Expired Study
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Houston, Texas 77030


Purpose:

The goal of this clinical research study is to learn if the combination of pembrolizumab and rituximab can help to control relapsed follicular lymphoma (FL), and if the combination of pembrolizumab, rituximab, and lenalidomide can help to control relapsed FL or diffuse large B-cell lymphoma (DLBCL). The safety of both combinations will also be studied. This is an investigational study. Pembrolizumab is FDA approved and commercially available for the treatment of melanoma. Rituximab is FDA approved and commercially available for the treatment of non-Hodgkin's lymphoma and certain types of leukemia. Lenalidomide is FDA approved and commercially available for the treatment of lymphoma. The combination of these drugs to treat FL or DLBCL is investigational. The study doctor can describe how the study drugs are designed to work. Up to 100 patients will take part in this study. All will be enrolled at MD Anderson.


Study summary:

Study Drug Administration: If participant is found to be eligible for this study, participant will be enrolled to either Group 1 or Group 2. Each cycle is 21 days. If participant is in Group 1, on Days 1, 8, 15, and 22 of Cycle 1, participant will receive rituximab by vein. The first infusion takes 6-8 hours. After that, infusions take about 4 hours each. Participant will receive pembrolizumab on Day 2 of cycle 1 and repeated every 3 weeks for up to 16 infusions. If participant is in Group 2, on Days 1, 8, 15 of Cycle 1, and Day 1 of Cycle 2, participant will receive rituximab by vein. The first infusion takes 6-8 hours. After that, infusions take about 4 hours each. On Day 2 of Cycle 1 and every 3 weeks for up to 2 years, participant will receive pembrolizumab by vein over 1 hour. Participant will take lenalidomide by mouth on Days 1-14 of each 3-week cycle for 12 cycles. Study Visits: On Day 1 of Cycle 1, participant's vital signs will be recorded. On Day 22 of Cycle 1, participant will have a physical exam. On Day 1 of Cycles 3-16: - Participant will have a physical exam. - Blood (about 2 tablespoons) will be drawn for routine tests. Every 2 cycles, part of this sample will also be used to check participant's thyroid function. Every 4 cycles, part of this sample will also be used to check the status of participant's immune system. On Day 1 of Cycles 5, 9, and 13: - Urine will be collected for routine tests. - Participant will have a CT scan to check the status of the disease (Cycle 5 only). On Day 1 of Cycle 9, participant will have a PET/CT scan to check the status of the disease. At any time, if participant's doctor think it is needed, participant may have a bone marrow biopsy and aspirate and/or a CT or PET/CT scan to check the status of the disease. If participant can become pregnant and participant has regular or no menstrual cycles, blood (about 3 teaspoons) will be drawn for a pregnancy test every week during Cycle 1 and then 1 time every other cycle after that. If participant can become pregnant and participant has irregular menstrual cycles, participant will have this testing every week during Cycle 1 and then every 2 weeks after that. Length of Study: If participant is in Group 1, participant may take rituximab for 21 cycles and pembrolizumab for up to 16 cycles. If participant is in Group 2, participant may take rituximab for 21 cycles, pembrolizumab for up to 2 years, and lenalidomide for 12 cycles. Participant will no longer be able to receive the drugs if the disease gets worse, if intolerable side effects occur, or if participant is unable to follow study directions. Participation on the study will be over once participant has completed follow-up. End-of-Treatment Visit: After participant stops receiving the study drug(s): - Participant will have a physical exam. - Blood (about 2 tablespoons) will be drawn for routine tests. - If participant's doctor thinks it is needed, participant will have a PET/CT scan to check the status of the disease. Long Term Follow-Up: 30 days after participant's End-of-Treatment visit: - Participant will have a physical exam. - Blood (about 2 tablespoons) will be drawn for routine tests, to check participant's thyroid function, and to check the status of participant's immune system. - Urine will be collected for routine tests. Every 3 months for 1 year and every 6 months after that until participant starts a new therapy, the disease gets worse, or the study ends: - Participant will have a physical exam. - Blood (about 2 tablespoons) will be drawn for routine tests, to check participant's thyroid function, and to check the status of participant's immune system. - Participant will have a CT scan to check the status of the disease.


Criteria:

Inclusion Criteria: 1. For cohort 1: Male or female subjects with histologic proof of follicular lymphoma grade 1, 2, or 3a relapsing after at least one prior systemic therapy that included rituximab (or other monoclonal CD20 antibody). Patients should have documented rituximab-sensitive disease defined as a documented complete or partial response lasting at least 6 months after the last rituximab containing therapy or rituximab-refractory disease defined as stable or progressive disease within 6 months of the last rituximab-containing therapy. 2. For cohort 2: Male or female subjects with histologic proof of follicular lymphoma grade 1, 2, or 3a relapsing after at least two prior systemic therapies, one of which must include rituximab (or other monoclonal CD20 antibody) or histologic proof of DLBCL relapsing after at least two prior systemic therapies, one of which must include rituximab (or other monoclonal CD20 antibody) and are considered ineligible for high dose therapy/autologous stem cell transplant. 3. Either the subject or his/her legally authorized representative be willing and able to provide written informed consent for the trial. 4. Be >/= 18 years of age on day of signing informed consent. 5. Have measurable disease (>/= 1.5 cm in the longest diameter for nodal or extranodal disease). 6. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale. 7. Demonstrate adequate organ function as defined below, all screening labs should be performed within 28 days of treatment initiation. Hematological: Absolute neutrophil count (ANC) >/=1.0 × 10^9/L; Platelets >/=75 × 10^9/L; Hemoglobin >/= 8.0 g/dL; Serum creatinine OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) (Creatinine clearance will be calculated per institutional standard.) </=1.5 × upper limit of normal (ULN) OR >/=60 mL/min GFR or CrCl for subjects with creatinine levels > 1.5 × institutional ULN; Hepatic: Serum total bilirubin </= 1.5 × ULN OR Direct bilirubin </= ULN for subjects with total bilirubin levels > 1.5 ULN; 8. #6 cont...aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/ serum glutamic pyruvic transaminase (SGPT) </= 2.5 × ULN OR </= 5 × ULN for subjects with lymphoma in the liver; Coagulation: International Normalized Ratio (INR) or Prothrombin Time (PT) </=1.5 × ULN unless subject is receiving anticoagulant therapy as long as PT or Partial Thromboplastin Time (PTT) is within therapeutic range of intended use of anticoagulants; Activated Partial Thromboplastin Time (aPTT) </=1.5 × ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants 9. Female subject of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. 10. Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Female subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year. a. Females of reproductive potential enrolled in the lenalidomide cohort must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program. 11. Male subjects should agree to use two methods of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy. 12. All study participants enrolled in the lenalidomide containing cohort (cohort 2) must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of the REMS® program. Exclusion Criteria: 1. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study drug or using an investigation device within 4 weeks of the first dose of treatment. 2. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. 3. Has had a prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e., </= Grade 1 or at baseline) from AEs due to agents administered more than 4 weeks earlier. 4. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., </= Grade 1 or at baseline) from AEs due to a previously administered agent. - Note: Subjects with </= Grade 2 neuropathy are an exception to this criterion and may qualify for the study. - Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy. 5. Has a known additional malignancy that is progressing and requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy. 6. Has known active central nervous system (CNS) lymphoma and/or lymphomatous meningitis. Subjects with previously treated CNS lymphoma and/or lymphomatous meningitis may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. 7. No active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators, local steroid injections or inhaled or topical steroids would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjorgen's syndrome will not be excluded from the study. 8. Has evidence of interstitial lung disease or active, non-infectious pneumonitis that required steroids or current pneumonitis. 9. Has an active infection requiring systemic therapy. 10. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. 11. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 12. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment. 13. .Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).- Note: Subjects that received prior therapy with pidilizumab are an exception to this criterion and may qualify for the study. 14. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). 15. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected). 16. Has received a live vaccine within 30 days prior to the first dose of trial treatment.


NCT ID:

NCT02446457


Primary Contact:

Study Chair
Loretta Nastoupil Nastoupil, MD
M.D. Anderson Cancer Center


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 22, 2017

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