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Assess the combination of efficacy of the combination of rituximab, bendamustine, mitoxantrone, dexamethasone in the treatment of patients with Follicular Lymphoma.
Assess the combination of efficacy and safety of the combination of rituximab, bendamustine, mitoxantrone, dexamethasone in the treatment of patients with Follicular Lymphoma who are refractory or in relapse.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R-BMD | Experimental | Rituximab, Bendamustine, Mitoxantrone, Dexamethasone Induction: 6 Rituximab, Bendamustine, Mitoxantrone, Dexamethasone cycles Maintenance: Rituximab every 3 months for 2 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab, Bendamustine, Mitoxantrone, Dexamethasone | Drug | Bendamustine: 90 mg/m2/day, days 1 and 2 of each cycle, iv Mitoxantrone: 6 mg/m2/day, day 1 of each cycle, iv Dexamethasone 20 mg / day, days 1 through 5 of each cycle, od Rituximab: 375 mg / m 2 / day, day 1 of each cycle, iv |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate | The primary endpoint is the number of Participants with Response according to the criteria of the International Workshop to Standardize Response Criteria for NHL Complete Remission (CR): Nodes returned to normal (if GTD >15 mm before therapy, GTD now ā¤15 mm; if GTD 11-15 and SA >10 mm before therapy, SA now ā¤10 mm) All (non-nodal) target lesions completely resolved Partial Remission (PR) SPD of target lesions decreased ā„50% from baseline Spleen and liver nodules regress by 50% in SPD or single lesion in GTD Stable Disease (SD) Not enough shrinkage for PR Not enough growth for PD Progressive Disease (PD): SPD increase ā„50% from nadir (smallest value seen during trial) in nodal target lesions overall or in any single nodal target lesion | 7 years |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Endpoints Included an Assessment of the Following Parameters: Progression-Free Survival, Disease-Free Survival, Global Survival, Duration of the Response. | 7 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francisco Javier PeƱalver PĆ”rraga, MD | Hospital Universitario FundaciĆ³n AlcorcĆ³n | Principal Investigator |
| Javier De la Serna Torroba, MD | Hospital 12 de Octubre | Principal Investigator |
| Francisca OƱa Compan, MD | Hospital de Getafe. | Principal Investigator |
| Patricia Font LĆ³pez, MD | Gregorio MaraĆ±Ć³n Hospital | Principal Investigator |
| Secundino Ferrer Bordas, MD | Hospital Dr. Peset | Principal Investigator |
| JosĆ© RamĆ³n Mayans Ferrer, MD | Hospital Arnau de Vilanova | Principal Investigator |
| Eulogio Conde GarcĆa, MD | Hospital MarquĆ©s de Valdecilla | Principal Investigator |
| JosƩ Antonio MƔrquez Navarro, MD | Hospital de Basurto | Principal Investigator |
| Ernesto PĆ©rez Persona, MD | Hospital Txagorritxu | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complejo Hospitalario Universitario de Santiago | Santiago | A CoruƱa | 15706 | Spain | ||
| Hospital Txagorritxu |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31573746 | Derived | Penalver FJ, Marquez JA, Duran S, Giraldo P, Martin A, Montalban C, Sancho JM, Ramirez MJ, Terol MJ, Capote FJ, Gutierrez A, Sanchez B, Lopez A, Salar A, Rodriguez-Caravaca G, Canales M, Caballero MD; GELTAMO (The Spanish Lymphoma Cooperative Group). Response-adapted treatment with rituximab, bendamustine, mitoxantrone, and dexamethasone followed by rituximab maintenance in patients with relapsed or refractory follicular lymphoma after first-line immunochemotherapy: Results of the RBMDGELTAMO08 phase II trial. Cancer Med. 2019 Nov;8(16):6955-6966. doi: 10.1002/cam4.2555. Epub 2019 Oct 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rituximab, Bendamustine, Mitoxantrone, Dexamethasone | Patient will receive Rituximab, Bendamustina, Mitoxantrone and Dexametasona Rituximab, Bendamustine, Mitoxantrone, Dexamethasone: Bendamustine: 90 mg/m2/day, days 1 and 2 of each cycle, iv Mitoxantrone: 6 mg/m2/day, day 1 of each cycle, iv DEXAMETHASONE 20 mg / day, days 1 through 5 of each cycle, od Rituximab: 375 mg / m 2 / day, day 1 of each cycle, iv |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
|
| Garazi Letamendi Madariaga, MD |
| Hospital de Galdakao |
| Principal Investigator |
| Pilar Giraldo Castellanos, MD | Hospital Miguel Servet | Principal Investigator |
| Luis Palomera Bernal, MD | Hospital ClĆnico de Zaragoza | Principal Investigator |
| AndrĆ©s LĆ³pez HernĆ”ndez, MD | Hospital Vall dĀ“Hebron | Principal Investigator |
| Blanca SƔnchez GonzƔlez, MD | Hospital del Mar | Principal Investigator |
| JosƩ Luis SƔnchez-Majado, MD | Hospital San Juan de Alicante | Principal Investigator |
| Antonio GutiĆ©rrez GarcĆa, MD | Hospital Son Espases | Principal Investigator |
| Francisco Javier Capote Huelva, MD | Hospital Universitario Puerta del Mar | Principal Investigator |
| FĆ”tima de la Cruz, MD | Hospital Virgen del RocĆo | Principal Investigator |
| MĀŖ JosĆ© RamĆrez, MD | Hospital de Jerez | Principal Investigator |
| Fernando Carnicero GonzƔlez, MD | Hospital San Pedro de Alcantara | Principal Investigator |
| MĀŖ JosĆ© RodrĆguez Salazar, MD | Hospital Universitario de Canarias | Principal Investigator |
| Miguel Ćngel Canales Albendea, MD | Hospital La Paz | Principal Investigator |
| JosĆ© Antonio GarcĆa Marco, MD | Hospital Puerta de Hierro | Principal Investigator |
| Carlos MontalbƔn Sanz, MD | Hospital Universitario Ramon y Cajal | Principal Investigator |
| RosalĆa Riaza Grau, MD | Hospital Severo Ochoa | Principal Investigator |
| MĀŖ Dolores Caballero BarrigĆ³n, MD | Hospital de Salamanca | Principal Investigator |
| MĀŖ JesĆŗs PeƱarrubia Ponce, MD | Hospital RĆo Hortega | Principal Investigator |
| JosƩ Antonio QueizƔn, MD | Hospital de Segovia | Principal Investigator |
| Roberto HernĆ”ndez MartĆn, MD | Hospital Virgen de la Concha | Principal Investigator |
| MĀŖ JosĆ© Terol Castera, MD | Hospital ClĆnico de Valencia | Principal Investigator |
| FĆ©lix Carbonell, MD | Hospital General Universitario de Valencia | Principal Investigator |
| MarĆa Rosario Varela GĆ³mez, MD | Complejo Hospitalario A CoruƱa | Principal Investigator |
| JosĆ© Luis Bello LĆ³pez, MD | C. H. U. Santiago | Principal Investigator |
| Carlos Panizo, MD | ClĆnica Universitaria de Navarra | Principal Investigator |
| Juan Manuel Sancho Cia, MD | Germans Trias i Pujol Hospital | Principal Investigator |
| Armando LĆ³pez Guillermo, MD | Hospital ClĆnic i Provincial | Principal Investigator |
| Elena PĆ©rez Ceballos, MD | Hospital Morales Meseguer | Principal Investigator |
| AndrƩs SƔnchez Salinas, MD | Hospital Universitario Virgen de la Arrixaca | Principal Investigator |
| MĀŖ Soledad DurĆ”n Nieto, MD | Hospital de JaĆ©n | Principal Investigator |
| Manuel Espeso de Haro, MD | Hospital Carlos Haya | Principal Investigator |
| Joan Bargay Lleonart, MD | Hospital Son LlĆ tzer | Principal Investigator |
| Vitoria-Gasteiz |
| Alava |
| 01009 |
| Spain |
| Hospital San Juan de Alicante | Sant Joan d'Alacant | Alicante | 03550 | Spain |
| Hospital Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain |
| Hospital de Galdakao | Galdakao | Bilbao | 48960 | Spain |
| Hospital MarquƩs de Valdecilla | Santander | Cantabria | 39008 | Spain |
| Hospital de Jerez | Jerez de la Frontera | CƔdiz | 11407 | Spain |
| Hospital FundaciĆ³n de AlcorcĆ³n | AlcorcĆ³n | Madrid | 289222 | Spain |
| Hospital de Getafe | Getafe | Madrid | 28901 | Spain |
| Hospital Severo Ochoa | LeganƩs | Madrid | 28911 | Spain |
| Hospital Puerta de Hierro | Majadahonda | Madrid | 28222 | Spain |
| Hospital Son LlĆ tzer | Palma de Mallorca | Mallorca | 07010 | Spain |
| Hospital Son Espases | Palma de Mallorca | Mallorca | 07014 | Spain |
| Hospital Universitario Virgen de Arrixaca | El Palmar | Murcia | 30120 | Spain |
| ClĆnica Universitaria de Navarra | Pamplona | Navarre | 31008 | Spain |
| Hospital Universitario de Canarias | San CristĆ³bal de La Laguna | Tenerife | 38320 | Spain |
| Complejo Hospitalario Universitario A CoruƱa | A CoruƱa | 15006 | Spain |
| Hospital del Mar | Barcelona | 08003 | Spain |
| Hospital Vall dĀ“Hebron | Barcelona | 08035 | Spain |
| Hospital Clinic i Provincial | Barcelona | 08036 | Spain |
| Hospital de Basurto | Bilbao | 48013 | Spain |
| Hospital Puerta del Mar | Cadiz | 11009 | Spain |
| Hospital San Pedro AlcƔntara | CƔceres | 10002 | Spain |
| Hospital de JaƩn | JaƩn | 23007 | Spain |
| Hospital Gregorio MaraĆ±Ć³n | Madrid | 28009 | Spain |
| Hospital RamĆ³n y Cajal | Madrid | 28034 | Spain |
| Hospital 12 de Octubre | Madrid | 28041 | Spain |
| Hospital La Paz | Madrid | 28046 | Spain |
| Complejo Hospitalario Carlos Haya | MƔlaga | 29010 | Spain |
| Hospital Morales Meseguer | Murcia | 30008 | Spain |
| Hospital de Salamanca | Salamanca | 37007 | Spain |
| Hospital General de Segovia | Segovia | 42002 | Spain |
| Hospital Virgen del RocĆo | Seville | 41013 | Spain |
| Hospital ClĆnico Universitario de Valencia | Valencia | 46010 | Spain |
| Hospital General de Valencia | Valencia | 46014 | Spain |
| Hospital Arnau de Vilanova | Valencia | 46015 | Spain |
| Hospital Universitario Dr. Peset | Valencia | 46017 | Spain |
| Hospital RĆo Hortega | Valladolid | 47012 | Spain |
| Hospital Virgen de la Concha | Zamora | 49022 | Spain |
| Hospital ClĆnico de Zaragoza | Zaragoza | 50009 | Spain |
| Hospital Miguel Servet | Zaragoza | 50009 | Spain |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rituximab, Bendamustine, Mitoxantrone, Dexamethasone | Patient will receive Rituximab, Bendamustina, Mitoxantrone and Dexametasona Rituximab, Bendamustine, Mitoxantrone, Dexamethasone: Bendamustine: 90 mg/m2/day, days 1 and 2 of each cycle, iv Mitoxantrone: 6 mg/m2/day, day 1 of each cycle, iv DEXAMETHASONE 20 mg / day, days 1 through 5 of each cycle, od Rituximab: 375 mg / m 2 / day, day 1 of each cycle, iv |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Response Rate | The primary endpoint is the number of Participants with Response according to the criteria of the International Workshop to Standardize Response Criteria for NHL Complete Remission (CR): Nodes returned to normal (if GTD >15 mm before therapy, GTD now ā¤15 mm; if GTD 11-15 and SA >10 mm before therapy, SA now ā¤10 mm) All (non-nodal) target lesions completely resolved Partial Remission (PR) SPD of target lesions decreased ā„50% from baseline Spleen and liver nodules regress by 50% in SPD or single lesion in GTD Stable Disease (SD) Not enough shrinkage for PR Not enough growth for PD Progressive Disease (PD): SPD increase ā„50% from nadir (smallest value seen during trial) in nodal target lesions overall or in any single nodal target lesion | Number of Participants analyzed in the Maintenance Rituximab Arm reflects all participants who received at least one dose of Rituximab during maintenance, and had available data for response during that phase | Posted | Count of Participants | Participants | 7 years |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Secondary Endpoints Included an Assessment of the Following Parameters: Progression-Free Survival, Disease-Free Survival, Global Survival, Duration of the Response. | Only those patients who started the maintenance treatmet were analyzed for Disease-Free Survival | Posted | Median | Full Range | months | 7 years |
|
|
9 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rituximab, Bendamustine, Mitoxantrone, Dexamethasone | Patient will receive Rituximab, Bendamustina, Mitoxantrone and Dexametasona Rituximab, Bendamustine, Mitoxantrone, Dexamethasone: Bendamustine: 90 mg/m2/day, days 1 and 2 of each cycle, iv Mitoxantrone: 6 mg/m2/day, day 1 of each cycle, iv DEXAMETHASONE 20 mg / day, days 1 through 5 of each cycle, od Rituximab: 375 mg / m 2 / day, day 1 of each cycle, iv Patients with response will receive Rituximab in maintenance: 375 mg / m2 every three months | 1 | 60 | 22 | 60 | 60 | 60 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations | Non-systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Fever | General disorders | Systematic Assessment |
| ||
| Febrile Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Left ventricular systolic dysfunction | Cardiac disorders | Non-systematic Assessment |
| ||
| Leucoencephalopathy | Nervous system disorders | Non-systematic Assessment |
| ||
| Renal insufficiency | Renal and urinary disorders | Systematic Assessment |
| ||
| Allergic reaction | Immune system disorders | Non-systematic Assessment |
| ||
| Intestinal Obstruction | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Surgery | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Progression suspicion | Investigations | Non-systematic Assessment |
| ||
| Oral ulcer | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Orthostatic hypotension | Vascular disorders | Non-systematic Assessment |
| ||
| Pancytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Tachycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| Arthritis | Immune system disorders | Non-systematic Assessment |
| ||
| Hepatic insufficiency | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Immunodeficiency | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Neuropathy caranial-CN VII | Nervous system disorders | Non-systematic Assessment |
| ||
| Pleural effussion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| plateletes | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| pain | General disorders | Non-systematic Assessment |
| ||
| Infection | Infections and infestations | Non-systematic Assessment |
| ||
| fatigue | General disorders | Non-systematic Assessment |
| ||
| Metabolic/laboratory | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Fever | General disorders | Non-systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Allergic reaction | Immune system disorders | Non-systematic Assessment |
| ||
| mucositis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| constipation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Febrile neutropenia | Infections and infestations | Non-systematic Assessment |
| ||
| cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| cold | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| mood alteration | Psychiatric disorders | Non-systematic Assessment |
| ||
| pruritus/itching | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| other | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| hearing | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| dispnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Francisco Javier PeƱalver | GELTAMO | 91 621 98 24 | fjpenalver@fhalcorcon.es |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D000069461 | Bendamustine Hydrochloride |
| D008942 | Mitoxantrone |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000880 | Anthraquinones |
| D000095322 | Anthrones |
| D000873 | Anthracenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011809 | Quinones |
| D011083 | Polycyclic Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D013259 | Steroids, Fluorinated |
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