A Randomized, Open-Label, Multicenter Study of VELCADE with Rituximab or Rituximab Alone in Subjects with Relapsed or Refractory, Rituximab Naive or Sensitive Follicular B-cell Non Hodgkin's Lymphoma - VELCADE with Rituximab vs. Rituximab alone in NHL

• Register: EUCTR
• Last refreshed on: 13 March 2017
• Main ID: EUCTR2005-005777-30-SK
• Date of registration: 12/01/2006
• Prospective Registration: Yes
• Primary sponsor: Janssen-Cilag International NV
• Public title: A Randomized, Open-Label, Multicenter Study of VELCADE with Rituximab or Rituximab Alone in Subjects with Relapsed or Refractory, Rituximab Naive or Sensitive Follicular B-cell Non Hodgkin's Lymphoma - VELCADE with Rituximab vs. Rituximab alone in NHL
• Scientific title: A Randomized, Open-Label, Multicenter Study of VELCADE with Rituximab or Rituximab Alone in Subjects with Relapsed or Refractory, Rituximab Naive or Sensitive Follicular B-cell Non Hodgkin's Lymphoma - VELCADE with Rituximab vs. Rituximab alone in NHL
• Date of first enrolment: 01/03/2006
• Target sample size: 670
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-005777-30
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Finland, Germany, Greece, Italy, Slovakia, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1. Man or woman and age 18 years or older

2. Diagnosis of follicular B-NHL of the following subtypes (WHO classification 1997): FL (Grades 1 and 2).

3. Documented relapse or progression following prior antineoplastic treatment. New lesions or objective evidence of progression of existing lesions must document relapse or progression following the previous therapy. If any prior regimen included rituximab, the subject must have responded (CR, CRu, PR), and the TTP from the first dose of rituximab must have been 6 months or more.

4. At least 1 measurable tumor mass (greater than 1.5 cm in the longest dimension and greater than 1.0 cm in the short axis) that has not been previously irradiated, or has grown since previous irradiation

5. No active central nervous system lymphoma

6. Eastern Cooperative Oncology Group status equal or smaller than 2


7.Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

8. In countries where health authorities have approved the pharmacogenomic testing, subjects or their legally acceptable representatives must have signed a separate informed consent that they agree to participate in the genetic part and protein testing part of the study; participation in the genetic and protein testing component is mandatory for testing described in Section 9.5, but optional for serum protein testing and future testing.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Diagnosed or treated for a malignancy other than NHL within 1 year of randomization, or who were previously diagnosed with a malignancy other than NHL and have any radiographic or biochemical marker evidence of malignancy. Subjects with completely resected basal cell carcinoma, squamous cell carcinoma of the skin, or in situ malignancy are not excluded.
2. Clinical evidence of a transformation from indolent NHL to a more aggressive form of NHL.
3. History of disallowed therapies:
4. Prior treatment with VELCADE
5. Antineoplastic (including unconjugated therapeutic antibodies), experimental, or radiation therapy within 3 weeks before randomization
6. Nitrosoureas within 6 weeks before randomization
7. Radioimmunoconjugates or toxin immunoconjugates within 10 weeks before randomization
8. Stem cell transplant within 6 months before randomization
9. Major surgery within 2 weeks before randomization
10. Residual toxic effects of previous therapy or surgery of Grade 3 or worse
11. Peripheral neuropathy or neuropathic pain of Grade 2 or worse
12. Have received an experimental drug or used an experimental medical device within 21 days before the planned start of treatment.
13. History of allergic reaction attributable to compounds containing boron or mannitol
14. Known anaphylaxis or immunoglobulin E (IgE)-mediated hypersensitivity to murine proteins or to any component of rituximab including polysorbate 80 and sodium citrate dihydrate
15. Concurrent treatment with another investigational agent
16. Female subject who is pregnant or breast-feeding



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Subjects with Relapsed or Refractory, Rituximab Naive or Sensitive Follicular B-cell Non Hodgkin's Lymphoma
MedDRA version: 8.1 Classification code 10025320

Intervention(s)

Trade Name: MabThera
Product Name: MabThera | rituximab 100 mg (10 mg/mL)
Pharmaceutical Form: Concentrate and solvent for solution for injection

Trade Name: Mabthera
Product Name: MabThera | rituximab 500 mg (10 mg/ml)
Pharmaceutical Form: Concentrate and solvent for solution for injection

Trade Name: Velcade
Product Name: VELCADE 3.5 mg powder for solution for injection
Product Code: PS-341, 26866138-AAA-PB-001
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: bortezomib
CAS Number: 179324-69-7
Current Sponsor code: 26866138
Other descriptive name: Boronic Acid: [(1R)-3-methyl-1-[[(2S)-1-oxo-3-phenyl-2[(pyrazinylcarbonyl)amino]propyl]amino]butyl
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3.5-

Primary Outcome(s)

Primary end point(s): The primary endpoint is Progression Free survival
is defined as the interval between the date of randomization and the date of PD or death, whichever is first reported in the intent-to-treat (ITT) population. Subjects who withdraw from the study (i.e., withdrawal of consent, lost to follow-up) or change therapy without documented progression will be censored at the time of the last adequate disease assessment. Subjects who complete the study, have not progressed, and are still alive at the cut-off date of the final analysis will be censored at the last adequate disease assessment.
Secondary Endpoints: please refer to the protocol.

Main Objective: The primary objective of this study is to determine whether VELCADE with rituximab provides benefit to subjects with relapsed or refractory, rituximab naive or sensitive follicular B-NHL relative to treatment with rituximab alone, as assessed by prolongation of PFS

Secondary Objective: Secondary objectives are to determine the:
-ORR (CR + CR unconfirmed [CRu] + PR) to VELCADE in combination with rituximab according to modified criteria developed by the International Workshop to Standardize Response Criteria for NHL (IWRC)
-Overall CR rate (CR + CRu)
-Duration of response
-TTP
-Overall survival (OS) rate
-One-year survival rate.
The safety objective is to evaluate the safety and tolerability of VELCADE in combination with rituximab

Exploratory objectives are mentioned in the protocol.

Secondary ID(s)

26866138-LYM-3001

2005-005777-30-GB