Rituximab and Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With B-Cell Non-Hodgkin's Lymphoma

NCT ID: NCT00278408

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 700 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-02
• Study Completion Date: 2018-02-28

Brief Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. Giving rituximab and combination chemotherapy together with radiation therapy may kill more cancer cells. It is not yet known which schedule of rituximab and combination chemotherapy is more effective when given with or without radiation therapy in treating non-Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying two different schedules of rituximab and combination chemotherapy with or without radiation therapy to compare how well they work in treating patients with aggressive B-cell non-Hodgkin's lymphoma.

Detailed Description

OBJECTIVES:

Primary

• Compare the time to treatment failure in patients with previously untreated, low-risk, aggressive, B-cell non-Hodgkin's lymphoma treated with 2 different schedules of immunochemotherapy comprising rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone with vs without radiotherapy.

Secondary

• Compare the time to progression in patients treated with these regimens.
• Compare the overall and disease-free/relapse-free survival of patients treated with these regimens.
• Compare the complete response rate in patients treated with these regimens.
• Compare the tumor control in patients treated with these regimens.
• Compare the safety of these regimens in these patients.
• Compare the pharmacoeconomics of these regimens.
• Compare patient adherence to these regimens.

OUTLINE: This is an open-label, randomized, multicenter study. Patients are stratified according to study center, serum lactic dehydrogenase level (≤ upper limit of normal [ULN] vs > ULN), disease stage (I or II vs III or IV), ECOG performance status (0-1 vs 2-3), bulky disease, and extranodal involvement. Patients with initial bulky disease and/or qualifying extranodal involvement are randomized to 1 of 4 treatment arms. Patients with non-bulky disease are randomized to treatment arms I or III.

All patients will be given the option of receiving a 1-week course of pretreatment therapy comprising vincristine IV once on day -6 and oral prednisone once daily on days -6 to 0.

• Arm I (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
• Arm II (R-CHOP-21 and radiotherapy): Patients receive R-CHOP as in arm I. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Beginning 2-6 weeks after the last course of R-CHOP, patients who achieve a complete remission (CR) undergo radiotherapy 5 days a week for approximately 5½ weeks.
• Arm III (R-CHOP-14): Patients receive R-CHOP as in arm I. Patients also receive filgrastim (G-CSF) subcutaneously once daily on days 4-13 or until blood counts recover. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
• Arm IV (R-CHOP-14 and radiotherapy): Patients receive R-CHOP as in arm I. Patients also receive G-CSF an in arm III. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Beginning 2-6 weeks after the last course of R-CHOP, patients who achieve CR undergo radiotherapy as in arm II.

Patients in all arms undergo restaging of their disease after courses 3 and 6 of R-CHOP. Patients with stable disease after 6 courses or disease progression after courses 3 or 6 proceed to salvage chemotherapy off study. Patients achieving a partial remission or an unconfirmed CR after 6 courses undergo additional restaging 4 weeks later. Patients with disease progression proceed to salvage chemotherapy off study. Patients who achieve CR after 6 courses of R-CHOP or have a confirmed CR after the additional restaging undergo radiotherapy according to randomization (as above).

After completion of study treatment, patients are followed periodically for 5 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 1,072 patients will be accrued for this study.

Conditions

Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Interventional: 6 R-CHOP-21

Arm I (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Group Type: ACTIVE_COMPARATOR

rituximab

Intervention Type: BIOLOGICAL

cyclophosphamide

Intervention Type: DRUG

doxorubicin hydrochloride

Intervention Type: DRUG

prednisone

Intervention Type: DRUG

vincristine sulfate

Intervention Type: DRUG

Interventional: 6 R-CHOP-21 + radiotherapy

Arm II (R-CHOP-21 and radiotherapy): Patients receive R-CHOP as in arm I. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Beginning 2-6 weeks after the last course of R-CHOP, patients who achieve a complete remission (CR) undergo radiotherapy 5 days a week for approximately 5½ weeks.

Group Type: ACTIVE_COMPARATOR

rituximab

Intervention Type: BIOLOGICAL

cyclophosphamide

Intervention Type: DRUG

doxorubicin hydrochloride

Intervention Type: DRUG

prednisone

Intervention Type: DRUG

vincristine sulfate

Intervention Type: DRUG

radiation therapy

Intervention Type: RADIATION

Interventional: 6 R-CHOP-14

Arm III (R-CHOP-14): Patients receive R-CHOP as in arm I. Patients also receive filgrastim (G-CSF) subcutaneously once daily on days 4-13 or until blood counts recover. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Group Type: ACTIVE_COMPARATOR

filgrastim

Intervention Type: BIOLOGICAL

rituximab

Intervention Type: BIOLOGICAL

cyclophosphamide

Intervention Type: DRUG

doxorubicin hydrochloride

Intervention Type: DRUG

prednisone

Intervention Type: DRUG

vincristine sulfate

Intervention Type: DRUG

Interventional: 6 R-CHOP-14 and radiotherapy

Arm IV (R-CHOP-14 and radiotherapy): Patients receive R-CHOP as in arm I. Patients also receive G-CSF an in arm III. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Beginning 2-6 weeks after the last course of R-CHOP, patients who achieve CR undergo radiotherapy as in arm II.

Group Type: ACTIVE_COMPARATOR

filgrastim

Intervention Type: BIOLOGICAL

rituximab

Intervention Type: BIOLOGICAL

cyclophosphamide

Intervention Type: DRUG

doxorubicin hydrochloride

Intervention Type: DRUG

prednisone

Intervention Type: DRUG

vincristine sulfate

Intervention Type: DRUG

radiation therapy

Intervention Type: RADIATION

Interventions

filgrastim

Intervention Type: BIOLOGICAL

rituximab

Intervention Type: BIOLOGICAL

cyclophosphamide

Intervention Type: DRUG

doxorubicin hydrochloride

Intervention Type: DRUG

prednisone

Intervention Type: DRUG

vincristine sulfate

Intervention Type: DRUG

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed aggressive B-cell non-Hodgkin's lymphoma, including the following subtypes:

• Grade 3 follicular lymphoma
• Diffuse B-cell lymphoma, including diffuse large cell lymphoma with the following variants:

• Centroblastic
• Immunoblastic
• Plasmablastic
• Anaplastic large cell
• T-cell-rich B-cell lymphoma
• Primary effusion lymphoma
• Intravascular B-cell lymphoma
• Primary mediastinal B-cell lymphoma
• Burkitt's or Burkitt-like lymphoma
• Mantle cell lymphoma (blastoid)
• Aggressive marginal zone lymphoma (monocytoid)
• Previously untreated disease
• CD20-positive disease
• International prognostic index (IPI) score 0 or 1 (age-adjusted)

• Only patients with bulky disease, as defined by largest single or conglomerate tumor ≥ 7.5 cm in diameter, are allowed to have an IPI score of 0
• No mucosa-associated lymphoid tissue (MALT) lymphoma
• No CNS involvement of lymphoma (intracerebral, meningeal, or intraspinal)

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2
• Platelet count ≥ 100,000/mm³
• WBC ≥ 2,500/mm³
• No known hypersensitivity to the study medications
• No known HIV-positivity
• No active hepatitis infection
• Not pregnant or lactating
• Negative pregnancy test
• No other malignancy within the past 5 years except carcinoma in situ or basal cell skin cancer
• No impaired left ventricular function
• No severe cardiac arrhythmias
• No other impaired organ function
• No other serious disorder

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy or radiotherapy
• No prior immunosuppressive treatment with cytostatics
• No concurrent participation in other treatment studies

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German High-Grade Non-Hodgkin's Lymphoma Study Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael G.M. Pfreundschuh, MD †

Role: STUDY_CHAIR

Universitaetsklinikum des Saarlandes

Viola Poeschel, MD

Role: STUDY_DIRECTOR

Study Office Homburg

Locations

Rigshospitalet, Department of Hematology

Copenhagen, , Denmark

Amtssygehuset i Herlev

Herlev, , Denmark

GMP Tummes/Weinberg

Aachen, , Germany

Klinikum St. Marien

Amberg, , Germany

Klinikum Augsburg

Augsburg, , Germany

Kreiskrankenhaus Aurich

Aurich, , Germany

Klinikum Bayreuth

Bayreuth, , Germany

Charite - Campus Charite Mitte

Berlin, , Germany

Charite University Hospital - Campus Virchow Klinikum

Berlin, , Germany

Helios Klinikum Berlin-Buch, Department of Hematology and Stem Cell Transplantation

Berlin, , Germany

Franziskus Hospital

Bielefeld, , Germany

Augusta-Kranken-Anstalt gGmbH

Bochum, , Germany

Johanniter Krankenhaus Bonn

Bonn, , Germany

Universitätsklinikum Bonn

Bonn, , Germany

Staedtisches Klinikum Braunschweig

Braunschweig, , Germany

Klinikum Bremen-Mitte

Bremen, , Germany

Evangelisches Diakonie-Krankenhaus gGmbH, Department of Internal Medicine

Bremen, , Germany

Praxis Dr. Obst

Burgwedel, , Germany

Onkologische Schwerpunktpraxis Celle

Celle, , Germany

Hospital Kuchwald Chemnitz - Department of Internal Medicine III

Chemnitz, , Germany

Klinikum Chemnitz

Chemnitz, , Germany

Klinikum Coburg

Coburg, , Germany

Praxis Fuer Haematologie Internistische Onkologie

Cologne, , Germany

Medizinische Universitaetsklinik I at the University of Cologne

Cologne, , Germany

Gemeinschaftspraxis Dres. Schmitz, Steinmetz, Severin

Cologne, , Germany

Krankenhaus Holweide

Cologne, , Germany

Lungenklinik Köln-Merheim

Cologne, , Germany

Carl - Thiem - Klinkum Cottbus

Cottbus, , Germany

Klinikum Dortmund

Dortmund, , Germany

Virngrund-Klinik Ellwangen

Ellwangen, , Germany

Hans - Susemihl - Krankenhaus

Emden, , Germany

Universitätsklinikum Erlangen

Erlangen, , Germany

St. Antonius Hospital

Eschweiler, , Germany

Universitaetsklinikum Essen

Essen, , Germany

Klinikum Esslingen

Esslingen am Neckar, , Germany

Krankenhaus Nordwest

Frankfurt, , Germany

Klinikum der J.W. Goethe Universitaet

Frankfurt, , Germany

Klinikum Frankfurt (Oder) GmbH

Frankfurt (Oder), , Germany

Universitaetsklinikum Freiburg

Freiburg im Breisgau, , Germany

GMP Dres. Marschner, Zaiss, Kirste, Semsek

Freiburg im Breisgau, , Germany

Praxis Dr. med. Reiber

Freiburg im Breisgau, , Germany

Klinikum Fulda

Fulda, , Germany

Klinikum Garmisch - Partenkirchen GmbH

Garmisch-Partenkirchen, , Germany

Saint Josef Hospital

Gelsenkirchen, , Germany

Praxis Dr. med. Schliesser

Giessen, , Germany

Wilhelm-Anton-Hospital gGmbH, Goch

Goch, , Germany

Universitaetsklinikum Goettingen, Department of Hematology and Oncology

Göttingen, , Germany

Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet

Greifswald, , Germany

Gemeinschaftspraxis

Güstrow, , Germany

St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH

Hagen, , Germany

Krankenhaus Martha-Maria Halle-Doelau gGmbH

Halle, , Germany

GMP Rohrberg, Hurtz, Schmidt, Frank-Gleich

Halle, , Germany

Asklepios Klinik St. Georg

Hamburg, , Germany

University Medical Center Hamburg - Eppendorf

Hamburg, , Germany

Hämatologisch-onkologische Praxis Altona (HOPA)

Hamburg, , Germany

Evangelisches Krankenhaus Hamm

Hamm, , Germany

Klinikum Stadt Hanau

Hanau, , Germany

Krankenhaus Siloah - Medizinische Klinik II

Hanover, , Germany

Medizinische Hochschule Hannover

Hanover, , Germany

Medizinische Universitaetsklinik und Poliklinik

Heidelberg, , Germany

Klinikum Kreis Herford

Herford, , Germany

Privatklinik Dr. R. Schindlbeck GmbH & Co. KG

Herrsching am Ammersee, , Germany

St. Bernward Krankenhaus

Hildesheim, , Germany

Evangelisches Krankenhaus Holzminden

Holzminden, , Germany

Haematologie und Internistische Onkologie Praxis

Homberg (Efze), , Germany

Universitaetsklinikum des Saarlandes

Homburg, , Germany

Clinic for Bone Marrow Transplantation and Hematology and Oncology

Idar-Oberstein, , Germany

Staedtisches Klinikum Karlsruhe gGmbH

Karlsruhe, , Germany

St. Vincentius Kliniken Karlsruhe

Karlsruhe, , Germany

Internistische Gemeinschaftspraxis - Kassel

Kassel, , Germany

Klinikum Kempten Oberallgaeu

Kempten, , Germany

Staedtisches Krankenhaus Kiel

Kiel, , Germany

University Hospital Schleswig-Holstein - Kiel Campus

Kiel, , Germany

Gemeinschaftspraxis Dres. Heymanns, Weide, Thomalla

Koblenz, , Germany

Praxis Dr. Stauch

Kronach, , Germany

Internistische Praxis - Landshut

Landshut, , Germany

Klinikum Landshut

Landshut, , Germany

Caritas Krankenhaus Lebach

Lebach, , Germany

Onkologische Schwerpunktpraxis Dr. Lothar Müller

Leer, , Germany

Klinikum St. Georg Leipzig

Leipzig, , Germany

Onkologische Praxis am Diakonissenhaus

Leipzig, , Germany

Klinikum Lippe-Lemgo

Lemgo, , Germany

St. Marienkrankenhaus

Ludwigshafen, , Germany

Klinikum der Stadt Ludwigshafen am Rhein

Ludwigshafen am Rhein, , Germany

Universitätsklinikum Schleswig-Holstein

Lübeck, , Germany

Kreiskrankenhaus Luedenscheid

Lüdenscheid, , Germany

Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg

Magdeburg, , Germany

Krankenhaus Altstadt Magdeburg

Magdeburg, , Germany

III Medizinische Klinik Mannheim

Mannheim, , Germany

Mannheimer Onkologie Praxis

Mannheim, , Germany

Universitätsklinikum Gießen und Marburg (UKGM)

Marburg, , Germany

Klinikum Minden

Minden, , Germany

Krankenhaus Maria Hilf GmbH

Mönchengladbach, , Germany

Klinikum der Universitaet Muenchen - Grosshadern Campus

Munich, , Germany

Klinikum Rechts Der Isar - Technische Universitaet Muenchen

Munich, , Germany

Gemeinschaftspraxis Abenhardt, Bojko, Bosse, Riedner

Munich, , Germany

Städtisches Klinikum München Harlaching

Munich, , Germany

Stauferklinikum Schwäbisch Gmünd

Mutlangen, , Germany

Gemeinschaftspraxis Dres. Schröder, Sieg

Mülheim, , Germany

Haematologisch - Onkologische Gemeinschaftspraxis - Muenster

Münster, , Germany

Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster

Münster, , Germany

Onkologische Schwerwpunktpraxis Dr. Ladda

Neumarkt, , Germany

Lukaskrankenhaus Neuss

Neuss, , Germany

BRK Schloßbergklinik Oberstaufen

Oberstaufen, , Germany

GMP Dres. Balló, Böck

Offenbach, , Germany

Klinikum Oldenburg - Department of Hematology and Oncology

Oldenburg, , Germany

Pius Hospital Oldenburg, Department of Internal Oncology

Oldenburg, , Germany

Paracelsus Krankenhaus Ruit

Ostfildern, , Germany

Bruederkrankenhaus St. Josef Paderborn

Paderborn, , Germany

Krankenhaus Siloah

Pforzheim, , Germany

Praxis Dr. Dencausse

Pforzheim, , Germany

Klinikum der Universitaet Regensburg

Regensburg, , Germany

Krankenhaus Barmherzige Brüder Regensburg

Regensburg, , Germany

Klinikum am Steinenberg

Reutlingen, , Germany

Klinikum Suedstadt Rostock

Rostock, , Germany

Universitätsklinikum Rostock

Rostock, , Germany

Gemeinschaftspraxis Dres. Jacobs, Daus, Schmits

Saarbrücken, , Germany

Leopoldina - Krankenhaus

Schweinfurt, , Germany

St. Marien - Krankenhaus Siegen GMBH

Siegen, , Germany

Onkologische Schwerpunktpraxis - Straubing

Straubing, , Germany

Klinik fuer Onkologie - Katharinenhospital Stuttgart

Stuttgart, , Germany

Diakonie Klinikum Stuttgart

Stuttgart, , Germany

Bürgerhospital

Stuttgart, , Germany

Krankenanstalt Mutterhaus der Borromaerinnen

Trier, , Germany

Krankenhaus Der Barmherzigen Brueder

Trier, , Germany

Praxis Fuer Internistische Haematologie / Onkologie

Troisdorf, , Germany

Universitätsklinikum Tübingen, Department of Internal Medicine II

Tübingen, , Germany

Praxis fuer Haematologie und Onkologie

Twistringen, , Germany

Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm

Ulm, , Germany

Katharinen Hospital Unna

Unna, , Germany

St. Marienhospital - Vechta

Vechta, , Germany

Praxis VS-Villingen

Villingen-Schwenningen, , Germany

Regional Hospital Waldbrol

Waldbröl, , Germany

Med. Versorgungszentrum Weiden

Weiden, , Germany

Harz-Klinikum-Wernigerode

Wernigerode, , Germany

Ammerland Klinik GmbH Westerstede

Westerstede, , Germany

Dr. Horst-Schmidt-Kliniken

Wiesbaden, , Germany

Kliniken St. Antonius

Wuppertal, , Germany

Helios Klinikum Wuppertal

Wuppertal, , Germany

Heinrich-Braun-Krankenhaus Zwickau

Zwickau, , Germany

Rabin Medical Center - Beilinson Campus

Petah Tikva, , Israel

Ospidale A. Cardarelli

Campobasso, , Italy

Azienda Ospedaliera di Cosenza

Cosenza, , Italy

AOU San Martino Genova

Genova, , Italy

Az. Ospedaliera Messina

Messina, , Italy

Policlinico Universitario "G. Martino" Messina

Messina, , Italy

Centro Oncologico Modenese, University of Modena and Reggio Emilia

Modena, , Italy

Ematologia - OSP. Civile Piacenza

Piacenza, , Italy

A. Santa Maria Nuova, Hematology Azienda

Reggio Emilia, , Italy

Osp. S. Vincenzo - Taormina

Taormina, , Italy

Ospedale San Giuseppe Moscati

Taranto, , Italy

Ospedale di circolo e Fondazione Macchi Varese

Varese, , Italy

Countries

Denmark; Germany; Israel; Italy

References

Radiotherapy (RT) to bulky (B) and extralymphatic (E) disease in combination with 6xR-CHOP-14 or R-CHOP-21 in young good-prognosis DLBCL patients: Results of the 2x2 randomized UNFOLDER trial of the DSHNHL/GLA. Michael Pfreundschuh, Niels Murawski, Marita Ziepert, Bettina Altmann, Martin H. Dreyling, Peter Borchmann, Stefano Luminari, Mathias Witzens-Harig, Judith Dierlamm, Mathias Haenel, Lorenz Truemper, Bernd Metzner, Eva Lengfelder, Ulrich B. Keller, Christian Ruebe, Christian Berdel, Norbert Schmitz, Gerhard Held, and Viola Poeschel Journal of Clinical Oncology 2018 36:15_suppl, 7574-7574

Reference Type: RESULT

Role of radiotherapy and dose-densification of R-CHOP in primary mediastinal B-cell lymphoma: A subgroup analysis of the unfolder trial of the German Lymphoma Alliance (GLA). Gerhard Held, Lorenz Thurner, Viola Poeschel, Christian Berdel, German Ott, Christian Schmidt, Andreas Viardot, Peter Borchmann, Ofer Shpilberg, Maike Nickelsen, Massimo Federico, Peter de Nully Brown, Niels Murawski, Lorenz H. Trumper, Heinz Schmidberger, Christian Ruebe, Jochen Fleckenstein, Norbert Schmitz, Markus Loeffler, Marita Ziepert, and German Lymphoma Alliance Journal of Clinical Oncology 2020 38:15_suppl, 8041-8041

Reference Type: RESULT

Thurner L, Ziepert M, Berdel C, Schmidt C, Borchmann P, Kaddu-Mulindwa D, Viardot A, Witzens-Harig M, Dierlamm J, Haenel M, Metzner B, Wulf G, Lengfelder E, Keller UB, Frickhofen N, Nickelsen M, Gaska T, Griesinger F, Mahlberg R, Marks R, Shpilberg O, Lindemann HW, Soekler M, Fischer von Weikersthal L, Kiehl M, Roemer E, Bentz M, Krammer-Steiner B, Trappe R, de Nully Brown P, Federico M, Merli F, Engelhard M, Glass B, Schmitz N, Truemper L, Bewarder M, Hartmann F, Murawski N, Stilgenbauer S, Rosenwald A, Altmann B, Schmidberger H, Fleckenstein J, Loeffler M, Poeschel V, Held G. Radiation and Dose-densification of R-CHOP in Aggressive B-cell Lymphoma With Intermediate Prognosis: The UNFOLDER Study. Hemasphere. 2023 Jul 5;7(7):e904. doi: 10.1097/HS9.0000000000000904. eCollection 2023 Jul.

Reference Type: DERIVED

PMID: 37427146 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

DSHNHL-2004-3

Identifier Type: -

Identifier Source: secondary_id

EUDRACT-2005-005218-19

Identifier Type: -

Identifier Source: secondary_id

EU-205111

Identifier Type: -

Identifier Source: secondary_id

CDR0000459796

Identifier Type: -

Identifier Source: org_study_id