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Induction and consolidation I therapy for standard and high risk patients, PH/BCR-ABL-negative Chemotherapy, immunotherapy, intrathecal prophylaxis, CNS irradiation according to randomisation I Drugs: Rituximab, Vincristine, Daunorubicin, Dexamethasone, Cyclophosphamide, Cytarabine, Mercaptopurine, PEG-Asparaginase, Methotrexate, Vindesine, VP16

Induction and consolidation I therapy for PH+ patients Chemotherapy, immunotherapy, intrathecal prophylaxis Drugs: Rituximab, Vincristine, Imatinib, Dexamethasone, PEG-Asparaginase, Cytarabine, Methotrexate, Vindesine, VP16

Chemotherapy according to Stratification I SR/HR CNS prophylaxis: CNS irradiation 24 Gy, intrathecal Methotrexate

Chemotherapy according to Stratification I SR/HR CNS prophylaxis: intrathecal Methotrexate

Chemotherapy, immunotherapy, intrathecal prophylaxis, consolidation II, reinduction, consolidation III - VI, maintenance Drugs: Rituximab, PEG-Asparaginase, Cytarabine, Methotrexate, Vindesine, Adriamycin, Prednisolone, Cyclophosphamide, Nelarabine, Dexamethasone

Chemotherapy or stem cell transplantation according to randomisation II

Chemotherapy or targeted therapy, followed by stem cell transplantation Drugs: Fludarabine, Idarubicin, Cytarabine, Nelarabine

Chemotherapy, immunotherapy, intrathecal prophylaxis, consolidation II, reinduction, consolidation III - VI, maintenance Drugs: Rituximab, Dexamethasone, PEG-Asparaginase, Cytarabine, Methotrexate, Vindesine, Adriamycin, Prednisolone, Cyclophosphamide, Nelarabine

Nelarabine

PEG-Asparaginase

Cranial irradiation

Imatinib

VP16

Daunorubicin (DNR)

Stem cell transplantation

Adriamycin

Nicola Gökbuget, Dr. med.

A phase IV study with the primary goal to optimize therapy of adult patients with acute lymphoblastic leukemia or lymphoblastic lymphoma (LBL) by dose and time intensive, pediatric based chemotherapy, risk adapted stem cell transplantation (SCT) and minimal residual disease (MRD) based individualised and intensified therapy. Study will further evaluate the role of asparaginase intensification, the extended use of rituximab and the use of nelarabine as consolidation therapy in T-ALL in a phase III-part of the study. Furthermore two randomisations will focus on the role of central nervous system (CNS) irradiation in combination with intrathecal therapy versus intrathecal therapy only in B-precursor ALL/LBL and the role of SCT in high-risk patients with molecular complete remission. Finally a new, dose reduced induction therapy in combination with Imatinib will be evaluated in Ph/BCR-ABL positive ALL.

Optimization of Therapy in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma by Individualised, Targeted and Intensified Treatment

Treatment Optimization in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma by Individualised, Targeted and Intensified Treatment - a Phase IV-trial With a Phase III-part to Evaluate Safety and Efficacy of Nelarabine in T-ALL Patients

Goethe University

GMALL Head

Antibodies

Thymoglobulin

Immunoglobulins

Busulfan

Thiotepa

Immunoglobulins, Intravenous

Antilymphocyte Serum

Treosulfan

Mesna

Fludarabine/Thiotepa/Treosulfan is used as conditioning regimen for haematopoietic stem cell transplantation (HSCT) in patients with:

* MSD (matched sibling donors) or MD (matched related or unrelated donors). In addition, patients undergoing MD HSCT will receive ATG Thymo- or Grafalon.
* MMD (mismatched donors) with CB (Cord blood) or TCD (T-Cell depletion) or CD34+ selection. In addition, these patients will receive ATG Thymo- or Grafalon.
* MMD (mismatched donors) patients receiving Post TX-Cyclophosphamide

TBI (Total Body Irradiation) / VP16 is used as conditioning regimen for haematopoietic stem cell transplantation (HSCT) in patients older than 48 months with:

* MSD (matched sibling donors) or MD (matched related or unrelated donors). In addition, patients undergoing MD HSCT will receive ATG Thymo- or Grafalon.
* MMD (mismatched donors) with CB (Cord blood) or TCD (T-Cell depletion) or CD34+ selection. In addition, these patients will receive ATG Thymo- or Grafalon.
* MMD (mismatched donors) patients receiving Post TX-Cyclophosphamide.

Patients aged 24-48 months may optionally receive Total Body Irradiation (TBI).

Fludarabine/Thiotepa/iV Busulfan is used as conditioning regimen for haematopoietic stem cell transplantation (HSCT) in patients with:

* MSD (matched sibling donors) or MD (matched related or unrelated donors). In addition, patients undergoing MD HSCT will receive ATG Thymo- or Grafalon.
* MMD (mismatched donors) with CB (Cord blood) or TCD (T-Cell depletion) or CD34+ selection. In addition, these patients will receive ATG Thymo- or Grafalon.
* MMD (mismatched donors) patients receiving Post TX-Cyclophosphamide

Busulfan/VP16/Cyclophosphamide is an alternative conditioning arm that may optionally be used for HSCT with MSD/MD and MMD graft in patients aged 0-24 months. Patients undergoing MD HSCT will also receive ATG Thymo- or Grafalon.

60 mg/kg BW,1 day in TBI/VP16 conditioning; 40 mg/kg BW in Bu/VP16/Cy conditioning

iV, dosage according therapeutic drug monitoring, 4 days

ATG Thymoglobulin

as part of conditioning 60 mg/kg BW 2 days or as GvHD Prophylaxis 50mg/kg BW/d 2 days with Mesna

MD: 15mg/kg BW/d 3 days MMD: 10mg/kg BW/d 3 days

Grafalon

Christina Peters, Prof. MD PhD

Tijana Frank, MD, MScEng

Raquel Staciuk, MD PhD

Alcira Fynn, MD PhD

Formisano Sandra, MD PhD

Sandra Formisano, MD PhD

Daniela Iglesias, MD PhD

Wolfgang Schwinger, MD PhD

Herwig Lackner, MD

Gabriele Kropshofer, MD PhD

Bernhard Meister, MD

Herbert Pichler, MD

herbert.pichler@stanna.at

Roswitha Lüftinger, MD

Elisabeth Salzer, MD

Nina Minakovskaya, MD

Alina Ferster, MD PhD

Benedicte Brichard, MD PhD

Viktoria Bourdon, MD, PhD

Marleen Renard, MD PhD

Marie Françoise Dresse, MD PhD

Henrique Bittencourt, MD PhD

Donna Wall, MD PhD

Kirk Schultz, MD PhD

Jeffery Davis, MD

Geoff Cuvelier, MD PhD

Julia Palma, MD PhD

Ernest Bilic, MD PhD

Toni Matic, MD PhD

Petr Sedlacek, MD PhD

Petr Riha, MD

Renata Formankova, MD

Petra Keslova, MD

Jan Stary, MD

Marianne Ifversen, MD PhD

Marianne Ifversen, MD PHD

Carsten Heilmann, MD

Kim Vettenranta, MD PhD

Evgenios Goussetis, MD

Dikaia Eleni Ioannidou, MD

Anna Paisiou, MD

Dikaia-Eleni Ionnidou, MD

George Vessalas, MD

Gergely Krivan, MD PhD

Krisztián Kallay, MD PhD

Roni Gefen, MD PhD

Jerry Stein, MD PhD

Ronit Elhasid, MD PhD

Fraia Melchionda, MD

Maura Faraci, MD

Adriana Balduzzi, MD PhD

Francesco Paolo Tambaro, MD

Manuela Tumino, MD

Mario Zecca, MD PhD

Gabriella Casazza, MD PhD

Franco Locatelli, MD PhD

Hany Ariffin, MD PhD

Alberto Olaya Vargas, MD PhD

Arjan Lankester, MD PhD

Marc Bierings, MD PhD

Jochen Büchner, MD PhD

Mariusz Wysocki, MD PhD

Jerzy R. Kowalczyk, MD

Jacek Wachowiak, MD PhD

Alicja Chybicka, MD PhD

Anca Colita, MD PhD

Cristian Jinca, MD PhD

Mohammed Essa, MD PhD

Peter Svec, MD PhD

Dominika Tanuskova, MD

Simona Avčin, MD

Isabel Badell, MD

Cristina Díaz de Heredia, MD

José Luis Fuster, MD

Antonia Isabel Pascual, MD

Antonia Pascual, MD

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Optimization of Therapy in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma by Individualised, Targeted and Intensified Treatment	NCT02881086	Acute Lymphobla... Lymphoblastic L...	Rituximab Nelarabine PEG-Asparaginas... Cranial irradia... Imatinib Idarubicin Dexamethasone Cyclophosphamid... Fludarabine Vincristine Mercaptopurine VP16 Daunorubicin (D... Methotrexate Stem cell trans... Cytarabine Vindesine Adriamycin Prednisolone	18 Years - 55 Years	Goethe University
Optimization of Therapy in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma by Individualised, Targeted and Intensified Treatment	NCT02881086	Acute Lymphobla... Lymphoblastic L...	Rituximab Nelarabine PEG-Asparaginas... Cranial irradia... Imatinib Idarubicin Dexamethasone Cyclophosphamid... Fludarabine Vincristine Mercaptopurine VP16 Daunorubicin (D... Methotrexate Stem cell trans... Cytarabine Vindesine Adriamycin Prednisolone	18 Years - 55 Years	Goethe University
Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia	NCT01949129	Acute Lymphobla...	VP16 TBI Thiotepa Treosulfan Fludarabine Busulfan ATG Thymoglobul... Cyclophosphamid... Grafalon	1 Month - 18 Years	St. Anna Kinderkrebsforschung
Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia	NCT01949129	Acute Lymphobla...	VP16 TBI Thiotepa Treosulfan Fludarabine Busulfan ATG Thymoglobul... Cyclophosphamid... Grafalon	1 Month - 18 Years	St. Anna Kinderkrebsforschung
Allogeneic Stem Cell Transplantation in Children and Adolescents With Acute Lymphoblastic Leukaemia	NCT01423747	Lymphoblastic L...	VP16 TBI VP16, ATG TBI Fludarabine, OK... VP16, ATG TBI	3 Months - 18 Years	St. Anna Kinderkrebsforschung
ALL-SCT BFM International- HSCT in Children and Adolescents With ALL	NCT01423500	Lymphoblastic L...	VP16 TBI VP16, ATG TBI Fludarabine, OK... VP16, ATG TBI	3 Months - 18 Years	St. Anna Kinderkrebsforschung

Spots Global Cancer Trial Database for vp16

Every month we try and update this database with for vp16 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for vp16

Every month we try and update this database with for vp16 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for vp16 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.