Trial record 1 of 524 for:    CLL-8
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Fludarabine and Cyclophosphamide With or Without Rituximab in Patients With Previously Untreated Chronic B-Cell Lymphocytic Leukemia (CLL-8)

This study has been completed.
Sponsor:
Collaborator:
German CLL Study Group
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00281918
First received: January 24, 2006
Last updated: September 9, 2013
Last verified: September 2013
  Purpose

This randomized phase III trial is studying fludarabine, cyclophosphamide, and rituximab to see how well they work compared to fludarabine and cyclophosphamide in treating patients with B-cell chronic lymphocytic leukemia.


Condition Intervention Phase
Leukemia
Drug: Rituximab
Drug: Cyclophosphamide
Drug: Fludarabine Phosphate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Trial of Combined Immunochemotherapy With Fludarabine, Cyclophosphamide and Rituximab (FCR) Versus Chemotherapy With Fludarabine and Cyclophosphamide (FC) Alone in Patients With Previously Untreated Chronic Lymphocytic Leukaemia

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free Survival (PFS) [ Time Frame: Median observation time at time of analysis was approximately 21 months ] [ Designated as safety issue: No ]
    Progression-free survival (PFS) was defined as the time between randomization and the date of first documented disease progression, relapse or death by any cause, whichever came first.

  • Final Analysis: Time to Progression-free Survival Event [ Time Frame: Median observation time was approximately 66.4 months ] [ Designated as safety issue: No ]
    Progression-free survival was defined as the time between randomization and the date of first documented disease progression, relapse or death by any cause, whichever came first.


Secondary Outcome Measures:
  • Event-free Survival (EFS) [ Time Frame: Median observation time at time of analysis was approximately 21 months ] [ Designated as safety issue: No ]
    Event-free survival (EFS) was defined as the time between randomization and the date of disease progression, relapse, start of new CLL treatment or death by any cause.

  • Overall Survival (OS) [ Time Frame: Median observation time at time of analysis was approximately 21 months ] [ Designated as safety issue: No ]
    Overall survival (OS) was defined as the time between randomization and the date of death due to any cause. Median OS was not reached.

  • Disease-free Survival (DFS) of Patients With Confirmed Complete Response (CR). [ Time Frame: Median observation time at time of analysis was approximately 21 months ] [ Designated as safety issue: No ]
    CR is defined by at least 8 weeks of: 1)Absence of lymphadenopathy 2)No hepatomegaly or splenomegaly 3)Absence of B-symptoms 4)Normal blood count 5)Bone marrow aspirate and biopsy 8 weeks after the clinical and laboratory results demonstrated that a CR was achieved. A marrow sample had to be normocellular for age with less than 30% lymphocytes. Lymphoid nodules had to be absent. If marrow was hypocellular,a repeat biopsy was taken 4 weeks later and samples were re-reviewed in conjunction with the prior pathology. DFS was calculated from time of CR to relapse or death. Median DFS was not reached.

  • Final Analysis: Time to Overall Survival Event [ Time Frame: Median observation time was approximately 66.4 months ] [ Designated as safety issue: No ]
    Overall survival (OS) was defined as the time between randomization and the date of death due to any cause.

  • Final Analysis: Time to Event-free Survival Event [ Time Frame: Median observation time was approximately 66.4 months ] [ Designated as safety issue: No ]
    Event-free survival was defined as the time between randomization and the date of disease progression, relapse, start of new Chronic Lymphocytic Leukemia treatment or death by any cause.

  • Final Analysis: Time to Disease-free Survival (DFS) Event in Participants With Complete Response (CR) [ Time Frame: Median observation time was approximately 66.4 months ] [ Designated as safety issue: No ]
    CR is defined by at least 8 weeks of: 1)Absence of lymphadenopathy 2)No hepatomegaly or splenomegaly 3)Absence of B-symptoms 4)Normal blood count 5)Bone marrow aspirate and biopsy 8 weeks after the clinical and laboratory results demonstrated that a CR was achieved. A marrow sample had to be normocellular for age with less than 30% lymphocytes. Lymphoid nodules had to be absent. If marrow was hypocellular,a repeat biopsy was taken 4 weeks later and samples were re-reviewed in conjunction with the prior pathology. DFS was calculated from time of CR to relapse or death

  • Final Analysis: Duration of Response [ Time Frame: Median observation time was approximately 66.4 months ] [ Designated as safety issue: No ]
    Duration of response was defined as the time from the first documented Complete Response, Partial Response to disease progression or death by any cause.

  • Final Analysis: Percentage of Participants With Complete Response (CR) and Partial Response [ Time Frame: Median observation time was approximately 66.4 months ] [ Designated as safety issue: No ]
    CR is defined by at least 8 weeks of: 1)Absence of lymphadenopathy 2)No hepatomegaly or splenomegaly 3)Absence of B-symptoms 4)Normal blood count 5)Bone marrow aspirate and biopsy 8 weeks after the clinical and laboratory results demonstrated that a CR was achieved. A marrow sample had to be normocellular for age with less than 30% lymphocytes. Lymphoid nodules had to be absent. If marrow was hypocellular,a repeat biopsy was taken 4 weeks later and samples were re-reviewed in conjunction with the prior pathology. Partial response is defined as a decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment.

  • Final Analysis: Time to New Treatment for Chronic Lymphocytic Leukemia(CLL) [ Time Frame: Median observation time was approximately 66.4 months ] [ Designated as safety issue: No ]
    The time from randomization to the start of a new treatment.


Enrollment: 817
Study Start Date: July 2003
Study Completion Date: October 2011
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fludarabine+Cyclophosphamide+Rituximab (FCR) Drug: Rituximab
Intravenous repeating dose
Drug: Cyclophosphamide
Intravenous repeating dose
Drug: Fludarabine Phosphate
Intravenous repeating dose
Active Comparator: Fludarabine+Cyclophosphamide (FC) Drug: Cyclophosphamide
Intravenous repeating dose
Drug: Fludarabine Phosphate
Intravenous repeating dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosed B-cell chronic lymphocytic leukemia (CLL) defined by the National Cancer Institute (NCI) Working Group criteria
  • Meets 1 of the following criteria:

    • Binet stage C disease
    • Binet stage B disease AND ≥ 1 of the following signs or symptoms*:

      • B symptoms (night sweats, weight loss ≥ 10% within the previous 6 months, fevers > 38°C or 100.4°F for ≥ 2 weeks without evidence of infection), or constitutional symptoms (fatigue)
      • Continuous progression (doubling of peripheral lymphocyte count within the past 6 months and absolute lymphocyte count > 50 G/I)
      • Evidence of progressive marrow failure as manifested by the development/worsening of anemia and/or thrombocytopenia
      • Massive, progressive or painful splenomegaly or hypersplenism
      • Massive lymph nodes or lymph node clusters (> 10 cm in longest diameter), danger of organ complications through large lymphoma (e.g., vascular compression or tracheal narrowing), or progressive lymphadenopathy
      • Occurrence of symptomatic hyperviscosity problems at leukocyte counts > 200 G/I (symptomatic leukostasis) NOTE: * Marked hypogammaglobulinemia or the development of a monoclonal protein in the absence of any of the above criteria for active disease is not sufficient for eligibility
  • No Binet stage A disease
  • No transformation to an aggressive B-cell malignancy (e.g., diffuse large cell lymphoma, Richter's syndrome, or prolymphocytic leukemia)

PATIENT CHARACTERISTICS:

  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Cumulative Illness Rating Scale (CIRS) score > 6
  • Life expectancy > 6 months
  • Bilirubin ≤ 2 times upper limit of normal (ULN)
  • Alkaline phosphatase and transaminases ≤ 2 times ULN
  • Creatinine clearance ≥ 70 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 2 months after study treatment
  • No known hypersensitivity with anaphylactic reaction to humanized monoclonal antibodies or any of the study drugs
  • No cerebral dysfunction that precludes chemotherapy
  • No active bacterial, viral, or fungal infection
  • No clinically significant autoimmune cytopenia or Coombs-positive hemolytic anemia
  • No other active malignancy requiring concurrent treatment except basal cell carcinoma or tumors treated curatively by surgery
  • No medical or psychological condition that would preclude study therapy
  • No concurrent disease that requires prolonged (> 1 month) therapy involving glucocorticoids

PRIOR CONCURRENT THERAPY:

  • No previous treatment of CLL by chemotherapy, radiotherapy, or immunotherapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00281918

  Hide Study Locations
Locations
Australia, New South Wales
Gosford Hospital
Gosford, New South Wales, Australia, 2250
Westmead Institute for Cancer Research at Westmead Hospital
Westmead - Wentworthville, New South Wales, Australia, 2145
Australia, Queensland
Princess Alexandra Hospital
Brisbane, Queensland, Australia, 4102
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia, 4029
Australia, Victoria
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia, 3002
Frankston Hospital
Frankston, Victoria, Australia, 3199
Austria
Hanuschkrankenhaus
Vienna, Austria, A-1140
Rudolfinerhaus
Vienna, Austria, A-1190
Allg. Krankenhaus der Stadt Wien Universitaets-Kinderklinik
Wien, Austria, 1090
Belgium
AZ Sint-Jan
Brugge, Belgium, 8000
Institut Jules Bordet
Brussels, Belgium, 1000
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, B-2650
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
Clinique Universitaire De Mont-Godinne
Mont-Godinne Yvoir, Belgium, 5530
Czech Republic
Masaryk University Hospital
Brno, Czech Republic, 62500
Fakultni Nemocnice Hradec Kralove
Hradec Kralove, Czech Republic, 50005
University Hospital - Olomouc
Olomouc, Czech Republic, 775 20
University Hospital in Pilsen - Lochotin
Pilsen-Lochotin, Czech Republic, 30460
First Medical Clinic of Charles University Hospital
Prague, Czech Republic, 128 08
Denmark
Copenhagen County Herlev University Hospital
Copenhagen, Denmark, DK-2730
Vejle Sygehus
Vejle, Denmark, DK-7100
France
Hopital Louis Pasteur
Colmar, France, 68024
Hopital Andre Mignot
Le Chesnay, France, 78157
Centre Leon Berard
Lyon, France, 69373
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, France, 13273
Centre Hospitalier Universitaire de Rennes
Rennes, France, 35033
Institut de Cancerologie de la Loire
Saint Priest en Jarez, France, 42270
Germany
Praxis Fur Hamatologie und Onkologie Ahaus
Ahaus, Germany, 48683
Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie
Ansbach, Germany, 91522
Hamatologische/Onkologische Gemeinschaftspraxis - Augsburg
Augsburg, Germany, 86150
Klinikum Augsburg
Augsburg, Germany, DOH-86156
Humaine - Clinic
Bad Saarow, Germany, 15526
Internistische Praxis - Bayreuth
Bayreuth, Germany, 95448
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
Berlin, Germany, D-12200
Internistische Gemeinschaftspraxis - Berlin
Berlin, Germany, 13347
Onkologische Schwerpunktpraxis Bielefeld
Bielefeld, Germany, D-33602
Krankenhaus Bietigheim
Bietigheim, Germany, D-74321
Augusta-Kranken-Anstalt gGmbH
Bochum, Germany, D-44791
Marienhospital Bottrop gGmbH
Bottrop, Germany, D-46236
DIAKO Ev. Diakonie Krankenhaus gGmbH
Bremen, Germany, D-28239
Krankenhaus Burglengenfeld
Burglengenfeld, Germany, D-93133
Onkologische Schwerpunktpraxis at Facharzt fuer Innere Medizin
Coesfeld, Germany, 48653
Medizinische Universitaetsklinik I at the University of Cologne
Cologne, Germany, D-50924
Praxis Fuer Haematologie Internistische Onkologie
Cologne, Germany, D-50677
Onkologische Schwerpunktpraxis
Cottbus, Germany, D-03046
Onkologische Gemeinschaftspraxis - Dresden
Dresden, Germany, 01127
Universitaetsklinikum Duesseldorf
Duesseldorf, Germany, D-40225
Krankenhaus Benrath
Dusseldorf, Germany, 40593
Internistische Praxis - Dusseldorf
Dusseldorf, Germany, 40211
Florence-Nightingale-Krankenhause, Deaconess Kaiserswerth
Dusseldorf, Germany, 40489
St. Georg Klinikum Eisenach GmbH
Eisenach, Germany, 99817
Internistiche Praxis
Erfurt, Germany, 99084
Helios Klinikum Erfurt
Erfurt, Germany, 99012
Onkologische Schwerpunkt Praxis
Erlangen, Germany, D-91052
St. Antonius Hospital
Eschweiler, Germany, DOH-52249
Evangelisches Krankenhaus Essen Werden
Essen, Germany, D-45239
Universitaetsklinikum Essen
Essen, Germany, D-45122
Staedtische Kliniken Esslingen
Esslingen, Germany, D-73730
Internistische Gemeinschaftspraxis - Forchheim
Forchheim, Germany, 91301
Staedtische Kliniken Frankfurt am Main - Hoechst
Frankfurt, Germany, D-65929
Klinikum Frankfurt (Oder) GmbH
Frankfurt (Oder), Germany, D-15236
Gemeinschaftspraxis - Freiburg
Freiburg, Germany, 79098
Klinikum Garmisch - Partenkirchen GmbH
Garmisch-Partenkirchen, Germany, D-82467
Internistische Praxis - Gerlingen
Gerlingen, Germany, 70839
Gemeinschaftspraxis Fuer Innere Medizin, Hematologie Und Onkologie
Giessen, Germany, 35392
Universitaetsklinikum Goettingen
Goettingen, Germany, D-37075
Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet
Greifswald, Germany, D-17475
St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH
Hagen, Germany, D-58095
Universitaetsklinikum Halle
Halle, Germany, D-06120
Internistische Praxis - Halle
Halle, Germany, 06108
University Medical Center Hamburg - Eppendorf
Hamburg, Germany, D-20246
Asklepios Klinik St. Georg
Hamburg, Germany, D-20099
Evangelische Krankenhaus Hamm
Hamm, Germany, DOH-59063
St. Marien-Hospital Hamm - Klinik Knappenstrasse
Hamm, Germany, D-59071
Krankenhaus Siloah - Medizinische Klinik II
Hannover, Germany, D-30449
Universitatsklinikum Heidelberg
Heidelberg, Germany, D-69115
Marienhospital at Ruhr University Bochum
Herne, Germany, D-44625
Privatklinik Dr. R. Schindlbeck GmbH & Co. KG
Herrsching, Germany, D-82211
Universitaetsklinikum des Saarlandes
Homburg, Germany, D-66424
Clinic for Bone Marrow Transplantation and Hematology and Oncology
Idar-Oberstein, Germany, D-55743
Gemeinschaftspraxis Innere Medizin
Jena, Germany, D-07743
Staedtisches Klinikum Karlsruhe gGmbH
Karlsruhe, Germany, 76133
St. Vincentius-Kliniken
Karlsruhe, Germany, D-76137
Internistische Gemeinschaftspraxis - Kassel
Kassel, Germany, D-34117
Klinikum Kempten Oberallgaeu
Kempten, Germany, D-87439
Internistische Praxis - Kiel
Kiel, Germany, 24105
University Hospital Schleswig-Holstein - Kiel Campus
Kiel, Germany, D-24116
Praxis fuer Haematologie und Onkologie
Koblenz, Germany, D-56068
Stiftungsklinikum Mittelrhein - Gesundheitszentrum Evangelisches Stift Sankt Martin Koblenz gGmbH
Koblez, Germany, D-56068
Internistische Onkologische Praxis - Kronach
Kronach, Germany, 96317
Klinikum Landshut
Landshut, Germany, 84034
Onkologische Schwerpunktpraxis - Leer
Leer, Germany, D-26789
Klinikum "St. Georg" Leipzig
Leipzig, Germany, D-04126
Klinikum Lippe - Lemgo
Lemgo, Germany, D-32657
Internistische Praxis - Loerrach
Loerrach, Germany, D-79539
Gemeinschaftspraxis - Ludwigshafen
Ludwigshafen, Germany, 67061
Sana Kliniken Luebeck
Luebeck, Germany, 23560
Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg
Magdeburg, Germany, D-39120
Internistische Gemeinschaftspraxis - Magdeburg
Magdeburg, Germany, D-39104
Staedtisches Klinikum Magdeburg - Altstadt
Magdeburg, Germany, D-39104
Universitatsklinik Mainz
Mainz, Germany, D-55101
III Medizinische Klinik Mannheim
Mannheim, Germany, D-68305
Krankenhaus Maria Hilf GmbH
Moenchengladbach, Germany, D-41063
Hamatologie/Onkologie Praxisgemeinschaft - Muenchen
Muenchen, Germany, D-81241
Haematologisch - Onkologische Gemeinschaftspraxis
Muenster, Germany, D-48149
University of Muenster
Muenster, Germany, D-48129
Staedtisches Krankenhaus Muenchen - Harlaching
Munich, Germany, D-81545
Haematologische Schwerpunktpraxis
Munich, Germany, D-81679
Klinikum der Universitaet Muenchen - Grosshadern Campus
Munich, Germany, D-81377
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
Munich, Germany, D-81675
Onkologische Schwerpunktpraxis Dr. Schmidt
Neunkirchen, Germany, D-66538
Praxis fuer Haematologie und Interne Onkologie
Norderstedt, Germany, 22844
Klinikum Nuernberg - Klinikum Nord
Nuernberg, Germany, D-90419
Gemeinschaftspraxis - Oberhausen
Oberhausen, Germany, D-46045
Internistische Gemeinschaftspraxis - Offenbach
Offenbach, Germany, D-63065
Klinikum Oldenburg
Oldenburg, Germany, D-26133
Internistische Gemeinschaftspraxis - Oldenburg
Oldenburg, Germany, D-26121
Asklepios Klinik Pasewalk
Pasewalk, Germany, 17309
Municipal Hospital Complex
Pforzheim, Germany, D-75178
Klinikum Ernst Von Bergmann
Potsdam, Germany, D-14467
Elisabeth Krankenhaus
Recklinghausen, Germany, 45661
Krankenhaus Barmherzige Brueder Regensburg
Regensburg, Germany, D-93049
Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock
Rostock, Germany, D-18055
Caritasklinik St. Theresia
Saarbrucken, Germany, D-66113
Nordwestkrankenhaus Sanderbusch
Sanderbusch, Germany, 26452
St. Marien - Krankenhaus Siegen GMBH
Siegen, Germany, D-57072
Marienhospital Stuttgart
Stuttgart, Germany, D-70199
Haematologische Praxis
Stuttgart, Germany, D-70173
Diakonie Klinikum Stuttgart
Stuttgart, Germany, D-70176
Klinik fuer Onkologie - Katharinenhospital Stuttgart
Stuttgart, Germany, D-70174
Internistische Gemeinschaftspraxis - Stuttgart
Stuttgart, Germany, 70176
KKH Torgau
Torgau, Germany, 04860
Onkologische Gemeinschaftspraxis - Trier
Trier, Germany, 54290
Krankenanstalt Mutterhaus der Borromaerinnen
Trier, Germany, D-54219
Praxis Fuer Internistische Haematologie / Onkologie
Troisdorf, Germany, 53840
Universitaetsklinikum Tuebingen
Tuebingen, Germany, D-72076
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
Ulm, Germany, D-89081
Municipal Hospital Complex
Villingen-Schwenningen, Germany, D-78045
Praxis fur Innere Medizin - Wanzleben
Wanzleben, Germany, 39164
Haematologische Praxis
Weiden, Germany, D-92637
Schwerpunktpraxis Hamatologie/Onkologie - Wesel
Wesel, Germany, 46483
Dr. Horst-Schmidt-Kliniken
Wiesbaden, Germany, D-65199
Medizinische Klinik und Poliklinik II - Universitaetsklinikum Wuerzburg
Wuerzburg, Germany, D-97080
Kliniken St. Antonius
Wuppertal 2, Germany, D-42283
Hamatologisch - Onkologische Praxis Wurzburg
Wurzburg, Germany, 97070
Israel
Soroka University Medical Center
Beer-Sheva, Israel, 84101
BNAI Zion Medical Center
Haifa, Israel, 31048
Rambam Medical Center
Haifa, Israel, 31096
Hadassah University Hospital
Jerusalem, Israel, 91120
Riverview Cancer Care Medical Associates, PC
Kfar Saba, Israel, 44281
Kaplan Hospital
Rehovot, Israel, 76100
Italy
Ospedale Oncologico A. Businco
Cagliari, Italy, 09121
Fondazione Centro San Raffaele Del Monte Tabor
Milano, Italy, 20132
Perugia Regional Cancer Center
Perugia, Italy, 06122
Ospedale Sant' Eugenio
Rome, Italy, 00144
Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
Rome, Italy, 00168
New Zealand
Auckland City Hospital
Auckland, New Zealand, 1
Canterbury Health Laboratories
Christchurch, New Zealand
Palmerston North Hospital
Palmerston North, New Zealand
Spain
Hospital General Universitario Morales Meseguer
Murcia, Spain, 30008
Hospital Virgen Del La Salud
Toledo, Spain, 45004
Sponsors and Collaborators
Hoffmann-La Roche
German CLL Study Group
Investigators
Study Chair: Michael Hallek, MD Medizinische Universitaetsklinik I at the University of Cologne
  More Information

Additional Information:
No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00281918     History of Changes
Other Study ID Numbers: CDR0000454560, GCLLSG-CLL-8, EU-20560, ML17102
Study First Received: January 24, 2006
Results First Received: December 21, 2009
Last Updated: September 9, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Hoffmann-La Roche:
B-cell chronic lymphocytic leukemia
stage I chronic lymphocytic leukemia
stage II chronic lymphocytic leukemia
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia
Leukemia, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Fludarabine phosphate
Fludarabine
Cyclophosphamide
Vidarabine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Immunosuppressive Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on September 30, 2014