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

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ClinicalTrials.gov Identifier: NCT02086175
Recruitment Status : Recruiting
First Posted : March 13, 2014
Last Update Posted : June 23, 2017
Sponsor:
Collaborator:
Biothera
Information provided by (Responsible Party):
Caron A. Jacobson, Dana-Farber Cancer Institute

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).

Condition or disease Intervention/treatment Phase
Relapsed/Refractory Indolent B Cell Non-Hodgkin Lymphomas Drug: Imprime PGG Drug: Rituximab Phase 2

Detailed Description:

After the screening procedures confirms eligibility:

Study Drugs: The participant will receive both Imprime PGG and rituximab weekly, for four weeks.

Clinical Exams: At the participant's weekly visit there will be have a physical exam and general health and specific questions about any problems they might be having and any medications the participant may be taking.

Scans (or Imaging tests):The Investigator will measure the participant's tumor 10 weeks after Week 4 of treatment by CT scan. Additional scans will be performed at 6 months and 12 months following the end of treatment.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Clinical Trial of Rituxan and B-Glucan PGG in Relapsed Indolent Non-Hodgkin Lymphoma
Study Start Date : December 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Imprime PGG and Rituximab
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
Other Names:
  • IDEC-102
  • IDEC-C2B8
  • Rituxan
  • Mabthera



Primary Outcome Measures :
  1. Overall Response Rate [ Time Frame: 2 Years ]
    To evaluate clinical efficacy of Imprime PGG in combination with rituximab in relapsed/refractory indolent B cell non-Hodgkin lymphoma (NHL), as measured by the overall response rate (ORR)


Secondary Outcome Measures :
  1. Determine progression-free survival (PFS) and duration of response. Evaluate safety of this combination in relapsed/refractory indolent NHL patients [ Time Frame: 2 Years ]
    Determine progression-free survival (PFS) and duration of response. Evaluate safety of this combination in relapsed/refractory indolent NHL patients

  2. To perform correlative laboratory studies using on-treatment peripheral blood samples and post-treatment tumor samples to quantify the binding of Imprime PGG to neutrophils and correlate with treatment response [ Time Frame: 2 Years ]
    To perform correlative laboratory studies using on-treatment peripheral blood samples and post-treatment tumor samples to quantify the binding of Imprime PGG to neutrophils and correlate with treatment response



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • Total bilirubin ≤ 1.5 X ULN (unless there is lymphoma in the liver)
  • Age ≥18 years
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • 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:

    • New York Heart Association Class III or IV cardiac disease, including pre-existing clinically significant arrhythmia, congestive heart failure, or cardiomyopathy
    • unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease
  • Other uncontrolled intercurrent illness that would limit adherence to study requirements.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02086175


Contacts
Contact: Caron Jacobson, MD 617-632-3470 cajacobson@partners.org

Locations
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Caron Jacobson, MD    617-632-3470    cajacobson@partners.org   
Principal Investigator: Caron Jacobsen, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Biothera
Investigators
Principal Investigator: Caron Jacobson, MD Dana-Farber Cancer Institute

Responsible Party: Caron A. Jacobson, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT02086175     History of Changes
Other Study ID Numbers: 13-398
First Posted: March 13, 2014    Key Record Dates
Last Update Posted: June 23, 2017
Last Verified: June 2017

Keywords provided by Caron A. Jacobson, Dana-Farber Cancer Institute:
relapsed/refractory indolent B cell non-Hodgkin lymphomas

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents