Long-term safety treatment for chronic myelogenous leukemia patients

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 open-label, multi-center global roll-over study focuses on the long-term safety of asciminib for patients who have previously participated in a Novartis-sponsored study. Participants who are deemed by their investigator to benefit from continued treatment will receive asciminib or other approved therapies. The study aims to provide ongoing access to treatment for those unable to obtain it outside of the clinical setting. It includes patients with Philadelphia chromosome-positive chronic myelogenous leukemia or acute lymphoblastic leukemia.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

1. Participant with PH+ CML or PH+ ALL currently receiving treatment with asciminib (single agent or in combination with imatinib, nilotinib or dasatinib), imatinib, nilotinib or bosutinib alone within a Novartis-sponsored study and, in the opinion of the Investigator, would benefit from continued treatment.
2. Participant has demonstrated compliance on the parent study protocol and is willing and able to comply with scheduled visits, treatment plans and any other study procedures.

Key Exclusion Criteria:

1. Participant has been discontinued from parent study treatment.
2. Participant currently has unresolved toxicities reported as possibly related to study treatment in the parent study.
3. Participant's ongoing treatment is currently approved and reimbursed at country level.
4. Pregnant or nursing (lactating) women.
5. Women of child-bearing potential, unless they are using highly effective methods of contraception and willing to continue while taking study treatment.
6. Sexually active males receiving imatinib, nilotinib, bosutinib or dasatinib unwilling to follow the relevant contraception requirements in the local prescribing information.
7. Applicable for participants on bosutinib treatment at the end of the CABL001A2301 and on other TKIs for CABL001A2202 study that switch to asciminib treatment:

   * Asymptomatic (grade 2) pancreatitis if not resolved within 28 days
   * QTcF\>480msec or inability to determine QTc interval
   * any grade 3 or 4 toxicity not resolved to grade 2 or lower within 28 days before starting asciminib treatment

Other protocol-defined Inclusion/Exclusion criteria may apply.

Where it's running

• Michigan Med University of Michigan
  Ann Arbor, Michigan, United States Recruiting
• Washington University School Of Medicine-Siteman Cancer Ctr
  St Louis, Missouri, United States Recruiting
• Memorial Sloan Kettering
  New York, New York, United States Recruiting
• Oncology Hematology Care Inc
  Cincinnati, Ohio, United States Recruiting
• Texas Oncology
  Dallas, Texas, United States Recruiting
• Uni Of TX MD Anderson Cancer Cntr
  Houston, Texas, United States Recruiting

+38 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: 1-888-669-6682

Similar studies

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

• Asciminib for children and teens with Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase

  This study will try asciminib as a treatment for children aged 1 to under 18 with Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase, including newly diagnosed patients and those who are resistant or intolerant to prior TKIs, with or without the T315I mutation.

  Recruiting at 39 sites Phase 2 Novartis · Chicago, Illinois and 38 other locations · NCT07354074

• Asciminib for chronic phase CML with T315I mutation

  This study tests asciminib 200 mg twice daily in adults with chronic phase CML and a T315I mutation after stem cell transplant to see if it helps control leukemia.

  Recruiting at 5 sites Phase 2 University of Jena · Aachen and 9 other locations · NCT07789574

• Asciminib for Ph+ CML-CP in Germany: real-world patient experiences

  This real-world study tests how asciminib performs in adults with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase, including those newly diagnosed or after one prior TKI.

  Recruiting at 74 sites Novartis · Baden-Baden, Baden-Wurttemberg and 73 other locations · NCT07549516

• 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

• Scemblix (asciminib) for newly diagnosed chronic-phase CML in China

  This project will try asciminib (Scemblix) in adults newly diagnosed with chronic-phase CML to see if it controls the disease and is safe.

  Recruiting Novartis · Wuhan, Hubei · NCT07375355

• Asciminib maintenance after alloHCT or CAR T for adults with Ph+ ALL

  Doctors will try asciminib in adults with Ph+ ALL who are in remission after an allogeneic stem cell transplant or CAR T therapy to check safety and find the best dose to help prevent relapse.

  Recruiting Phase 1 H. Lee Moffitt Cancer Center and Research Institute · Tampa, Florida · NCT07250087

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.