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An Efficacy and Tolerability Study of Bortezomib in Combination With Rituximab Standard Therapy in Participants With Relapsed or Refractory Follicular Lymphoma

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ClinicalTrials.gov Identifier: NCT01902862
Recruitment Status : Terminated (Recruitment too slow)
First Posted : July 18, 2013
Last Update Posted : April 1, 2014
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag G.m.b.H

Brief Summary:
The purpose of this study is to evaluate the efficacy (effectiveness) and tolerability (how well a participant can stand a particular medicine or treatment; ability to be used) of bortezomib in combination with rituximab standard therapy (medicine or medical care given to a participant for a disease or condition) in participants with relapsed or refractory (not responding to treatment) follicular lymphoma (a cancer of the lymph nodes [or tissues] in follicle).

Condition or disease Intervention/treatment Phase
Lymphoma, Follicular Drug: Bortezomib Drug: Rituximab Phase 2

Detailed Description:
This is a prospective (study following participants forward in time), open-label (all people know the identity of the intervention), multi-center (conducted in more than 1 center), non-randomized (study drug not assigned by chance), single-arm study in participants with relapsed or refractory cluster of differentiation 20 plus (CD-20+) follicular Grade 1 or 2 lymphoma Stage III or IV with at least 2 previous lines of therapy. The study will include 2 phases: a Screening phase and a Treatment phase. The Screening phase will be conducted 2 weeks before the Treatment phase. The Treatment phase will include 3 cycles. The duration of each cycle will be 5 weeks (35 days). After the second cycle, a response will be evaluated. In case of complete response (CR), participants will be followed-up for a period of 1 year. In case of progressive disease (PD), the participant will be excluded from the study, and in case of stable disease (SD) or partial response (PR), an additional cycle of 5 weeks will be applied and a follow-up of 1 year will be performed. In each cycle, participants will receive 1.6 milligram per meter square (mg per m^2) of bortezomib as intravenous (through a vein in the body) infusion (a fluid or a medicine delivered into a vein by way of a needle) on Days 1, 8, 15, 22 of Cycle 1, Days 36, 43, 50 and 57 of Cycle 2 and on Days 71, 78, 85 and 92 of Cycle 3 (if applicable). Cycle 3 will be applicable only in case of SD or PR according to remission criteria after Cycle 2. In Cycles 2 and (if applicable) 3, injection of bortezomib followed by administration of rituximab (in a dose of 375 mg per m^2) will be given as intravenous infusion. If neuropathy (a disturbance in the function of the brain or spinal cord that may affect the nerves and muscles of the body) grade of more than or equal to 2 will occur then a dose of bortezomib will be reduced from 1.6 mg per m^2 to 1.3 mg per m^2 and then to 1.0 mg per m^2. Participants will be analyzed for time to disease progression or relapse, disease free survival, overall survival and remission (when a medical problem gets better or goes away at least for a while) status. Participants' safety will be monitored throughout the study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study With Bortezomib in Combination With Rituximab Standard Therapy in Patients With Relapsed or Refractory Follicular Lymphoma and at Least 2 Previous Therapies
Study Start Date : February 2006
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Bortezomib plus rituximab
Bortezomib will be administered as intravenous infusion as 1.6 milligram per meter square (mg per m^2) on Days 1, 8, 15 and 22 of cycle 1 and Days 36, 43, 50, 57 of cycle 2 and (if applicable) on Days 71, 78, 85, and 92 of Cycle 3. Rituximab will be administered as intravenous infusion as 375 mg per m^2 on Days 36, 43, 50, 57 of cycle 2 and (if applicable) on Days 71, 78, 85, and 92 of Cycle 3.
Drug: Bortezomib
Bortezomib will be administered as intravenous infusion as 1.6 milligram per meter square (mg per m^2) on Days 1, 8, 15 and 22 of cycle 1 and Days 36, 43, 50, 57 of cycle 2 and (if applicable) on Days 71, 78, 85, and 92 of Cycle 3.
Other Name: VELCADE

Drug: Rituximab
Rituximab will be administered as intravenous infusion as 375 mg pert m^2 on Days 36, 43, 50, 57 of cycle 2 and (if applicable) on Days 71, 78, 85, and 92 of Cycle 3.




Primary Outcome Measures :
  1. Time to Progression or Relapse [ Time Frame: Start of treatment (Day 1 of Cycle 1) up to Month 15 ]
    Time to disease progression is defined as the time from start of treatment to the time of first documentation of disease progression.


Secondary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) of Bortezomib in Combination With Rituximab [ Time Frame: Start of treatment (Day 1 of Cycle 1) up to Month 15 ]
    MTD is defined as the dose level combination below the dose level that produces a dose-limiting toxicity. If MTD is not reached, the recommended MTD is the maximum dose that the participants received. Tolerability of bortezomib in combination with rituximab standard therapy will be monitored.

  2. Number of Participants With Remission Status [ Time Frame: Start of treatment (Day 1 of Cycle 1) up to Month 15 ]
    Participants with complete response (CR), partial response (PR) and stable disease (SD) separately for each category as well as participants with CR or PR (cumulative, i.e., either CR or PR) or participants with CR, PR or SD (cumulative, i.e., either CR or PR or SD) as best remission status will be reported.

  3. Disease-Free Survival [ Time Frame: Start of treatment (Day 1 of Cycle 1) up to Month 15 ]
    Disease-free survival is the time until the date of documentation of first progressive disease (PD) or death.

  4. Overall Survival [ Time Frame: Start of treatment (Day 1 of Cycle 1) up to Month 15 ]
    Overall survival is defined as the time from the start of treatment until death (whatever the cause). Participants still alive will be censored at the moment of last visit or contact.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants with histologically confirmed relapsed or refractory follicular Stage III or IV, Grade 1 and 2, cluster of differentiation 20 plus (CD20+) lymphoma (WHO - World Health Organization) that requires therapy
  • Participants in whom treatment with rituximab is planned after greater than or equal to 2 cytostatic (inhibition of cell growth) previous therapies
  • Women must be either postmenopausal or sterilized; negative pregnancy test at Screening
  • Participants with total bilirubin below 1.5-fold upper limit of normal (ULN) and creatinine below 2-fold ULN
  • Participants with Karnofsky Status greater than or equal to 60 percent

Exclusion Criteria:

  • Participants with previous treatment with bortezomib within 6 months before enrollment or previous treatment with a combination of rituximab and bortezomib
  • Participants with previous known allergic reaction to bortezomib, boron or mannitol
  • Participants with life-expectancy of less than 3 months
  • Participants with malignant neoplasm (cancerous - new growth that is not normal; tumor) (except basalioma) within previous 5 years
  • Participants with peripheral (not central) neuropathy (a disturbance in the function of the brain or spinal cord that may affect the nerves and muscles of the body) common terminology criteria for adverse events (CTCAE) grade greater than or equal to 2

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01902862


Locations
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Germany
Kiel, Germany
Regensburg, Germany
Stuttgart, Germany
Sponsors and Collaborators
Janssen-Cilag G.m.b.H
Investigators
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Study Director: Janssen-Cilag G.m.b.H, Germany Clinical Trial Janssen-Cilag G.m.b.H

Additional Information:
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Responsible Party: Janssen-Cilag G.m.b.H
ClinicalTrials.gov Identifier: NCT01902862     History of Changes
Other Study ID Numbers: CR010342
26866138LYM2021
2005-003949-14
First Posted: July 18, 2013    Key Record Dates
Last Update Posted: April 1, 2014
Last Verified: March 2014

Keywords provided by Janssen-Cilag G.m.b.H:
Lymphoma, follicular
Bortezomib
Rituximab

Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Bortezomib
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents