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

NCT03679455 | Unknown Phase 2 DMC

• 1 other identifier: ML39235
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Waldenstrom Macroglobulinemia

Outcome Measures

Primary Outcomes (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.

  Up to 3,5 years

Secondary Outcomes (4)

• Progression Free Survival (PFS)

  Up to 3,5 years

• Overall Survival (OS)

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

• Overall Response Rate (ORR)

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

• Overall Response Rate (ORR)

  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;

Study Arms (1)

Treatment arm

EXPERIMENTAL

Obinutuzumab (RO5072759) 25 MG/ML; Obinutuzumab will be administered by iv. infusion as an absolute (flat) dose of 1000 mg.

Drug: Obinutuzumab 25 MG/ML

Interventions

Obinutuzumab 25 MG/ML DRUG

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.

Also known as: Gazyvaro

Treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Polish Myeloma Consortium: lead
• Roche Pharma AG: collaborator
• Bioscience, S.A.: collaborator

Study Sites (2)

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

Poznan, Greater Poland Voivodeship, 60-569, Poland

RECRUITING

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

Wroclaw, Lower Silesian Voivodeship, 50-367, Poland

RECRUITING

Related Publications (1)

• 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.

  PMID: 40756965 DERIVED

MeSH Terms

Conditions

Waldenstrom Macroglobulinemia

Interventions

obinutuzumab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Tomasz Wróbel, MD.PhD

  USK Wrocław

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tomasz Wróbel, MD, PhD

CONTACT

+48 501 419 272; wrobeltw@gmail.com

Dominik Dytfeld, MD, PhD

CONTACT

+48 602 464 708; dytfeld@me.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: multi-center, single-arm, open label, non-randomized

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: September 20, 2018
• Study Start: September 21, 2018
• Primary Completion: April 1, 2019
• Study Completion: December 1, 2022
• Last Updated: November 13, 2018

Record last verified: 2018-11

Locations

PL (2)