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Leukemia, Lymphocytic, Chronic, B-CellPhase 2ICLL07GAINCT02666898

Phase II Trial GA101 Inbrutinib B CLL

A Phase 2 study testing GA101, Ibrutinib and Cyclophosphamide in people with Leukemia, Lymphocytic, Chronic, B-Cell, run by French Innovative Leukemia Organisation at 1 site in France.

Completed

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

Official record
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Trial summary

Phase II study testing chemo-free induction therapy with Ibrutinib + Obinutuzumab nine months / Study Part 1: All patients will receive 8 courses of GA101 + ibrutinib 420mg PO every 28 days Study Part 2: After evaluation at D1 of month 9: If patients are in CR with BM MRD < 10-4, they will continue ibrutinib alone at… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Leukemia, Lymphocytic, Chronic, B-Cell
What is being tested?
GA101, Ibrutinib and Cyclophosphamide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
135 participants
Where
1 siteFrance
Study dates
Oct 2015to Sep 2023
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Patient information and written informed consent
  • Age 18 years or older
  • Immunophenotypically confirmed B-CLL (IWCLL2008 and Matutes score 4 or 5)
  • Binet stage C according to IWCLL 2008 criteria or Binet stage A and B with active disease could be considered for inclusion.
  • Patients with no prior treatment (chemotherapy, radiotherapy, immunotherapy) except steroids for less than 1 month
  • Absence of 17p deletion as assessed by FISH (< 10 % positive nuclei)
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  • Performance status ECOG < 2
  • CIRS (Cumulative Illness Rating Scale) ≤ 6 (see appendix 4 for calculation of CIRS score) Mandatory inclusion criteria for treatment with ibrutinib
  • Hematology values must be within the following limits:
  • Absolute neutrophil count (ANC) <1 G/L independent of growth factor support
  • Platelets <100 G/L or <50 G/L if bone marrow involvement independent of transfusion support in either situation
  • Biochemical values within the following limits:
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x upper limit of normal (ULN)
  • Total bilirubin ≤ 1.5 x ULN unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin
  • Serum creatinine ≤ 2 x ULN or estimated Glomerular Filtration Rate (Cockroft Gault≥ 40 mL/min/1.73m2
  • Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials. Men must agree to not donate sperm during and after the study. For females, these restrictions apply for 1 month after the last dose of study drug. For males, these restrictions apply for 3 months after the last dose of study drug.
  • Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [Beta-hCG]) or urine pregnancy test at Screening. Women who are pregnant or breastfeeding are ineligible for this study.
  • Sign (or their legally-acceptable representatives must sign) an informed consent document indicating that they understand the purpose of and procedures required for the study, including biomarkers, and are willing to participate in the study

Who cannot join

  • Binet stage A and B without active disease according to IWCLL 2008 criteria
  • Known HIV seropositivity
  • Hepatitis B or C seropositivity (unless clearly due to vaccination)
  • Active hemolysis (isolated positive DAT is not an exclusion criteria)
  • Life expectancy < 6 months
  • Patient refusal to perform the bone marrow biopsy for evaluation points
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  • Clinically significant auto-immune anemia
  • Active second malignancy currently requiring treatment (except basal cell carcinoma in situ endometrial carcinoma and incidental prostate carcinoma) and/or less than 5 years CR after breast cancer
  • Any severe co-morbid conditions such as Class III or IV heart failure, myocardial infarction within months, unstable angina, ventricular tachyarrhythmias requiring ongoing treatment, severe chronic obstructive pulmonary disease with hypoxemia, uncontrolled diabetes mellitus, or uncontrolled hypertension
  • Concomitant disease requiring prolonged use of corticosteroids (> 1 month)
  • Known hypersensitivity with anaphylactic reaction to humanized monoclonal antibodies or any of the study drugs
  • Contraindication to the use of Obinutuzumab.
  • Contraindication to use of Ibrutinib
  • Transformation to aggressive B-cell malignancy (e.g. diffuse large cell lymphoma, Hodgkin lymphoma, or prolymphocytic leukaemia)
  • Active bacterial, viral or fungal infection
  • Abnormal renal function with creatinine clearance < 60 ml/min calculated according to the formula of Cockcroft and Gault
  • Total bilirubin, gamma glutamyltransferase or transaminase levels > 2.5 ULN.
  • Any coexisting medical or psychological condition that would preclude participation in the required study procedures
  • Patient with mental deficiency preventing proper understanding of the requirements of treatment.
  • Pregnant or breastfeeding women.
  • Adult under law-control
  • Fertile male and female patients who cannot or do not wish to use an effective method of contraception, during and for 18 months after the final treatment used for the purposes of the study.
  • No affiliate to social security
  • Mandatory exclusion criteria for treatment with Ibrutinib
  • Major surgery within 4 weeks of randomization.
  • Known central nervous system lymphoma.
  • History of stroke or intracranial hemorrhage within 6 months prior to randomization.
  • Requires anticoagulation with warfarin or equivalent vitamin K antagonists
  • Requires treatment with strong CYP3A inhibitors.
  • Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification.
  • Vaccinated with live, attenuated vaccines within 4 weeks of randomization.
  • Known history of human immunodeficiency virus (HIV) or active Hepatitis C Virus or active Hepatitis B Virus infection or any uncontrolled active systemic infection requiring intravenous (IV) antibiotics.
  • Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Sponsor FILO

    Tours, 37054

Other trials in France

About this study

Official title: Phase II, Multicenter, Trial, Exploring "Chemo-free" Treatment (GA101+Ibrutinib) and MRD-driven Strategy in Previously Untreated Symptomatic B-chronic Lymphocytic Leukemia Medically Fit. A FILO Study. A Study From the Goelams/GCFLLC/MW Intergroup

Phase II study testing chemo-free induction therapy with Ibrutinib + Obinutuzumab nine months /

Study Part 1:

All patients will receive 8 courses of GA101 + ibrutinib 420mg PO every 28 days

Study Part 2:

After evaluation at D1 of month 9:

If patients are in CR with BM MRD < 10-4, they will continue ibrutinib alone at a dose of 420mg daily If patients have BM MRD >10-4 whatever IWCLL 2008 responses or PR they will receive four courses of GA101 + FC at 28-day intervals + Ibrutinib PO until final evaluation of M16

Read the detailed description

Phase II study testing chemo-free induction therapy with Ibrutinib + Obinutuzumab during nine months followed by a MRD-driven strategy. Assessment of response as well as bone marrow MRD evaluation will be performed at Day 1 month 9:

  1. Patients reaching CR with marrow MRD below 10-4 threshold will continue ibrutinib during 6 additional months.
  2. Patients in PR or bone marrow MRD > 10-4 will receive Ibrutinib during 6 additional months and 4 courses of FC+ GA101. At Day 1 Month 16, patients in CR but with MRD> 10-4 will continue Ibrutinib until progressive disease.
  3. Patients in stable or progressive disease will be excluded out of the trial.

Final evaluation of response (with BM MRD) will be performed at Day 1 Month 16.

Keywords
Residual disease
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Neoplasm, Residual

What participants receive

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

  • GA101Drug

    Also called Obinutuzumab

    Part 1 :6 cycles

    Obinutuzumab/GA101:

    First cycle:

    D1: 100mg, D2: 900mg D8 and D15: 1000 mg i.v

    Cycle 2 to 6 (every 28 days) :

    D1 of every cycle: 1000 mg i.v PART 2 4 cycles

    -patients have BM MRD >10-4 or PR: Cycle 1 to 4 Obitinuzumab/GA101: 1000 mg i.v on day 1

  • IbrutinibDrug

    Also called Imbruvica

    Part 1 :6 cycles

    Cycle 2 to 6 (every 28 days) :Ibrutinib:

    D3 Month 1 to Day 30 Month 15: 420mg daily PO PART 2:4 cycles

    • patients in CR with BM MRD < 10-4 : Ibrutinib alone 420mg daily
    • patients with BM MRD >10-4 whatever responses or PR :Cycle 1 to 4 Ibrutinib 420mg daily with Cyclophosphamide and Fludarabine

  • CyclophosphamideDrug

    Also called Endoxan

    PART 2 :

    patients with BM MRD >10-4 or PR (except PD and SD), receive : 4 cycles of FC+GA101 every 28 days Cyclophosphamide : 250 mg/m² per os, D2 to D4 in association with GA101, ibrutinib and fludarabine

  • FludarabineDrug

    Also called Fludara

    PART 2 :

    patients with BM MRD >10-4 or PR (except PD and SD), receive : 4 cycles of FC+GA101 every 28 days : Fludarabine : 40 mg/m² per os, D2 to D4 in association with GA101, ibrutinib and cyclophosphamide

Study groups in NCT02666898
Study groupRoleWhat they receive
Obinutuzumab and Ibrutinib CLL treatmentExperimental3 parts PART 1: 6 cycles of GA101 + Ibrutinib 420mg PO/ 28 days: GA101: C 1 D1: 100mg, D2: 900mg D8 and D15: 1000 mg i.v C 2 to 6 :D1 1000 mg i.v Ibrutinib: D3 Month 1 to Day 30 Month 15: 420mg daily PO PART 2: 4 cycles / 28 days After evaluation at D1 month 9: * patients in CR with BM MRD < 10-4, Ibrutinib 420mg daily * patients with BM MRD >10-4 or PR 4 courses of GA101 + FC/ 28-day + Ibrutinib PO until M16 Cycle 1 to 4 - GA101: 1000 mg i.v on day 1 * Fludarabine : 40 mg/m² per os, days 2-4, / 28 days * Cyclophosphamide : 250 mg/m² per os, days 2-4, / 28 days * Ibrutinib 420mg/day PO PART 3 (only in GAI-FC+Ibru arm) : After evaluation at D1 of M16: * patients CR with BM MRD< 10-4, treatment stopped * patients CR with BM MRD >10-4, Ibrutinib continued until PD or PB MRD becomes negative.
Receives: Drug: GA101; Drug: Ibrutinib; Drug: Cyclophosphamide; Drug: Fludarabine

What is being measured

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

  1. Study treatment response

    IWCLL criteria response

    Measured: month 16

  2. Study treatment response

    MRD

    Measured: month 16

Secondary outcomes (4)

  1. progression free survival

    relapse

    Measured: month 16

  2. progression free survival

    death

    Measured: month 16

  3. overall survival

    death

    Measured: month 16

  4. time to next treatment

    date of new treatment after first relapse

    Measured: 36 months

Timeline

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

  1. First posted28 Jan 2016 (estimated)
  2. Study startOct 2015
  3. Primary completionMay 2017
  4. Study completionSep 2023

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
135 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02666898
Sponsor's protocol ID
ICLL07GAI
Acronym
ICLL07GAI
Status last verified
Nov 2025
First submitted
26 Oct 2015
Last updated
26 Nov 2025
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Michallet AS, Letestu R, Le Garff-Tavernier M, Campos L, Ticchioni M, Dilhuydy MS, Morisset S, Rouille V, Mahe B, Laribi K, Villemagne B, Ferrant E, Tournilhac O, Delmer A, Molina L, Leblond V, Tomowiak C, de Guibert S, Orsini-Piocelle F, Banos A, Carassou P, Cartron G, Fornecker LM, Ysebaert L, Dartigeas C, Truchan-Graczyk M, Vilque JP, Schleinitz TA, Cymbalista F, Lepretre S, Levy V, Nguyen-Khac F, Feugier P. A fixed-duration immunochemotherapy approach in CLL: 5.5-year results from the phase 2 ICLL-07 FILO trial. Blood Adv. 2023 Aug 8;7(15):3936-3945. doi: 10.1182/bloodadvances.2022009594.

    PubMed 37026799

  • Michallet AS, Letestu R, Le Garff-Tavernier M, Aanei C, Ticchioni M, Dilhuydy MS, Subtil F, Rouille V, Mahe B, Laribi K, Villemagne B, Salles G, Tournilhac O, Delmer A, Portois C, Pegourie B, Leblond V, Tomowiak C, De Guibert S, Orsini Piocelle F, Banos A, Carassou P, Cartron G, Fornecker LM, Ysebaert L, Dartigeas C, Truchan-Graczyk M, Vilque JP, Aurran T, Cymbalista F, Lepretre S, Levy V, Nguyen-Khac F, Feugier P. A fixed-duration, measurable residual disease-guided approach in CLL: follow-up data from the phase 2 ICLL-07 FILO trial. Blood. 2021 Feb 25;137(8):1019-1023. doi: 10.1182/blood.2020008164.

    PubMed 33167024

  • Michallet AS, Dilhuydy MS, Subtil F, Rouille V, Mahe B, Laribi K, Villemagne B, Salles G, Tournilhac O, Delmer A, Portois C, Pegourie B, Leblond V, Tomowiak C, de Guibert S, Orsini F, Banos A, Carassou P, Cartron G, Fornecker LM, Ysebaert L, Dartigeas C, Truchan Graczyk M, Vilque JP, Aurran T, Cymbalista F, Lepretre S, Levy V, Nguyen-Khac F, Le Garff-Tavernier M, Aanei C, Ticchioni M, Letestu R, Feugier P. Obinutuzumab and ibrutinib induction therapy followed by a minimal residual disease-driven strategy in patients with chronic lymphocytic leukaemia (ICLL07 FILO): a single-arm, multicentre, phase 2 trial. Lancet Haematol. 2019 Sep;6(9):e470-e479. doi: 10.1016/S2352-3026(19)30113-9. Epub 2019 Jul 16.

    PubMed 31324600

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GA101, Ibrutinib and Cyclophosphamide in people with Leukemia, Lymphocytic, Chronic, B-Cell, run by French Innovative Leukemia Organisation at 1 site in France.

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 18 inclusion and 33 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 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. 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 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Study treatment response (time frame: month 16). 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 NCT02666898, 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 26 Nov 2025.

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