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Trial record 2 of 3 for:    ofatumumab nhl 9

Ofatumumab and Bendamustine Combination Therapy Compared With Bendamustine Monotherapy in Indolent B-cell Non-Hodgkin's Lymphoma (NHL) Unresponsive to Rituximab or a Rituximab-Containing Regimen (COMPLEMENT A+B)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01077518
First received: February 25, 2010
Last updated: August 7, 2016
Last verified: August 2016
  Purpose
The purpose of this study is to evaluate the safety and efficacy of ofatumumab and bendamustine combination therapy in patients with indolent B-cell NHL that did not respond to rituximab or a rituximab-containing regimen during or within 6 months of the last rituximab treatment.

Condition Intervention Phase
Lymphoma, Follicular
Drug: Ofatumumab and Bendamustine infusions (Arm A)
Drug: Bendamustine infusion (Arm B)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open Label Study of Ofatumumab and Bendamustine Combination Therapy Compared With Bendamustine Monotherapy in Indolent B-cell Non-Hodgkin's Lymphoma Unresponsive to Rituximab or a Rituximab-Containing Regimen During or Within Six Months of Treatment

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Progression-free-survival following ofatumumab and bendamustine combination therapy [ Time Frame: 68 months ]

Secondary Outcome Measures:
  • Clinical benefit, changes in patient reported outcome measures, and pharmacokinetics following ofatumumab and bendamustine combination therapy [ Time Frame: 62 months ]
  • Overall response rate, overall survival, time to and duration of response following ofatumumab and bendamustine combination therapy [ Time Frame: 62 months ]
  • Safety and tolerability of ofatumumab and bendamustine combination therapy [ Time Frame: 62 months ]

Estimated Enrollment: 346
Study Start Date: August 2010
Estimated Study Completion Date: July 2023
Estimated Primary Completion Date: July 2023 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ofatumumab and Bendamustine (Arm A)
Up to 8 cycles of bendamustine (90 mg/m2) on Days 1,2 every 21 days with12 doses of ofatumumab (1000 mg, Day 1 q21 days when with bendamustine and q28 days when given as monotherapy)
Drug: Ofatumumab and Bendamustine infusions (Arm A)
Up to 8 cycles of Bendamustine (90 mg/m2 Days 1 and 2, every 21 days) given in combination with 12 doses of ofatumumab (1000 mg). Ofatumumab will be given on day 1 of each cycle of bendamustine as long as patients in Arm A receive bendamustine. Once patients in Arm A complete bendamustine therapy, the remaining doses of ofatumumab will be given monthly until all 12 doses are completed.
Active Comparator: Bendamustine (Arm B)
Up o 8 cycles of bendamustine (120 mg/m2) on Days 1,2 every 21 days
Drug: Bendamustine infusion (Arm B)
Bendamustine (120 mg/m2 Days 1 and 2, every 21 days, up to 8 cycles).

Detailed Description:

Ofatumumab is an anti-CD20 monoclonal antibody shown to have monotherapy activity in patients with follicular lymphoma that has relapsed following rituximab-containing therapy. Bendamustine was approved by FDA for the treatment of in patients with indolent B-cell Non-Hodgkin's Lymphoma (NHL) that did not respond to rituximab or a rituximab-containing regimen during or within 6 months of the last rituximab treatment.

Biologics have demonstrated enhanced efficacy when added to chemotherapeutic combinations in the frontline treatment for indolent NHL. The combination of ofatumumab and bendamustine may provide additional clinical benefit and efficacy to those who no longer respond to rituximab or rituximab-containing regimens.

The objective of this study is to determine the effect of ofatumumab and bendamustine combination therapy in patients with indolent B-cell NHL that did not respond to rituximab or a rituximab-containing regimen during or within 6 months of the last rituximab treatment.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Indolent lymphoma including Grades 1-3a follicular, small lymphocytic, lymphoplasmacytic, and marginal zone lymphoma; Stages III-IV, or bulky disease, Stage II. Tumor verified CD20+ and CT imaging done at screening verifying disease
  • Indolent B-cell NHL that remains stable or unresponsive during or within 6 months of treatment with rituximab or a rituximab-containing regimen
  • Indolent lymphoma including grades 1-3a follicular, small lymphocytic, lymphoplasmacytic, and marginal zone lymphoma; stages III-IV, or bulky disease stage II (i.e. as any single mass > 5 cm in any direction)
  • ECOG Performance Status of 0, 1, or 2
  • Life expectancy of at least 6 months
  • 18 years or older
  • Signed, written informed consent

Exclusion Criteria:

  • Grade 3b follicular lymphoma or evidence that the indolent lymphoma has transformed to aggressive lymphoma
  • Previous allogeneic stem cell transplant
  • Previous autologous stem cell transplant, fludarabine therapy, or radioimmunotherapy in the past 12 months
  • Previous external beam radiation therapy to the pelvis. Previous external beam radiation therapy for bony disease to the cranium, mediastinum, and axilla, or to two or to more than 3 vertebral bodies
  • High dose steroids greater to or equal to 60 mg prednisone/day (or equivalent) within 3 months of randomization. No more than 10 mg prednisone (or equivalent) daily at the time of randomization
  • Prior bendamustine treatment within 1 year of randomization not resulting in a CR or PR for at least 6 months
  • Treatment with anti-CD20 monoclonal antibody within 3 months of randomization
  • Known CNS involvement of indolent lymphoma
  • Other past or current malignancy. Subjects free of malignancy for at least 5 years or have history of definitively treated non-melanoma skin cancer, or successfully treated in situ carcinoma, are eligible
  • Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment
  • Clinically significant cardiac disease
  • History of significant cerebrovascular disease or event with significant symptoms
  • Positive serology for Hepatitis B
  • Current active liver or biliary disease (except Gibler's syndrome or asymptomatic gallstones, liver metastases, or otherwise stable chronic liver disease)
  • Known HIV positive
  • Abnormal/inadequate blood values, liver and kidney function
  • Current participation in other clinical study
  • Inability to comply with the protocol activities
  • Lactating or pregnant women or female patients of child-bearing potential (or male patients with such partners) not willing to use adequate contraception
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01077518

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

  Hide Study Locations
Locations
United States, Arizona
Novartis Investigative Site Recruiting
Tucson, Arizona, United States, 85715
United States, California
Novartis Investigative Site Completed
Beverly Hills, California, United States, 90211
Novartis Investigative Site Completed
Palm Springs, California, United States, 92262
United States, District of Columbia
Novartis Investigative Site Completed
Washington, District of Columbia, United States, 20037
United States, Florida
Novartis Investigative Site Withdrawn
Tampa, Florida, United States, 33612
United States, Georgia
Novartis Investigative Site Recruiting
Atlanta, Georgia, United States, 30341
United States, Idaho
Novartis Investigative Site Recruiting
Coeur d'Alene, Idaho, United States, 83814
United States, Maryland
Novartis Investigative Site Withdrawn
Clinton, Maryland, United States, 20735
Novartis Investigative Site Completed
Silver Spring, Maryland, United States, 21044
United States, Michigan
Novartis Investigative Site Completed
Detroit, Michigan, United States, 48202
United States, Minnesota
Novartis Investigative Site Withdrawn
Minneapo;is, Minnesota, United States, 55455
United States, Missouri
Novartis Investigative Site Completed
St. Louis, Missouri, United States, 63141
United States, New York
Novartis Investigative Site Completed
Mineola, New York, United States, 11501
Novartis Investigative Site Completed
Rochester, New York, United States, 14642
United States, North Carolina
Novartis Investigative Site Withdrawn
Chapel Hill, North Carolina, United States, 27599-7305
United States, Pennsylvania
Novartis Investigative Site Recruiting
Danville, Pennsylvania, United States, 17822
Novartis Investigative Site Completed
Philadelphia, Pennsylvania, United States, 19106
United States, South Carolina
Novartis Investigative Site Completed
Charleston, South Carolina, United States, 29425
United States, Tennessee
Novartis Investigative Site Recruiting
Nashville, Tennessee, United States, 37203
United States, Virginia
Novartis Investigative Site Withdrawn
Charlottesville, Virginia, United States, 22908
Novartis Investigative Site Completed
Richmond, Virginia, United States, 23230
United States, Washington
Novartis Investigative Site Completed
Seattle, Washington, United States, 98108
United States, West Virginia
Novartis Investigative Site Recruiting
Morgantown, West Virginia, United States, 26506
Argentina
Novartis Investigative Site Recruiting
Capital Federal, Buenos Aires, Argentina, C1417DTN
Novartis Investigative Site Recruiting
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1431FWO
Novartis Investigative Site Recruiting
Derqui, Pilar, Buenos Aires, Argentina, B1629AHJ
Novartis Investigative Site Recruiting
La Plata, Buenos Aires, Argentina, B1900AXI
Novartis Investigative Site Recruiting
Ciudad Autonoma de Buenos Aires, Argentina, C1437JCP
Austria
Novartis Investigative Site Completed
Graz, Austria, 8036
Novartis Investigative Site Recruiting
Innsbruck, Austria, 6020
Novartis Investigative Site Recruiting
Leoben, Austria, 8700
Novartis Investigative Site Recruiting
Linz, Austria, 4020
Novartis Investigative Site Completed
Salzburg, Austria, A-5020
Novartis Investigative Site Recruiting
Steyr, Austria, 4400
Novartis Investigative Site Recruiting
Wien, Austria, 1090
Belgium
Novartis Investigative Site Recruiting
Brugge, Belgium, 8000
Novartis Investigative Site Completed
Brussels, Belgium, 1090
Novartis Investigative Site Recruiting
Bruxelles, Belgium, 1000
Novartis Investigative Site Recruiting
Gent, Belgium, 9000
Novartis Investigative Site Recruiting
Leuven, Belgium, 3000
Brazil
Novartis Investigative Site Active, not recruiting
Jau, São Paulo, Brazil, 17210-080
Novartis Investigative Site Active, not recruiting
Sao Paulo, São Paulo, Brazil, 04039-901
Novartis Investigative Site Active, not recruiting
Brasila/DF, Brazil, 70.390-055
Novartis Investigative Site Active, not recruiting
Rio de Janeiro, Brazil, 20230 -130
Novartis Investigative Site Active, not recruiting
São Paulo - SP, Brazil, 01323-900
Novartis Investigative Site Withdrawn
São Paulo, Brazil, 01221-020
Canada, Alberta
Novartis Investigative Site Recruiting
Calgary, Alberta, Canada, T2N 4N2
Canada, British Columbia
Novartis Investigative Site Withdrawn
Kelowna, British Columbia, Canada, V1W 5L3
Canada, Nova Scotia
Novartis Investigative Site Recruiting
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Novartis Investigative Site Recruiting
Barrie, Ontario, Canada, L4M 6M2
Novartis Investigative Site Recruiting
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Novartis Investigative Site Withdrawn
Sherbrooke, Quebec, Canada, J1H 5N4
Canada, Saskatchewan
Novartis Investigative Site Withdrawn
Saskatoon, Saskatchewan, Canada, S7N 4H4
Novartis Investigative Site Recruiting
Saskatoon, Saskatchewan, Canada, S7N 4H4
France
Novartis Investigative Site Completed
Avignon cedex 9, France, 84902
Novartis Investigative Site Recruiting
Clermont-Ferrand Cedex 1, France, 63003
Novartis Investigative Site Completed
Grenoble cedex 9, France, 38043
Novartis Investigative Site Recruiting
La Roche sur Yon Cedex 9, France, 85925
Novartis Investigative Site Recruiting
Le Mans, France, 72015
Novartis Investigative Site Recruiting
Marseille Cedex 9, France, 13273
Novartis Investigative Site Completed
Nantes cedex 1, France, 44093
Novartis Investigative Site Completed
Nantes cedex, France, 44202
Novartis Investigative Site Recruiting
Pessac cedex, France, 33604
Novartis Investigative Site Recruiting
Saint Pierre cedex, France, 97448
Novartis Investigative Site Recruiting
Saint-Denis cedex, France, 97405
Novartis Investigative Site Completed
Tours cedex 9, France, 37044
Germany
Novartis Investigative Site Completed
Mannheim, Baden-Wuerttemberg, Germany, 68167
Novartis Investigative Site Recruiting
Aschaffenburg, Bayern, Germany, 63739
Novartis Investigative Site Completed
Fuerth, Bayern, Germany, 90766
Novartis Investigative Site Completed
Muenchen, Bayern, Germany, 80335
Novartis Investigative Site Completed
Muenchen, Bayern, Germany, 81241
Novartis Investigative Site Completed
Weilheim, Bayern, Germany, 82362
Novartis Investigative Site Completed
Frankfurt, Hessen, Germany, 60488
Novartis Investigative Site Recruiting
Giessen, Hessen, Germany, 35392
Novartis Investigative Site Completed
Hanau, Hessen, Germany, 63450
Novartis Investigative Site Completed
Kassel, Hessen, Germany, 34119
Novartis Investigative Site Completed
Marburg, Hessen, Germany, 35037
Novartis Investigative Site Completed
Bielefeld, Nordrhein-Westfalen, Germany, 33604
Novartis Investigative Site Completed
Bottrop, Nordrhein-Westfalen, Germany, 46236
Novartis Investigative Site Completed
Essen, Nordrhein-Westfalen, Germany, 45122
Novartis Investigative Site Recruiting
Goch, Nordrhein-Westfalen, Germany, 47574
Novartis Investigative Site Completed
Herford, Nordrhein-Westfalen, Germany, 32049
Novartis Investigative Site Completed
Leverkusen, Nordrhein-Westfalen, Germany, 51375
Novartis Investigative Site Completed
Paderborn, Nordrhein-Westfalen, Germany, 33098
Novartis Investigative Site Completed
Recklinghausen, Nordrhein-Westfalen, Germany, 45657
Novartis Investigative Site Completed
Kaiserslautern, Rheinland-Pfalz, Germany, 67655
Novartis Investigative Site Completed
Koblenz, Rheinland-Pfalz, Germany, 56068
Novartis Investigative Site Completed
Neunkirchen, Saarland, Germany, 66538
Novartis Investigative Site Completed
Berlin, Germany, 12200
Novartis Investigative Site Completed
Bremen, Germany, 28239
Greece
Novartis Investigative Site Recruiting
Alexandroupolis, Greece, 68100
Novartis Investigative Site Recruiting
Athens,, Greece, 11 527
Novartis Investigative Site Recruiting
Athens, Greece, 106 76
Novartis Investigative Site Recruiting
Haidari, Athens, Greece, 12462
Novartis Investigative Site Recruiting
Heraklion, Crete, Greece, 71201
Novartis Investigative Site Recruiting
Ioannina, Greece, 45 500
Novartis Investigative Site Recruiting
Piraeus, Greece, 18537
Hong Kong
Novartis Investigative Site Withdrawn
Kowloon, Hong Kong
Novartis Investigative Site Recruiting
Shatin, New Territories, Hong Kong
Novartis Investigative Site Recruiting
Tuen Mun, Hong Kong
Italy
Novartis Investigative Site Recruiting
Reggio Calabria, Calabria, Italy, 89100
Novartis Investigative Site Recruiting
Napoli, Campania, Italy, 80131
Novartis Investigative Site Recruiting
Meldola (FC), Emilia-Romagna, Italy, 47014
Novartis Investigative Site Recruiting
Ravenna, Emilia-Romagna, Italy
Novartis Investigative Site Recruiting
Rimini, Emilia-Romagna, Italy, 47900
Novartis Investigative Site Recruiting
Roma, Lazio, Italy, 00168
Novartis Investigative Site Recruiting
Genova, Liguria, Italy, 16132
Novartis Investigative Site Recruiting
Milano, Lombardia, Italy, 20133
Novartis Investigative Site Recruiting
Milano, Lombardia, Italy, 20162
Novartis Investigative Site Recruiting
Novara, Piemonte, Italy, 28100
Novartis Investigative Site Recruiting
San Giovanni Rotondo, Puglia, Italy, 71013
Novartis Investigative Site Recruiting
Terni, Umbria, Italy, 05100
Novartis Investigative Site Recruiting
Verona, Veneto, Italy, 37134
Japan
Novartis Investigative Site Recruiting
Aichi, Japan, 466-8650
Novartis Investigative Site Recruiting
Fukuoka, Japan, 810-8563
Novartis Investigative Site Recruiting
Hiroshima, Japan, 737-0023
Novartis Investigative Site Recruiting
Hyogo, Japan, 670-8520
Novartis Investigative Site Recruiting
Ibaraki, Japan, 305-8576
Novartis Investigative Site Recruiting
Kanagawa, Japan, 259-1143
Novartis Investigative Site Recruiting
Miyagi, Japan, 980-8574
Novartis Investigative Site Completed
Okayama, Japan, 710-8602
Novartis Investigative Site Recruiting
Osaka, Japan, 545-8586
Novartis Investigative Site Recruiting
Tokyo, Japan, 104-0045
Novartis Investigative Site Recruiting
Tokyo, Japan, 135-8550
Poland
Novartis Investigative Site Completed
Gdansk, Poland, 80-952
Novartis Investigative Site Recruiting
Gdynia, Poland
Novartis Investigative Site Recruiting
Legnica, Poland, 59-200
Novartis Investigative Site Recruiting
Opole, Poland, 45-061
Novartis Investigative Site Recruiting
Warszawa, Poland, 02-097
Novartis Investigative Site Completed
Warszawa, Poland, 02-507
Novartis Investigative Site Completed
Warszawa, Poland, 02-776
Novartis Investigative Site Completed
Warszawa, Poland
Novartis Investigative Site Recruiting
Wroclaw, Poland, 50-367
Novartis Investigative Site Completed
Wroclaw, Poland, 53-439
Puerto Rico
Novartis Investigative Site Completed
Hato Rey, Puerto Rico, 00919
Novartis Investigative Site Completed
San Juan, Puerto Rico, 00927
Russian Federation
Novartis Investigative Site Completed
Chelyabinsk, Russian Federation, 454087
Novartis Investigative Site Withdrawn
Cherepovez, Russian Federation, 162602
Novartis Investigative Site Withdrawn
Eketerinburg, Russian Federation, 620905
Novartis Investigative Site Completed
Kaluga, Russian Federation, 248007
Novartis Investigative Site Completed
Kazan, Russian Federation, 420029
Novartis Investigative Site Completed
Moscow, Russian Federation, 115478
Novartis Investigative Site Withdrawn
Moscow, Russian Federation, 129301
Novartis Investigative Site Completed
Nizhniy Novgorod, Russian Federation, 603126
Novartis Investigative Site Recruiting
Novosibirsk, Russian Federation, 630087
Novartis Investigative Site Recruiting
Penza, Russian Federation, 440071
Novartis Investigative Site Recruiting
St'Petersburg, Russian Federation, 197341
Novartis Investigative Site Completed
St. Petersburg, Russian Federation, 197758
Novartis Investigative Site Recruiting
Tula, Russian Federation, 300053
Novartis Investigative Site Recruiting
Ufa,, Russian Federation, 450054
Novartis Investigative Site Recruiting
Volgograd, Russian Federation, 400138
Slovakia
Novartis Investigative Site Recruiting
Bratislava, Slovakia, 833 10
Ukraine
Novartis Investigative Site Recruiting
Kyiv, Ukraine, 03022
Novartis Investigative Site Recruiting
Lviv, Ukraine, 79044
Novartis Investigative Site Completed
Makiivka, Ukraine, 86132
United Kingdom
Novartis Investigative Site Recruiting
Plymouth, Devon, United Kingdom, PL68DH
Novartis Investigative Site Recruiting
Northwood, Middlesex, United Kingdom, HA6 2RN
Novartis Investigative Site Withdrawn
Bradford, United Kingdom, BD9 6RJ
Novartis Investigative Site Withdrawn
Cheltenham, United Kingdom, GL53 7AN
Novartis Investigative Site Withdrawn
Cornwall, United Kingdom, TR1 3LJ
Novartis Investigative Site Withdrawn
Cottingham, United Kingdom, HU16 5JQ
Novartis Investigative Site Recruiting
Harrow, United Kingdom, HA1 3UJ
Novartis Investigative Site Withdrawn
Liverpool, United Kingdom, L7 8XP
Novartis Investigative Site Withdrawn
London, United Kingdom, NW1 2PQ
Novartis Investigative Site Withdrawn
Maidstone, United Kingdom, ME16 9QQ
Novartis Investigative Site Withdrawn
Manchester, United Kingdom, M20 4BX
Novartis Investigative Site Recruiting
Southampton, United Kingdom, SO16 6YD
Novartis Investigative Site Recruiting
Uxbridge, United Kingdom, UB8 3NN
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01077518     History of Changes
Other Study ID Numbers: 110918
Study First Received: February 25, 2010
Last Updated: August 7, 2016

Keywords provided by Novartis:
Refractory
Safety
Efficacy
Rituximab refractory
Oncology

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Bendamustine Hydrochloride
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on March 29, 2017