Health TrialsbyHealthPanel

Glofitamab With Obinutuzumab Pre-treatment for the Treatment of Central Nervous System Lymphoma

ConditionsPrimary Central Nervous System LymphomaSecondary Central Nervous System Lymphoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCity of Hope Medical Center

About this trial

This phase Ib trial tests the safety and side effects of glofitamab after pre-treatment with obinutuzumab and how well they work in treating patients with central nervous system (CNS) lymphoma. Glofitamab is a bispecific antibody that can bind to two different antigens (substances that cause the body to make a specific immune response) at the same time. Glofitamab binds to CD20 on lymphoma cells, and CD3 on T-cells (a type of white blood cell) and may interfere with the ability of cancer cells to grow and spread. Obinutuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Obinutuzumab can also be administered as a pre-treatment to make glofitamab safer and more tolerable. Giving glofitamab with obinutuzumab pre-treatment may be safe, tolerable, and/or effective in treating patients with CNS lymphoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Documented informed consent of the participant and/or legally authorized representative

Assent, when appropriate, will be obtained per institutional guidelines

Agreement to allow the use of archival tissue from diagnostic tumor biopsies

If unavailable, exceptions may be granted with study principal investigator (PI) approval

Disqualifiers

Contraindication to any of the individual components of glofitamab or history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products

Prior solid organ transplantation

Prior treatment with systemic immunotherapeutic agents, including but not limited to, radio-immuno-conjugates, antibody-drug conjugates, immune/cytokines and monoclonal antibodies (mAbs) (e.g., anti cytotoxic T lymphocyte associated protein 4, anti PD-1, and anti PD-L1) within 2 weeks or five half-lives of the drug, whichever is shorter, prior to day 1 of protocol therapy

Prior treatment with glofitamab or other CD20 x CD3 bispecific antibodies

Trial design

Design model

Single group

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo CSF and blood sample collection

  • Computed Tomography

    Procedure/Surgery

    Undergo CT or PET/CT

  • Glofitamab

    Biological/Vaccine

    Given IV

  • Lumbar Puncture

    Procedure/Surgery

    Undergo lumbar puncture

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo brain MRI

  • Obinutuzumab

    Biological/Vaccine

    Given IV

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET/CT

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Treatment (obinutuzumab, glofitamab)Experimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

Incidence of grade 3 or higher non-hematologic toxicity that does not resolve to grade 1 or better within 7 days

For continuous variables, descriptive statistics such as number, mean, standard deviation, standard error, median (range) etc. will be provided. For categorical variables, counts and percentages will be provided. Observed toxicities will be summarized by type, severity, and attribution.

Time frame
During first 2 cycles of treatment (cycle length = 21 days)
2

Incidence of grade 3 or 4 thrombocytopenia associated with grade >= 3 bleeding

For continuous variables, descriptive statistics such as number, mean, standard deviation, standard error, median (range) etc. will be provided. For categorical variables, counts and percentages will be provided. Observed toxicities will be summarized by type, severity, and attribution.

Time frame
During first 2 cycles of treatment (cycle length = 21 days)
3

Incidence of grade 4 neutropenia or grade 4 thrombocytopenia (without clinically significant bleeding) that lasts > 14 days

For continuous variables, descriptive statistics such as number, mean, standard deviation, standard error, median (range) etc. will be provided. For categorical variables, counts and percentages will be provided. Observed toxicities will be summarized by type, severity, and attribution.

Time frame
During first 2 cycles of treatment (cycle length = 21 days)
4

Incidence of grade >= 3 cytokine release syndrome (CRS) not resolving to grade 1 or better within 7 days

For continuous variables, descriptive statistics such as number, mean, standard deviation, standard error, median (range) etc. will be provided. For categorical variables, counts and percentages will be provided. Observed toxicities will be summarized by type, severity, and attribution.

Time frame
During first 2 cycles of treatment (cycle length = 21 days)

Secondary outcomes

1

Overall response rate (ORR)

Will be defined as achieving a best response of complete response (CR) or partial response (PR). Will be tabulated by the response categories. ORR will be estimated as a percentage along with the 95% exact binomial confidence interval.

Time frame
From start of protocol therapy to disease progression and/or start of other anti-lymphoma therapy, assessed up to 24 months
2

CR rate

Will be tabulated by the response categories. CR rate will be estimated as a percentage along with the 95% exact binomial confidence interval.

Time frame
From start of protocol therapy to disease progression and/or start of other anti-lymphoma therapy, assessed up to 24 months
3

Duration of response (DOR)

Will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error; 95% confidence interval will be constructed based on log-log transformation. Median DOR will be estimated when available.

Time frame
From first achievement of PR or CR to time of progression, relapse, or death, whichever is earlier, assessed up to 24 months
4

Duration of CR (DOCR)

Will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error; 95% confidence interval will be constructed based on log-log transformation. Median DOCR will be estimated when available.

Time frame
From first achievement of CR to time of progression, relapse or death, whichever is earlier, assessed up to 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

City of Hope Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
Apply now