Study of olverembatinib with chemotherapy versus standard therapy in adults with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia

3 1 1 1

What is this study about?

This clinical trial is studying a treatment for Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL) in newly diagnosed patients. The study tests a new medication called olverembatinib used together with chemotherapy drugs. The chemotherapy medications include vincristine, cytarabine, methotrexate, dexamethasone, and prednisolone.

The study compares two treatment approaches: one group receives olverembatinib with chemotherapy, while the other group receives different medications called tyrosine kinase inhibitors (which may include dasatinib, ponatinib, or imatinib) combined with the same chemotherapy drugs. The main purpose is to find out how well olverembatinib works compared to current treatments in eliminating cancer cells from the body.

During the study, patients will receive their assigned medications for several months. Doctors will regularly check the amount of cancer cells in the blood and bone marrow to see how well the treatment is working. They will also monitor patients for any side effects from the medications and track their overall health and survival over time.

1 Initial phase – Induction therapy

You will receive a combination of chemotherapy and a study medication called olverembatinib

The medications will be given through different methods:

– Vincristine sulfate through IV infusion

– Prednisolone as oral tablets

– Methotrexate through IV infusion and spinal injection

– Dexamethasone as oral tablets and through IV

– Cytarabine through IV infusion and spinal injection

2 Response evaluation

Your response to the treatment will be checked through blood tests and bone marrow examination

The main goal is to achieve a complete response, which means:

– No cancer cells in blood

– Less than 5% cancer cells in bone marrow

– Normal blood cell counts

– No signs of cancer outside the bone marrow

3 Continuation therapy

If you respond well to the initial treatment, you will continue receiving therapy

The treatment will include regular doses of:

– Olverembatinib taken by mouth

– Additional chemotherapy medications as prescribed by your doctor

Regular blood tests and examinations will monitor your progress

4 Follow-up period

After completing the treatment phase, you will have regular follow-up visits

These visits will include:

– Blood tests

– Physical examinations

– Monitoring for any signs of disease return

The total study duration is expected to continue until February 2027

Who Can Join the Study?

  • Must be 18 years or older
  • Must be newly diagnosed with Philadelphia chromosome-positive Acute Lymphoblastic Leukemia (Ph+ ALL) and not have received previous systemic treatment, except for:
    – Hydroxycarbamide treatment
    – One-time vincristine treatment
    – Steroid therapy lasting no more than 28 days
  • Must have a life expectancy of at least 3 months
  • Must have an ECOG performance status of 2 or less (a measure of patient’s ability to perform daily activities)
  • Must have adequate organ function, including:
    – Liver function within specified limits
    – Kidney function within specified limits
    – Normal blood clotting measures
    – Heart function showing ejection fraction above 50%
    – Normal cardiac markers
    – Normal heart rhythm measurements
  • Must agree to use effective birth control methods during treatment and for 4 months after the last dose. This applies to:
    – Both men and women who can have children
    – Male participants must not donate sperm
  • Women who can become pregnant must have a negative pregnancy test within 7 days before starting treatment
  • Must be able to understand and sign an informed consent form and complete all study procedures and follow-up examinations

Who Cannot Join the Study?

  • Prior treatment with any therapy for Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL), except for emergency treatment with steroids for up to 7 days
  • History of another type of cancer within the past 3 years, except for successfully treated skin cancer or early-stage cancer
  • Serious heart conditions including:
    • Uncontrolled high blood pressure
    • Heart attack in the past 6 months
    • Severe heart rhythm problems
  • Active, uncontrolled infections requiring treatment
  • Known active hepatitis B or C infection
  • HIV positive patients
  • Severe kidney or liver problems
  • Pregnant or breastfeeding women
  • Unable to swallow oral medications
  • Any condition that could interfere with the patient’s ability to follow study requirements
  • Participation in another clinical trial within 30 days before starting this study

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Centre Hospitalier De Versailles Le Chesnay-Rocquencourt France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Institute Of Hematology And Blood Transfusion Prague Czechia
Hospital San Pedro De Alcantara Caceres Spain
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Azienda Socio Sanitaria Territoriale Dei Sette Laghi Varese Italy
Spitalul Clinic Colentina Bucuresti Bucharest Romania
Institutul Regional De Oncologie Iasi Iasi Romania
Virgen del Rocío University Hospital Sevilla Spain
Ospedale San Raffaele S.r.l. Milan Italy
Fakultni Nemocnice Brno Brno Czechia
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Centre Hospitalier Universitaire De Nice Nice France
University Of Pecs Pecs Hungary
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Centre Hospitalier Universitaire De Nantes Nantes France
University Hospital Ostrava Ostrava Czechia
Specialized Hospital For Active Treatment Of Hematological Diseases EAD Sofia Bulgaria
Cpnfth Lmgu Buobis Lyon France
Hyaovvfh Ubcjwfuezbcnf Df Ld Pjbsapqb Madrid Spain
Hqvfltnp Utbezggxjxwfs Mlvambw Dk Vzahydepqj Santander Spain
Ictpcffr Czuoxw Dvfnmscwnwsmjxfet L'hospitalet De Llobregat Spain
Shkqxhnu Cztnnf Mwwbxtmfh Fwjgosqoysg Chlavjq Craiova Romania
Ijodqbyc Rkqoamwlk Plo Li Shpefw Dxn Ttgpvu Diyo Aeugolr Itch Smghvq Meldola Italy
Aapavkp Ocdxyeerecs Ussmstqjdrweu Czziegclfhmx Dvcoj Sdscay E Dbbtb Suquroz Dw Tlqoae Turin Italy
Alvfbqs Uanfc Sfclopbzt Lsybbu Do Batdwbd Bologna Italy
Hilabjaj Utjfwadelcbau Hfzggice Tygad y Pidcvi Iduaigja Cduyxu djlohtcdlcksmbwuq (crkj Badalona Spain
Hfuswhxi Vvvj denprbod Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not recruiting
25.07.2025
Czechia Czechia
Not yet recruiting
25.07.2025
France France
Recruiting
25.07.2025
Hungary Hungary
Not yet recruiting
25.07.2025
Italy Italy
Recruiting
25.07.2025
Romania Romania
Not yet recruiting
25.07.2025
Spain Spain
Recruiting
25.07.2025

Trial locations

Olverembatinib is a targeted therapy medication known as a tyrosine kinase inhibitor (TKI). It works by blocking specific proteins that contribute to cancer cell growth in patients with Philadelphia chromosome-positive acute lymphoblastic leukemia. This medication is given in combination with chemotherapy drugs to treat newly diagnosed patients.

Tyrosine Kinase Inhibitors (TKIs) are a class of medications that work by blocking specific proteins involved in cancer cell growth. In this trial, various TKIs are used as comparison treatments, combined with chemotherapy, according to the investigator’s choice.

Chemotherapy refers to traditional cancer-fighting medications that work by killing rapidly dividing cells in the body. These medications are used in combination with either olverembatinib or other TKIs to treat leukemia.

Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL) – A type of blood and bone marrow cancer where the body produces abnormal white blood cells containing a specific genetic mutation called the Philadelphia chromosome. The disease develops rapidly, with abnormal lymphoid cells (lymphoblasts) multiplying quickly and replacing normal blood cells in the bone marrow. These malignant cells eventually spread into the bloodstream and can infiltrate other organs. The condition affects the body’s ability to produce normal blood cells, leading to decreased production of red blood cells, platelets, and healthy white blood cells. The presence of the Philadelphia chromosome makes this form of leukemia distinct from other types of acute lymphoblastic leukemia.

Trial ID:
2024-511496-14-00
Protocol code:
HQP1351AG301
NCT ID:
NCT06051409
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Study of Ruxolitinib and Venetoclax for Children with Relapsed or Refractory Leukemia or Lymphoma with IL-7R/JAK-STAT Pathway Mutations

    Recruiting

    1 1 1 1
    Investigated drugs:
    Austria Belgium Denmark Finland France Germany +5
  • Study of Blinatumomab and a drug combination for older adults with newly diagnosed Philadelphia-negative B-cell precursor Acute Lymphoblastic Leukemia

    Recruiting

    3 1 1 1
    Austria Belgium Bulgaria Czechia Denmark Estonia +11