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AzTrials

B-Cell Chronic Lymphocytic LeukemiaPhase 3ORIGINNCT00910910

Study Of The Effectiveness & Safety Of Lenalidomide Versus Chlorambucil As First Line Therapy For Elderly Patients With B-Cell CLL (The ORIGIN Trial)

A Phase 3 study testing Lenalidomide and Chlorambucil in people with B-Cell Chronic Lymphocytic Leukemia, run by Celgene at 165 sites in 27 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 determine the safety and efficacy of lenalidomide as a first line therapy in treating patients with B-cell Chronic Lymphocytic Leukemia. This study will compare the effects (good and bad) of lenalidomide with chlorambucil. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
B-Cell Chronic Lymphocytic Leukemia
What is being tested?
Lenalidomide and Chlorambucil
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
165 sitesin 27 countries
Study dates
13 Oct 2009to 9 May 2018
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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Must sign an informed consent form.
  • Age ≥ 65 years
  • Must be able to adhere to the study visit schedule and other protocol requirements.
  • Must have a documented diagnosis of B-cell CLL.
  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of ≤2.
  • Must agree to follow pregnancy precautions as required by the protocol.
  • Must agree to receive counseling related to teratogenic and other risks of lenalidomide.
  • Must agree not to donate blood or semen as defined by the protocol

Who cannot join

  • Prior treatment for B-cell CLL.
  • Any medical condition, that would prevent the subject from signing the informed consent form.
  • Active infections requiring systemic antibiotics.
  • Systemic infection that has not resolved > 2 months prior to initiating lenalidomide
  • Pregnant or lactating females.
  • Participation in any clinical study or having taken any investigational therapy within 28 days.
Show all 24Show fewer
  • Known presence of alcohol and/or drug abuse.
  • Central nervous system (CNS) involvement.
  • Prior history of malignancies, other than CLL, unless the subject has been free of the disease for ≥3 years. Exceptions include the following:
  • Basal cell carcinoma of the skin
  • Squamous cell carcinoma of the skin
  • Carcinoma in situ of the cervix
  • Carcinoma in situ of the breast
  • Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b)
  • History of renal failure requiring dialysis.
  • Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and/or Hepatitis C Virus (HCV) infection.
  • Prior therapy with lenalidomide.
  • Evidence of TLS at screening
  • Presence of specific hematology and/or chemistry abnormalities
  • Uncontrolled hyperthyroidism or hypothyroidism
  • Venous thromboembolism within one year
  • ≥ Grade-2 neuropathy
  • Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
  • Disease transformation [i.e. Richter's Syndrome (lymphomas) or prolymphocytic leukemia]

Trial locations and contacts

165 sites in 27 countries.

165 sites in 27 countries

United States28 sites

  • Roswell Park Cancer Center

    Buffalo, New York, 14263

  • Gabrail Cancer Center Research

    Canton, Ohio, 44718

  • University Hematology Oncology Inc.

    Centralia, Illinois, 62801

  • Charleston Hematology Oncology P.A.

    Charleston, South Carolina, 29403

  • Oncology and Hematology Associates, PA

    Denville, New Jersey, 07834

  • California Cancer Associates for Research and Excellence cCARE

    Escondido, California, 92025

  • The Cancer Center, Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • South Carolina Cancer Specialists

    Hilton Head Island, South Carolina, 29926

  • Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Columbia St Marys Cancer Center

    Milwaukee, Wisconsin, 53211

  • University of Minnesota

    Minneapolis, Minnesota, 55455-0392

  • Medical Consultants, PC

    Muncie, Indiana, 47303

  • Floyd Memorial Cancer Center of Indiana, a division of Floyd Memorial Hospital and Health Services

    New Albany, Indiana, 47150

  • The Hospital of Central Connecticut

    New Britain, Connecticut, 06050

  • North Chicago VA Medical Center

    North Chicago, Illinois, 60064

  • Purchase Cancer Group

    Paducah, Kentucky, 42001

  • Drexel University, College of Medicine

    Philadelphia, Pennsylvania, 19102

  • Pottstown Memorial Medical Center

    Pottstown, Pennsylvania, 19464

  • Swedish Tumor Institute

    Seattle, Washington, 98104

  • Somerset Hematology-Oncology Associates

    Somerville, New Jersey, 08876

  • Cancer Center of Central Connecticut

    Southington, Connecticut, 06489

  • Saint Louis University Cancer Center

    St Louis, Missouri, 63110

  • Central Texas Veterans Health Care System

    Temple, Texas, 76504

  • New York Medical College

    Valhalla, New York, 10595

  • Providence St. Mary Regional Cancer Center

    Walla Walla, Washington, 99362

  • Berks Hematology-Oncology Associates

    West Reading, Pennsylvania, 19611

  • Innovative Clinical Research Institute

    Whittier, California, 90603

  • Geisinger Health System

    Wilkes-Barre, Pennsylvania, 18711

Other trials in United States

Brazil14 sites

  • Fundacao Pio XII - Hospital de Cancer de Barretos

    Barretos, São Paulo, 14784-400

  • BIOCANCER - Centro de Pesquisa e Tratamento do Câncer S/A

    Belo Horizonte, Minas Gerais, 30150-281

  • Hospital Universitario de Brasilia

    Brasílía, 70840-050

  • Hospital Erasto Gaertner

    Curitiba, 81520-060

  • Pro Onco Centro de Tratamento Oncologico

    Londrina, 86050-190

  • Hospital Israelita Albert Einstein

    Morumbi, 05651-901

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Hospital Nossa Senhora da Conceicao

    Porto Alegre, Rio Grande do Sul, 91350-200

  • Instituto Estadual Arthur de Siqueira Cavalcanti - HEMORIO

    Rio de Janeiro, 20211-030

  • Instituto Nacional de Cancer - INCA

    Rio de Janeiro, 20230-130

  • Monte Tabor - Hospital Sao Rafael

    Salvador, Estado de Bahia, 41253-190

  • Centro de Estudos e Pesquisas de Hematologia e Oncologia da Faculdade de Medicina do ABC

    Santo André, 09060-650

  • Instituto de Ensino e Pesquisa Sao Lucas

    São Paulo, 01236-030

  • Fundação Antonio Prudente - AC Camargo Câncer center

    São Paulo, 01509-900

Other trials in Brazil

Italy14 sites

  • Azienda Ospedaliera Policlinico di Bari

    Bari, 70124

  • Azienda Ospedaliera Universitaria Careggi

    Florence, 50134

  • IRCSS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena

    Milan, 20122

  • Ospedale San Raffaele S.r.l.

    Milan, 20132

  • Istituto Europeo di Oncologia - IEO

    Milan, 20141

  • Azienda Ospedaliero Universitaria di Modena

    Modena, 41100

  • Ospedale Cardarelli

    Naples, 80131

  • Universita del Piemonte Orientale

    Novara, 28100

  • AOU San Luigi Gonzaga

    Orbassano, 10043

  • Universita degli Studi di Padova

    Padova, 35128

  • Ospedale S. Chiara

    Pisa, 56126

  • Azienda Ospedaliera Ospedale San Carlo

    Potenza, 85100

  • Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte

    Siena, 53100

  • Ospedale Umberto I

    Torrette Di Ancona, 60020

Other trials in Italy

Israel11 sites

  • Ha'Emek Medical Center

    Afula, 18101

  • Barzilai Medical Center

    Ashkelon, 78278

  • Soroka University Medical Center

    Beersheba, 84101

  • Bnei Zion Medical Center

    Haifa, 31048

  • Shaare Zedek Medical Center

    Jerusalem, 91031

  • Meir Medical Center

    Kfar Saba, 44281

  • Western Galilee Hospital

    Nahariya, 22100

  • Rabin Medical Center

    Petah Tikva, 49100

  • Kaplan Medical Center

    Rehovot, 76100

  • Tel Aviv Sourasky Medical Center Department of Hematology

    Tel Aviv, 64239

  • Sheba Medical Center

    Tel HaShomer, 52621

Other trials in Israel

Russia11 sites

  • Archangelsk Regional Clinical Hospital

    Arkhangelsk, 163045

  • City Hospital 8

    Barnaul, 659010

  • Russian Academy of Medical Sciences Institution

    Moscow, 115478

  • Moscow GUZ City Clinical Hospital

    Moscow, 125284

  • NUZ Central Clinical Hospital

    Moscow, 129128

  • GUZ Nizhegorodskaya Regional Clinical Hospital

    Nizhny Novgorod, 603126

  • MUZ City clinical hospital

    Novosibirsk, 630051

  • St. Petersburg Research Institute of Hematology and Blood Transfusion

    Saint Petersburg, 191024

  • GUS Leningrad Regional Clinical Hospital

    Saint Petersburg, 194291

  • Federal Centre of Heart, Blood and Endocrinology of Rosmed technlologies V.A. Almazov

    Saint Petersburg, 197341

  • Regional Clinical Hospital 1

    Yekaterinburg, 620102

Other trials in Russia

Spain10 sites

  • Hospital Germans Trias I Pujol

    Badalona, 08916

  • Hospital Universitario Vall D hebron

    Barcelona, 08035

  • Hospital Donostia

    Donostia / San Sebastian, 20014

  • Hospital Universitario de la Princesa

    Madrid, 28006

  • Hospital Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario Puerta de Hierro-Majadahonda

    Majadahonda, 28222

  • Hospital General Universitario Morales Messeguer

    Murcia, 30008

  • Hospital Universitario de Salamanca

    Salamanca, 37007

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008

  • Hospital Universitario La Fe

    Valencia, 46009

Other trials in Spain

Australia9 sites

  • IMVS

    Adelaide, South Australia, 5000

  • Flinders Medical Centre

    Bedford Park, 5042

  • St. Vincent Hospital

    Fitzroy, 3065

  • Western Hospital

    Footscray, Victoria, 3011

  • Nepean Hospital

    Kingswood, NSW, 2751

  • Royal Melbourne Hospital

    Melbourne, Victoria, 3050

  • Calvary Mater Hospital

    Waratah, 2298

  • Westmead Hospital Australia

    Westmead, NSW2145

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Belgium6 sites

  • Institut Jules Bordet

    Brussels, 1000

  • Hopital Erasme

    Brussels, 1070

  • Hopital de Jolimont

    Haine-Saint-Paul, 7100

  • AZ Groeninge

    Kortrijk, 8500

  • UZ Leuven

    Leuven, 3000

  • CHU Mont -Godinne

    Yvoir, 5530

Other trials in Belgium

France6 sites

  • Bergonie Institut

    Bordeaux, 33076

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, 33300

  • CHRU

    Grenoble, 38043

  • CHU Dupuytren

    Limoges, 87042

  • Hopital de l'Archet 1

    Nice, 06200

  • CHU Hautepierre

    Strasbourg, 67098

Other trials in France

Bulgaria5 sites

  • MHAT Georgi Stranski PlevenHematology Clinic

    Pleven, 5800

  • University hospital Sveti Georgi Hematology Clinic

    Plovdiv, 4002

  • Military Medical Academy

    Sofia, 1606

  • National Specialized Hospital for Active Treatment of Hematology Diseases

    Sofia, 1756

  • University hospital Sveta Marina

    Varna, 9010

Other trials in Bulgaria

Hungary5 sites

  • Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum

    Debrecen, 4032

  • Kaposi Mor Oktato Korhaz

    Kaposvár, 7400

  • Szegedi TudomanyegyetemII Belgyogyaszati Klinika

    Szeged, 6720

  • Komarom-Esztergom Megye Onkormanyzat Szent Borbala Korhaza

    Tatabánya

  • Petz Aladar Country Hospital

    Vasvari Pal U. 2, 9023

Other trials in Hungary

Poland5 sites

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952

  • Wojewodzki Szpital Specjalistczny im. Mikolaja Kopernika

    Lodz, 93-510

  • Specjalistyczny Szpital miejski im. Kopernika

    Torun, 87-100

  • Klinika Chorob wewnetrznych i Hematologii

    Warsaw, 00-909

  • Nowotworww Krwi i Transplantacji Szpiku

    Wroclaw, 50-367

Other trials in Poland

Romania5 sites

  • Institutul Clinic Fundeni

    Bucharest, 022328

  • Spitalul Clinic Coltea

    Bucharest, 030171

  • Spitalul Clinic Judetean de Urgenta Sf Spiridon Iasi

    Iași, 700111

  • Spitalul Clinic Judetean de Urgenta Sibiu

    Sibiu, 550245

  • Spitalul Clinic Municipal de Urgenta Timisoara

    Timișoara, 300079

Other trials in Romania

Canada4 sites

  • Hospital Charles LeMoyne

    Greenfield Park, Quebec, J4V2H1

  • Sacre-Couer Hospital

    Montreal, Quebec, H4J 1C5

  • Regional Health Authority B-Saint John Regional Hospital

    Saint John, New Brunswick, E2L 4L2

  • General Hospital, Eastern Health

    St. John's, Newfoundland and Labrador, A1B 3V6

Other trials in Canada

Croatia4 sites

  • University Hospital Centre Split

    Split, 21000

  • General Hospital Sveti Duh

    Zagreb, 10000

  • Klinicka bolnica Dubrava Klinika za unutarnje bolesti Odjel za Hematologiju

    Zagreb, 10000

  • University Hospital Centre Zagreb

    Zagreb, 10000

Other trials in Croatia

Czechia3 sites

  • University Hospital2.Dep.Intern.Med. Hematology

    Hradec Králové, 500 05

  • Fakultni nemocnice Ostrava

    Ostrava, 70852

  • Faculty Hospital Kralovske Vinohrady

    Prague, 100 00

Other trials in Czechia

Denmark3 sites

  • Rigshospitalet University Hospital

    Copenhagen, 2100

  • Herlev University Hospital Dep of hematology

    Harlev, 2730

  • Roskilde University Hospital

    Roskilde, 4000

Other trials in Denmark

Netherlands3 sites

  • Maxima Medisch Centrum

    Eindhoven, 5631

  • Spaame Ziekenhuis

    Hoofddorp, 2135

  • Isala Klinieken

    Zwolle, 8025 AB

Other trials in Netherlands

South Africa3 sites

  • University Witwatersrand Oncology

    Parktown, 2193

  • Pretoria Academic Hospital

    Pretoria, 0002

  • Mary Potter Oncology Centre

    Pretoria

Other trials in South Africa

United Kingdom3 sites

  • Royal Bournemouth General Hospital

    Bournemouth, BH7 7DW

  • St. Bartholomew's and The Royal London Hospital

    London, EC1A 7BE

  • St George's Healthcare NHS Trust

    London, SW17 0QT

Other trials in United Kingdom

Austria2 sites

  • Universitaetsklinik Innsbruck

    Innsbruck, 6020

  • Medical University of Vienna Internalmedicine 1, Hematology

    Vienna, 1190

Other trials in Austria

Chile2 sites

  • Instituto Oncologico

    Reñaca, 2540364

  • Instituto Clinico Oncologico del Sur ICOS

    Temuco, 4810469

Other trials in Chile

New Zealand2 sites

  • Christchurch Hospital

    Christchurch, 8011

  • North Shore University Hospital

    Takapuna, 1309

Other trials in New Zealand

Portugal2 sites

  • Hospitais da Universidade de Coimbra

    Coimbra, 3000-075

  • Instituto Portugues Oncologia do Porto Francisco Gentil EPE

    Porto, 4200-072

Other trials in Portugal

Serbia2 sites

  • Clinical Center Kragujevac

    Kragujevac, 34000

  • Clinical Center Nis

    Niš, 18000

Other trials in Serbia

Slovakia2 sites

  • Narodny onkologicky ustav

    Bratislava, 83101

  • Martinska Fakultna Nemocnica

    Martin, 03659

Other trials in Slovakia

Colombia1 site

  • Oncomedica S.A.

    Montería

Other trials in Colombia

About this study

Official title: A Phase 3, Multicenter, Randomized, Openlabel, Parallel-Group Study of the Efficacy and Safety of Lenalidomide (Revlimid®) Versus Chlorambucil as First-Line Therapy for Previously Untreated Elderly Patients With B-Cell Chronic Lymphocytic Leukemia (The Origin Trial)

The purpose of this study is to determine the safety and efficacy of lenalidomide as a first line therapy in treating patients with B-cell Chronic Lymphocytic Leukemia. This study will compare the effects (good and bad) of lenalidomide with chlorambucil.

Read the detailed description

After notification from the US Food and Drug Administration (FDA) on 12 July 2013, Celgene agreed to discontinue the lenalidomide treatment for all patients due to an imbalance in the number of deaths in patients treated with lenalidomide versus patients treated with chlorambucil. No specific causality for this imbalance has been identified to date. Investigators were instructed to immediately discontinue all participants from experimental lenalidomide treatment and inform their patients accordingly. Participants on the Chlorambucil arm may continue up to 12 months (13 cycles) with the last participant completing in March 2014. All randomized participants will continue to be followed for overall survival and secondary primary malignancies.

Being tested
Lenalidomide, Chlorambucil
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

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

  • LenalidomideDrug

    Also called Revlimid

    For patients with normal renal function (defined as CrCl ≥ 60 mL/min), 5 mg once daily on Days 1 through 28 of the first 28-day cycle, 10 mg once daily on Days 1 through 28 starting at the second cycle, 15 mg once daily starting at the third cycle and for the remainder of the study until PD or unacceptable toxicity, whichever occurs first.

    For patients with moderate renal impairment (defined as CrCl ≥ 30 to < 60 mL/min), 2.5 mg once daily on Days 1 through 28 of the first 28-day cycle, 5 mg once daily on Days 1 through 28 starting at the second cycle, 7.5 mg once daily starting at the third cycle and for the remainder of the study until PD or unacceptable toxicity, whichever occurs first.

  • ChlorambucilDrug

    Also called Leukeran

    Patients assigned to the chlorambucil arm will receive oral chlorambucil tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).

Study groups in NCT00910910
Study groupRoleWhat they receive
1 - LenalidomideExperimental1 - Lenalidomide
Receives: Drug: Lenalidomide
2- ChlorambucilActive comparator2- Chlorambucil
Receives: Drug: Chlorambucil

What is being measured

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

  1. Kaplan-Meier Estimate of Progression Free Survival (PFS)

    Progression-free survival was defined as the time from randomization to the first documented progression confirmed per investigator's assessment or death due to any cause on study, whichever occurred first. The progression date was assigned to the earliest time when any progression was observed without prior missing assessments. If withdrawal of consent or lost to follow-up occurred before documented progression or death, then these observations were censored at the date when the last complete tumor assessments determined a lack of progression

    Measured: From first dose of study drug to date of data cut-off of 18 Feb 2013; up to approximately 39 months

  2. Kaplan-Meier Estimate of Progression Free Survival (PFS) With a Later Cut-off Date of 14 March 2014

    Progression-free survival was defined as the time from randomization to the first documented progression confirmed per investigator's assessment or death due to any cause on study, whichever occurred first. Progressive disease included lymphadenopathy, an appearance of any new lesion such as enlarged lymph nodes (> 1.5 cm), splenomegaly, hepatomegaly or other organ infiltrates, an increase by 50% or more in greatest determined diameter of any previous site or an increase by 50% or more in the sum of the product of diameters of multiple nodes. The progression date was assigned to the earliest time when any progression was observed without prior missing assessments. If withdrawal of consent or lost to follow-up occurred before documented progression or death, then these observations were censored at the date when the last complete tumor assessments determined a lack of progression.

    Measured: From randomization to data cut off date of 31 March 2014; median follow up time for all participants was 12.6 months

Secondary outcomes (13)

  1. Number of Participants With Adverse Events (AEs)

    AEs = any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, regardless of cause. Serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); AEs were evaluated for severity according to the following scale: Grade 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death

    Measured: From randomization up to data cut-off of 18 Feb 2013; Up to approximately 39 months; maximum duration of exposure for Lenalidomide was 1086 days and 406 days for Chlorambucil

  2. Number of Participants With Adverse Events With a Later Cut-off Date of 31 March 2014

    AEs = any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, regardless of cause. Serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); AEs were evaluated for severity according to the following scale: Grade 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death

    Measured: From randomization to the data cut-off date of 31 March 2014; Up to 53 months; maximum duration of exposure for Lenalidomide was 1140 days and 406 days for Chlorambucil

  3. Percentage of Participants With the Best Overall Response Based on the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Guidelines

    A best overall response rate is a CR, CRi, nPR or PR and is defined as:

    Complete Remission (CR):

    • No lymphadenopathy
    • No hepatomegaly or splenomegaly
    • Absence of constitutional symptoms
    • Polymorphonuclear leukocytes ≥ 1500/ul
    • No circulating clonal B-lymphocytes
    • Platelets > 100,000/ul
    • Hemoglobin > 11.0 g/dl
    • Normocellular <30% lymphocytes, no B-lymphoid nodules;

    Incomplete Clinical Response (CRi):

    • CR without bone marrow biopsy confirmation.

    Nodular Partial Response (nPR):

    • CR with the presence of residual clonal nodules.

    Partial Response (PR) requires:

    • ≥ 50% decrease in peripheral blood lymphocyte count
    • ≥ 50% reduction in lymphadenopathy
    • ≥ 50% reduction in size of liver and/or spleen
    • 1 or more of the following:
    • Polymorphonuclear leukocytes ≥ 1500/ul
    • Platelets >100,000/ul

    Measured: Up to data cut-off date of 18 Feb 2013; approximately 39 months

  4. Percentage of Participants With a Best Overall Response Based on IWCLL Guidelines With a Later Cut-off Date of 31 March 2014

    A best overall response rate is a CR, CRi, nPR or PR and is defined as:

    Complete Remission (CR):

    • No lymphadenopathy
    • No hepatomegaly or splenomegaly
    • Absence of constitutional symptoms
    • Polymorphonuclear leukocytes ≥ 1500/ul
    • No circulating clonal B-lymphocytes
    • Platelets > 100,000/ul
    • Hemoglobin > 11.0 g/dl
    • Normocellular <30% lymphocytes, no B-lymphoid nodules;

    Incomplete Clinical Response (CRi):

    • CR without bone marrow biopsy confirmation.

    Nodular Partial Response:

    • CR with the presence of residual clonal nodules.

    Partial Response requires:

    • ≥ 50% decrease in peripheral blood lymphocyte count
    • ≥ 50% reduction in lymphadenopathy
    • ≥ 50% reduction in size of liver and/or spleen
    • 1 or more of the following:
    • Polymorphonuclear leukocytes ≥ 1500/ul
    • Platelets >100,000/ul

    Measured: Up to data cut-off of 31 March 2014; approximately 53 months

  5. Kaplan-Meier Estimate for Duration of Response

    Duration of response was defined as the time from first nPR, PR, CRi, or CR to PD. Duration of response was censored at the last date that the patient was known to be progression-free for: 1) participants who had not progressed at the time of analysis; 2) participants who had withdrawn consent or were lost to follow-up prior to documentation of progression

    Measured: Up to data cut-off of 18 Feb 2013; up to approximately 39 months

  6. Kaplan-Meier Estimate for Duration of Response With a Later Cut-off Date of 31 March 2014

    Duration of response was defined as the time from first nPR, PR, CRi, or CR to PD. Duration of response was censored at the last date that the patient was known to be progression-free for: 1) patients who had not progressed at the time of analysis; 2) patients who had withdrawn consent or were lost to follow-up prior to documentation of progression

    Measured: Up to data cut-off of 31 March 2014; up to approximately 53 months

  7. Time to Response

    Time to response was calculated as the time from randomization to the first nPR, PR, CRi or CR based on IWCLL guidelines

    Measured: Up to data cut-off of 18 Feb 2013; up to approximately 39 months

  8. Time to Response for a Later Cut-off Date of 31 March 2014

    Time to response was calculated as the time from randomization to the first nPR, PR, CRi or CR based on IWCLL guidelines

    Measured: Up to data cut-off of 31 March 2014; up to approximately 53 months

  9. Kaplan Meier Estimate of Overall Survival

    Overall Survival is defined as the time between randomization and death from any cause.

    Measured: Up to data cut off of 31 March 2014; median follow-up for all participants was 18.8 months

  10. Kaplan Meier Estimate for Overall Survival at the Final Analysis

    Overall Survival is defined as the time between randomization and death from any cause. Overall survival was censored at the last date that the subject was known to be alive for participants who were alive as of the data cutoff date and for participants who were lost to follow-up before death was documented.

    Measured: Up to the last patient last visit date of 19 May 2018; median follow-up for all participants was 46.7 months

  11. Functional Assessment of Cancer Therapy-General to Create the FACT-Leukemia (FACT-Leu) Quality of Life Instrument

    The FACT-Leu scale is a valid, reliable, and efficient measure of leukemia-specific health-related quality of life for acute and chronic disease. The FACT-Leu is described as including 27 items that assess 17 physical symptoms (fevers, bleeding, general pain, stomach pain, chills, night sweats, bruising, lymph node swelling, weakness, tiredness, weight loss, appetite, shortness of breath, functional ability, diarrhea, concentration, and mouth sores) and 10 emotional/social concerns (frustration with activity limitation, discouraged by illness, future planning, uncertainty, worry about illness, emotional lability, isolation, infertility concern, family worry, and worry about infections).

    Measured: Day 1 and once every 8 weeks

  12. Euro Quality of Life Five Dimension (EQ-5D) Questionnaire

    The standardized extended version of EQ-5D was designed for the collection of health state values using a visual analogue scale (VAS) rating scale - a vertical 20 cm visual analogue scale with the end points labeled best imaginable health state at the top and worst imaginable health state at the bottom having numeric values of 100 and 0 respectively. The participant is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions.

    Measured: Day 1 and once every 8 weeks

  13. Number of Participants and Types of Subsequent Anti-cancer Therapies Received Post Treatment

    Subsequent anti-cancer therapies administered to participants following the discontinuation of study drug (either Lenalidomide or Chlorambucil)

    Measured: Up to the last patient last visit date of 19 May 2018; median follow-up for all participants was 46.7 months

Timeline

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

  1. First posted1 Jun 2009 (estimated)
  2. Study start13 Oct 2009
  3. Primary completion31 Mar 2014
  4. Study completion9 May 2018

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
None (open label)
Enrolment
450 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00910910
Sponsor's protocol ID
CC-5013-CLL-008
Other IDs
2008-003079-32, 2008
Acronym
ORIGIN
Status last verified
Jun 2019
First submitted
28 May 2009
Last updated
9 Jul 2019
Data monitoring committee
Yes

Publications

  • Chanan-Khan A, Egyed M, Robak T, Martinelli de Oliveira FA, Echeveste MA, Dolan S, Desjardins P, Blonski JZ, Mei J, Golany N, Zhang J, Gribben JG. Randomized phase 3 study of lenalidomide versus chlorambucil as first-line therapy for older patients with chronic lymphocytic leukemia (the ORIGIN trial). Leukemia. 2017 May;31(5):1240-1243. doi: 10.1038/leu.2017.47. Epub 2017 Jan 31. No abstract available.

    PubMed 28140392

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lenalidomide and Chlorambucil in people with B-Cell Chronic Lymphocytic Leukemia, run by Celgene at 165 sites in 27 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 24 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 9 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 165 sites in United States, Brazil, Italy, Israel, Russia and 22 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 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 21 Dec 2016). 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?

Kaplan-Meier Estimate of Progression Free Survival (PFS) (time frame: From first dose of study drug to date of data cut-off of 18 Feb 2013; up to approximately 39 months). The study lists 2 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 NCT00910910, which also lists 1 linked publication.

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 9 Jul 2019.

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