BENdamustine at Elevated Dose for Relapsed Follicular Lymphoma in Intensification Therapy and Transplantation (BENEFIT) (BENEFIT)
4. Januar 2019 aktualisiert von: Centre Leon Berard
A Multicenter Phase II Study Evaluating BeEAM (Bendamustine, Etoposide, Cytarabine, Melphalan) Prior to Autologous Stem Cell Transplant for First and Second Chemosensitive Relapses in Patients With Follicular Lymphoma
The purpose of this study is to evaluate the efficacy and safety of BeEAM (bendamustine, etoposide, cytarabine and melphalan) regimen prior to autologous stem cell transplant for first and second chemosensitive relapses in patients with follicular lymphoma (World Health Organisation (WHO) grade 1, 2, 3a).
Studienübersicht
Detaillierte Beschreibung
The natural history of this follicular lymphoma (FL) is marked by multiple relapses.
The prognosis of FL has improved with the use of effective sequential chemotherapy and the introduction of anti-cluster of differentiation antigen 20 (anti-CD20) monoclonal antibody.
Based on the multiple phases II, high dose chemotherapy (HDT) followed by autologous stem cell transplantation (ASCT) appear to be an effective treatment in relapsed FL.
At rituximab era, the 3-years EFS rate was 75% for relapsed transplanted patients treated in first line therapy in FL2000 protocol.
Bendamustine that combines alkylating and antimetabolite activities had proven clinical activity in relapse and in first line therapy of FL.
Carmustine (BCNU), etoposide, cytarabine, and melphalan (BEAM regimen) is one of the most used schedule of HDT in non hodgkin lymphoma.
Regarding the good safety profile of Bendamustine, Visani et al. proposed a phase I/II of bendamustine at day -7 and -6, followed by etoposide, cytarabine and melphalan with similar dose than BEAM regimen.
The bendamustine maximal dose is 200 mg/m² day -7, -6.
Data from engraftment showed closed results than those observed after BEAM.
None of patients experienced a dose limiting toxicity.
In this context, the investigators proposed to perform a multicentric phase II of this regimen with 200 mg/m² day-7 and -6 of bendamustine for first and second relapsed FL with a chemosensitive disease after salvage therapy.
No FL was evaluated in Visani et al. study.
In addition, the investigators can observe a shortage of the BCNU these last years that incline to evaluate new schedule of HDT.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
21
Phase
- Phase 2
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Côte d'Or
-
Dijon, Côte d'Or, Frankreich, 21000
- CHU de Dijon - Hôpital le Bocage
-
-
Haute Normandie
-
Rouen, Haute Normandie, Frankreich, 76038
- Centre Henri Becquerel
-
-
Hérault
-
Montpellier, Hérault, Frankreich, 34295
- CHRU de Montpellier, Hôpital Saint-Eloi
-
-
Ile De France
-
Paris, Ile De France, Frankreich, 75743
- APHP Hôpital Necker
-
-
Ile-de-France
-
Paris, Ile-de-France, Frankreich, 75475
- AP-HP Hôpital Saint-Louis
-
-
Ille Et Vilaine
-
Rennes, Ille Et Vilaine, Frankreich, 35033
- CHU de Rennes - Hopital Pontchaillou
-
-
Isère
-
Grenoble, Isère, Frankreich, 38043
- CHU Grenoble - Hôpital MICHALLON
-
-
Loire Atlantique
-
Nantes, Loire Atlantique, Frankreich, 44093
- CHU de Nantes hotel Dieu
-
-
Meurthe Et Moselle
-
Vandoeuvre Lès Nancy, Meurthe Et Moselle, Frankreich, 54511
- CHU de Nancy
-
-
Nord Pas De Calais
-
Lille, Nord Pas De Calais, Frankreich, 59037
- CHRU de Lille Hopital Claude Huriez
-
-
Rhône
-
Lyon, Rhône, Frankreich, 69473
- Centre Léon Bérard
-
Pierre Bénite, Rhône, Frankreich, 69495
- CHU Lyon Sud
-
-
Val De Marne
-
Créteil, Val De Marne, Frankreich, 94010
- CHU Henri Mondor
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
INCLUSION CRITERIA:
- Histologically confirmed follicular lymphoma relapsed (WHO grade 1, 2, 3a)
- Patients aged from 18 to 65 years
- First or second chemosensitive relapses after salvage therapy (rituximab-chemotherapy) based on 2007 Cheson et al. international response criteria (CR and PR) before the decision of BeEAM (HDT) and ASCT (autologous stem cell transplantation) treatment
- Eligible for ASCT
- Autologous graft with a minimum of a number of cluster of differentiation 34 (CD34+) cells 3.0x106/kg.
- Autologous transplantation will be performed in hematopoietic stem cell transplantation authorized centers.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 to 2
- Minimum life expectancy of 3 months
- Cardiovascular baseline corrected QT interval F ( QTcF) ≤ 450 msec (male) or 470 msec (female)
- Medications that may cause corrected QT interval (QTc) interval prolongation should be avoided by patients entering on trial
Normal organ and marrow function as defined below:
- Absolute neutrophil count ≥ 1.5 G/l
- Platelet count ≥ 100 G/l or > 75 G/l if the bone marrow is involved
- Creatine clearance ≥ 50 ml/min
- Serum Glutamate Oxaloacetate Transaminase (SGOT) and Serum Glutamate Pyruvate Transaminase (SGPT) ≤ 2.5 x Upper Limit of Normal (ULN) or ≤ 5 x ULN if liver metastasis
- Total bilirubin ≤ 1.5 x ULN
- Cardiac ejection fraction greater than 50% by echocardiogram or multiple gated acquisition scan (MUGA scan)
- Negative serum pregnancy test for women of childbearing potential*
- Pregnancy tests will include a negative serum pregnancy test (with a sensitivity of at least 25 mill-International Unit (mIU)/ml)
Women of childbearing potential* and men must agree to use adequate contraception prior to study entry, for the duration of study participation and until 6 months after the end of treatment
- Female patients who meet at least one of the following criteria are defined as women of non-childbearing potential:
- ≥ 50 years old and naturally amenorrheic for ≥ 1 year
- Permanent premature ovarian failure confirmed by a specialist gynecologist
- Previous bilateral oophorectomy
- XY genotype, Turner's syndrome or uterine agenesis
- Female patients who do not meet at least of the above criteria are defined as women of childbearing potential
- Ability to understand and willingness to sign a written informed consent document
- Covered by a medical insurance
- Signed informed consent
EXCLUSION CRITERIA:
- Transformed follicular lymphoma
- Prior autologous or allogeneic transplantation
- Presence of a none chemosensitive disease before HDT according to 2007 Cheson et al. international response criteria (stable or progressive disease)
- Contraindication to any drug contained in the chemotherapy regimens
- Bone marrow infiltration > 25% before HDT+ASCT
- Positive HIV, Hepatitis C Virus (HCV) and Hepatitis B (HBs)Ag serologies
- Current bacterial, viral or fungal infection
- Treatment with any investigational drug within 30 days before enrolment
- Major surgery within 30 days before enrolment
- Participation in another clinical trial within 30 days prior to enrolment in the study and during study
- Any serious active disease or co-morbid medical conditions that would interfere with therapy
- Prior history of malignancies other than lymphoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for ≥ 5 years
- Known or suspected hypersensitivity to any of the agents or excipients of the regime under evaluation
- Concomitant treatment with chemotherapy or immunotherapy or radiotherapy
- Yellow fever vaccination (attenuated virus vaccine )
- Pregnant or lactating female
- Abnormalities in cardiac function or clinically significant heart disease such as acute myocardial infarction or unstable angina within 6 months prior to the start of study treatment, heart failure New York Heart Association (NYHA) class III or IV, uncontrolled hypertension or a history of antihypertensive treatment poor compliance, uncontrolled arrhythmias with treatment, except extrasystoles or minor conduction disorders
- Known involvement of the central nervous system by lymphoma
- History of chronic liver disease
- History of hepatic veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS)
- Excessive alcohol use
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: BeEAM
High Dose Chemotherapy (HDT) containing :
HDT will be followed by an Autologous Stem Cell Transplantation |
High Dose Chemotherapy (HDT) containing :
HDT will be followed by an Autologous Stem Cell Transplantation on D0
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Event Free Survival rate (EFS)
Zeitfenster: Evaluated by the time from inclusion to the time of event appearance with a time of observation of 2 years after inclusion
|
EFS will be measured from the date of inclusion to the date of event defined as : death due to any cause, relapse/progression, or changes in therapies.
Patients with no event at the time of analysis will be censored at the date of the last contact
|
Evaluated by the time from inclusion to the time of event appearance with a time of observation of 2 years after inclusion
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Safety profile of BeEAM
Zeitfenster: Evaluated all along the 4 years study follow up for each patient
|
The safety analyzable population include all patients who received at least one dose of BeEAM regimen
|
Evaluated all along the 4 years study follow up for each patient
|
|
Overall Response Rate (ORR) according to Cheson at al. 2007
Zeitfenster: Evaluated at day 100 after graft
|
ORR is defined by the rate of patients in Complete Response (CR) and in Partial Response (PR) at time of evaluation. ORR is assessed according to Cheson et al. 2007 criteria |
Evaluated at day 100 after graft
|
|
Overall Response Rate (ORR) according to Cheson et al. 1999
Zeitfenster: Evaluated at day 100 after graft
|
ORR is defined by the rate of patients in Complete Response (CR) and in Partial Response (PR) at time of evaluation. ORR assessed according to Cheson et al. 1999 criteria |
Evaluated at day 100 after graft
|
|
Progression Free Survival (PFS)
Zeitfenster: Evaluated by the time from inclusion to the time of progression with a study duration of 5 years maximum
|
PFS will be measured from the date of inclusion to the date of event defined as : progression/relapse or death due to any cause. Patients with no event at the time of analysis will be censored at the date of the last contact. PFS will be assessed among all included patients and in the subgroup of complete responders at the beginning of HDT. |
Evaluated by the time from inclusion to the time of progression with a study duration of 5 years maximum
|
|
Overall Survival (OS)
Zeitfenster: Evaluated by the time from inclusion to the time of death with a study duration of 5 years maximum
|
OS will be measured from the date of inclusion to the date of death due to any cause and will be censored at the date of last contact for the patients alive at last contact
|
Evaluated by the time from inclusion to the time of death with a study duration of 5 years maximum
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Hervé Ghesquières, Dr, Centre Leon Berard, Lyon
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- Visani G, Malerba L, Stefani PM, Capria S, Galieni P, Gaudio F, Specchia G, Meloni G, Gherlinzoni F, Giardini C, Falcioni S, Cuberli F, Gobbi M, Sarina B, Santoro A, Ferrara F, Rocchi M, Ocio EM, Caballero MD, Isidori A. BeEAM (bendamustine, etoposide, cytarabine, melphalan) before autologous stem cell transplantation is safe and effective for resistant/relapsed lymphoma patients. Blood. 2011 Sep 22;118(12):3419-25. doi: 10.1182/blood-2011-04-351924. Epub 2011 Aug 3.
- Cheson BD, Pfistner B, Juweid ME, Gascoyne RD, Specht L, Horning SJ, Coiffier B, Fisher RI, Hagenbeek A, Zucca E, Rosen ST, Stroobants S, Lister TA, Hoppe RT, Dreyling M, Tobinai K, Vose JM, Connors JM, Federico M, Diehl V; International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007 Feb 10;25(5):579-86. doi: 10.1200/JCO.2006.09.2403. Epub 2007 Jan 22.
- A clinical evaluation of the International Lymphoma Study Group classification of non-Hodgkin's lymphoma. The Non-Hodgkin's Lymphoma Classification Project. Blood. 1997 Jun 1;89(11):3909-18.
- Armitage JO, Weisenburger DD. New approach to classifying non-Hodgkin's lymphomas: clinical features of the major histologic subtypes. Non-Hodgkin's Lymphoma Classification Project. J Clin Oncol. 1998 Aug;16(8):2780-95. doi: 10.1200/JCO.1998.16.8.2780.
- Harris NL, Jaffe ES, Diebold J, Flandrin G, Muller-Hermelink HK, Vardiman J, Lister TA, Bloomfield CD. World Health Organization classification of neoplastic diseases of the hematopoietic and lymphoid tissues: report of the Clinical Advisory Committee meeting-Airlie House, Virginia, November 1997. J Clin Oncol. 1999 Dec;17(12):3835-49. doi: 10.1200/JCO.1999.17.12.3835.
- Sabattini E, Bacci F, Sagramoso C, Pileri SA. WHO classification of tumours of haematopoietic and lymphoid tissues in 2008: an overview. Pathologica. 2010 Jun;102(3):83-7. No abstract available.
- Salles GA. Clinical features, prognosis and treatment of follicular lymphoma. Hematology Am Soc Hematol Educ Program. 2007:216-25. doi: 10.1182/asheducation-2007.1.216.
- Ott G, Katzenberger T, Lohr A, Kindelberger S, Rudiger T, Wilhelm M, Kalla J, Rosenwald A, Muller JG, Ott MM, Muller-Hermelink HK. Cytomorphologic, immunohistochemical, and cytogenetic profiles of follicular lymphoma: 2 types of follicular lymphoma grade 3. Blood. 2002 May 15;99(10):3806-12. doi: 10.1182/blood.v99.10.3806.
- Freedman AS. Biology and management of histologic transformation of indolent lymphoma. Hematology Am Soc Hematol Educ Program. 2005:314-20. doi: 10.1182/asheducation-2005.1.314.
- Montoto S, Fitzgibbon J. Transformation of indolent B-cell lymphomas. J Clin Oncol. 2011 May 10;29(14):1827-34. doi: 10.1200/JCO.2010.32.7577. Epub 2011 Apr 11.
- Federico M, Bellei M, Marcheselli L, Luminari S, Lopez-Guillermo A, Vitolo U, Pro B, Pileri S, Pulsoni A, Soubeyran P, Cortelazzo S, Martinelli G, Martelli M, Rigacci L, Arcaini L, Di Raimondo F, Merli F, Sabattini E, McLaughlin P, Solal-Celigny P. Follicular lymphoma international prognostic index 2: a new prognostic index for follicular lymphoma developed by the international follicular lymphoma prognostic factor project. J Clin Oncol. 2009 Sep 20;27(27):4555-62. doi: 10.1200/JCO.2008.21.3991. Epub 2009 Aug 3.
- Solal-Celigny P, Roy P, Colombat P, White J, Armitage JO, Arranz-Saez R, Au WY, Bellei M, Brice P, Caballero D, Coiffier B, Conde-Garcia E, Doyen C, Federico M, Fisher RI, Garcia-Conde JF, Guglielmi C, Hagenbeek A, Haioun C, LeBlanc M, Lister AT, Lopez-Guillermo A, McLaughlin P, Milpied N, Morel P, Mounier N, Proctor SJ, Rohatiner A, Smith P, Soubeyran P, Tilly H, Vitolo U, Zinzani PL, Zucca E, Montserrat E. Follicular lymphoma international prognostic index. Blood. 2004 Sep 1;104(5):1258-65. doi: 10.1182/blood-2003-12-4434. Epub 2004 May 4.
- Carreras J, Lopez-Guillermo A, Fox BC, Colomo L, Martinez A, Roncador G, Montserrat E, Campo E, Banham AH. High numbers of tumor-infiltrating FOXP3-positive regulatory T cells are associated with improved overall survival in follicular lymphoma. Blood. 2006 Nov 1;108(9):2957-64. doi: 10.1182/blood-2006-04-018218. Epub 2006 Jul 6.
- Dave SS, Wright G, Tan B, Rosenwald A, Gascoyne RD, Chan WC, Fisher RI, Braziel RM, Rimsza LM, Grogan TM, Miller TP, LeBlanc M, Greiner TC, Weisenburger DD, Lynch JC, Vose J, Armitage JO, Smeland EB, Kvaloy S, Holte H, Delabie J, Connors JM, Lansdorp PM, Ouyang Q, Lister TA, Davies AJ, Norton AJ, Muller-Hermelink HK, Ott G, Campo E, Montserrat E, Wilson WH, Jaffe ES, Simon R, Yang L, Powell J, Zhao H, Goldschmidt N, Chiorazzi M, Staudt LM. Prediction of survival in follicular lymphoma based on molecular features of tumor-infiltrating immune cells. N Engl J Med. 2004 Nov 18;351(21):2159-69. doi: 10.1056/NEJMoa041869.
- Glas AM, Kersten MJ, Delahaye LJ, Witteveen AT, Kibbelaar RE, Velds A, Wessels LF, Joosten P, Kerkhoven RM, Bernards R, van Krieken JH, Kluin PM, van't Veer LJ, de Jong D. Gene expression profiling in follicular lymphoma to assess clinical aggressiveness and to guide the choice of treatment. Blood. 2005 Jan 1;105(1):301-7. doi: 10.1182/blood-2004-06-2298. Epub 2004 Sep 2.
- Alvaro T, Lejeune M, Salvado MT, Lopez C, Jaen J, Bosch R, Pons LE. Immunohistochemical patterns of reactive microenvironment are associated with clinicobiologic behavior in follicular lymphoma patients. J Clin Oncol. 2006 Dec 1;24(34):5350-7. doi: 10.1200/JCO.2006.06.4766.
- Wahlin BE, Sander B, Christensson B, Kimby E. CD8+ T-cell content in diagnostic lymph nodes measured by flow cytometry is a predictor of survival in follicular lymphoma. Clin Cancer Res. 2007 Jan 15;13(2 Pt 1):388-97. doi: 10.1158/1078-0432.CCR-06-1734.
- Dreyling M, Ghielmini M, Marcus R, Salles G, Vitolo U; ESMO Guidelines Working Group. Newly diagnosed and relapsed follicular lymphoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2011 Sep;22 Suppl 6:vi59-63. doi: 10.1093/annonc/mdr388. No abstract available.
- Sebban C, Mounier N, Brousse N, Belanger C, Brice P, Haioun C, Tilly H, Feugier P, Bouabdallah R, Doyen C, Salles G, Coiffier B. Standard chemotherapy with interferon compared with CHOP followed by high-dose therapy with autologous stem cell transplantation in untreated patients with advanced follicular lymphoma: the GELF-94 randomized study from the Groupe d'Etude des Lymphomes de l'Adulte (GELA). Blood. 2006 Oct 15;108(8):2540-4. doi: 10.1182/blood-2006-03-013193. Epub 2006 Jul 11.
- Fisher RI, LeBlanc M, Press OW, Maloney DG, Unger JM, Miller TP. New treatment options have changed the survival of patients with follicular lymphoma. J Clin Oncol. 2005 Nov 20;23(33):8447-52. doi: 10.1200/JCO.2005.03.1674. Epub 2005 Oct 17.
- Herold M, Haas A, Srock S, Neser S, Al-Ali KH, Neubauer A, Dolken G, Naumann R, Knauf W, Freund M, Rohrberg R, Hoffken K, Franke A, Ittel T, Kettner E, Haak U, Mey U, Klinkenstein C, Assmann M, von Grunhagen U; East German Study Group Hematology and Oncology Study. Rituximab added to first-line mitoxantrone, chlorambucil, and prednisolone chemotherapy followed by interferon maintenance prolongs survival in patients with advanced follicular lymphoma: an East German Study Group Hematology and Oncology Study. J Clin Oncol. 2007 May 20;25(15):1986-92. doi: 10.1200/JCO.2006.06.4618. Epub 2007 Apr 9.
- Hiddemann W, Kneba M, Dreyling M, Schmitz N, Lengfelder E, Schmits R, Reiser M, Metzner B, Harder H, Hegewisch-Becker S, Fischer T, Kropff M, Reis HE, Freund M, Wormann B, Fuchs R, Planker M, Schimke J, Eimermacher H, Trumper L, Aldaoud A, Parwaresch R, Unterhalt M. Frontline therapy with rituximab added to the combination of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) significantly improves the outcome for patients with advanced-stage follicular lymphoma compared with therapy with CHOP alone: results of a prospective randomized study of the German Low-Grade Lymphoma Study Group. Blood. 2005 Dec 1;106(12):3725-32. doi: 10.1182/blood-2005-01-0016. Epub 2005 Aug 25.
- Marcus R, Imrie K, Belch A, Cunningham D, Flores E, Catalano J, Solal-Celigny P, Offner F, Walewski J, Raposo J, Jack A, Smith P. CVP chemotherapy plus rituximab compared with CVP as first-line treatment for advanced follicular lymphoma. Blood. 2005 Feb 15;105(4):1417-23. doi: 10.1182/blood-2004-08-3175. Epub 2004 Oct 19.
- Marcus R, Imrie K, Solal-Celigny P, Catalano JV, Dmoszynska A, Raposo JC, Offner FC, Gomez-Codina J, Belch A, Cunningham D, Wassner-Fritsch E, Stein G. Phase III study of R-CVP compared with cyclophosphamide, vincristine, and prednisone alone in patients with previously untreated advanced follicular lymphoma. J Clin Oncol. 2008 Oct 1;26(28):4579-86. doi: 10.1200/JCO.2007.13.5376. Epub 2008 Jul 28.
- Salles G, Mounier N, de Guibert S, Morschhauser F, Doyen C, Rossi JF, Haioun C, Brice P, Mahe B, Bouabdallah R, Audhuy B, Ferme C, Dartigeas C, Feugier P, Sebban C, Xerri L, Foussard C. Rituximab combined with chemotherapy and interferon in follicular lymphoma patients: results of the GELA-GOELAMS FL2000 study. Blood. 2008 Dec 15;112(13):4824-31. doi: 10.1182/blood-2008-04-153189. Epub 2008 Sep 17.
- Salles G, Seymour JF, Offner F, Lopez-Guillermo A, Belada D, Xerri L, Feugier P, Bouabdallah R, Catalano JV, Brice P, Caballero D, Haioun C, Pedersen LM, Delmer A, Simpson D, Leppa S, Soubeyran P, Hagenbeek A, Casasnovas O, Intragumtornchai T, Ferme C, da Silva MG, Sebban C, Lister A, Estell JA, Milone G, Sonet A, Mendila M, Coiffier B, Tilly H. Rituximab maintenance for 2 years in patients with high tumour burden follicular lymphoma responding to rituximab plus chemotherapy (PRIMA): a phase 3, randomised controlled trial. Lancet. 2011 Jan 1;377(9759):42-51. doi: 10.1016/S0140-6736(10)62175-7. Epub 2010 Dec 20. Erratum In: Lancet. 2011 Apr 2;377(9772):1154.
- Deconinck E, Foussard C, Milpied N, Bertrand P, Michenet P, Cornillet-LeFebvre P, Escoffre-Barbe M, Maisonneuve H, Delwail V, Gressin R, Legouffe E, Vilque JP, Desablens B, Jaubert J, Ramee JF, Jenabian A, Thyss A, Le Pourhiet-Le Mevel A, Travade P, Delepine R, Colombat P; GOELAMS. High-dose therapy followed by autologous purged stem-cell transplantation and doxorubicin-based chemotherapy in patients with advanced follicular lymphoma: a randomized multicenter study by GOELAMS. Blood. 2005 May 15;105(10):3817-23. doi: 10.1182/blood-2004-10-3920. Epub 2005 Feb 1.
- Gyan E, Foussard C, Bertrand P, Michenet P, Le Gouill S, Berthou C, Maisonneuve H, Delwail V, Gressin R, Quittet P, Vilque JP, Desablens B, Jaubert J, Ramee JF, Arakelyan N, Thyss A, Molucon-Chabrot C, Delepine R, Milpied N, Colombat P, Deconinck E; Groupe Ouest-Est des Leucemies et des Autres Maladies du Sang (GOELAMS). High-dose therapy followed by autologous purged stem cell transplantation and doxorubicin-based chemotherapy in patients with advanced follicular lymphoma: a randomized multicenter study by the GOELAMS with final results after a median follow-up of 9 years. Blood. 2009 Jan 29;113(5):995-1001. doi: 10.1182/blood-2008-05-160200. Epub 2008 Oct 27.
- Ladetto M, De Marco F, Benedetti F, Vitolo U, Patti C, Rambaldi A, Pulsoni A, Musso M, Liberati AM, Olivieri A, Gallamini A, Pogliani E, Rota Scalabrini D, Callea V, Di Raimondo F, Pavone V, Tucci A, Cortelazzo S, Levis A, Boccadoro M, Majolino I, Pileri A, Gianni AM, Passera R, Corradini P, Tarella C; Gruppo Italiano Trapianto di Midollo Osseo (GITMO); Intergruppo Italiano Linfomi (IIL). Prospective, multicenter randomized GITMO/IIL trial comparing intensive (R-HDS) versus conventional (CHOP-R) chemoimmunotherapy in high-risk follicular lymphoma at diagnosis: the superior disease control of R-HDS does not translate into an overall survival advantage. Blood. 2008 Apr 15;111(8):4004-13. doi: 10.1182/blood-2007-10-116749. Epub 2008 Jan 31.
- Lenz G, Dreyling M, Schiegnitz E, Forstpointner R, Wandt H, Freund M, Hess G, Truemper L, Diehl V, Kropff M, Kneba M, Schmitz N, Metzner B, Pfirrmann M, Unterhalt M, Hiddemann W; German Low-Grade Lymphoma Study Group. Myeloablative radiochemotherapy followed by autologous stem cell transplantation in first remission prolongs progression-free survival in follicular lymphoma: results of a prospective, randomized trial of the German Low-Grade Lymphoma Study Group. Blood. 2004 Nov 1;104(9):2667-74. doi: 10.1182/blood-2004-03-0982. Epub 2004 Jul 6.
- Morschhauser F, Radford J, Van Hoof A, Vitolo U, Soubeyran P, Tilly H, Huijgens PC, Kolstad A, d'Amore F, Gonzalez Diaz M, Petrini M, Sebban C, Zinzani PL, van Oers MH, van Putten W, Bischof-Delaloye A, Rohatiner A, Salles G, Kuhlmann J, Hagenbeek A. Phase III trial of consolidation therapy with yttrium-90-ibritumomab tiuxetan compared with no additional therapy after first remission in advanced follicular lymphoma. J Clin Oncol. 2008 Nov 10;26(32):5156-64. doi: 10.1200/JCO.2008.17.2015. Epub 2008 Oct 14.
- van Oers MH, Van Glabbeke M, Giurgea L, Klasa R, Marcus RE, Wolf M, Kimby E, van t Veer M, Vranovsky A, Holte H, Hagenbeek A. Rituximab maintenance treatment of relapsed/resistant follicular non-Hodgkin's lymphoma: long-term outcome of the EORTC 20981 phase III randomized intergroup study. J Clin Oncol. 2010 Jun 10;28(17):2853-8. doi: 10.1200/JCO.2009.26.5827. Epub 2010 May 3.
- Freedman AS, Neuberg D, Mauch P, Soiffer RJ, Anderson KC, Fisher DC, Schlossman R, Alyea EP, Takvorian T, Jallow H, Kuhlman C, Ritz J, Nadler LM, Gribben JG. Long-term follow-up of autologous bone marrow transplantation in patients with relapsed follicular lymphoma. Blood. 1999 Nov 15;94(10):3325-33.
- Kornacker M, Stumm J, Pott C, Dietrich S, Sussmilch S, Hensel M, Nickelsen M, Witzens-Harig M, Kneba M, Schmitz N, Ho AD, Dreger P. Characteristics of relapse after autologous stem-cell transplantation for follicular lymphoma: a long-term follow-up. Ann Oncol. 2009 Apr;20(4):722-8. doi: 10.1093/annonc/mdn691. Epub 2009 Jan 29.
- Montoto S, Canals C, Rohatiner AZ, Taghipour G, Sureda A, Schmitz N, Gisselbrecht C, Fouillard L, Milpied N, Haioun C, Slavin S, Conde E, Fruchart C, Ferrant A, Leblond V, Tilly H, Lister TA, Goldstone AH; EBMT Lymphoma Working Party. Long-term follow-up of high-dose treatment with autologous haematopoietic progenitor cell support in 693 patients with follicular lymphoma: an EBMT registry study. Leukemia. 2007 Nov;21(11):2324-31. doi: 10.1038/sj.leu.2404850. Epub 2007 Jul 19.
- Rohatiner AZ, Nadler L, Davies AJ, Apostolidis J, Neuberg D, Matthews J, Gribben JG, Mauch PM, Lister TA, Freedman AS. Myeloablative therapy with autologous bone marrow transplantation for follicular lymphoma at the time of second or subsequent remission: long-term follow-up. J Clin Oncol. 2007 Jun 20;25(18):2554-9. doi: 10.1200/JCO.2006.09.8327. Epub 2007 May 21.
- Vose JM, Bierman PJ, Loberiza FR, Lynch JC, Bociek GR, Weisenburger DD, Armitage JO. Long-term outcomes of autologous stem cell transplantation for follicular non-Hodgkin lymphoma: effect of histological grade and Follicular International Prognostic Index. Biol Blood Marrow Transplant. 2008 Jan;14(1):36-42. doi: 10.1016/j.bbmt.2007.06.016. Epub 2007 Dec 3.
- Schouten HC, Qian W, Kvaloy S, Porcellini A, Hagberg H, Johnsen HE, Doorduijn JK, Sydes MR, Kvalheim G. High-dose therapy improves progression-free survival and survival in relapsed follicular non-Hodgkin's lymphoma: results from the randomized European CUP trial. J Clin Oncol. 2003 Nov 1;21(21):3918-27. doi: 10.1200/JCO.2003.10.023. Epub 2003 Sep 29.
- Witzens-Harig M, Dreger P. Autologous transplant of follicular lymphoma in the era of rituximab. Leuk Lymphoma. 2010 Jun;51(6):967-74. doi: 10.3109/10428191003793341.
- Sebban C, Brice P, Delarue R, Haioun C, Souleau B, Mounier N, Brousse N, Feugier P, Tilly H, Solal-Celigny P, Coiffier B. Impact of rituximab and/or high-dose therapy with autotransplant at time of relapse in patients with follicular lymphoma: a GELA study. J Clin Oncol. 2008 Jul 20;26(21):3614-20. doi: 10.1200/JCO.2007.15.5358. Epub 2008 Jun 16.
- Le Gouill S, De Guibert S, Planche L, Brice P, Dupuis J, Cartron G, Van Hoof A, Casasnovas O, Gyan E, Tilly H, Fruchart C, Deconinck E, Fitoussi O, Gastaud L, Delwail V, Gabarre J, Gressin R, Blanc M, Foussard C, Salles G; GELA and GOELAMS. Impact of the use of autologous stem cell transplantation at first relapse both in naive and previously rituximab exposed follicular lymphoma patients treated in the GELA/GOELAMS FL2000 study. Haematologica. 2011 Aug;96(8):1128-35. doi: 10.3324/haematol.2010.030320. Epub 2011 Apr 12.
- Decaudin D, Mounier N, Tilly H, Ribrag V, Ghesquieres H, Bouabdallah K, Morschhauser F, Coiffier B, Le Gouill S, Bologna S, Delarue R, Huynh A, Bosly A, Briere J, Gisselbrecht C. (90)Y ibritumomab tiuxetan (Zevalin) combined with BEAM (Z -BEAM) conditioning regimen plus autologous stem cell transplantation in relapsed or refractory low-grade CD20-positive B-cell lymphoma. A GELA phase II prospective study. Clin Lymphoma Myeloma Leuk. 2011 Apr;11(2):212-8. doi: 10.1016/j.clml.2011.03.007. Epub 2011 Apr 9.
- Weigert O, Uysal A, Metzner B., et al.: Impact of autologous stem cell transplantation and/or rituximab on outcome of patients with relapsed follicular lymphoma - Retrospective analysis of 2 randomized trials of the German Low Grade Lymphoma Study Group (GLSG). ASH Annual Meeting Abstracts 112:2189, 2008 (abstr)
- Chow KU, Boehrer S, Napieralski S, Nowak D, Knau A, Hoelzer D, Mitrou PS, Weidmann E. In AML cell lines Ara-C combined with purine analogues is able to exert synergistic as well as antagonistic effects on proliferation, apoptosis and disruption of mitochondrial membrane potential. Leuk Lymphoma. 2003 Jan;44(1):165-73. doi: 10.1080/1042819021000054670.
- Leoni LM, Bailey B, Reifert J, Bendall HH, Zeller RW, Corbeil J, Elliott G, Niemeyer CC. Bendamustine (Treanda) displays a distinct pattern of cytotoxicity and unique mechanistic features compared with other alkylating agents. Clin Cancer Res. 2008 Jan 1;14(1):309-17. doi: 10.1158/1078-0432.CCR-07-1061.
- Fischer K, Stilgenbauer S, Schweighofer CD, et al.: Bendamustine in combination with rituximab (BR) for patients with relapsed chronic lymphocitic leukemia (CLL): a multicenter phase II trial of the German CLL study group. Blood 112, 2008 (abstr)
- Robinson KS, Williams ME, van der Jagt RH, Cohen P, Herst JA, Tulpule A, Schwartzberg LS, Lemieux B, Cheson BD. Phase II multicenter study of bendamustine plus rituximab in patients with relapsed indolent B-cell and mantle cell non-Hodgkin's lymphoma. J Clin Oncol. 2008 Sep 20;26(27):4473-9. doi: 10.1200/JCO.2008.17.0001. Epub 2008 Jul 14.
- Rummel M, iederle N, aschmeyer G, et al.: Bendamustine plus rituximab is superior in respect of progression-free survival and CR rate when compared to CHOP plus rituximab as first-line treatment of patients with advanced follicular, indolent, and mantle cell lymphomas: Final results of a randomized phase III study of the StiL (Study Group Indolent Lymphomas, Germany). Lancet. 2013 Feb 19 (In press)
- Rummel MJ, Al-Batran SE, Kim SZ, Welslau M, Hecker R, Kofahl-Krause D, Josten KM, Durk H, Rost A, Neise M, von Grunhagen U, Chow KU, Hansmann ML, Hoelzer D, Mitrou PS. Bendamustine plus rituximab is effective and has a favorable toxicity profile in the treatment of mantle cell and low-grade non-Hodgkin's lymphoma. J Clin Oncol. 2005 May 20;23(15):3383-9. doi: 10.1200/JCO.2005.08.100.
- Friedberg JW, Cohen P, Chen L, Robinson KS, Forero-Torres A, La Casce AS, Fayad LE, Bessudo A, Camacho ES, Williams ME, van der Jagt RH, Oliver JW, Cheson BD. Bendamustine in patients with rituximab-refractory indolent and transformed non-Hodgkin's lymphoma: results from a phase II multicenter, single-agent study. J Clin Oncol. 2008 Jan 10;26(2):204-10. doi: 10.1200/JCO.2007.12.5070. Erratum In: J Clin Oncol. 2008 Apr 10;26(11) 1911.
- Herold M, Schulze A, Niederwieser D, Franke A, Fricke HJ, Richter P, Freund M, Ismer B, Dachselt K, Boewer C, Schirmer V, Weniger J, Pasold R, Winkelmann C, Klinkenstein C, Schulze M, Arzberger H, Bremer K, Hahnfeld S, Schwarzer A, Muller C, Muller C; East German Study Group Hematology and Oncology (OSHO). Bendamustine, vincristine and prednisone (BOP) versus cyclophosphamide, vincristine and prednisone (COP) in advanced indolent non-Hodgkin's lymphoma and mantle cell lymphoma: results of a randomised phase III trial (OSHO# 19). J Cancer Res Clin Oncol. 2006 Feb;132(2):105-12. doi: 10.1007/s00432-005-0023-2. Epub 2005 Aug 9.
- Rasschaert M, Schrijvers D, Van den Brande J, Dyck J, Bosmans J, Merkle K, Vermorken JB. A phase I study of bendamustine hydrochloride administered once every 3 weeks in patients with solid tumors. Anticancer Drugs. 2007 Jun;18(5):587-95. doi: 10.1097/CAD.0b013e3280149eb1.
- Rasschaert M, Schrijvers D, Van den Brande J, Dyck J, Bosmans J, Merkle K, Vermorken JB. A phase I study of bendamustine hydrochloride administered day 1+2 every 3 weeks in patients with solid tumours. Br J Cancer. 2007 Jun 4;96(11):1692-8. doi: 10.1038/sj.bjc.6603776. Epub 2007 May 8.
- Cheson BD, Horning SJ, Coiffier B, Shipp MA, Fisher RI, Connors JM, Lister TA, Vose J, Grillo-Lopez A, Hagenbeek A, Cabanillas F, Klippensten D, Hiddemann W, Castellino R, Harris NL, Armitage JO, Carter W, Hoppe R, Canellos GP. Report of an international workshop to standardize response criteria for non-Hodgkin's lymphomas. NCI Sponsored International Working Group. J Clin Oncol. 1999 Apr;17(4):1244. doi: 10.1200/JCO.1999.17.4.1244. Erratum In: J Clin Oncol 2000 Jun;18(11):2351.
- Boellaard R, O'Doherty MJ, Weber WA, Mottaghy FM, Lonsdale MN, Stroobants SG, Oyen WJ, Kotzerke J, Hoekstra OS, Pruim J, Marsden PK, Tatsch K, Hoekstra CJ, Visser EP, Arends B, Verzijlbergen FJ, Zijlstra JM, Comans EF, Lammertsma AA, Paans AM, Willemsen AT, Beyer T, Bockisch A, Schaefer-Prokop C, Delbeke D, Baum RP, Chiti A, Krause BJ. FDG PET and PET/CT: EANM procedure guidelines for tumour PET imaging: version 1.0. Eur J Nucl Med Mol Imaging. 2010 Jan;37(1):181-200. doi: 10.1007/s00259-009-1297-4.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
9. Juli 2014
Primärer Abschluss (Tatsächlich)
12. Juli 2018
Studienabschluss (Tatsächlich)
12. Juli 2018
Studienanmeldedaten
Zuerst eingereicht
6. Dezember 2013
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
10. Dezember 2013
Zuerst gepostet (Schätzen)
11. Dezember 2013
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
8. Januar 2019
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
4. Januar 2019
Zuletzt verifiziert
1. Januar 2019
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Immunsystems
- Neubildungen nach histologischem Typ
- Neubildungen
- Lymphoproliferative Erkrankungen
- Lymphatische Erkrankungen
- Immunproliferative Erkrankungen
- Lymphom, Non-Hodgkin
- Lymphom
- Lymphom, follikulär
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Antiinfektiva
- Antivirale Mittel
- Enzym-Inhibitoren
- Antimetaboliten, antineoplastisch
- Antimetaboliten
- Antineoplastische Mittel
- Immunsuppressive Mittel
- Immunologische Faktoren
- Antineoplastische Mittel, alkylierend
- Alkylierungsmittel
- Myeloablative Agonisten
- Antineoplastische Mittel, Phytogen
- Topoisomerase-II-Inhibitoren
- Topoisomerase-Inhibitoren
- Etoposid
- Bendamustinhydrochlorid
- Melphalan
- Cytarabin
Andere Studien-ID-Nummern
- BENEFIT
- 2013-000076-16 (EudraCT-Nummer)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Follikuläres Lymphom
-
SWOG Cancer Research NetworkNational Cancer Institute (NCI); Genentech, Inc.RekrutierungDiffuses großzelliges B-Zell-Lymphom | Wiederkehrendes diffuses großzelliges B-Zell-Lymphom | Refraktäres diffuses großzelliges B-Zell-Lymphom | Primäres mediastinales (thymisches) großes B-Zell-Lymphom | Follikuläres Lymphom Grad 3b | Transformierte follikuläre Lymphe zu Diff Large B-Zell-Lymphom und andere BedingungenVereinigte Staaten
Klinische Studien zur BeEAM
-
Insel Gruppe AG, University Hospital BernHanusk Krankenhaus WienAbgeschlossenLymphom, follikulär | Lymphom, große B-Zelle, diffus | Lymphom, MantelzelleSchweiz, Österreich
-
Northside Hospital, Inc.Teva Pharmaceuticals USAAbgeschlossenMultiples MyelomVereinigte Staaten
-
Insel Gruppe AG, University Hospital BernMundipharma Medical CompanySuspendiert