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GMALL 08/2013

AcronymISRCTNEudraCTClinicaltrials.govDRKS
GMALL 08/20132013-003466-13NCT02881086

A randomized, riskstratifaction study, to optimize therapy in acute lymphatic leukaemia (ALL) in adults.

Status: Active

Purpose / Objectives

Primary Outcome

 Overall survival compared to the GMALL study 07/2003

Secondary Outcomes

 
  • Haematological and molecular remission rate
  • Recurrence-free survival and recurrence rate (cytological, molecular)
  • Recurrence localization
  • Disease-free survival
  • Early mortality and mortality in CR
  • Co-morbidities and ECOG status in the course
  • Therapy implementation (time compliance, administration of therapy blocks and defined individual substances, rate of therapy discontinuation) 

 



 

 

 

Diagnosis

 ALL- ( all subtypes except Burkitt's leukemia, KM- Infiltraton ≥ 25%)

Patient attributes

Age

18-55

Inclusion criteria

  • Acute lymphocytic leukemia (all subtypes except mature B-ALL, infiltration KM <25%) or lymphoblastic lymphoma of B- or T-cell line (BM-infiltration <25%)
  • [...]

Exclusion criteria

  • Serious complications related to leukemia (e.g. sepsis, haemorrhage, non leukemia related renal failure, congestive heart failure, pulmonary diseases, HIV-infection)
  • Late relapse of childhood ALL
  • Cytostatic treatment (allowed standard prephase)
  • [...]

Trial design

  • Phase III
  • Phase IV
  • Multicenter
  • Prospective
  • Three-arm
  • Open Label

Intervention

There are different options of treatment in this study, depending on the BCR-ABL status, of immunological subtype, CD20 expression and the degree of infiltration of the bone marrow.

(see protocol)

Miscellaneous

Risk stratification is done by the study center

Classification treatment arms:

Ph / BCR-ABL-negative ALL, Ph/BCR-ABL-positive ALL and LBL

Risk Stratification:

(SR) standard risk and LBL, (HR) high risk (PH) Ph/BCR-ABL-positive
 

 

CNS prophylaxis is performed by randomisation in subjects with PH-negative B-ALL or B-LBL.

Documents (password protected)

Responsibilities in overall trial

Universitätsklinikum Frankfurt

National Coordinating Investigator

Dr. med. Nicola Gökbuget

Study Sites

Klinik I für Innere Medizin

Study office

  • Klinisches Studienzentrum der Klinik I für Innere Medizin Köln

Status

Active

Principal Investigator

Prof. Dr. med. Hans Christian Reinhardt

Deputy of Principal Investigator

  • Prof. Dr. med. Karl-Anton Kreuzer

Subinvestigator

  • Dr. med. Armin Tuchscherer
  • Prof. Dr. med. Karl-Anton Kreuzer
  • Prof. Dr. med. Christian Pallasch
  • Univ.-Prof. Dr. med. Dr. rer.-nat. Roland Ullrich
  • PD Dr. med. Thomas Zander
  • Dr. med. Othman Al-Sawaf
  • Dr.med. Vangica Galkin geb.Ristovska
  • Carolin Groß-Ophoff-Müller
  • Dr. med. Janine Böll, geb. Schwamb
  • Florian Simon
  • Dr. med. Anja Jühling
  • Johanna Prinz

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