A Phase 2 Clinical Trial of Rituxan and B-Glucan PGG in Relapsed Indolent Non-Hodgkin Lymphoma

NCT02086175 | Completed Phase 2 Results DMC

• 1 other identifier: 13-398
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is evaluating a drug combination called Imprime PGG and Rituximab as a possible treatment for relapsed/refractory indolent B cell non-Hodgkin lymphomas (NHL).

Conditions

Relapsed/Refractory Indolent B Cell Non-Hodgkin Lymphomas

Keywords

relapsed/refractory indolent B cell non-Hodgkin lymphomas

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  Overall response rate is percentage of participants with complete (CR) and partial (PR) responses as best response during treatment. CR: * Nodal Masses: 1. For FDG-avid or PET positive prior to therapy; mass of any size permitted if PET negative 2. For variably FDG-avid or PET negative; regression to normal size on CT. * Liver/Spleen: No palpable nodules -Bone Marrow Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry should be negative. PR: * Nodal Masses: * 50% decrease in SPD of up to 6 largest dominant masses; no increase in size of other nodes. 1. FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site. 2. Variably FDG-avid or PET negative; regression on CT. * Liver/Spleen: * 50% decrease in SPD of nodules; no increase in size of liver or spleen. * Bone Marrow: Irrelevant if positive prior to therapy; cell type should be specified.

  Response assessed at week 14 of study calendar (10 weeks after the 4-week treatment regimen).

Secondary Outcomes (3)

• Median Progression-free Survival (PFS)

  Patients were followed for a median (range) of 13.6 months (3-25).

• Duration of Response (DOR)

  Patients were followed for a median (range) of 13.6 months (3-25).

• Imprime PGG-bound Neutrophils Status by Response

  Up to 14 weeks with a median (range of) 13 weeks (12-14).

Study Arms (1)

Imprime PGG and Rituximab

EXPERIMENTAL

The study drug, Imprime PGG, will be administered intravenously at a dose of 4mg/kg weekly for 4 weeks. Rituximab will be administered intravenously by institutional standards concurrently at a dose of 375mg/m2 weekly for 4 weeks. Response will be assessed with CT scans 10 weeks +/- 3 days following the completion of treatment

Drug: Imprime PGG; Drug: Rituximab

Interventions

Imprime PGG DRUG

Imprime PGG and Rituximab

Rituximab DRUG

Also known as: IDEC-102, IDEC-C2B8, Rituxan, Mabthera

Imprime PGG and Rituximab

Eligibility Criteria

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

You may qualify if:

• Participants must meet the following criteria on screening examination to be eligible to participate in the study:
• Patients must have histologically determined indolent NHL that is relapsed or primary refractory after initial therapy. Indolent NHL includes the morphologic and clinical variants:
• Follicular lymphoma, grades 1-3a
• Marginal zone lymphoma (extranodal, nodal, or splenic)
• All nodal marginal zone lymphomas are eligible
• Extranodal marginal zone lymphomas of the stomach (gastric MALT lymphomas) may not be candidates for cure with antibiotics or local radiotherapy. Patients who have failed antibiotics or local therapy are eligible for the protocol as long as they have measurable disease and are naïve to chemotherapy and monoclonal antibody therapy.
• Splenic marginal zone lymphoma patients may have received prior splenectomy as long as they have measurable disease and are naïve to chemotherapy and monoclonal antibody therapy.
• Re-biopsy is not mandated at relapse unless there is clinical suspicion about an alternate diagnosis.
• Between 1-3 prior lines of chemoimmunotherapy and/or monotherapy with rituximab. Patients may not have had prior autologous or allogeneic stem cell transplantation.
• Measurable disease that has not been previously irradiated on CT scans of at least 2 cm, OR if the patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation. Imaging must be completed no greater than 4 weeks prior to study enrollment.
• ECOG performance status 0-2 (Appendix B, Section 17.2)
• Absolute neutrophil count ≥1000 prior to treatment
• Oxygen saturation ≥ 90%, no more than 2 LPM oxygen
• Serum creatinine ≤ 1.5 X ULN
• AST ≤ 3 X ULN

You may not qualify if:

• Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
• Patients currently receiving anticancer therapies or who have received anticancer therapies within 30 days of the start of study drug (including chemotherapy, radiation therapy, antibody based therapy, etc.). Steroids for symptom palliation are allowed, but must be either discontinued or on stable doses at the time of initiation of protocol therapy.
• Patients may not be receiving any other investigational agents, or have received investigational agents within 4 weeks of beginning treatment.
• Patients who have previously received PGG-Betafectin (Betafectin®) or Imprime PGG.
• Patients, who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia) or patients that may require major surgery during the course of the study.
• Patients with known leptomeningeal or brain metastases. Imaging or spinal fluid analysis to exclude CNS involvement is not required, unless there is clinical suspicion by the treating investigator.
• History of severe allergic or anaphylactic reactions to monoclonal antibody therapy or a known hypersensitivity to baker's yeast.
• Patients with known HIV infection or hepatitis B or C infection.HIV testing is not mandated and is to be performed at the discretion of the treating investigator.
• Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
• Prior history of another malignancy (except for non-melanoma skin cancer or in situ cervical or breast cancer) unless disease free for at least three years. Patients with prostate cancer are allowed if PSA is less than 1.
• Patients should not receive immunization with attenuated live vaccine within one week of study entry or during study period.
• Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. Women of child bearing potential (WOCBP) or male study participants of reproductive potential must agree to use double barrier birth control method of contraception during the course of the study treatment period and for 3 months after completing study treatment.
• \-- WOCBP are defined as sexually mature women who have not undergone a hysterectomy or who are not postmenopausal (no menses) for at least 12 consecutive months. WOCBP must have a negative urine or serum pregnancy test within 7 days prior to administration of treatment.
• History of noncompliance to medical regimens.
• Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• HiberCell, Inc.: collaborator

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Recurrence

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Caron A. Jacobson, MD
• Organization: Dana-Farber Cancer Institute

cajacobson@partners.org

617-632-6404

Study Officials

• Caron Jacobson, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 11, 2014
• First Posted: March 13, 2014
• Study Start: December 1, 2014
• Primary Completion: July 11, 2019
• Study Completion: February 1, 2021
• Last Updated: April 9, 2024
• Results First Posted: January 7, 2021

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (1)