A Phase 2 Study of Velcade™ in Subjects With Relapsed or Refractory Follicular B-Cell Lymphoma

NCT00136591 | Terminated Phase 2 DMC

• 3 other identifiers: FL05-1Janssen: 28866138-LYM-2003Eudrac: 2005-000734-21
• Study Type: interventional
• Target: 87
• Locations: 2 countries
• Sites: 4

Brief Summary

This is a prospective, randomized, sequential, international, multicentric, 2-arm, non-comparative, open-label, 2-stage clinical study to determine disease response rates to Velcade™ therapy in subjects who have relapsed or refractory follicular B-cell lymphoma. Qualitative comparisons of the 2 treatment arms based on safety, efficacy and dosing convenience will be made in order to recommend a dose schedule for further clinical study.

Conditions

Follicular Lymphoma

Keywords

follicular lymphoma; bortezomib; relapse

Outcome Measures

Primary Outcomes (1)

• To determine the response rate to Velcade™ as a single agent

  End of treatment

Secondary Outcomes (7)

• To determine the overall complete response (CR) rate (CR + complete response unconfirmed [CRu])

  End of treatment

• To determine time to progression (TTP)

  End of study

• To determine overall survival

  End of study

• To determine duration of response

  End of study

• To determine the time to best response

  End of study

Study Arms (2)

A

ACTIVE COMPARATOR

Arm A: a 21-day cycle of 1.5 mg/m2 Velcade™ twice weekly for 2 weeks. Days 1, 4, 8, and 11 of a 21-day cycle. Subjects in this treatment arm will receive a total of 8 cycles of treatment,

Drug: Bortezomib

B

EXPERIMENTAL

Drug: Bortezomib

Interventions

Bortezomib DRUG

Arm A: a 21-day cycle of 1.5 mg/m2 Velcade™ twice weekly for 2 weeks. Days 1, 4, 8, and 11 of a 21-day cycle

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subject 18 years or older.
• Initial diagnosis of follicular B-cell lymphoma (CD20+) (grades 1, 2, and 3 based on the World Health Organization 1997 classification), in first or subsequent relapse or progression after prior anti-neoplastic treatment including previous rituximab treatment. Relapse or progression since previous anti-neoplastic therapy must be documented by new lesions or objective evidence of progression of existing lesions.
• At least 1 measurable lymph node mass that is \>1.5 cm in 2 perpendicular dimensions, and has not been previously irradiated or has grown since previous irradiation.
• No active central nervous system (CNS) lymphoma
• Karnofsky Performance Status (KPS) \>50% (Eastern Cooperative Oncology Group \[ECOG\] 0-2)
• The following laboratory values at screening, unless abnormalities are related to the lymphoma:
• Absolute neutrophil count (ANC) \>1000 cells/dL;
• Platelets \>50,000 cells/dL;
• Aspartate transaminase (AST) \<3 x upper limit of normal (ULN);
• Alanine transaminase (ALT) \<3 x ULN;
• Total bilirubin \<2 x ULN;
• Creatinine level \<150 µmol/L
• Toxic effects of previous therapy or surgery resolved to Grade 2 or better.
• Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. Women are neither breast feeding nor pregnant for the duration of the study. Confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women. Male subject agrees to use an acceptable method of contraception for the duration of the study.
• Voluntary signed informed consent before performance of any study-related procedure not part of normal medical care.

You may not qualify if:

• Any other type of lymphoma.
• Previous treatment with Velcade™.
• Anti-neoplastic or experimental or radiation therapy within 3 weeks before Day 1 of Cycle 1.
• Major surgery within 2 weeks before Day 1 of Cycle 1.
• Rituximab, alemtuzumab (Mabcampath®), or other unconjugated therapeutic antibody within 10 weeks before Day 1 of Cycle 1.
• Nitrosoureas within 6 weeks before Day 1 of Cycle 1.
• Radioimmunoconjugates or toxin immunoconjugates such as ibritumomab tiuxetan (Zevalin™), or tositumomab (Bexxar®) within 10 weeks before Day 1 of Cycle 1.
• Peripheral neuropathy or neuropathic pain of Grade 3 or worse.
• History of allergic reaction attributable to compounds containing boron or mannitol.
• Diagnosed or treated for a malignancy other than non-Hodgkin's lymphoma (NHL) within 5 years before Day 1 of Cycle 1, with the exception of complete resection of basal cell carcinoma, squamous cell carcinoma of the skin, or in situ malignancy.
• Active systemic infection requiring treatment.
• Previously known HIV positive serology.
• Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
• Concurrent treatment with another investigational agent.
• Adult patient under guardian.

Sponsors & Collaborators

• Lymphoma Study Association: lead
• Janssen-Cilag International NV: collaborator

Study Sites (4)

Groupe d'Etude des Lymphomes de l'adulte

Mont-Godinne, Belgium

Location

Service d'Hématologie - Centre Hospitalier Lyon-Sud

Pierre-Bénite, 69495, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Institut Gustave Roussy

Villejuif, France

Location

Related Publications (2)

• O'Connor OA, Wright J, Moskowitz C, Muzzy J, MacGregor-Cortelli B, Stubblefield M, Straus D, Portlock C, Hamlin P, Choi E, Dumetrescu O, Esseltine D, Trehu E, Adams J, Schenkein D, Zelenetz AD. Phase II clinical experience with the novel proteasome inhibitor bortezomib in patients with indolent non-Hodgkin's lymphoma and mantle cell lymphoma. J Clin Oncol. 2005 Feb 1;23(4):676-84. doi: 10.1200/JCO.2005.02.050. Epub 2004 Dec 21.

  PMID: 15613699 BACKGROUND

• Goy A, Younes A, McLaughlin P, Pro B, Romaguera JE, Hagemeister F, Fayad L, Dang NH, Samaniego F, Wang M, Broglio K, Samuels B, Gilles F, Sarris AH, Hart S, Trehu E, Schenkein D, Cabanillas F, Rodriguez AM. Phase II study of proteasome inhibitor bortezomib in relapsed or refractory B-cell non-Hodgkin's lymphoma. J Clin Oncol. 2005 Feb 1;23(4):667-75. doi: 10.1200/JCO.2005.03.108. Epub 2004 Dec 21.

  PMID: 15613697 BACKGROUND

Related Links

• Official site of the Groupe d'Etudes des Lymphomes de l'Adulte (In french)

MeSH Terms

Conditions

Lymphoma, Follicular; Recurrence

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Bertrand Coiffier, MD

  Hospices Civils de Lyon, Lyon, France

  STUDY CHAIR

• Vincent Ribrag, MD

  Institut Gustave Roussy, Villejuif, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 26, 2005
• First Posted: August 29, 2005
• Study Start: September 1, 2005
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: October 26, 2010

Record last verified: 2010-10

Locations

BE (1); FR (3)