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Waldenstrom MacroglobulinemiaPhase 2RemodelWM3NCT02962401

Efficacity of Idelalisib and Obinutuzumab in Patient With Relapsed Refractory Waldenstrom's Macroglobulinemia

A Phase 2 study testing Obinutuzumab and Idelalisib in people with Waldenstrom Macroglobulinemia, 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
Search all trials

Trial summary

Prospective national multicenter open label phase II Remodel WM3 trial Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Waldenstrom Macroglobulinemia
What is being tested?
Obinutuzumab and Idelalisib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteFrance
Study dates
7 Mar 2017to 13 Apr 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

  • Age 18 years or older
  • Confirmed CD20 positive WM, according to the recommendations of the 2nd Workshop on WM.
  • Presence of at least one criterion for initiation of therapy, according to the 2nd Workshop on WM.
  • Recurrent fever, night sweats, weight loss, fatigue
  • Hyperviscosity
  • Lympadenopathy which is either symptomatic or bulky more or equal to 5cm in maximum diameter
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  • Symptomatic hepatomegaly and/or splenomegaly
  • Symptomatic organomegaly and/or organ or tissue infiltration
  • Peripheral neuropathy due to WM
  • Symptomatic cryoglobulinemia
  • Cold agglutinin anemia
  • Immune hemolytic anemia and/or thrombocytopenia
  • Nephropathy related to WM
  • Amyloidosis related to WM
  • Hemoglobin less or equal than 10g dL
  • Platelet count less than 100 109 L
  • Prior treatment for WM comprising at least one regimen containing a therapeutic anti CD20 monoclonal antibody rituximab administered for more or equal than 2 doses of antibody treatment and or a therapeutic chemotherapy, alkylating agent, purine analogue, bendamustine administered for more or equal than 2 cycles of treatment
  • Patients may be either relapsing progressing at least 6 months after the last administration of first line or subsequent treatment or refractory progressing on or within 6 months of first line or subsequent treatment
  • Number of prior regimens per lines 1 to 3
  • Life expectancy more than 3 months.
  • ECOG less or equal than 2.
  • Meet the following pretreatment laboratory criteria at the screening visit conducted within 28 days of study enrollment:
  • ASAT 2.5 times the upper limit of institutional laboratory normal value.
  • ALAT 2.5 times the upper limit of institutional laboratory normal value.
  • Total bilirubin 1.5 times the upper limit of institutional laboratory normal value unless clearly related to the disease or Gilbert syndrome
  • Calculated or measured creatinin clearance by MDRD 40 mL minute.
  • Premenopausal fertile females must agree to use a highly effective method of birth control for the duration of the therapy up to 6 months after end of therapy.
  • A highly effective method of birth control is defined as those which result in a low failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.
  • Men must agree not to father a child for the duration of therapy and 6 months after and must agree to advice a female partner to use a highly effective method of birth control.
  • Voluntary written informed consent before carrying out any study related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.

Who cannot join

  • Prior treatment with phosphatidylinositol 3 kinase PI3K inhibitors including idelalisib or GA101
  • History of anaphylactic reaction following exposure to humanized monoclonal antibodies
  • Previous allogeneic transplantation
  • Treatment with any other investigational agent or participating in another trial within 30 days prior to entering this study
  • History of other malignancy or chemotherapy radiotherapy for any neoplastic disease other than WM prior to the study.
  • EXCEPTION: History of malignancy except basal cell carcinoma of the skin, in situ carcinoma of breast or cervix treated surgically with curative intent, or any malignancy that has been in CR for 5 years at minimum, or as deemed appropriate for inclusion in the trial as per approval by the investigator
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  • Medical condition requiring the long-term estimated to be more than one month use of oral corticosteroids.
  • Patients with signs of bacterial, viral or fungal infection
  • Preexisting hepatic enzyme elevation ASAT, ALAT
  • CMV PCR or antigenemia testing positive
  • Known history of drug induced liver injury, chronic active hepatitis C HCV, chronic active hepatitis B HBV, alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, on-going extra-hepatic obstruction caused by cholelithiasis, cirrhosis of the liver or portal hypertension
  • HIV antibody positive
  • Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb): Patients with presence of HBcAb, but absence of HBsAg, are eligible if hepatitis B virus (HBV) DNA is undetectable (< 20 IU). Patients with positive serology should be referred to a hepatologist or gastroenterologist before start of treatment and should be monitored and managed following local standards to prevent hepatitis reactivation. Furthermore transaminases and HBV DNA quantification must be tested at weeks 4 and 8 after treatment start. Then transaminases must be tested at week 12 of treatment start.
  • Preexisting pulmonary disease
  • Known history of drug induced pneumonitis
  • On-going inflammatory bowel disease
  • Women who are pregnant. Women who are breast-feeding and do not consent to discontinue breast-feeding Women of childbearing age who are not willing to use effective anti-conceptive methods for the duration of the study and 6 months after end of therapy
  • Concurrent severe diseases which exclude the administration of therapy:
  • Heart insufficiency NYHA grade III IV, LVEF < 50% and or RF <30%, myocardial infarction within the past 6 months prior to study
  • Severe chronic obstructive lung disease with hypoxemia
  • Severe diabetes mellitus
  • Hypertension difficult to control
  • Cerebral dysfunction
  • Richter's syndrome
  • Cardiac amyloidosis
  • Any of the following laboratory abnormalities, if not related to lymphoma:
  • Absolute neutrophils count <1.5 x 109/L if not result of a bone marrow infiltration Platelet count <75 x 109/L if not result of a bone marrow infiltration.
  • Central Nervous System involvement by lymphoma
  • Vaccination with live vaccines within 28 days prior to study entry
  • Hypersensitivity to the active substance or to any of the excipients listed on part 6.1 of GAZYVARO and ZYDELIG SmCP
  • Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
  • No consent for registration, storage and processing of the individual disease-characteristics and course as well as information of the family physician about study participation
  • Patient with mental deficiency preventing proper understanding of the requirements of treatment
  • Person major under law control.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Project manager

    Tours, 37044

Other trials in France

About this study

Official title: An Open Label Non-randomized Phase II Study Exploring "Chemo-free " Treatment Association With Idelalisib + Obinutuzumab in Patient With Relapsed/Refractory Waldenstrom's Macroglobulinemia

Prospective national multicenter open label phase II Remodel WM3 trial

Read the detailed description

An Open Label non-randomized Phase II Study exploring chemo-free treatment association with Idelalisib and Obinutuzumab in Patient with relapsed refractory Waldenstrom's Macroglobulinemia

Being tested
Obinutuzumab, Idelalisib
Medical subject headings
Waldenstrom Macroglobulinemia

What participants receive

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

  • ObinutuzumabDrug

    Also called GA101

    6 cycles every 28 days Cycle 1 :Obinutuzumab 1000mg I.V.(2 parts) 100mg day 1 and 900mg day 2 day 1, 8 and 15

    Cycle 2 - 6 :

    Obinutuzumab 1000mg I.V.day 1

  • IdelalisibDrug

    Also called Zydelig

    6 cycles every 28 days

    Cycle 1 :

    Idelalisib 150 mg x 2 p.o. day 1 to 28 Cycle 2 - 6 Idelalisib 150 mg x 2 p.o. day 1 to 28 Consolidation Idelalisib alone 150 mg twice a day until day 672 = 2 years after the beginning of the treatment

Study groups in NCT02962401
Study groupRoleWhat they receive
Idelalisib and ObinutuzumabExperimental6 cycles of Idelalisib and Obinutuzumab Cycle 1 : Idelalisib 150 mg x 2 p.o. day 1 to 28 Obinutuzumab 1000mg I.V. (2 parts) 100mg day 1 and 900mg day 2 day 1, 8 and 15 Cycle 2 - 6 : Idelalisib 150 mg x 2 p.o. day 1 to 28 Obinutuzumab 1000mg I.V. day 1 Consolidation Idelalisib alone 150 mg twice a day until day 672 = 2 years after the beginning of the treatment
Receives: Drug: Obinutuzumab; Drug: Idelalisib

What is being measured

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

  1. Progression free survival

    From date of registration until the date of first documented progression or date of death

    Measured: 8 years

Secondary outcomes (4)

  1. Overall response rates (ORR)

    treatment response

    Measured: Month 8

  2. Duration of response (RD)

    from end of induction to the date of progression, relapse or death

    Measured: 7 years and 4 months

  3. Time to treatment failure (TTF)

    time from start of induction to stable disease, progression or death from any cause

    Measured: through study completion, an average of 8 years

  4. Time to next treatment (TTNT)

    time from start of induction day 1 cycle 1 to time of the next treatment for progression or relapse

    Measured: through study completion, an average of 8 years

Timeline

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

  1. First posted11 Nov 2016 (estimated)
  2. Study start7 Mar 2017
  3. Primary completion31 Aug 2020
  4. Study completion13 Apr 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
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02962401
Sponsor's protocol ID
RemodelWM3
Acronym
RemodelWM3
Status last verified
Aug 2023
First submitted
26 Oct 2016
Last updated
29 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: E CRF

Publications

  • Tomowiak C, Poulain S, Nudel M, Feugier P, Herbaux C, Mahe B, Morel P, Aurran T, Tournilhac O, Lepretre S, Assaad S, Villemagne B, Casasnovas O, Lhermitte A, Roos-Weil D, Torregrosa-Diaz J, Chevret S, Leblond V; on the behalf of the FILO group. Six-year follow-up of phase II study exploring chemo-free treatment association with idelalisib and obinutuzumab in symptomatic relapsed/ refractory patients with Waldenstrom's macroglobulinemia. Ann Hematol. 2025 Jan;104(1):685-690. doi: 10.1007/s00277-024-06076-1. Epub 2024 Nov 5.

    PubMed 39499299

  • Tomowiak C, Poulain S, Herbaux C, Perrot A, Mahe B, Morel P, Aurran T, Tournilhac O, Lepretre S, Assaad S, Villemagne B, Casasnovas O, Nollet D, Roos-Weil D, Chevret S, Leblond V. Obinutuzumab and idelalisib in symptomatic patients with relapsed/refractory Waldenstrom macroglobulinemia. Blood Adv. 2021 May 11;5(9):2438-2446. doi: 10.1182/bloodadvances.2020003895.

    PubMed 33961019

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Obinutuzumab and Idelalisib in people with Waldenstrom Macroglobulinemia, 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 30 inclusion and 34 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 29 Aug 2023. 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?

Progression free survival (time frame: 8 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 NCT02962401, which also lists 2 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 29 Aug 2023.

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