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Waldenstrom MacroglobulinemiaPhase 2OBI-1NCT03679455

A Study of Obinutuzumab (RO5072759) Induction in Patients With Relapsed/ Refractory Waldenström Macroglobulinemia, OBI-1

A Phase 2 study testing Obinutuzumab 25 MG/ML in people with Waldenstrom Macroglobulinemia, run by Polish Myeloma Consortium at 2 sites in Poland.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is a multi-center, single-arm, open label, non-randomized, phase II study designed to investigate the efficacy, safety and tolerability of obinutuzumab given as monotherapy in patients with relapsed/refractory Waldenström Macroglobulinemia (R/R MW). 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 25 MG/ML
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesPoland
Study dates
21 Sep 2018to Dec 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

  • Signed written informed consent prior to beginning study-related procedures.
  • Male and female subjects aged ≥ 18 years.
  • Able to comply with the study protocol, in the investigator's judgment.
  • Confirmed clinicopathological diagnosis of WM with detectable CD20 positive of the tumor cells
  • Measurable disease defined as serum monoclonal IgM >0.5 g/dL
  • Active disease and indication for treatment based on the Seventh IWWM recommendations (Dimopoulos et al., 2014) defined by presence of at least any one of the following conditions:
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  • Recurrent fever, night sweats, weight loss, fatigue
  • Hyperviscosity
  • Lymphadenopathy which is either symptomatic or bulky (≥5 cm in maximum diameter)
  • 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 ≤10 g/dL
  • Platelet count <100 × 109/L
  • Subjects must have received prior therapies for their WM and have relapsed or refractory WM requiring therapy. Any number of prior therapies is acceptable. Relapsed WM: defined as a subject who has received at least one prior WM therapy and previously achieved a complete or partial remission/response lasting at least 6 months Refractory WM: is defined as progression on treatment; disease progression < 6 months of the last anti-WM therapy
  • Subjects must have adequate organ and marrow function as defined below:
  • Absolute neutrophil count ≥ 1.5 x 109/l (unless decreased due to WM involvement of the bone marrow)
  • Platelets ≥ 75 x 109/l (unless decreased due to WM involvement of the bone marrow)
  • Hemoglobin ≥ 9 g/dL
  • Total bilirubin ≤ 1.5 x ULN or < 2 x ULN if attributable to hepatic infiltration by neoplastic disease
  • AST and ALT < 2.5 x ULN
  • Calculated creatinine clearance by Cockcroft-Gault formula >40 mL/min
  • INR ≤ 1.5
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
  • Fertile men or women of childbearing potential, unless ≥ 2 years after the onset of menopause (for women), must be willing to use a highly effective contraceptive method (Pearl Index < 1) such as oral contraceptives, intrauterine device, sexual abstinence or barrier method of contraception in conjunction with spermicidal jelly, during study treatment and for 18 months after end of obinutuzumab treatment.

Who cannot join

  • Lactating women, women with a positive pregnancy test at Visit 1 or women (of childbearing potential) as well as men with partners of childbearing potential, who are not willing to use adequate contraception from study start through 18 months after end of obinutuzumab treatment.
  • Known involvement of the central nervous system by WM.
  • Vaccination with a live vaccine a minimum of 28 days prior to study enrolment (vaccination day considered as Day 0).
  • History of stroke or intracranial hemorrhage within 12 months prior to study enrollment.
  • Currently active, clinically significant cardiovascular disease.
  • Any active systemic infection. Caution should be exercised when considering the use of obinutuzumab in patients with a history of recurring or chronic infections.
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  • Positive for hepatitis C antibody at screening.
  • Positive test result for chronic hepatitis B virus (HBV) infection (defined as a positive HBsAg serology). Patients with occult or prior HBV infection (defined as negative hepatitis B surface antigen [HBsAg] and positive total hepatitis B core antibody [HBcAb]) may be included if HBV DNA is undetectable, provided that they are willing to undergo monthly DNA testing during treatment and follow-up until 12 months after the last dose of obinutuzumab.
  • Known HIV infection at screening.
  • Any serious illness, medical condition, organ system dysfunction or abnormality in clinical laboratory test that, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk.
  • Concurrent use of other anti-cancer agents or treatments.
  • Prior use of any investigational monoclonal antibody therapy within 6 months of study start.
  • History of severe allergic or anaphylactic reactions to monoclonal antibody therapy, known hypersensitivity to any of the study drugs or sensitivity to murine products.
  • Treatment with any known non-marketed drug substance or experimental therapy within 5 terminal half-lives or 4 Weeks prior to first study treatment dose, whichever is longer, or participation in any other interventional clinical study.
  • Prior use of radiation therapy within 4 weeks of enrollment.
  • History of other malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer.
  • History of illicit drug or alcohol abuse within 12 months prior to screening, in the investigator's judgment.

Trial locations and contacts

2 sites in 1 country.

Tomasz Wróbel, MD, PhD contact

+48 501 419 272

wrobeltw@gmail.com

Dominik Dytfeld, MD, PhD contact

+48 602 464 708

dytfeld@me.com

Poland2 sites, 2 recruiting

  • Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu; Oddział Hematologii i Transplantacji Szpiku

    Poznan, Greater Poland Voivodeship, 60-569

    Dominik Dytfeld, MD, PhD, +48 602464708, dytfeld@me.com

    Elżbieta Gwazdacz-Magiera, +48 535818919, egm1@tlen.pl

    Recruiting

  • Uniwersytecki Szpital kliniczy im. Jana Mikulicza-Radeckiego we Wrocławiu; Klinika Hematologii, Nowotworów Krwi Transplantacji Szpiku

    Wroclaw, Lower Silesian Voivodeship, 50-367

    Tomasz Wróbel, MD, PhD, +48 501 419 272, wrobeltw@gmail.com

    Agnieszka Szeremet, MD, +48 71 784 22 77, agnieszka.szeremet@wp.pl

    Recruiting

Other trials in Poland

About this study

Official title: A Multicenter, Single-arm, Phase II Study to Evaluate a Safety and Efficacy of Obinutuzumab Induction Followed by 2 Years of Maintenance in Patients With Relapsed/Refractory Waldenström Macroglobulinemia.

This is a multi-center, single-arm, open label, non-randomized, phase II study designed to investigate the efficacy, safety and tolerability of obinutuzumab given as monotherapy in patients with relapsed/refractory Waldenström Macroglobulinemia (R/R MW).

Read the detailed description

Study to investigate the efficacy, safety and tolerability of obinutuzumab administered as monotherapy in patients with relapsed/refractory Waldenström Macroglobulinemia (R/R WM)

Being tested
Obinutuzumab 25 MG/ML
Medical subject headings
Waldenstrom Macroglobulinemia

What participants receive

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

  • Obinutuzumab 25 MG/MLDrug

    Also called Gazyvaro

    Study treatment, obinutuzumab is a Type II humanized anti-CD20 monoclonal antibody of the IgG1 subclass derived by humanization of the parental B-Ly1 mouse antibody and produced in the Chinese Hamster Ovary cell line by recombinant DNA technology. The Study Treatment, obinutuzumab is a liquid concentrate for infusion. Obinutuzumab vials are type 1 glass vials with a butyl rubber stopper. Obinutuzumab is provided as a single 1000 mg dose liquid concentrate with a strength of 25 mg/mL. It is supplied in 50 mL glass vials containing 40 mL of the 25 mg/mL liquid concentrate.

Study groups in NCT03679455
Study groupRoleWhat they receive
Treatment armExperimentalObinutuzumab (RO5072759) 25 MG/ML; Obinutuzumab will be administered by iv. infusion as an absolute (flat) dose of 1000 mg.
Receives: Drug: Obinutuzumab 25 MG/ML

What is being measured

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

  1. Best Overall Response (BOR)

    BOR is the best response recorded from the start of the treatment until disease progression: response assessments recorded as CR, VGPR, PR, MR, SD, PD. As a responder is considered patient with at least MR (CR, VGPR, PR, MR). BOR will be presented as rates with corresponding exact 95% CI.

    Measured: Up to 3,5 years

Secondary outcomes (4)

  1. Progression Free Survival (PFS)

    PFS will be calculated as time from fist treatment dose until progression or death of any cause. The PFS will be defined as well-documented and verifiable data. The Kaplan-Meier curve will be provided. The median time to PFS along with associated 95% confidence interval will be provided as well.

    Measured: Up to 3,5 years

  2. Overall Survival (OS)

    OS is defined as time from first study treatment dose to death due to any cause. Survival distributions will be estimated using the Kaplan-Meier method. Each subject will be followed for 1 year after the treatment period.

    Measured: from first study treatment dose till 1 year after the treatment period

  3. Overall Response Rate (ORR)

    ORR as a secondary endpoint will be assessed after completion of induction phase and after maintenance phase. Responders include subjects with at least MR (CR, VGPR, PR, MR). Non-responders include subjects with Stable Disease (SD) and Progressive Disease (PD). Subjects with unknown or missing responses will be considered as non-responders.

    Measured: after 6 Cycles of obinutuzumab treatment (after induction phase); each cycle is 21 days in Induction Phase;

  4. Overall Response Rate (ORR)

    ORR as a secondary endpoint will be assessed after completion of induction phase and after maintenance phase. Responders include subjects with at least MR (CR, VGPR, PR, MR). Non-responders include subjects with Stable Disease (SD) and Progressive Disease (PD). Subjects with unknown or missing responses will be considered as non-responders.

    Measured: after all 12 Cycles of treatment in Maintenance Phase (at first visit in follow-up phase FU2M) or after the last dose, if not after 12 Cycles of obinutuzumab (each cycle is 8 weeks in Maintenance Phase;

Timeline

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

  1. First posted20 Sep 2018
  2. Study start21 Sep 2018
  3. Primary completionApr 2019 (estimated)
  4. Study completionDec 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
Not applicable
Intervention model
Single group
Model description
multi-center, single-arm, open label, non-randomized
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03679455
Sponsor's protocol ID
ML39235
Acronym
OBI-1
Status last verified
Nov 2018
First submitted
4 Jun 2018
Last updated
13 Nov 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wrobel T, Kalicinska E, Zaucha JM, Morawska M, Giannopoulos K, Jamroziak K, Lech-Maranda E, Taszner M, Szeremet A, Malecki B, Druzd-Sitek A, Lojko-Dankowska A, Dytfeld D. Obinutuzumab induction and maintenance in patients with Waldenstrom macroglobulinaemia: an open-label, single-arm phase 2 study. EClinicalMedicine. 2025 Jul 25;86:103383. doi: 10.1016/j.eclinm.2025.103383. eCollection 2025 Aug.

    PubMed 40756965

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Obinutuzumab 25 MG/ML in people with Waldenstrom Macroglobulinemia, run by Polish Myeloma Consortium at 2 sites in Poland.

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 17 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 13 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Poland. 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?

Contact Tomasz Wróbel, MD, PhD (+48 501 419 272, wrobeltw@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Best Overall Response (BOR) (time frame: Up to 3,5 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 NCT03679455, 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 13 Nov 2018.

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