Study Stopped
The study was terminated early as it did not meet the Primary efficacy objective after primary analysis.
Ofatumumab Bendamustine Combination Compared With Bendamustine Monotherapy in Indolent B-cell NHL Unresponsive to Rituxtherapy
A+B
Randomized Open Label of Ofatumumab and Bendamustine Combination 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
3 other identifiers
interventional
346
17 countries
140
Brief Summary
The purpose of this study was 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2010
Longer than P75 for phase_3
140 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2010
CompletedFirst Posted
Study publicly available on registry
March 1, 2010
CompletedStudy Start
First participant enrolled
August 26, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 3, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 26, 2018
CompletedResults Posted
Study results publicly available
March 27, 2020
CompletedMarch 27, 2020
March 1, 2020
7.4 years
February 25, 2010
December 24, 2019
March 25, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free Survival (PFS) as Assessed by the Independent Review Committee (IRC)
PFS is defined as the time interval between randomization until disease progression or death (due to any cause).
From randomization to the date of first documented disease progression or death due to any cause (67.5 months)
Secondary Outcomes (27)
Progression-free Survival (PFS) in Participants With Follicular Lymphoma (FL) Per IRC
From randomization to the date of first documented disease progression or death due to any cause (67.5 months)
Overall Response Rate (ORR) in All Participants Per IRC
From randomization until the 217th PFS event occurred, up to about 67.5 months
Overall Response Rate (ORR) in Participants With FL Per IRC
From randomization until the 217th PFS event occurred, up to about 67.5 months
Overall Survival (OS) in All Participants
From randomization up to about 89 months
Overall Survival (OS) in Participants With FL
From randomization up to about 89 months
- +22 more secondary outcomes
Study Arms (2)
Ofatumumab and Bendamustine (Arm A)
EXPERIMENTALUp 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)
Bendamustine (Arm B)
ACTIVE COMPARATORUp to 8 cycles of bendamustine (120 mg/m2) on Days 1,2 every 21 days
Interventions
Ofatumumab was a liquid concentrate solution for infusion presented in glass vials containing 50 mL of solution at a concentration of 20 mg/mL to provide 1000 mg per vial. The ofatumumab infusions were prepared in 1000 mL sterile, pyrogen-free 0.9% NaCl to yield a 1 mg/mL ofatumumab concentration infusion.
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.
Bendamustine (120 mg/m2 Days 1 and 2, every 21 days, up to 8 cycles).
Eligibility Criteria
You may qualify if:
- 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
- years or older
- Signed, written informed consent
You may not qualify if:
- 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 Gibber's syndrome or asymptomatic gallstones, liver metastases, or otherwise stable chronic liver disease)
- Known HIV positive
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (140)
Novartis Investigative Site
Tucson, Arizona, 85715, United States
Novartis Investigative Site
Beverly Hills, California, 90211, United States
Novartis Investigative Site
Palm Springs, California, 92262, United States
Novartis Investigative Site
Washington D.C., District of Columbia, 20037, United States
Novartis Investigative Site
Atlanta, Georgia, 30341, United States
Novartis Investigative Site
Coeur d'Alene, Idaho, 83814, United States
Novartis Investigative Site
Silver Spring, Maryland, 21044, United States
Novartis Investigative Site
Detroit, Michigan, 48202, United States
Novartis Investigative Site
St Louis, Missouri, 63141, United States
Novartis Investigative Site
Mineola, New York, 11501, United States
Novartis Investigative Site
Rochester, New York, 14642, United States
Novartis Investigative Site
Danville, Pennsylvania, 17822, United States
Novartis Investigative Site
Philadelphia, Pennsylvania, 19106, United States
Novartis Investigative Site
Charleston, South Carolina, 29425, United States
Novartis Investigative Site
Nashville, Tennessee, 37203, United States
Novartis Investigative Site
Richmond, Virginia, 23230, United States
Novartis Investigative Site
Seattle, Washington, 98108, United States
Novartis Investigative Site
Morgantown, West Virginia, 26506, United States
Novartis Investigative Site
Capital Federal, Buenos Aires, C1417DTN, Argentina
Novartis Investigative Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1431FWO, Argentina
Novartis Investigative Site
Derqui, Pilar, Buenos Aires, B1629AHJ, Argentina
Novartis Investigative Site
La Plata, Buenos Aires, B1900AXI, Argentina
Novartis Investigative Site
Buenos Aires, C1437JCP, Argentina
Novartis Investigative Site
Graz, 8036, Austria
Novartis Investigative Site
Innsbruck, 6020, Austria
Novartis Investigative Site
Leoben, 8700, Austria
Novartis Investigative Site
Linz, 4020, Austria
Novartis Investigative Site
Salzburg, A-5020, Austria
Novartis Investigative Site
Steyr, 4400, Austria
Novartis Investigative Site
Vienna, 1090, Austria
Novartis Investigative Site
Bruges, 8000, Belgium
Novartis Investigative Site
Brussels, 1000, Belgium
Novartis Investigative Site
Brussels, 1090, Belgium
Novartis Investigative Site
Ghent, 9000, Belgium
Novartis Investigative Site
Leuven, 3000, Belgium
Novartis Investigative Site
Calgary, Alberta, T2N 4N2, Canada
Novartis Investigative Site
Halifax, Nova Scotia, B3H 2Y9, Canada
Novartis Investigative Site
Barrie, Ontario, L4M 6M2, Canada
Novartis Investigative Site
Toronto, Ontario, M4N 3M5, Canada
Novartis Investigative Site
Saskatoon, Saskatchewan, S7N 4H4, Canada
Novartis Investigative Site
Avignon, 84902, France
Novartis Investigative Site
Clermont-Ferrand, 63003, France
Novartis Investigative Site
Grenoble, 38043, France
Novartis Investigative Site
La Roche-sur-Yon, 85925, France
Novartis Investigative Site
Le Mans, 72015, France
Novartis Investigative Site
Marseille, 13273, France
Novartis Investigative Site
Nantes, 44093, France
Novartis Investigative Site
Nantes, 44277, France
Novartis Investigative Site
Pessac, 33604, France
Novartis Investigative Site
Saint-Denis, 97405, France
Novartis Investigative Site
Saint-Pierre, 97448, France
Novartis Investigative Site
Tours, 37044, France
Novartis Investigative Site
Mannheim, Baden-Wurttemberg, 68167, Germany
Novartis Investigative Site
Aschaffenburg, Bavaria, 63739, Germany
Novartis Investigative Site
Fürth, Bavaria, 90766, Germany
Novartis Investigative Site
Munich, Bavaria, 80335, Germany
Novartis Investigative Site
Munich, Bavaria, 81241, Germany
Novartis Investigative Site
Weilheim, Bavaria, 82362, Germany
Novartis Investigative Site
Frankfurt am Main, Hesse, 60488, Germany
Novartis Investigative Site
Giessen, Hesse, 35392, Germany
Novartis Investigative Site
Hanau, Hesse, 63450, Germany
Novartis Investigative Site
Kassel, Hesse, 34119, Germany
Novartis Investigative Site
Marburg, Hesse, 35037, Germany
Novartis Investigative Site
Bielefeld, North Rhine-Westphalia, 33604, Germany
Novartis Investigative Site
Bottrop, North Rhine-Westphalia, 46236, Germany
Novartis Investigative Site
Essen, North Rhine-Westphalia, 45122, Germany
Novartis Investigative Site
Goch, North Rhine-Westphalia, 47574, Germany
Novartis Investigative Site
Herford, North Rhine-Westphalia, 32049, Germany
Novartis Investigative Site
Leverkusen, North Rhine-Westphalia, 51375, Germany
Novartis Investigative Site
Paderborn, North Rhine-Westphalia, 33098, Germany
Novartis Investigative Site
Recklinghausen, North Rhine-Westphalia, 45657, Germany
Novartis Investigative Site
Kaiserslautern, Rhineland-Palatinate, 67655, Germany
Novartis Investigative Site
Koblenz, Rhineland-Palatinate, 56068, Germany
Novartis Investigative Site
Neunkirchen, Saarland, 66538, Germany
Novartis Investigative Site
Berlin, 12200, Germany
Novartis Investigative Site
Bremen, 28239, Germany
Novartis Investigative Site
Alexandroupoli, 68100, Greece
Novartis Investigative Site
Athens, 106 76, Greece
Novartis Investigative Site
Athens, 11 527, Greece
Novartis Investigative Site
Haidari, Athens, 12462, Greece
Novartis Investigative Site
Heraklion, Crete, 71201, Greece
Novartis Investigative Site
Ioannina, 45 500, Greece
Novartis Investigative Site
Piraeus, 18537, Greece
Novartis Investigative Site
Shatin, New Territories, Hong Kong
Novartis Investigative Site
Tuenmen, Hong Kong
Novartis Investigative Site
San Giovanni Rotondo, Apulia, 71013, Italy
Novartis Investigative Site
Reggio Calabria, Calabria, 89100, Italy
Novartis Investigative Site
Napoli, Campania, 80131, Italy
Novartis Investigative Site
Meldola (FC), Emilia-Romagna, 47014, Italy
Novartis Investigative Site
Rome, Lazio, 00168, Italy
Novartis Investigative Site
Genoa, Liguria, 16132, Italy
Novartis Investigative Site
Milan, Lombardy, 20133, Italy
Novartis Investigative Site
Milan, Lombardy, 20162, Italy
Novartis Investigative Site
Novara, Piedmont, 28100, Italy
Novartis Investigative Site
Terni, Umbria, 05100, Italy
Novartis Investigative Site
Verona, Veneto, 37134, Italy
Novartis Investigative Site
Aichi, 466-8650, Japan
Novartis Investigative Site
Fukuoka, 810-8563, Japan
Novartis Investigative Site
Hiroshima, 737-0023, Japan
Novartis Investigative Site
Hyōgo, 670-8520, Japan
Novartis Investigative Site
Ibaraki, 305-8576, Japan
Novartis Investigative Site
Kanagawa, 259-1143, Japan
Novartis Investigative Site
Miyagi, 980-8574, Japan
Novartis Investigative Site
Okayama, 710-8602, Japan
Novartis Investigative Site
Osaka, 545-8586, Japan
Novartis Investigative Site
Tokyo, 104-0045, Japan
Novartis Investigative Site
Tokyo, 135-8550, Japan
Novartis Investigative Site
Gdansk, 80-952, Poland
Novartis Investigative Site
Gdynia, Poland
Novartis Investigative Site
Legnica, 59-200, Poland
Novartis Investigative Site
Opole, 45-061, Poland
Novartis Investigative Site
Warsaw, 02-097, Poland
Novartis Investigative Site
Warsaw, 02-507, Poland
Novartis Investigative Site
Warsaw, 02-776, Poland
Novartis Investigative Site
Warsaw, Poland
Novartis Investigative Site
Wroclaw, 50-367, Poland
Novartis Investigative Site
Wroclaw, 53-439, Poland
Novartis Investigative Site
Hato Rey, 00919, Puerto Rico
Novartis Investigative Site
San Juan, 00927, Puerto Rico
Novartis Investigative Site
Chelyabinsk, 454087, Russia
Novartis Investigative Site
Kaluga, 248007, Russia
Novartis Investigative Site
Kazan', 420029, Russia
Novartis Investigative Site
Moscow, 115478, Russia
Novartis Investigative Site
Nizhny Novgorod, 603126, Russia
Novartis Investigative Site
Novosibirsk, 630087, Russia
Novartis Investigative Site
Penza, 440071, Russia
Novartis Investigative Site
Saint Petersburg, 197758, Russia
Novartis Investigative Site
St'Petersburg, 197341, Russia
Novartis Investigative Site
Tula, 300053, Russia
Novartis Investigative Site
Ufa, 450054, Russia
Novartis Investigative Site
Volgograd, 400138, Russia
Novartis Investigative Site
Bratislava, 833 10, Slovakia
Novartis Investigative Site
Kyiv, 03022, Ukraine
Novartis Investigative Site
Lviv, 79044, Ukraine
Novartis Investigative Site
Makiivka, 86132, Ukraine
Novartis Investigative Site
Plymouth, Devon, PL68DH, United Kingdom
Novartis Investigative Site
Northwood, Middlesex, HA6 2RN, United Kingdom
Novartis Investigative Site
Harrow, HA1 3UJ, United Kingdom
Novartis Investigative Site
Southampton, SO16 6YD, United Kingdom
Novartis Investigative Site
Uxbridge, UB8 3NN, United Kingdom
Related Publications (1)
Rummel MJ, Janssens A, MacDonald D, Keating MM, Zaucha JM, Davis J, Lasher J, Babanrao Pisal C, Izquierdo M, Friedberg JW. A phase 3, randomized study of ofatumumab combined with bendamustine in rituximab-refractory iNHL (COMPLEMENT A + B study). Br J Haematol. 2021 Jun;193(6):1123-1133. doi: 10.1111/bjh.17420. Epub 2021 May 10.
PMID: 33973233DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
As the primary endpoint of the study was not met, secondary efficacy endpoints were not fully tested. The data being reported is for information only and not intended to be inferential.
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2010
First Posted
March 1, 2010
Study Start
August 26, 2010
Primary Completion
January 3, 2018
Study Completion
December 26, 2018
Last Updated
March 27, 2020
Results First Posted
March 27, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com