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Philadelphia Positive Acute Lymphoblastic LeukemiaPhase 2NCT01724879

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

A Phase 2 study testing Dasatinib in people with Philadelphia Positive Acute Lymphoblastic Leukemia, run by Goethe University at 22 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 55 years
What is being tested?
Dasatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
22 sitesGermany
Study dates
Nov 2011to Sep 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 11Show fewer
  • 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.

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

Germany22 sites

  • Uniklinik Aachen

    Aachen, 52074

  • Charité Universitätsmedizin Berlin

    Berlin, 13353

  • Universitätsklinik Köln

    Cologne, 50937

  • Universitätsklinik Dresden

    Dresden, Saxony, 01307

  • University Hospital Düsseldorf

    Düsseldorf, 40225

  • Universitätsklinikum Essen

    Essen, North Rhine-Westphalia, 45147

  • University Hospital of Frankfurt, Medical Dept. II

    Frankfurt am Main, Hesse, 60590

  • Universitätsklinikum Göttingen

    Göttingen, 37075

  • Asklepios Klinik St. Georg

    Hamburg, 20099

  • Medizinische Hochschule Hannover

    Hanover, Lower Saxony, 30625

  • Universität Leipzig, José-Carreras-Haus

    Leipzig, 04103

  • Universitätskliniken Mainz

    Mainz, 55101

  • Klinikum Mannheim

    Mannheim, 68167

  • Universitätsklinikum Großhadern

    München, 81377

  • Universitätsklinik Münster

    Münster, North Rhine-Westphalia, 48149

  • Klinikum Nürnberg Nord

    Nuremberg, 90419

  • Klinikum Oldenburg

    Oldenburg, 26133

  • Klinikum der Universität Regensburg

    Regensburg, Bavaria, 93042

  • Universität Rostock

    Rostock, 18055

  • Robert Bosch Krankenhaus

    Stuttgart, Baden-Wurttemberg, 70376

  • Medizinische Universitätsklinik Ulm

    Ulm, 89070

  • Medizinische Poliklinik der Universität Würzburg

    Würzburg, 97070

Other trials in Germany

About this study

Official title: 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.

Read the detailed 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.

Being tested
Dasatinib
Keywords
philadelphia chromosome, BCR-ABL, ALL, acute lymphoblastic leukemia, dasatinib, Sprycel
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma, Philadelphia Chromosome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DasatinibDrug

    Also called Sprycel (R), BMS-354825

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

Study groups in NCT01724879
Study groupRoleWhat they receive
Dasatinib and chemotherapyExperimentalDasatinib, QD p.o. administration, day 1 to EOS
Receives: Drug: Dasatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Day 120

Secondary outcomes (3)

  1. Molecular complete remission rate (CR)

    Measured: Day 120

  2. Hematologic complete remission rate

    Measured: Day 120

  3. Grade III and IV txicity by Common Terminology Criteria for Adverse Events Version 3

    Measured: Day 120

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2012 (estimated)
  2. Study startNov 2011
  3. Primary completionSep 2015
  4. Study completionSep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01724879
Sponsor's protocol ID
GMALL-PH-01
Other IDs
2010-022854-18
Status last verified
Jan 2022
First submitted
3 Feb 2012
Last updated
26 Jan 2022
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dasatinib in people with Philadelphia Positive Acute Lymphoblastic Leukemia, run by Goethe University at 22 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment-related discontinuation of study treatment (Proportion of Patients) (time frame: Day 120). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01724879.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2022.

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