EVALUATION OF SAFETY OF STANDARD CHEMOTHERAPY IN COMBINATION WITH DASATINIB IN ADULT PATIENTS WITH 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) - GMALL-PH-01

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-022854-18-DE

Enrollment

Registered

2011-01-25

Start date

2011-02-23

Completion date

Unknown

Last updated

2015-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Philadelphia chromosome positive Acute Lymphoblastic Leukemia

Interventions

Trade Name: Sprycel® Product Name: Sprycel (R) (Dasatinib) Product Code: BMS-354825-03 Pharmaceutical Form: Coated tablet INN or Proposed INN: DASATINIB CAS Number: 302962-49-8 Concentration unit: mg

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Confirmed new diagnosis of Philadelphia chromosome or BCR-ABL positive acute lymphoblastic leukaemia 2.Male or female patients aged 18-55 years 3.Not previously treated except for prephase therapy 4.Signed written inform consent 5.Molecular detection of BCR-ABL transcripts 6.Women of child-bearing potential or partner of men with child-bearing potential must use a highly effective method of contraception (pearl index =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Patients with ECOG status > 2 2. Patients with QTcF > 470 ms 3. Cardiac insufficiency NYHA grade III/IV, LEVF 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 8. Concurrent severe diseases which exclude the administration of therapy 9. Expected non-compliance or inability to understand informed consent 10. Female patients who are breast feeding, 11. Treatment with other investigational antileukemic agents after informed consent.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the feasibility of a combination of Dasatinib and standard chemotherapy in adult ALL;Secondary Objective: - Determine the hematologic response - assess the molecular CR rate during combined Dasatinib and chemotherapy - Assess the frequency and type of bcr-abl tyrosine kinase domain mutations - Determine rate of death during induction and death in complete remission ;Primary end point(s): Survival and rate of treatment-related discontinuation of study treatment during induction and consolidation chemotherapy;Timepoint(s) of evaluation of this end point: After consolidation (after approx. 3 Month of treatment)	—

Measure

Time frame

Main Objective: To evaluate the feasibility of a combination of Dasatinib and standard chemotherapy in adult ALL;Secondary Objective: - Determine the hematologic response - assess the molecular CR rate during combined Dasatinib and chemotherapy - Assess the frequency and type of bcr-abl tyrosine kinase domain mutations - Determine rate of death during induction and death in complete remission ;Primary end point(s): Survival and rate of treatment-related discontinuation of study treatment during induction and consolidation chemotherapy;Timepoint(s) of evaluation of this end point: After consolidation (after approx. 3 Month of treatment)

—

Secondary

Measure	Time frame
Secondary end point(s): Molecular CR rate Hematologic CR-rate at end of induction II BCR-ABL mutations occurring during treatment Grade III and IV toxicity by CTC;Timepoint(s) of evaluation of this end point: After consolidation (after approx. 3 Month of treatment)	—

Countries

Germany

Contacts

Public ContactStudienzentrale, Med. Klinik II

J. W. Goethe Universität

gmall@em.uni-frankfurt.de+49(0)6963016366

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026