A Phase II Study of VELCADE (Bortezomib) in Combination With Bendamustine and Rituximab in Subjects With Relapsed or Refractory Follicular Lymphoma (VERTICAL)

Millennium Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Follicular Lymphoma

Treatments

Drug: Bendamustine

Drug: VELCADE

Drug: Rituximab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00636792

C05011

Details and patient eligibility

About

This is a phase 2, single-arm, open label, multicenter study evaluating the efficacy and safety of the combination of VELCADE, bendamustine, and rituximab in subjects with relapsed or refractory follicular lymphoma, who have received 4 or more doses of rituximab. Subjects may be sensitive or refractory to prior therapies, including rituximab.

Enrollment

73 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female subject 18 years of age or older
Pathological diagnosis of follicular lymphoma (any grade)
Documented relapse or progression following prior antineoplastic therapy
Have received 4 or more prior doses of rituximab
At least 1 measurable tumor mass (>1.5 cm in the long axis and >1.0 cm in the short axis that has not been previously irradiated, or has grown since previous irradiation
No clinically significant central nervous system lymphoma
Karnofsky performance status (KPS) ≥50 (equivalent to Eastern Cooperative Group Oncology Group [ECOG] status ≤2

Exclusion criteria

Diagnosed or treated for a malignancy other than non-Hodgkin's lymphoma (NHL) within 2 years of first dose, or who were previously diagnosed with a malignancy other than NHL and have any radiographic or biochemical marker evidence of malignancy. Subjects with prostate cancer who were treated with definitive radiotherapy and have a serum prostate-specific antigen (PSA) <1 ng/mL are not excluded. Subjects are also not excluded if they have had basal cell or squamous cell carcinoma of the skin that was completely resected, or any in situ malignancy that was adequately treated.
Prior treatment with VELCADE® or bendamustine
Antineoplastic (including unconjugated therapeutic antibodies and toxin immunoconjugates), experimental, or radiation therapy within 3 weeks before Day 1 of Cycle 1
Nitrosoureas within 6 weeks before Day 1 of Cycle 1
Radioimmunoconjugates within 10 weeks before Day 1 of Cycle 1
Autologous stem cell transplant within 3 months before Day 1 of Cycle 1, or prior allogeneic stem cell transplant at any time
Major surgery within 2 weeks before Day 1 of Cycle 1
Platelet transfusion within 7 days of Day 1 of Cycle 1 (applies to subjects enrolled in the dose escalation phase only. This does not apply to subjects enrolled in phase 2 of the study).
Ongoing therapy with corticosteroids. Prednisone ≤15 mg per day or its equivalent is allowed.