Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
A Phase I/II Trial of CpG 7909, Rituximab Immunotherapy, and Y-90 Zevalin Radioimmunotherapy for Patients With Previously Treated CD20+ Non-Hodgkin Lymphoma
Verified date | September 2015 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
RATIONALE: Biological therapies, such as agatolimod sodium, may stimulate the immune system
in different ways and stop cancer cells from growing. Monoclonal antibodies, such as
rituximab, can block cancer growth in different ways. Some block the ability of cancer cells
to grow and spread. Others find cancer cells and help kill them or carry cancer-killing
substances to them. Radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab
tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming
normal cells. Giving agatolimod sodium together with rituximab and yttrium Y 90 ibritumomab
tiuxetan may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of agatolimod
sodium when given together with rituximab and yttrium Y 90 ibritumomab tiuxetan and to see
how well it works in treating patients with recurrent or refractory non-Hodgkin lymphoma.
Status | Completed |
Enrollment | 38 |
Est. completion date | November 2014 |
Est. primary completion date | October 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - The following histologic types by REAL classification and International Working Formulation (IWF) when applicable (NOTE: Closed to accrual as of 10/29/07): Small lymphocytic lymphoma; Lymphoplasmacytoid lymphoma; Follicular center lymphoma, follicular grades 1, 2, and 3; Extranodal marginal zone B cell lymphoma of MALT type; Nodal marginal zone B cell lymphoma - The following histologic types by REAL classification and International Working Formulation (IWF) when applicable: Diffuse large cell; Transformed lymphoma - Less than 25% bone marrow involvement of cellular marrow with lymphoma as determined by bilateral bone marrow aspirate and biopsy (the percent involvement should be estimated by the hematopathologist using all of the biopsy material) - There is no limit on the number of prior therapies (patients who have previously received rituximab are eligible) - Bi-dimensionally measurable disease: The patients must have >= 1 lesion that has a single diameter of >= 2 cm - Absolute neutrophil count >= 1500/mm^3 - Platelet count >= 150,000 - Total lymphocyte count < 5000/mm^3 only for patients with small lymphocytic lymphoma - HGB >= 8 - Biopsy-proven relapsed, refractory, or residual CD20+ non-Hodgkin's lymphomas; previous biopsies =<6 months prior to treatment on this protocol will be acceptable as long as there has not been intervening therapy; if the patient has received therapy for NHL between the time of the last biopsy and this protocol, then a re-biopsy is necessary - ECOG performance status (PS) 0, 1, or 2 - Expected survival >= 3 months - Willingness to provide all biologic specimens as required by the protocol - Total bilirubin =< 2 x ULN mg/dL (if abnormal, direct bilirubin =< 1.5 x ULN) Exclusion Criteria: - Prior myeloablative therapies with autologous or allogeneic bone marrow transplantation or peripheral blood stem cell support - Prior radioimmunotherapy including Y-90 Zevalin or 131-Iodine anti-B1 antibody or Lym-1 - Presence of CNS lymphoma - Serious non-malignant disease such as active infection or other condition which in the opinion of the investigator would compromise other protocol objectives - Major surgery other than diagnostic surgery =< 4 weeks prior to registration - Another active primary malignancy - Known HAMA/HACA (Human anti-mouse or anti-chimeric antibodies) - Myelodysplastic syndrome or marrow chromosomal changes suggesting myelodysplasia - Pregnant women - Nursing women - Men or women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, abstinence, etc.) - Failed stem cell collection - Marrow cellularity =< 15% (as determined on all bone marrow samples) - Known to have lymphoma related to HIV or AIDS (these patients are excluded because it is unknown what effects prolonged B-cell depletion will have on these patient's immune system) - G-CSF or GM-CSF therapy =< 1 week prior to study registration (pegylated filgrastim =< 3 weeks) - Myelosuppressive chemotherapy =< 3 weeks prior to study registration (=< 6 weeks if rituximab, nitrosourea, or Mitomycin C) - Skin rash (such as Stevens-Johnson's syndrome or toxic epidermal necrolysis) with prior rituximab therapy should not be entered on this study because of the risk of reoccurrence of that skin toxicity - Abnormal renal function (serum creatinine > 2 mg/dL) - Pre-existent clinical autoimmune or antibody mediated diseases, including systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, and autoimmune thrombocytopenia (patients that have no clinical symptoms of these diseases, but merely have previously detected antibodies are eligible) - Received prior external beam radiation therapy to > 25% of active bone marrow - Corticosteroid therapy at the time the patient enters the protocol; patients using prednisone or its equivalent for adrenal failure or using < 20mg of prednisone/day for other benign causes are accepted |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Iowa/Holden Comprehensive Cancer Center | Iowa City | Iowa |
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum Tolerated Dose of CpG 7909 as Determined Using the Number of Participants With a DLT at Each Dose Level | Participants will be treated in cohorts of 6 patients at each dose level of CpG 7909 (0.08 mg/kg, 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg) and observed for at least 10 weeks post treatment. If at most one of the 6 patients experiences a dose limiting toxicity (DLT), a new cohort of 6 patients will be treated at the next higher dose level. A DLT for this study is defined as patients with one of the following: Absolute neutrophil counts or platelet counts below 10*10^9/L for 14 days Absolute neutrophil counts greater than 0.5 or less than 1*10^9/L Platelet counts greater than 10 or less than 50*10^9/L for 28 days. Any grade 3 non-hematologic toxicity not explainable by another obvious cause as assessed using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. We are reporting the number of DLTs at each of the dose levels. The maximum tolerated dose will be 0.48 mg/kg or the largest dose level where 1 or fewer participants reports a dose limiting toxicity. |
at least 10 weeks post treatment up to 3 months. | Yes |
Primary | Tumor Response | Complete Response (CR): No measurable or nonmeasurable disease. No symptoms of Lymphoma. Non-palpable spleen, if palpable at baseline. Histologically negative bone marrow, if positive at baseline. All nodes <1.5 cm in transverse diameter. Partial Response (PR): greater than 50% decrease from baseline in the sum of the products of the longest perpendicular diameters of the six largest dominant lesions. No new lesions We are reporting the number of participants that attained a status of CR or PR. |
Evaluations occur every three months up to a year | No |
Secondary | Progression-free Survival | The Progression-free survival (PFS) is defined as the time from registration to progression or death due to any cause. The distribution of PFS will be estimated using the method of Kaplan-Meier. | Up to 1 year from treatment start date | No |
Secondary | Duration of Response | Duration of response (DoR) will be calculated from the documentation of response until the date of progression in the subset of patients who respond. | Up to 1 year from treatment start date | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
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