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New treatment option for Chronic Myelogenous Leukemia
Official title Asciminib Roll-over Study
ClinicalTrials.gov ID: NCT04877522
What this study is testing
What is Asciminib single agent?
Asciminib single agent is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for chronic myelogenous leukemia.
Also referred to as ABL001.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a long term safety study for patients who have completed a Novartis sponsored asciminib study and are judged by the investigator to benefit from continued treatment
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 7 to 100
You may be able to join if
- Participant with PH+ CML or PH+ ALL currently receiving treatment with asciminib (single agent or in combination with imatinib, nilotinib or...
- Participant has demonstrated compliance on the parent study protocol and is willing and able to comply with scheduled visits, treatment plans and any...
You likely can't join if
- Participant has been discontinued from parent study treatment.
- Participant currently has unresolved toxicities reported as possibly related to study treatment in the parent study.
- Participant's ongoing treatment is currently approved and reimbursed at country level.
- Pregnant or nursing (lactating) women.
- Women of child-bearing potential, unless they are using highly effective methods of contraception and willing to continue while taking study...
- Sexually active males receiving imatinib, nilotinib, bosutinib or dasatinib unwilling to follow the relevant contraception requirements in the local...
See the full eligibility criteria
- 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...
- 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
- Participant has been discontinued from parent study treatment.
- Participant currently has unresolved toxicities reported as possibly related to study treatment in the parent study.
- Participant's ongoing treatment is currently approved and reimbursed at country level.
- Pregnant or nursing (lactating) women.
- Women of child-bearing potential, unless they are using highly effective methods of contraception and willing to continue while taking study treatment.
- Sexually active males receiving imatinib, nilotinib, bosutinib or dasatinib unwilling to follow the relevant contraception requirements in the local prescribing information.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
- New York, New York, United States
- Portland, Oregon, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Milwaukee, Wisconsin, United States
- CABA, Buenos Aires, Argentina
- Capital Federal, Argentina
- Graz, Austria
- Vienna, Austria
- Rio de Janeiro, Rio de Janeiro, Brazil
- São Paulo, São Paulo, Brazil
- Varna, Bulgaria
- Montreal, Quebec, Canada
- Chongqing, Chongqing Municipality, China
- Guangzhou, Guangdong, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Changchun, Jilin, China
- Xian, Shanxi, China
+ 58 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 7 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States; New York, New York, United States; Portland, Oregon, United States; Dallas, Texas, United States; Houston, Texas, United States; Milwaukee, Wisconsin, United States and 72 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.