Study of Frontline Dasatinib Plus Chemotherapy in Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (PH+ALL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01724879
Recruitment Status : Completed
First Posted : November 12, 2012
Last Update Posted : February 11, 2016
Information provided by (Responsible Party):
Nicola Goekbuget, Johann Wolfgang Goethe University Hospital

February 3, 2012
November 12, 2012
February 11, 2016
November 2011
September 2015   (Final data collection date for primary outcome measure)
Treatment-related discontinuation of study treatment (Proportion of Patients) [ Time Frame: Day 120 ]
Same as current
Complete list of historical versions of study NCT01724879 on Archive Site
  • Molecular complete remission rate (CR) [ Time Frame: Day 120 ]
  • Hematologic complete remission rate [ Time Frame: Day 120 ]
  • Grade III and IV txicity by Common Terminology Criteria for Adverse Events Version 3 [ Time Frame: Day 120 ]
Same as current
Not Provided
Not Provided
Study of Frontline Dasatinib Plus Chemotherapy in Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (PH+ALL)
Open Label Phase II Study to Evaluate the Safety of Standard Induction and Consolidation Therapy in Combination With Dasatinib in Newly Diagnosed Adult Patients With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (PH+ALL)

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.

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.

Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Philadelphia Positive Acute Lymphoblastic Leukemia
Drug: Dasatinib
Dasatinib p.o. + Chemotherapy (Dexamethasone, Cyclophosphamide, Vincristine, Methotroxate, 6-Mercapto-Purine, Cytarabine, Vindesine, VP16 (Etoposide))
Other Names:
  • Sprycel (R)
  • BMS-354825
Experimental: Dasatinib and chemotherapy
Dasatinib, QD p.o. administration, day 1 to EOS
Intervention: Drug: Dasatinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2015
September 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
2010-022854-18 ( EudraCT Number )
Not Provided
Not Provided
Nicola Goekbuget, Johann Wolfgang Goethe University Hospital
Johann Wolfgang Goethe University Hospital
Not Provided
Principal Investigator: Nicola Gökbuget, Johann Wolfgang Goethe University Hospital
Johann Wolfgang Goethe University Hospital
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP