Trials Sponsors Conditions Drugs Pricing

Conditions

Chronic Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

MR2 is defined as ≤ 1% BCR::ABL1 at 6 months.

Secondary Outcomes (14)

Cmax and Tmax will be determinate.
A complete cytogenetic response (CCyR) is defined as absence of the Ph among at least 20 cells in meta phase in a bone marrow aspirate at 6 months.
Type, frequency, and severity of adverse events.
A complete cytogenetic response (CCyR) is defined as absence of the Ph among at least 20 cells in metaphase in a bone marrow aspirate at 12 months.
MR2, MR3/MMR, MR4, and MR4.5 at 3month intervals and MR1 (≤ 10% BCR::ABL1) at 3 months.
+9 more secondary outcomes

Interventions

Scemblix 40 mg film-coated tabletsType not reported

Scemblix 20 mg film-coated tabletsType not reported

Iclusig 45 mg film-coated tabletsType not reported

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
Scemblix 40 mg film-coated tablets
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry record
Formulated product
Scemblix 20 mg film-coated tablets
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry record
Formulated product
Iclusig 45 mg film-coated tablets
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

Scemblix 40 mg film-coated tablets
Named ingredient: Asciminib hydrochloride
View registry record
Scemblix 20 mg film-coated tablets
Named ingredient: Asciminib hydrochloride
View registry record
Iclusig 45 mg film-coated tablets
Named ingredient: ponatinib
View registry record

Eligibility Criteria

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Diagnosed patients with CML resistant to ponatinib and/or asciminib. Resistance to prior TKI therapy is defined as follows (patients must meet at least 1 criterion): a) Three months after the initiation of prior TKI therapy: No cytogenetic response (> 95% Ph+) or failure to achieve CHR or new mutation. b) Three months after the initiation of prior TKI therapy: BCR::ABL1BCR::ABL1 >10% and/or Ph+ >65% or new mutation. c) Six months after the initiation of prior TKI therapy: BCR::ABL1 >1% and/or Ph+ >35% or new mutation. d) At any time after the initiation of prior TKI therapy, development of new BCR::ABL1 kinase domain mutations in the absence of CCyR or PCyR. e) At any time after the initiation of prior TKI therapy, development of new clonal evolution in the absence of CCyR or PCyR. f) At any time after the initiation of prior TKI therapy, loss of CHR, loss of CCyR or PCyR, or the confirmed loss of MMR in 2 consecutive tests, one of which has a BCR::ABL1 BCR::ABL1 transcript level of ≥1% or new mutation.

Sponsors & Collaborators

Grupo Espanol De Leucemia Mieloide Cronica (GELMC)
Otherlead

Study Sites (10)

Hospital Universitario Regional De Malaga

Malaga, 29010, Spain

María Concepción Ruiz+34951291952 conchirn@hotmail.com

Hospital Universitario Y Politecnico La Fe

Valencia, 46026, Spain

Elvira Mora+34961245876 mora_elv@gva.es

Hospital Universitario La Paz

Madrid, 28046, Spain

Raquel De Paz+34659632201

Central Study Contacts

Gemma Sánchez

0034656728655 gemma.sanchez@sehh.es

Study Design

Study Type: interventional
Phase: phase 2

Study Record Dates

First Submitted

March 9, 2026

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2025-521126-15-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-30 06:14:44 UTC

Documents

PONTHIAC_Protocolo-V1_05-03-2026_Redacted

Willingness to avoid pregnancy or fathering children based on the criteria below. a) Male participants with reproductive potential must agree to take appropriate precautions to avoid fathering children (with at least 99% certainty) from screening through 180 days (6 months) after the last dose of study treatment, even if they have undergone a successful vasectomy, and must refrain from donating sperm during this period. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the participants and their understanding confirmed. b) WOCBP participants: i) Must commit either to abstain continuously from heterosexual sexual intercourse or agree to take appropriate precautions to avoid pregnancy (by using 2 different methods of birth control: one with at least 99% certainty and an additional effective [barrier] method) starting at least 4 weeks before taking the study treatment, while taking the study treatment, during breaks (dose interruptions), and for at least 180 days (6 months) after stopping the study treatment. Permitted methods that are at least 99% effective in preventing pregnancy and the permitted additional effective (barrier) methods should be communicated to the participants and their understanding confirmed. Note: Because of the increased risk of venous thromboembolism, combined oral contraceptive pills are not recommended. If a participant is currently using combined oral contraception, the participant should switch to other effective methods. The risk of venous thromboembolism continues for 4 to 6 weeks after discontinuing combined oral contraception. ii) Must have a negative serum pregnancy test at screening (within 10-14 days of the first study drug treatment) and before the first dose on Day 1 (within 24 hours of initiating treatment). iii) Agree to ongoing pregnancy testing during the course of the study; weekly during the first month of study drug treatment, then monthly thereafter for women with regular menstrual cycles or every 2 weeks for women with irregular menstrual cycles (even if true abstinence is the chosen method of birth control) up to and including the EOT visit. iv) Must refrain from breastfeeding and donating oocytes during the course of study and for 180 days (6 months) after the last dose of study treatment. v) A female participant who is not considered to be of childbearing potential as defined in Appendix A is eligible. Note: The participants should be informed about the option of donation and cryopreservation of germ cells before the study if applicable.

You may not qualify if:

Previous intolerance to ponatinib or asciminib defined as: a) Previous CT-CAE > or =3 not resolved after temporary discontinuation of the drug. b) Discontinuation of treatment due to permanent intolerance according to investigator judgment. c) Adverse effect that required permanent discontinuation.
Have a significant bleeding disorder unrelated to CML.
Have a history of alcohol abuse according to medical records.
Have a history of either acute pancreatitis within 1 year of study or chronic pancreatitis.
Have malabsorption syndrome or other gastrointestinal illness that could affect oral absorption of study drug.
Have a history of another malignancy, other than cervical cancer in situ or basal cell or squamous cell carcinoma of the skin; the exception is if patients have been disease-free for at least 5 years.
Known hypersensitivity or severe reaction to ponatinib or excipients of ponatinib.
Known hypersensitivity or severe reaction to ascinimib or excipients of ascinimib.
Females who are pregnant or lactating.
Receipt of live (including attenuated) vaccines or anticipation of need for such vaccines during the study.
Inability or unlikeliness to comply with the dose schedule and study evaluations, in the opinion of the investigator.
Have used any approved TKIs or investigational agents within 2 weeks or half-lives of the agent, whichever is longer, prior to receiving study drug.
Any condition or illness that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
Inability of the participant (or guardian, or legally authorized representative) to comprehend the ICF or unwillingness to sign the ICF.
Have undergone autologous or allogeneic stem cell transplant (SCT) < 60 days prior to receiving the first dose of ponatinib or have any evidence of ongoing graft versus-host disease (GVHD) or GVHD requiring immunosuppressive therapy.
+7 more criteria

Safety and efficacy of treatment combination with ponatinib and asciminib in chronic myeloid leukemia patients resistant to ponatinib and/or asciminib

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (14)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (10)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (14)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (10)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations