Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Symptoms and General Pathology

Heart and Blood Diseases

Rare Diseases

Lymphoma

Lymphoma, Non-Hodgkin

Leukemia, Lymphocytic, Chronic, B-Cell

Lymphoma, Mantle-Cell

Lymphoma, Follicular

Lymphoma, B-Cell, Marginal Zone

Lymphoma, B-Cell

Waldenstrom Macroglobulinemia

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Chronic Lymphocytic Leukemia

Mantle Cell Lymphoma

Follicular Lymphoma

B-cell Lymphoma

Marginal Zone Lymphoma

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Rituximab

Bortezomib

Ofatumumab

Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22 Bortezomib 1.6 mg/m2 IV Ofatumumab 1000 mg IV on day 1 maintenance phase Patients will remain until progression

Ofatumumab and Bortezomib

Jorge Castillo, MD

The purpose of this study is to: Investigate the Overall Response Rate (ORR) of the combination of ofatumumab and bortezomib in patients with low-grade B-cell non-Hodgkin lymphoma (LG-NHL) that relapse beyond 6 months of a previous rituximab-containing regimen.

41 patients will be enrolled in this trial with low grade lymphomas and will be given Ofatumumab 1000 mg and Bortezomib IV 1.6 mg/m2 weekly times 4 treatments and will then receive maintenance treatment with the 2 agents every 2 months for 1 year unless disease progression.

Ofatumumab and Bortezomib for Patients With Low-grade B-cell Non-hodgkin Lymphoma That Relapse After Rituximab

Ofatumumab in Combination With Bortesomib in Patients With Relapsed or Refractory Low-Grade Non-Hodgkins Lymphoma

Response was assessed based on Bone marrow biopsy and CT scan. Best responses are used for Response Rate and CR and PR only.

Complete Response - CR:

• Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.

Partial Response - PR:

• At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses.

Stable Disease - SD:

• A patient is considered to have SD when he or she fails to attain the criteria needed for a CR or PR, but does not fulfill those for progressive disease

Relapsed Disease:

• Lymph nodes should be considered abnormal if the long axis is more than 1.5 cm regardless of the short axis.

Rhode Island Hospital

The Miriam Hospital

Memorial Hospital of Rhode Island

Dartmouth-Hitchcock Medical Center

Brown University

Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22,

Ofatumumab and Bortezomib: Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22- in the induction phase Ofatumumab 1000 mg IV on day 1- will receive in the maintenance phase Patients will remain until progression

Ofatumumab IV,

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Eric Winer, MD

Progression

8/10 patients were evaluable as 2 withdrew

Overall Response Rate (ORR) of the Combination of Ofatumumab and Bortezomib in Patients Receiving Study Treatment

Overall Study

Spots Global Cancer Trial Database for waldenström macroglobulinemia.