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Chronic Lymphocytic LeukemiaPhase 2NCT03280160

Protocol GELLC-7: Ibrutinib Followed by Ibrutinib Consolidation in Combination With Ofatumumab

A Phase 2 study testing Ibrutinib 140 MG Oral Capsule [Imbruvica] in people with Chronic Lymphocytic Leukemia, run by PETHEMA Foundation at 20 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Based on the promising results obtained with ibrutinib as single agent, the results obtained with ibrutinib in combination with ofatumumab in a previous phase I/IIb study (Jaglowski 2015), and since data from in vitro studies do not support a synergistic effect of the combination of ibrutinib and anti-CD20 mAbs, we… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Lymphocytic Leukemia
What is being tested?
Ibrutinib 140 MG Oral Capsule [Imbruvica]
How many people
84 participants
Where
20 sitesSpain
Study dates
7 Sep 2017to Sep 2022
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

  • Adult patients with previously untreated CLL or SLL defined following IWCLL criteria (Hallek, 2008).
  • Must understand and voluntarily sign an informed consent form.
  • Age ≥ 18 years at the time of signing the informed consent form and must be able to adhere to the study visit schedule and other protocol requirements.
  • Must have a documented diagnosis of CLL or SLL [IWCLL guidelines for diagnosis and treatment of CLL (Hallek, 2008)] meeting at least one of the following criteria:
  • Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia.
  • Massive (i.e. > 6 cm below the left costal margin) or progressive or symptomatic splenomegaly.
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  • Massive nodes (i.e. > 10 cm in longest diameter) or progressive or symptomatic lymphadenopathy.
  • Progressive lymphocytosis with an increase of > 50% over a 2-month period, or lymphocyte doubling time (LDT) of less than 6 months.
  • A minimum of any one of the following disease-related symptoms: unintentional weight loss ≥ 10% within the previous 6 months, significant fatigue (i.e., ECOG PS 2; cannot work or unable to perform usual activities), fevers of greater than 38.0° C or 100.5F for 2 or more weeks without other evidence of infection, or night sweats for more than 1 month without evidence of infection
  • Physically fit patients defined as CIRS < 6 (CIRS Scale, Appendix E).
  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of ≤2.
  • All sexually active subjects with the capacity to reproduce (male and female) must use high-efficacy contraceptive methods during the course of the study. These restrictions apply for 12 months after the last dose of ofatumumab or 3 months after the last dose of ibrutinib, whichever happens later. High-efficacy contraceptive methods include:
  • Total abstinence when consistent with the subject's typical and preferred lifestyle (periodic abstinence [e.g. calendar methods, ovulation, symptothermal and post-ovulation methods] and the withdrawal method are not acceptable contraceptive methods).
  • Female sterilisation defined as surgical hysterectomy, bilateral oophorectomy, or tubal ligation at least six weeks prior to the study treatment (a simple oophorectomy does not meet the definition of female sterilisation).
  • Male sterilisation (at least six months before screening). A man who has undergone a vasectomy must be the only partner who is a study subject.
  • Combination of two of the following methods (a+b or a+c or b+c):
  • Use of oral, injected or implanted hormonal contraceptives, or other hormonal contraceptive methods that have a comparable efficacy (failure rate < 1%), for example, hormonal vaginal ring or transdermal hormonal contraceptive. If an oral contraceptive is used, women must use the same pill for a minimum of three months before taking the study treatment.
  • Placement of an intrauterine device (IUD) or an intrauterine system (IUS).
  • Barrier contraceptive methods: condom or cervical cap (cervical/vault diaphragm or cap) with foam/gel/film/spermicidal cream/vaginal suppository.
  • Female subjects of childbearing potential must have a negative pregnancy test at screening. Females of child bearing potential are defined as sexually mature women without prior hysterectomy or who have had any evidence of menses in the past 12 months. However, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to other causes, including prior chemotherapy, anti-estrogens, or ovarian suppression

Who cannot join

  • Prior treatment for CLL or SLL.
  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent form.
  • Systemic infection that has not resolved prior to initiating study treatment in spite of adequate anti-infective therapy.
  • Pregnant or lactating females.
  • Participation in any clinical study or having taken any investigational therapy within 28 days prior to initiating study therapy.
  • Central nervous system (CNS) involvement as documented by spinal fluid cytology or imaging.
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  • Prior history of malignancies, other than CLL, unless the patient 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)
  • Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and/or Hepatitis C Virus (HCV) infection.
  • Any of the following laboratory abnormalities:
  • Serum creatinine ≥ 2 x ULN or estimated Glomerular Filtration Rate (Cockroft-GaultAppendix C) ≤ 40 mL/min/1.73m2 Absolute neutrophil count (ANC) < 1.0 X 109/L, unless secondary to bone marrow involvement by CLL.
  • Platelet count <100,000/mm3 or <50,000/mm3 if bone marrow involvement independent of transfusion support in either situation Serum aspartate aminotransferase (AST)/serum glutamic-oxaloacetictransaminase (SGOT) or alanine transaminase (ALT)/serum glutamate pyruvate transaminase (SGPT) >3 x upper limit of normal (ULN).
  • Serum total bilirubin > 1.5 x ULN, except in cases of Gilbert's syndrome.
  • Presence of autoimmune haemolytic anemia or autoimmune thrombocytopenia.
  • Disease transformation [i.e. Richter's Syndrome (lymphomas) or prolymphocytic leukemia.
  • Major surgery within the last 28 days prior to registration.
  • History of stroke or intracranial hemorrhage within 6 months prior to enrolment.
  • Currently active, clinically significant cardiovascular disease or a history of myocardial infarction within 3 months prior to enrolment.
  • Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists within 28 days of first dose of study drug.
  • 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

20 sites in 1 country.

20 sites in 1 country

Spain20 sites

  • Hospital de Badalona Germans Trias i Pujol

    Badalona

  • Hospital Clínic de Barcelona

    Barcelona

  • Hospital de la Santa Creu i Sant Pau

    Barcelona

  • Hospital Universitario Vall d'Hebron

    Barcelona

  • ICO Hospitalet - Hospital Duran i Reynals

    Barcelona

  • Hospital Reina Sofía de Córdoba

    Córdoba

  • Fundación Jiménez Díaz

    Madrid

  • Hospital Infanta Leonor

    Madrid

  • Hospital Universitario 12 de Octubre

    Madrid

  • Hospital Universitario de la Princesa

    Madrid

  • Hospital Universitario La Paz

    Madrid

  • Hospital Universitario Puerta de Hierro

    Madrid

  • Hospital Universitario Central de Asturias

    Oviedo

  • Hospital Son Espases (Son Dureta)

    Palma de Mallorca, Balearic Islands, 07010

  • Hospital Universitario de Salamanca

    Salamanca

  • Hospital Universitario Marqués de Valdecilla

    Santander

  • Hospital Nuestra Señora de Valme

    Seville

  • Hospital Virgen de la Salud de Toledo

    Toledo

  • Hospital Clínico de Valencia

    Valencia

  • Hospital La Fe de Valencia

    Valencia

Other trials in Spain

About this study

Official title: A Multicenter, Non-randomized, Open Label Study to Evaluate the Efficacy and Security of Ibrutinib Followed by Ibrutinib Consolidation in Combination With Ofatumumab in Previously Untreated Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

Based on the promising results obtained with ibrutinib as single agent, the results obtained with ibrutinib in combination with ofatumumab in a previous phase I/IIb study (Jaglowski 2015), and since data from in vitro studies do not support a synergistic effect of the combination of ibrutinib and anti-CD20 mAbs, we propose a chemotherapy-free combined strategy based on ibrutinib monotherapy as front line treatment for patients with CLL, with the addition of a consolidation phase with ofatumumab in patients not attaining CR under ibrutinib in order to improve the quality of their response. Since median time to CR with ibrutinib was nearly 12 months, patients will be evaluated at this time point, and those patients not in CR will add consolidated treatment with Ofatumumab. Thus, this multi-center, non-randomized phase 2 study is designed to evaluate the efficacy and safety of ibrutinib alone or in combination with Ofatumumab in patients no attaining CR under ibrutinib as front-line therapy for patients with chronic lymphocytic leukemia.

Read the detailed description

Multicenter, non- randomized, open-label, double agent, phase II study of the Spanish Group of CLL (GELLC).

Patients with untreated CLL/SLL. Ibrutinib will be administered orally 420 mg (3 x 140 mg capsules) once daily on a continuous schedule on an outpatient basis until disease progression or unacceptable toxicity.

After 12 cycles of ibrutinib, patients that do not achieve a complete response (CR) will be treated with the combination of ibrutinib and ofatumumab. Patients in CR after 12 cycles of ibrutinib will continue with ibrutinib alone.

Ofatumumab will be administered by IV infusion, 300mg on Day 1 and 1,000 mg on Day 8 of cycle 13, followed by 5 monthly infusions of 1,000 mg (Day 1 of subsequent 28-day cycles for cycles C14, C15, C16, C17, and C18).

A treatment cycle will be defined as lasting 28 days. Patients will be treated with ibrutinib, within the study frame, until progression, unacceptable toxicity or cycle C42 of treatment).

All patients still on study treatment at the time of cycle C42, or if the study is stopped early, will be transitioned to prescribed ibrutinib.

Being tested
Ibrutinib 140 MG Oral Capsule [Imbruvica]
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.

  • Ibrutinib 140 MG Oral Capsule [Imbruvica]Drug

    Also called Ofatumumab

    Ibrutinib will be administered orally 420 mg (3 x 140 mg capsules) once daily on a continuous schedule on an outpatient basis until disease progression or unacceptable toxicity.

    After 12 cycles of ibrutinib, patients that do not achieve a complete response (CR) will be treated with the combination of ibrutinib and ofatumumab. Patients in CR after 12 cycles of ibrutinib will continue with ibrutinib alone.

    Ofatumumab will be administered by IV infusion, 300mg on Day 1 and 1,000 mg on Day 8 of cycle 13, followed by 5 monthly infusions of 1,000 mg (Day 1 of subsequent 28-day cycles for cycles C14, C15, C16, C17, and C18).

    A treatment cycle will be defined as lasting 28 days

What is being measured

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

  1. Efficacy in terms of response rate

    To determine the complete response rate obtained with the combination of Ibrutinib and ofatumumab

    Measured: 18 months

Timeline

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

  1. First posted12 Sep 2017
  2. Study start7 Sep 2017
  3. Primary completion13 Jul 2018
  4. Study completionSep 2022 (estimated)

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03280160
Sponsor's protocol ID
GELLC-7
Status last verified
Sep 2022
First submitted
9 Sep 2017
Last updated
16 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ibrutinib 140 MG Oral Capsule [Imbruvica] in people with Chronic Lymphocytic Leukemia, run by PETHEMA Foundation at 20 sites in Spain.

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 20 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Spain. 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?

Results are not available in the source record.

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?

Efficacy in terms of response rate (time frame: 18 months). 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 NCT03280160.

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 16 Sep 2022.

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