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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01724879
Other study ID # GMALL-PH-01
Secondary ID 2010-022854-18
Status Completed
Phase Phase 2
First received
Last updated
Start date November 2011
Est. completion date September 2015

Study information

Verified date January 2022
Source Goethe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The current standard treatment approach for young patients with Positive Acute Lymphoblastic Leukemia (Ph+ALL) is the combination of a chemotherapy protocol employing four to five cytotoxic agents typically used for ALL together with imatinib. It is recommended to propose allogeneic Standard Induction and Consolidation Therapy (SCT) to all eligible patients with a suitable donor and to continue imatinib with or without additional therapy in patients not undergoing SCT. This protocol is a study for newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia in patients aged 18 to 55 years. The objective of this strategy is to improve the overall results in the treatment of adult ALL with the addition of specific molecules to the common chemotherapeutic schedule.


Description:

In the present study, the potent ABL tyrosine kinase inhibitor, Dasatinib will be added to standard induction and consolidation chemotherapy for the Philadelphia positive chromosome sub-group of ALL patients aged 18 to 55 years. The Study hypothesis is, that Dasatinib in combination with standard chemotherapy according to GMALL protocol 07/2003 is feasible and induces cytologic and molecular remission rates comparable to chemotherapy in combination with imatinib without increased treatment-related mortality.


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date September 2015
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - Confirmed new diagnosis of Philadelphia chromosome or BCR-ABL positive acute lymphoblastic leukemia - Male or female patients aged 18-55 years - Not previously treated except for prephase (corticosteroids, cyclophosphamide, single dose VCR will be permitted) therapy during establishment of the diagnosis - Signed written inform consent, willingness and ability to comply with all study procedures - Molecular detection of BCR-ABL transcripts - Willingness of women of child-bearing potential (WOCBP) and male subjects whose sexual partners are WOCBP, to use an effective form of contraception (pearl index < 1%), such as complete sexual abstinence, combined oral contraceptive, hormone IUCD, vaginal hormone ring, transdermal contraceptive patch, contraceptive implant or depot contraceptive injection in combination with a second method of contraception like a condom or a cervical cap / diaphragm with spermicide or surgical sterilisation (vasectomy) in male patients or male partners during the study and at least 6 months thereafter. WOCBP are defined as sexually mature women who have not undergone a hysterectomy or surgical sterilization or who have not been naturally postmenopausal for at least 12 consecutive months (i.e., who has had menses any time in the preceding 12 consecutive months). - Negative pregnancy test for women of child-bearing potential. Exclusion Criteria: - Patients with ECOG status > 2 - Patients with QTcF > 470 ms - Cardiac insufficiency NYHA grade III/IV, LEVF < 50%, myocardial infarction within the past 6 months prior to study - Active secondary malignancy requiring treatment - Patients with active, uncontrolled bacterial, viral or fungal infection - Known infection with HIV, Hepatitis B (except post vaccinal profile) or C - Inadequate hepatic functions defined as ASAT or ALAT > 2,5 times the institutional upper limit of normal and total bilirubin > 2 fold the institutional upper limit unless considered to be due to organ involvement by the leukemia - Concurrent severe diseases which exclude the administration of therapy - Expected non-compliance or inability to understand informed consent - Female patients who are pregnant or breast feeding - Treatment with other investigational antileukemic agents after informed consent.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dasatinib
Dasatinib p.o. + Chemotherapy (Dexamethasone, Cyclophosphamide, Vincristine, Methotroxate, 6-Mercapto-Purine, Cytarabine, Vindesine, VP16 (Etoposide))

Locations

Country Name City State
Germany Uniklinik Aachen Aachen
Germany Charité Universitätsmedizin Berlin Berlin
Germany Universitätsklinik Dresden Dresden Sachsen
Germany University Hospital Düsseldorf Düsseldorf
Germany Universitätsklinikum Essen Essen NRW
Germany University Hospital of Frankfurt, Medical Dept. II Frankfurt Hessen
Germany Universitätsklinikum Göttingen Göttingen
Germany Asklepios Klinik St. Georg Hamburg
Germany Medizinische Hochschule Hannover Hannover Niedersachsen
Germany Universitätsklinik Köln Köln
Germany Universität Leipzig, José-Carreras-Haus Leipzig
Germany Universitätskliniken Mainz Mainz
Germany Klinikum Mannheim Mannheim
Germany Universitätsklinikum Großhadern München
Germany Universitätsklinik Münster Münster NRW
Germany Klinikum Nürnberg Nord Nürnberg
Germany Klinikum Oldenburg Oldenburg
Germany Klinikum der Universität Regensburg Regensburg Bayern
Germany Universität Rostock Rostock
Germany Robert Bosch Krankenhaus Stuttgart Baden-Württemberg
Germany Medizinische Universitätsklinik Ulm Ulm
Germany Medizinische Poliklinik der Universität Würzburg Würzburg

Sponsors (1)

Lead Sponsor Collaborator
Goethe University

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Treatment-related discontinuation of study treatment (Proportion of Patients) Day 120
Secondary Molecular complete remission rate (CR) Day 120
Secondary Hematologic complete remission rate Day 120
Secondary Grade III and IV txicity by Common Terminology Criteria for Adverse Events Version 3 Day 120
See also
  Status Clinical Trial Phase
Completed NCT03821727 - SCT in Ph Positive Acute Lymphoblastic Leukemia
Recruiting NCT00199186 - Study Comparing Imatinib With Chemotherapy as Induction in Elderly Patients With Philadelphia Positive Acute Lymphoblastic Leukemia (ALL) Phase 2
Recruiting NCT04260022 - Study of HQP1351 in Subjects With Refractory CML and Ph+ ALL Phase 1
Completed NCT01914484 - Phase I/II Study of Nilotinib/Ruxolitinb Therapy for TKI Resistant Ph-Leukemia Phase 1/Phase 2