Ublituximab Followed by Response-driven Addition of Umbralisib for Treatment-naive Follicular or Marginal Zone Lymphoma

NCT04508647 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: 18-2128.ccNCI-2021-00405U2-NTG-009
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, Phase II interventional study in order to assess efficacy and safety of single agent ublituximab as initial therapy for FL (Follicular lymphoma) and MZL (Marginal zone lymphoma ) with response driven addition of umbralisib for suboptimal response.

Conditions

Marginal Zone Lymphoma; Follicular Lymphoma

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Complete Response Rate (CR) at 8 Weeks Post Single Agent Induction

  Number of subjects that reached a complete response at the end of single agent induction as defined by a Lugano score of 3 or less on arm MONO - Monotherapy: Ublituximab. Complete response assessed via PET CT scan utilizing the Lugano-Deauville Criteria where none of the lymphoma lesions had FDG ( FluoroDeoxyglucose) avidity greater than the liver uptake. Patients who did not reach complete response at this point were then bridged to arm COMBO - Combotherapy: Ublituximab + Umbralisib.

  8 weeks post induction

• Number of Participants With Complete Response Rate (CR) at up to 12 Months Post MONO - Monotherapy: Ublituximab or Combotherapy: Ublituximab + Umbralisib.

  Number of subjects that reached a complete response at up to 12 months post induction as defined by a Lugano score of 3 or less on arms MONO - Monotherapy: Ublituximab.OR Combotherapy: Ublituximab + Umbralisib. Complete response assessed via PET CT scan utilizing the Lugano-Deauville Criteria where none of the lymphoma lesions had FDG ( FluoroDeoxyglucose) avidity greater than the liver uptake.

  up to 12 months post induction

Secondary Outcomes (1)

• Overall Response Rates (ORR) for Number of Participants

  up to 12 months post induction

Study Arms (2)

Ublituximab Only

EXPERIMENTAL

Treatment-Naive Stage II (non-contiguous), Stage III, Stage IV FL + MZL will receive Ublituximab 900mg IV weekly x 4 doses. End of treatment assessment 8 weeks post last dose of single agent ublituximab will be performed.

Drug: Ublituximab

Ublituximab first, then Ublituximab and Umbralisib

EXPERIMENTAL

Patients who achieve less than a complete response will receive a combination of ublituximab AND umbralisib for a total of 12 cycles. (In the combination arm ublituximab will be administered on day 1,8 and 15 on cycle 1 and on day 1 on each cycle thereafter. Umbralisib will be administered at 800 mg daily for 12 cycles)

Drug: Ublituximab; Drug: Umbralisib

Interventions

Ublituximab DRUG

Ublituximab will be administered as an intravenous infusion through a dedicated line. All infusions will be administered per institutional guidelines. During ublituximab monotherapy (initial treatment), Cycle 1 Day 1 administration time frame: Over 4 hours. Cycle 1 days 8 and 15 will be over 3 hours, and Cycle 1 Day 22 will be over 90 minutes. During combination treatment with umbralisib, ublituximab will be administered over 90 minutes.

Ublituximab Only; Ublituximab first, then Ublituximab and Umbralisib

Umbralisib DRUG

Umbralisib will be administered orally once daily within 30 minutes of starting a meal.

Ublituximab first, then Ublituximab and Umbralisib

Eligibility Criteria

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

You may qualify if:

• Disease Related
• Subjects with histologically documented Follicular lymphoma CD20+ (Grade 1, 2 or 3a) OR Marginal zone lymphoma CD20+ (nodal, extranodal or splenic) according to World Health Organization (WHO) criteria.
• Ann Arbor Stage II (Non-contiguous), III or IV disease
• Patients must have a whole body or limited whole body PET/CT scan performed within 42 days prior to registration. CT portion of PET/CT will be done with contrast based on current NCCN guidelines unless patient has borderline renal function or allergic to contrast dye.
• Patients must have bone marrow biopsy performed within 6 months prior to registration
• Measurable node must have an LDi greater than 1.5 cms. In the absence of nodal lesions, measurable extranodal disease should have an LDi greated than 1 cm. In patients with Splenic Marginal Zone lymphoma, in the absence of nodal lesions, spleen size should should be over 14 cms with evidence of lymphoma in the bone marrow biopsy.
• For low tumor burden lymphomas (as determined by GELF criteria) : Include patients diagnosed within 2 years of diagnosis. Low tumor burden patients diagnosed more than 2 years from study entry will be allowed provided patients have documented progression.
• Prior Therapy Criteria
• \. Patients must be untreated advanced stage disease (Stage III or Stage IV) or Stage II (noncontiguous). (Exception: Involved field or involved site radiation given for localized diagnosis is not considered a line of therapy).
• Clinical/Laboratory Criteria
• Patients must be ≥ 18 years of age and be able to swallow and retain oral medication
• ECOG performance status of 0-2
• Patients must have adequate bone marrow function as evidenced by ANC ≥ 1000/µL and platelets ≥ 50,000µL and Hb \>= 8g/dl within 28 days prior to registration unsupported by growth factors.
• Serum creatinine \< 2.0 mg/dL or calculated creatinine clearance (CrCl) \> 45 mL/min
• Patients must have adequate hepatic function obtained within 28 days prior to registration and documented by all of the following:

You may not qualify if:

• Disease-Related
• Transformed lymphoma; if clinical evidence of transformed lymphoma is present, transformation should be ruled out by biopsy of the suspicious lymph node/lesion
• Prior treatment for follicular lymphoma or marginal zone lymphoma (Except: involved field or site radiation therapy is allowed)
• Medically apparent central nervous system lymphoma or leptomeningeal disease
• Tumor burden where administration of other FDA approved anti-CD20 antibodies like singleagent rituximab would be inappropriate.
• Patients in need of immediate cytoreduction with chemotherapy based regimen.
• Concurrent Conditions
• Evidence of chronic active Hepatitis B (HBV, not including patients with prior hepatitis B vaccination; or positive serum Hepatitis B antibody) or chronic active Hepatitis C infection (HCV), active cytomegalovirus (CMV), or known history of HIV (or positive HIV test during screening). If HBc antibody is positive, the subject must be evaluated for the presence of HBV DNA by PCR. If HCV antibody is positive, the subject must be evaluated for the presence of HCV RNA by PCR. See Appendix: HEPATITIS B SEROLOGIC TEST RESULTS. If the subject is CMV IgG or CMV IgM positive, the subject must be evaluated for the presence of CMV DNA by PCR. Subjects with positive HBc antibody and negative HBV DNA by PCR are eligible. Subjects with positive HCV antibody and negative HCV RNA by PCR are eligible (subjects who are CMV IgG or CMV IgM positive but who are CMV DNA negative by PCR are eligible).
• Ongoing drug-induced liver injury, alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic obstruction caused by stones, or cirrhosis of the liver
• Inflammatory bowel disease (such as Crohn's disease or ulcerative colitis)
• Irritable bowel syndrome with greater than 3 loose stools per day as a baseline
• Active autoimmune disease requiring ongoing immunosuppressive therapy including systemic corticosteroids (prednisone or equivalent ≤10 mg daily allowed as clinically warranted) within 12 months prior to enrollment. Patients are allowed to use topical or inhaled corticosteroids or levothyroxine for hypothyroidism or hypogylcemic agents for diabetes mellitis.
• Any severe and/or uncontrolled medical conditions or other conditions that could affect participation in the study such as:
• Symptomatic, or history of documented congestive heart failure NYHA (New York Heart Association) functional classification III-IV \[see Appendix: New York Heart Association Classifications\]
• Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, CHF, or myocardial infarction within 6 months of enrollment.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

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  BACKGROUND

MeSH Terms

Conditions

Lymphoma, B-Cell, Marginal Zone; Lymphoma, Follicular

Interventions

ublituximab; umbralisib

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Manali Kamdar, MD
• Organization: University of Colorado Hospital

manali.kamdar@cuanschutz.edu

720-848-6400

Study Officials

• Manali Kamdar, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2020
• First Posted: August 11, 2020
• Study Start: November 23, 2020
• Primary Completion: July 14, 2022
• Study Completion: July 14, 2022
• Last Updated: March 21, 2024
• Results First Posted: November 9, 2023

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)