WithdrawnPhase 1/2

Study of Pomalidomide Combined With Modified DA-EPOCH and Rituximab in KSHV-Associated Lymphomas

0Started 2014-08-15

Plain-language summary

Background: \- The chemotherapy combination DA-EPOCH-RP includes the drugs etoposide (E), prednisone (P), vincristine (O), cyclophosphamide (C), doxorubicin (H), rituximab (R), and pomalidomide (P). Researchers want to see if including pomalidomide will help people with two rare lymphomas. Objectives: \- To study the safety and efficacy of the chemotherapy drugs DA-EPOCH-RP. Eligibility: \- Adults at least 18 years old. They must have primary effusion lymphoma or large cell lymphoma arising from Kaposi sarcoma Herpesvirus-associated multicentric Castleman disease. Design: * Participants will be with screened with blood tests, scans, spinal tap, and bone marrow sample. They may have skin or lymph node samples taken and fluid removed from around some organs. * Participants will have breathing and eye tests. A camera may take pictures inside their body. * Participants will take pomalidomide alone by mouth for up to 21 days. Then they will get rituximab by intravenous (IV) catheter, which is a small tube that goes into a vein.. * Participants will have an IV inserted in an arm or chest vein to get the IV chemotherapy drugs, at the same time the will take pomalidomide by mouth for 5 days. * They will get DA-EPOCH-RP in 21-day cycles. Most people will have 6 cycles. * They will get 4 study drugs by IV for 5 days and 2 others by mouth for 5 days. * They will get daily filgrastim injections in the skin until white blood counts are acceptable * For 2 days of some cycles, methotrexate will be injected into the spinal fluid. * After completing EPOCH-RP, some participants who have Kaposi sarcoma will be prescribed pomalidomide for 3-weeks, followed by a one week break, for up to 12 months. * Participants will repeat the blood tests often. They will also have repeated medical history, physical exam, urine and stool tests, and pictures of any rashes associated with these lymphomas. * Participants will have several follow-up visits over 4 years.

Who can participate

Age range18 Years – 99 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓.1.1.1 KSHV-associated non-Hodgkin lymphoma, with pathology reviewed and confirmed at the NIH. May include WHO recognized tumors
✓.1.1.1.1 Primary effusion lymphoma (PEL), including extracavitary variant
✓.1.1.1.2 Large cell lymphoma arising in the setting of KSHV-associated MCD.
✓.1.1.2 Measurable or assessable lymphoma
✓.1.1.3 Any HIV status
✓.1.1.4 Age 18 years or greater. Because no dosing or adverse event data are currently available on the use of pomalidomide in combination with EPOCH-R in patients \<18 years of age, children are excluded from this study, but may be eligible for future pediatric trials.
✓.1.1.5 ECOG performance status 0-4.
✓.1.1.6 Females of childbearing potential (FCBP) 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 24 hours before starting pomalidomide and must either commit to continued abstinence from heterosexual 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 she starts taking pomalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a vasectomy. All subjects must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control

What they're measuring

(Phase I) To determine the maximum tolerated dose and/or recommended phase II dose of pomalidomide in combination with DA-EPOCH-R.

Timeframe: one-year

Trial details

NCT IDNCT02228512

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2015-05-05

View on ClinicalTrials.gov More Large Cell Lymphoma Arising in KSHV-associated Multicentric Castleman Disease trials

Plain-language summary

Who can participate

Age range18 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓.1.1.1 KSHV-associated non-Hodgkin lymphoma, with pathology reviewed and confirmed at the NIH. May include WHO recognized tumors
✓.1.1.1.1 Primary effusion lymphoma (PEL), including extracavitary variant
✓.1.1.1.2 Large cell lymphoma arising in the setting of KSHV-associated MCD.
✓.1.1.2 Measurable or assessable lymphoma
✓.1.1.3 Any HIV status
✓.1.1.4 Age 18 years or greater. Because no dosing or adverse event data are currently available on the use of pomalidomide in combination with EPOCH-R in patients \<18 years of age, children are excluded from this study, but may be eligible for future pediatric trials.
✓.1.1.5 ECOG performance status 0-4.
✓.1.1.6 Females of childbearing potential (FCBP) 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 24 hours before starting pomalidomide and must either commit to continued abstinence from heterosexual 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 she starts taking pomalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a vasectomy. All subjects must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control

Study of Pomalidomide Combined With Modified DA-EPOCH and Rituximab in KSHV-Associated Lymphomas

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Study of Pomalidomide Combined With Modified DA-EPOCH and Rituximab in KSHV-Associated Lymphomas

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Exclusion criteria