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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)


Phase 2
18 Years
55 Years
Open (Enrolling)
Both
Philadelphia Positive Acute Lymphoblastic Leukemia

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Trial Information

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)


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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Treatment-related discontinuation of study treatment (Proportion of Patients)

Outcome Time Frame:

Day 120

Safety Issue:

Yes

Principal Investigator

Oliver G. Ottmann, Prof.Dr.med

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johann Wolfgang Goethe University Hospitals

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

GMALL-PH-01

NCT ID:

NCT01724879

Start Date:

November 2011

Completion Date:

May 2014

Related Keywords:

  • Philadelphia Positive Acute Lymphoblastic Leukemia
  • philadelphia chromosome
  • BCR-ABL
  • ALL
  • acute lymphoblastic leukemia
  • dasatinib
  • Sprycel
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Philadelphia Chromosome

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