Comparing treatments for Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial evaluates the effectiveness of Ponatinib versus Imatinib, both combined with low-dose chemotherapy, in treating adults with Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL). It also investigates the continuation of therapy with Blinatumomab for patients who respond well to treatment and the use of Blinatumomab for those who do not respond adequately. The study aims to optimize treatment strategies and improve outcomes for patients with this aggressive form of leukemia.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male or female patients \>= 18 years, \<=65 years
* Philadelphia chromosome or BCR-ABL1 positive ALL
* Not previously treated except with corticosteroids ≤ 7 days, standard GMALL prephase with dexamethasone and cyclophosphamide including intrathecal therapy, hydroxyurea, a single dose vincristine or other cytostatic drugs and start of standard induction for Ph-positive ALL (1 dose vincristine, 1 dose of Rituximab, 2 doses dexamethasone and up to 5 days Imatinib)
* ECOG performance status ≤2
* Signed written inform consent
* Molecular evaluation for BCR-ABL1 performed
* Negative pregnancy test in women of childbearing potential
* Woman of childbearing potential willing to use 2 highly effective methods of contraception while receiving study treatment and for an additional 3 months after the last dose of study treatment (Pearl-Index \<1%). Male who has a female partner of childbearing potential willing to use 2 highly effective forms of contraception while receiving study treatment and for at least an additional 3 months after the last dose of study treatment (Pearl-Index \<1%).
* Normal serum levels \> LLN (lower limit of normal) of potassium and magnesium, or corrected to within normal limits with supplements, prior to the first dose of study medication
* Serum lipase ≤ 1.5 x ULN. For serum lipase \> ULN - ≤ 1.5 x ULN, value must be considered not clinically significant and not associated with risk factors for acute pancreatitis
* Normal QTcF interval ≤450 ms for males and ≤470 ms for females
* Signed and dated written informed consent is available
* Participation in the registry of the German Multicenter Study Group for Adult ALL (GMALL)

Exclusion Criteria:

* History of malignancy other than ALL diagnosed within 5 years (yrs) prior to start of protocol-specified therapy with defined exceptions
* Contraindications against the use of Imatinib, Ponatinib, chemotherapy or Blinatumomab
* Patient previously treated with tyrosine kinase inhibitors
* Nursing women
* Known impaired cardiac function, including any of the following: as detailed in protocol
* Symptomatic peripheral vascular disease
* Any history of ischemic stroke or transient ischemic attacks (TIAs)
* Uncontrolled hypertriglyceridaemia
* History or presence of clinically relevant CNS pathology as detailed in protocol
* History or active relevant autoimmune disease
* Known hypersensitivity to immunoglobulins or to any other component of the study drug formulation
* Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory) or active infection with Hepatitis B or C
* History of pancreatitis within 6 months previous to start of treatment within the trial
* Treatment with any other investigational agent or participating in another trial within 30 days prior to entering this study
* Inadequate hepatic functions defined as ASAT or ALAT \> 2,5 times the institutional upper limit of normal or \> 5 times ULN if considered due to leukemia
* Total bilirubin \> 1.5-fold the institutional upper limit unless considered to be due to organ involvement by the leukemia or to M. Gilbert / M. Meulengracht
* Concurrent severe diseases which exclude the administration of therapy e.g. severe, uncontrolled acute or chronic infections
* Inability to understand and/or unwillingness to sign a written informed consent

Where it's running

• Uniklinik RWTH Aachen
  Aachen, Germany Recruiting
• Klinikum Aschaffenburg
  Aschaffenburg, Germany Recruiting
• Klinikum Augsburg
  Augsburg, Germany Recruiting
• Helios Klinikum Bad Saarow
  Bad Saarow, Germany Recruiting
• Klinikum Bayreuth
  Bayreuth, Germany Recruiting
• Vivantes Klinikum am Urban
  Berlin, Germany Recruiting

+35 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Nicola Goekbuget, MD — Department of Medicine, Hematology and Oncology, Goethe University Frankfurt, Frankfurt, Germany
• Study coordinator: Nicola Goekbuget, MD
• Email: goekbuget@em.uni-frankfurt.de
• Phone: 0049-6963016365

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• LP-118 in combination with standard therapy for newly diagnosed Ph+ ALL

  This study tests whether adding LP-118 to the standard therapy for adults with Philadelphia chromosome–positive ALL is safe and useful.

  Recruiting at 2 sites Phase 1 Wake Forest University Health Sciences · Charlotte, North Carolina and 1 other locations · NCT07614022

• Asciminib in children and young adults with relapsed or refractory Ph+ or ABL-class Ph-like ALL

  This study tests asciminib in kids and young adults with relapsed or refractory Philadelphia-positive or ABL-class Ph-like ALL to see if it is safe and helps treat the leukemia.

  Recruiting at 4 sites Phase 1/2 Novartis · Sydney, New South Wales and 3 other locations · NCT07387926

• Combining blinatumomab with dasatinib or imatinib plus chemotherapy for young people with Ph+ or ABL-class Ph-like B‑ALL

  This pilot will see if adding three cycles of blinatumomab and a continuous tyrosine kinase inhibitor (dasatinib or imatinib) to a modified chemotherapy plan helps children, adolescents, and young adults with Ph+ or ABL-class Ph-like B‑ALL stay in remission longer.

  Recruiting at 159 sites Phase 2 National Cancer Institute (NCI) · Birmingham, Alabama and 160 other locations · NCT06124157

• Inotuzumab ozogamicin and blinatumomab with optional ponatinib for CD22-positive B-cell acute lymphoblastic leukemia

  This trial will test whether inotuzumab ozogamicin followed by blinatumomab, with or without ponatinib, can help people with CD22-positive B-cell acute lymphoblastic leukemia who are newly diagnosed, have relapsed, or are refractory to prior therapy.

  Recruiting at 89 sites Phase 2 National Cancer Institute (NCI) · Birmingham, Alabama and 284 other locations · NCT03739814

• Combining blinatumomab, methotrexate, cytarabine, and ponatinib for treating certain types of leukemia

  This study is testing a new combination of four medications to see if it can help people with certain types of leukemia that have come back or didn't respond to previous treatments.

  Recruiting Phase 2 M.D. Anderson Cancer Center · Houston, Texas · NCT03263572

• Using ponatinib for patients with chronic myeloid leukemia who didn't respond to other treatments

  This study is testing if ponatinib can help people with chronic myeloid leukemia who didn't respond to other treatments feel better and improve their health.

  Recruiting Phase 2 M.D. Anderson Cancer Center · Houston, Texas · NCT01746836

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.