This study is currently recruiting participants.
Number
000274-C
Sponsoring Institute
National Cancer Institute (NCI)
Recruitment Detail
Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 18 Years Max Age: N/A
Referral Letter Required
No
Population Exclusion(s)
Children
Keywords
Non-Hodgkin Lymphoma; Epstein Barr Virus; Plasmablastic Lymphoma; Chemotherapy; Immune Modulatory
Recruitment Keyword(s)
None
Condition(s)
Diffuse Large Cell Lymphoma; Non-Hodgkin Lymphoma; Burkitt Lymphoma; Plasmablastic Lymphoma; B-Cell Neoplasm
Investigational Drug(s)
Doxorubicin Rituximab
Investigational Device(s)
Intervention(s)
Drug: Vincristine Drug: Prednisone Drug: Doxorubicin Drug: Etoposide Drug: Pomalidomide Drug: Cyclophosphamide Drug: Rituximab
Supporting Site
National Cancer Institute
Non-Hodgkin lymphoma (NHL) is the most common cancer among people living with HIV in the United States. People with HIV are up to 17 times more likely to get NHL than people who do not have HIV. The disease may also be different in these two groups. More study is needed for treating
people with both HIV and NHL.
Objective:
To test a study drug (pomalidomide) in combination with chemotherapy with or without another drug (rituximab) in people with HIV-associated NHL.
Eligibility:
Adults aged 18 years or older diagnosed with HIV-associated B-cell NHL with high-risk features.
Design:
Participants will undergo screening. They will have a physical exam. They will have blood and urine tests and tests of heart function. They may have imaging scans. Researchers will review tissue samples of participant s tumors. In some cases, a new biopsy may be needed.
Participants will receive up to 6 cycles of treatment.
The first cycle is 26 days: Participants will take pomalidomide by mouth for 10 days. After 5 days they will start receiving chemotherapy drugs through a tube attached to a needle placed in a vein (IV). Some participants will receive rituximab on day 5. All participants will receive a second set of IV drugs that will last for 4 days (96 hours). They will receive another IV drug after the previous treatment is complete.
The remaining cycles are each 21 days. Participants will take pomalidomide by mouth for the first 10 days. Other chemotherapy treatments will also be repeated starting on day 1 of each cycle.
Screening tests will be repeated at study visits.
Follow-up visits will continue for 4 years.
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INCLUSION CRITERIA: -Participants must have histologically or cytologically confirmed B-cell non-Hodgkin lymphoma confirmed by the Laboratory of Pathology, NCI, with one or more of the following features: -- Leptomeningeal/CSF involvement -- High-risk for CNS relapse per CNS-IPI (score 4-6) -- Plasmablastic histology -- Gammaherpesvirus positive tumor -- Presence of Kaposi sarcoma -Measurable or evaluable lymphoma. -Positive HIV1/2 serology. -Participants may not have received prior curative-intent chemotherapy for lymphoma. Participants who have received prior treatment as a bridge to curative-intent therapy will be considered per Protocol Chair discretion if >= 2 weeks since administration. Steroids given for any reason or rituximab given for multicentric Castleman disease may be given any time prior to treatment start. -Age >=18 years -ECOG performance status <=4 -Persons of childbearing potential (PCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 14 days prior to and again within 1 day before starting pomalidomide and must either commit to continued abstinence from penetrative vaginal intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before the participant starts taking pomalidomide and for 12 months after the last dose of combined chemotherapy. -All study participants must agree to be registered into the mandatory POMALYST REMS[Registered]TM program and be willing and able to comply with the requirements of the POMALYST REMS[Registered]TM program. -Able to take aspirin 81mg orally daily or another substitute thromboprophylaxis. -Participants must have adequate organ and marrow function as defined below unless abnormalities are attributed to lymphoma or HIV as determined by investigator: -- absolute neutrophil count >=1,000/mcL -- platelets >=75,000/mcL -- total bilirubin <=1.5 X institutional upper limit of normal (participants with history of Gilbert disease are eligible if total bilirubin <= 5 mg/dL with <80% unconjugated bilirubin) -- AST(SGOT)/ALT(SGPT) <=3 X institutional upper limit of normal -- creatinine clearance >=60 mL/min/1.73 m^2 for participants with creatinine levels above institutional normal. -Participants with hepatitis B virus (HBV) infection must be on suppressive antiviral therapy. -Participants must be willing to take and adhere to antiretroviral therapy (participants are not required to be on any specific regimen of antiretroviral therapy). -Participants must understand and sign a written informed consent document. EXCLUSION CRITERIA: -Participants may not receive investigational agents on other clinical trials. -Participants requiring any of the agents listed as prohibited thearapies. -History of allergic reactions attributed to compounds of similar chemical or biologic composition to pomalidomide or other agents used in study. -Parenchymal brain involvement with lymphoma. -Ejection fraction less than 40% by echocardiography (ECHO) -CTCAEv5.0 Grade 3-4 neuropathy -History of malignant tumors other than Kaposi sarcoma or KSHV-associated multicentric Castleman Disease, unless: --In complete remission for >= 1 year from the time response was first documented; or, -- Completely resected basal cell carcinoma; or, -- In situ squamous cell carcinoma of the cervix or anus; or, -- Prior or concurrent malignancy has a natural history or treatment which does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen per Protocol Chair discretion. -Known drug-related, inherited, or acquired procoagulant disorder including prothrombin gene mutation 20210, antithrombin III deficiency, protein C deficiency, protein S deficiency and antiphospholipid syndrome but not including heterozygosity for the Factor V Leiden mutation or the presence of a lupus anticoagulant in the absence of other criteria for the antiphospholipid syndrome. -Symptomatic congestive heart failure -Unstable angina pectoris, or cardiac arrhythmia. -Uncontrolled intercurrent illness or participants considered to be of poor medical health due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active uncontrolled infection (excluding lymphoma or HIV) as documented in prior records or suggested by medical history, physical examination or standard clinical assessments such as imaging and laboratory studies. -Pregnant or breast-feeding persons (if lactating, must agree not to breast feed while taking pomalidomide).
-Participants must have histologically or cytologically confirmed B-cell non-Hodgkin lymphoma confirmed by the Laboratory of Pathology, NCI, with one or more of the following features:
-- Leptomeningeal/CSF involvement
-- High-risk for CNS relapse per CNS-IPI (score 4-6)
-- Plasmablastic histology
-- Gammaherpesvirus positive tumor
-- Presence of Kaposi sarcoma
-Measurable or evaluable lymphoma.
-Positive HIV1/2 serology.
-Participants may not have received prior curative-intent chemotherapy for lymphoma. Participants who have received prior treatment as a bridge to curative-intent therapy will be considered per Protocol Chair discretion if >= 2 weeks since administration. Steroids given for any reason or rituximab given for multicentric Castleman disease may be given any time prior to treatment start.
-Age >=18 years
-ECOG performance status <=4
-Persons of childbearing potential (PCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 14 days prior to and again within 1 day before starting pomalidomide and must either commit to continued abstinence from penetrative vaginal intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before the participant starts taking pomalidomide and for 12 months after the last dose of combined chemotherapy.
-All study participants must agree to be registered into the mandatory POMALYST REMS[Registered]TM program and be willing and able to comply with the requirements of the POMALYST REMS[Registered]TM program.
-Able to take aspirin 81mg orally daily or another substitute thromboprophylaxis.
-Participants must have adequate organ and marrow function as defined below unless abnormalities are attributed to lymphoma or HIV as determined by investigator:
-- absolute neutrophil count >=1,000/mcL
-- platelets >=75,000/mcL
-- total bilirubin <=1.5 X institutional upper limit of normal (participants with history of Gilbert disease are eligible if total bilirubin <= 5 mg/dL with <80% unconjugated bilirubin)
-- AST(SGOT)/ALT(SGPT) <=3 X institutional upper limit of normal
-- creatinine clearance >=60 mL/min/1.73 m^2 for participants with creatinine levels above institutional normal.
-Participants with hepatitis B virus (HBV) infection must be on suppressive antiviral therapy.
-Participants must be willing to take and adhere to antiretroviral therapy (participants are not required to be on any specific regimen of antiretroviral therapy).
-Participants must understand and sign a written informed consent document.
EXCLUSION CRITERIA:
-Participants may not receive investigational agents on other clinical trials.
-Participants requiring any of the agents listed as prohibited thearapies.
-History of allergic reactions attributed to compounds of similar chemical or biologic composition to pomalidomide or other agents used in study.
-Parenchymal brain involvement with lymphoma.
-Ejection fraction less than 40% by echocardiography (ECHO)
-CTCAEv5.0 Grade 3-4 neuropathy
-History of malignant tumors other than Kaposi sarcoma or KSHV-associated multicentric Castleman Disease, unless:
--In complete remission for >= 1 year from the time response was first documented; or,
-- Completely resected basal cell carcinoma; or,
-- In situ squamous cell carcinoma of the cervix or anus; or,
-- Prior or concurrent malignancy has a natural history or treatment which does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen per Protocol Chair discretion.
-Known drug-related, inherited, or acquired procoagulant disorder including prothrombin gene mutation 20210, antithrombin III deficiency, protein C deficiency, protein S deficiency and antiphospholipid syndrome but not including heterozygosity for the Factor V Leiden mutation or the presence of a lupus anticoagulant in the absence of other criteria for the antiphospholipid syndrome.
-Symptomatic congestive heart failure
-Unstable angina pectoris, or cardiac arrhythmia.
-Uncontrolled intercurrent illness or participants considered to be of poor medical health due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active uncontrolled infection (excluding lymphoma or HIV) as documented in prior records or suggested by medical history, physical examination or standard clinical assessments such as imaging and laboratory studies.
-Pregnant or breast-feeding persons (if lactating, must agree not to breast feed while taking pomalidomide).
Principal Investigator
Referral Contact
For more information: