CML failed TKI and now transplant - clinical trial?

Going through treatment
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Hi

I was diagnosed with Chronic myeloid leukaemia ('CML') in September 2024 aged 35. I have two young children, now aged 3 and 5.

Both imatanib and dastanib failed to get molecular response. Been on ponatanib 45mg for 7 months, only now has it come down to 4.7. Scheduled for transplant in April. Great donor match and I’m for and healthy. However I want to know if I can go on a clinical trial? I’m having treatment at clatterbridge.

As I’m in chronic phase, Am I eligible for POLARIS-2 or any olverembatinib trial before transplant?

I understand they are recruiting from the Christie annd in London and is often done before transplant especially for people younger with my Chronic myeloid leukaemia ('CML') profile.

Thanks

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To add I have no mutations, peripheral bloods always been in range and never any side effects to medication

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Hi @hph, and welcome back to the forum. I’m sorry to hear about your diagnosis, but glad to read that you’re fit and healthy going into the transplant process.

I’m going to tag our Clinical Trials team here, as they’re the best people to help with your specific question (@ClinicalTrialsSupportService). They run a dedicated Clinical Trials Support Service and can carry out a personalised search based on your diagnosis, treatment history, and profile. Please do take a moment to self-refer directly here as well, as that’s likely to be what the team advise you to do initially anyway.

Given that your transplant is scheduled for April, I’d also encourage you to raise this with your team at Clatterbridge as soon as possible if you haven’t already as your consultant will be best placed to advise on whether a pre-transplant trial pathway is feasible within your current timeline, and whether a referral to another recruiting centre would be worth exploring.

Take good care of yourself, and please do let us know how you get on.

Ceri - Blood Cancer UK Support Services

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Hello @hph

I’m Rachel, one of the Clinical Trial Support Nurses, it’s lovely to meet you here, and I’m really glad you reached out. We’re always here to help however we can.

I also want to echo what @Ceri_BloodCancerUK said: anything to do with treatment decisions or timing alongside your transplant is best explored with your own team, just because they have the full picture. It can be really helpful to let them know that you’re keen to explore trials, it often opens up a really constructive conversation about what might be available.

Regarding the POLARIS-2 trial (Study Details | NCT06423911 | Study of Olverembatinib (HQP1351) in Patients With CP-CML | ClinicalTrials.gov).

At the moment, the public registry shows one recruiting site in the U.S. (MD Anderson) and no UK sites currently listed as open. That said, the UK Health Research Authority has issued a Favourable Opinion for the study (March 2025), so UK sites may open, it’s just not shown as active yet on the public registry. I’ve reached out to a UK team involved to see if there’s any update because registries can lag behind reality. I wasn’t able to find evidence of any other trials investigating Olverembatinib at this time.

In terms of the public eligibility criteria for POLARIS-2, people in a chronic phase who have had two previous TKIs are included in Part A, and Part B is specifically for those with a T315I mutation. From what you’ve shared, you may meet some of the published criteria ,but suitability always comes down to your own consultants looking at the whole picture , including your response to treatment and considerations around your plan for transplant.

If helpful, I also pulled together a quick overview of other Chronic myeloid leukaemia ('CML') trials that are currently showing as open in the UK. Just to note, even if the public criteria look like they might fit, trial eligibility always depends on your own team reviewing how you’re responding to treatment and what options are available to you. This allows teams to assess whether a trial is clinically appropriate for you at this stage. There are also studies related to transplants, mostly focused on preventing Graft-versus-host-disease ('GVHD'). I haven’t added those here, but I’m really happy to if you’d find that useful. Please do let me know.

:one: TRIAL: NCT06163430

Drug: TERN‑701

Acronym: CARDINAL

Entry criteria:

  • Must have BCR-ABL1 positive Chronic myeloid leukaemia ('CML') in chronic phase

  • Have received treatment with at least one prior TKI and have treatment failure, suboptimal response, or treatment intolerance

Locations:

  • Imperial College Hospital, London

:two: TRIAL: NCT05304377

Drug: ELVN‑001

Entry criteria:

  • Must have BCR-ABL1 positive Chronic myeloid leukaemia ('CML') in chronic phase, with or without T315I mutation.

  • Must have failed, is intolerant to, or not a candidate for, available therapies known to be active for treatment of their Chronic myeloid leukaemia ('CML') (may vary depending on the country)

Locations:

  • Beatson West of Scotland Cancer Centre, Glasgow

  • Hammersmith Hospital, London

  • The Christie, Manchester

:three: TRIAL: NCT06645886

Drug: KQB198

Entry criteria:

  • For study part 1 and 2, must have BCR-ABL1 positive Chronic myeloid leukaemia ('CML') who have been previously treated with at least 2 different tyrosine kinase inhibitors (TKIs) and are relapsed from or intolerant to those TKIs and ineligible for alternative therapeutic options likely to produce clinical benefit

Locations:

  • Hammersmith Hospital, London

  • Nottingham University Hospital

If you’d like all of this as a small document you can keep or share with your team, please do let me know, or if you’d rather chat through any of this privately, you’re always welcome to email us at trials@bloodcancer.org.uk.

Take care,

Rachel.

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