Phase 2 Study of VELCADE With Fludarabine in Comparison to Rituximab With Fludarabine in Follicular Lymphoma Patients Previously Treated With Rituximab

Follicular Lymphoma Clinical Trial

Official title:

A Randomized, Open-Label, Multicenter Phase 2 Study of VELCADE With Fludarabine in Comparison to Rituximab With Fludarabine in Follicular Lymphoma Patients Previously Treated With Rituximab

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00850499
• Other study ID #: 26866138-LYM-2033
• Status: Terminated
• Phase: Phase 2
• First received: February 24, 2009
• Last updated: December 10, 2012
• Start date: September 2009
• Est. completion date: October 2011

Study information

• Verified date: December 2012
• Source: Millennium Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a randomized, open-label, active-control, multicenter Phase 2 study of VELCADE+fludarabine in comparison with rituximab+fludarabine in subjects with relapsed advanced follicular lymphoma. Eligible subjects will be randomized in a 1:1 ratio between the 2 treatment arms (55 subjects per arm).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: October 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female subjects 18 years or older

• Histologically proven diagnosis of follicular non-Hodgkin's lymphoma grades 1or 2 according to the World Health Organization classification

• Subjects must have received at least 12 doses (375mg/m2 or appropriately adjusted dose) of rituximab for the treatment of this lymphoma as single agent rituximab or in rituximab-containing regimens as documented in the subject's medical record

• Documented relapse or progression following last antineoplastic treatment

• At least 1 measurable tumor mass (=1.5 cm x =1.0 cm)

Exclusion Criteria:

• Subjects with histological or clinical transformation to an aggressive lymphoma

• prior treatment with VELCADE or fludarabine.

• antineoplastic (including unconjugated therapeutic antibodies), experimental, or radiation therapy within 3 weeks before randomization

• nitrosoureas within 6 weeks before randomization

• radioimmunoconjugates or toxin immunoconjugates within 10 weeks before randomization

• major surgery within 3 weeks before randomization

• chronic use of corticosteroids, such as dexamethasone

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Follicular Lymphoma
• Lymphoma
• Lymphoma, Follicular

Intervention

Drug:
• fludarabine
fludarabine 40mg/m2/day orally on Days 1 to 5 of every 35-day cycle
• rituximab
rituximab 375mg/m2 on Day 1 of every 35-day cycle
• VELCADE
1.6 mg/m2 intravenously (IV) on Days 1, 8, 15, and 22 of every 35-day cycle

Locations

Country	Name	City	State
France	CHU d'Amiens	Amiens, 80
France	Institut Bergonie	Bordeaux, 33
France	CHU Hotel Dieu	Clermont Ferrand, 63
France	Centre Victor Hugo	Le Mans, 72
France	CHU Caremeau	Nimes, 30
France	Hoptial Saint Louis	Paris Cedex 10, 75
France	Hopital Cochin	Paris, 75, Cedex 14
Germany	Klinikum Bamberg, fachbereich 3	Bamberg
Germany	Charite, group Benjamin Franklin	Berlin
Germany	Hospital Spandau	Berlin
Germany	Vivantes Klinikum am Urban	Berlin, BE
Germany	Universitaetsklinikum Frankfurt	Frankfurt
Germany	Universitatsklinikum Gottingen, zentrum Innere medicin	Gottingen
Germany	Evangelisches Krankenhaus Hamm	Hamm
Germany	Klinikum Idar-Oberstein GmbH	Idar-Oberstein
Germany	Universitaetsklinikum Jena	Jena
Germany	Universitaetsklinikum Leipzig	Leipzig
Germany	Universitaetsklinikum Mainz	Mainz
Germany	Robert Bosch Krankenhaus	Stuttgart
Germany	Mutterhaus der Borromaeerinnen	Trier
Germany	Universitatsklinikum Ulm	Ulm
Germany	Klinikum der Stadt Villinger-Schwenningen	Villingen-Schwenningen
Greece	Laiko Hospital - 1st Dept. of Propaedeutic Internal Medicine	Athens
Greece	University Hospital of Heraklion- Department of Hematology	Heraklion- Crete
Israel	Haemek Medical Center - Hematology Department	Afula
Israel	Rambam Med.Center - Hematology Institute	Haifa
Israel	Hadassah University Hospital - Hematology Department	Jerusalem
Israel	Rabin Medical Center - Hematology Institute	Petach Tikva
Israel	Sheba MC - Hematology Institute	Ramat Gan
Italy	Policlinico di Bari	Bari
Italy	Istituto Di Ematologia E Oncologia Medica - L.A. Seragnoli - Policlinico S.Orsola Malpighi	Bologna
Italy	Clinica di Ematologia DIMI - A.O. Ospedale S. Martino	Genova
Italy	Ospedale Niguarda Ca' Granda	Milano
Italy	Azienda Ospedaliera Antonio Cardarelli	Napoli
Italy	Ospedale Policlinico San Matteo Irccs	Pavia
Italy	A.O.Univ.Pisana-Osp. Santa Chiara	Pisa
Italy	Università La Sapienza, Dipartimento di Biotecnologie Cellulari ed Ematologia, Via Benevento, 6	Roma
Italy	Azienda Ospedaliera Santa Maria di Terni	Terni
Italy	Divisione di Ematologia Ospedale San Bortolo - Hematology	Vicenza
Spain	Hospital Puerta del Mar, Secretaría de Hematología, 1ª planta	Cadiz N/a
Spain	Hospital General Universitario Morales Meseguer, Secretaría de Hematología, 1ª planta	Murcia N/a
Spain	Hospital Clinico Universitario Salamanca, Servicio de Hematología, 4º Planta	Salamanca
Switzerland	Kantonsspital St.Gallen Department of Oncology/Hematology	St. Gallen

Sponsors (2)

Lead Sponsor	Collaborator
Millennium Pharmaceuticals, Inc.	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Countries where clinical trial is conducted

France,  Germany,  Greece,  Israel,  Italy,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Response Rate	The proportion of response-evaluable subjects who achieved a confirmed complete response (CR) or complete response unconfirmed (CRu). Disease response and progression were evaluated according to modified International Workshop Response Criteria (IWRC) criteria by radiographic imaging and other procedures as necessary.	Up to 8 cycles (1 cycle is 35 days: 280 days)	No
Secondary	Overall Response Rate	The proportion of subjects who achieve CR, CRu, or partial response (PR) relative to the response evaluable population. Disease response and progression were evaluated according to the modified IWRC criteria by radiographic imaging and other procedures as necessary.	Up to 8 cycles (1 cycle is 35 days: 280 days)	No