydrochloride and Rituximab in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Janssen Research & Development, LLC at 155 sites in 21 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 8 inclusion and 15 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 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 155 sites in United States, Germany, Russia, Ukraine, Canada and 16 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 3 Mar 2020). 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?

Progression-free Survival (PFS) (time frame: Up to 5 years). 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 NCT01611090, which also lists 5 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 3 Mar 2020.

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