Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Rituximab

Panobinostat

Histone Deacetylase Inhibitors

Antineoplastic Agents, Immunological

Immunologic Factors

Enzyme Inhibitors

single-arm, open-label; Panobinostat with Rituximab: Panobinostat 40 mg orally 3 x weekly Rituximab 375 mg/m\^2 IV days 1,8,15,and 22 of cycle 1, and then on day 1 of subsequent cycles.

Panobinostat 40 mg orally 3 x weekly Rituximab 375 mg/m\^2 IV days 1,8,15,and 22 of cycle 1, and then on day 1 of subsequent cycles.

Panobinostat with Rituximab

Jeremy S Abramson, MD

Panobinostat is a drug that may slow down the growth of cancer cells or kill cancer cells by blocking certain enzymes. Panobinostat has shown effects against cancer in laboratory studies. However, it is not known if it will show the same activity in humans. Panobinostat has been given to participants with various types of cancers, including DLBCL, in previous research studies. In this study panobinostat will be given with the the antibody rituximab, which is FDA approved to be given with chemotherapy in DLBCL.

Study treatment will be given in 4 week periods called cycles. Panobinostat will be taken orally on Monday, Wednesday, and Friday of each week. Rituximab will be given as an intravenous infusion weekly during Cycle 1 and then once per month on day 1 of subsequent cycles. Subjects can receive up to 6 cycles of treatment. Blood draws and 2 EKGs (electrocardiograms) will be done weekly in Cycle 1 and then once in each cycle. PET/CT (Positron Emission Tomography/Computed Tomography) scans will be done every 2 months.

If disease has not progressed after 6 cycles on combination of panobinostat and rituximab, subjects may continue on panobinostat alone for up to 6 additional months.

Panobinostat With Rituximab for Relapsed/Refractory Diffuse Large B Cell Lymphoma

Panobinostat in Combination With Rituximab For Relapsed/Refractory Diffuse Large B Cell Lymphoma

Overall response rate is defined by the Revised International Workshop Response Criteria (2007) (see reference in protocol section).

Overall response (OR) = Complete response (CR) + Partial response (PR)

Progression is defined by the Revised International Workshop Response Criteria (2007) (see reference in protocol section).

Evaluate safety of this combination in relapsed/refractory DLBCL patients Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening

Dana-Farber Cancer Institute

Beth Israel Deaconess Medical Center

Massachusetts General Hospital

Director, Lymphoma Program

single-arm, open-label; Panobinostat with Rituximab: Panobinostat 40 mg orally 3 x weekly Rituximab 375 mg/m\^2 IV days 1,8,15,and 22 of cycle 1, and then on day 1 of subsequent cycles.

Panobinostat with Rituximab: Panobinostat 40 mg orally 3 x weekly Rituximab 375 mg/m\^2 IV days 1,8,15,and 22 of cycle 1, and then on day 1 of subsequent cycles.

Panobinostat/Rituximab

Panobinostat with Rituximab: Panobinostat 40 mg orally 3 x weekly Rituximab 375 mg/m\^2 IV days 1,8,15,and 22 of cycle 1, and then on day 1 of subsequent cycles.

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

White

Other

Race/Ethnicity, Customized

United States

Region of Enrollment

Histology

EKG (electrocardiogram)

elevated LDH (Lactate dehydrogenase)

ECOG PS (Eastern Cooperative Oncology Group Performance Status)

Disease status

Number of extranodal sites

Number of target lesions

Number of non-target lesions

Time from last prior therapy

Number of prior therapies

Number of prior non-surgical therapies

Number of prior surgeries

Number of prior radiation treatments

Jeremy Abramson, MD

Overall Response Rate

Progression-free Survival Rate

Platelet count decreased

Fatigue

Anemia

Diarrhea

Nausea

Lymphocyte count decreased

Anorexia

Hypophosphatemia

Neutrophil count decreased

Hypoalbuminemia

Dyspnea

Constipation

Alkaline phosphatase increased

Creatinine increased

White blood cell decreased

Hypocalcemia

Hypokalemia

Hypomagnesemia

Dry mouth

Flatulence

Gatstroesophageal reflux disease

Mucositis oral

Vomiting

Edema face

Edema limbs

Fever

Hepatobiliary disorders - other

Aspartate aminotransferase increased

Blood bilirubin increased

Metabolism and nutrition disorders - other

Bone pain

Dysgeusia

Headache

Insomnia

Epistaxis

Skin and subcutaneous tissue disorders - other

Toxicities

Overall Study

Anti-Inflammatory Agents

Cyclophosphamide

Prednisone

Vincristine

Rituximab 375mg/m2 IV administered on day 1. Cyclophosphamide 750mg/m2 IV for 2hours,Adriamycin 50mg/m2 ,Vincristine 1.4mg/m2 IV respectively. Prednisone 60mg P.O. per day for 5 days.

NKCell about 100mg IV for 6times in each chemotherapy period.

NKM injection

Seok-Goo Cho, MD,PhD

Primary objective:

* To compare the event free survival for 3years of R-CHOP plus Biocell Natural Killer Cell to R-CHOP therapy with DLBCL patients.

Biocell Natural Killer Mixture in Diffuse Large B Cell Lymphoma (DLBCL) Patients

R-CHOP Therapy Compared With R-CHOP Plus Biocell Natural Killer Mixture in Patients With DLBCL (Diffuse Large B Cell Lymphoma);A Randomized, Open-label,Multi-center Trail

NKBio Co.Ltd.

Lee,Jae-Kyu

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Panobinostat With Rituximab for Relapsed/Refractory Diffuse Large B Cell Lymphoma	NCT01282476	Diffuse Large B...	Panobinostat wi...	18 Years -	Massachusetts General Hospital
Biocell Natural Killer Mixture in Diffuse Large B Cell Lymphoma (DLBCL) Patients	NCT00846157	Diffuse Large B...	NKM injection	20 Years - 70 Years	NKBio Co.Ltd.

Spots Global Cancer Trial Database for dlbcl (diffuse large b cell lymphoma)