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Asciminib & Standard-of-Care Integration in Maintenance Therapy for POST Allogeneic Stem Cell Transplant (Allo-HSCT) of Patient With Ph+ B-ALL or Blastic Transformed CML

ConditionsPh+ Acute Lymphoblastic Leukemia (Ph+ALL)Blastic Transformation of Chronic Myeloid LeukemiaPhiladelphia Chromosome-positive B-cell Acute Lymphoblastic Leukemia (Ph+ B-ALL)Haematopoietic Stem Cell Transplant, Allogeneic
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Hong Kong

About this trial

The goal of this clinical trial is to learn if Asciminib, a first in class allosteric inhibitor, as a add-on maintenance therapy can provides benefits and further prevents relapse in post allogenic hematopoietic stem-cell transplant (HSCT) of patients with Philadelphia chromosome-positive B-cell acute lymphoblastic leukemia (Ph+ B-ALL) or blastic transformed Chronic Myeloid Leukemia (CML-BP).

The main questions it aims to answer are:

Would Ascminib add-on maintenance therapyimprove Morphological relapse-free survival rate? Would Ascminib add-on maintenance therapy improve Molecular relapse-free survival and Overall survival ? Any toxicity or intolerable events during Ascminib add-on maintenance therapy?

Researchers will compare Study arm (Ascminib plus tyrosine-kinase inhibitors \[TKIs\]) and Control arm (TKIs only) to see if Ascminib add-on maintenance therapy would provide better relapse-free survival (RFS) with optimal tolerability.

Participants will

* Enrolled and Randomized into either Study arm or Control arm * Take Ascminib plus selected TKI or selected TKI only according to schedule * Visit the clinic once every 2-4 weeks for checkups and tests * Record and Report any adverse event and graft-versus-host-disease (GvHD) development

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The subject (or the subject's legally acceptable representative, if applicable) must be capable of giving written informed consent and, prior to the commencement of any study-specific procedure, must sign an informed consent form (ICF) indicating the consent on the subject's voluntary participation in the study and compliance with the requirements and restrictions listed on the ICF.

Age ≥ 18 years

Patients with Ph+ B-ALL or CML-BP, who had undergone allogeneic HSCT

Patients must have received TKI therapy in induction/consolidation therapy

Disqualifiers

Patients with known atypical transcript that cannot be measured by available polymerase chain reaction (PCR) methods.

Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2

Uncontrolled hypertension

Corrected QT interval (QTc) > 460 milliseconds for women or > 450 milliseconds for men

Trial design

Design model

Parallel

Treatments tested in this trial

  • Asciminib add-on

    Drug

    Asciminib 80mg QD (in combination with Nilotinib or Dasatinib) or Asciminib 60mg QD (in combination with Imatinib)

  • Imatinib

    Drug

    Imatinib 300mg QD (Ramp-up from 100mg QD for first 4-weeks, 200mg QD for following 4-weeks then 300mg QD for subsequent weeks), Maximum 2-years treatment

  • Dasatinib

    Drug

    Dasatinib 50mg QD (Ramp-up from 20mg QD for first 4-weeks, 40mg QD for following 4-weeks then 50mg QD for subsequent weeks), Maximum 2-years treatment

  • Nilotinib

    Drug

    Nilotinib 200mg BID (Ramp-up from 200mg QD for first 4-weeks then 200mg BID for subsequent weeks), Maximum 2-years treatment

Treatment groups

45 Participants
are divided into 2 treatment groups
Group A: Study Arm (ASC + TKIs)Experimental treatment 4 interventions
Group B: Control Arm (TKIs only)Other 3 interventions

Trial outcomes

Primary outcomes

1

Morphological relapse-free survival (M-RFS)

Morphological relapse-free survival (M-RFS) is defined as the time from date of allogeneic Hematopoietic Stem Cell Transplantation (HSCT) until the date of first documented morphological relapse or death from any cause, whichever occurs earlier. Morphological relapse is defined as the presence of ≥ 5% blasts in the bone marrow and/or evidence of new onset extramedullary disease.

Time frame
From date of allogeneic HSCT until the date of first documented morphological relapse or death from any cause, whichever occurs earlier, up to 12 years.

Secondary outcomes

1

Molecular relapse-free survival (m-RFS)

Molecular RFS is defined as the time from the date of randomization to the date of documented molecular relapse or the date of death from any causes, whichever occurs earlier. Molecular relapse was defined as loss of major molecular response (MMR, defined as BCR::ABL1 transcript ≤0.1% on the international scale for p210 transcript and/or a 3-log reduction from baseline for p190 transcript).

Time frame
From date of randomization until the date of first documented molecular relapse or death from any cause, whichever occurs earlier, up to 12 years.
2

Cumulative incidence of grade II-IV acute Graft versus Host Disease (acute GvHD)

Cumulative incidence of grade II-IV acute GvHD (by Mount Sinai Acute GvHD International Consortium \[MAGIC\] criteria)

Time frame
Within 100 day after allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
3

Cumulative incidence of chronic Graft versus Host Disease (chronic GvHD)

Cumulative incidence of moderate to severe chronic GvHD (by National Institute of Health \[NIH\] criteria) requiring systemic treatment

Time frame
From enrollment through study completion, an average of 2 years
4

Treatment toxicities and Adverse Events (AEs)

Number of incidence of Treatment toxicities and adverse events will be assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 throughout the study duration, from baseline through 24 months post-treatment or end of study participation.

Time frame
From randomization through treatment completion, an average of 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Hong Kong

Lead sponsor

Novartis

Collaborator

Queen Mary Hospital, Hong Kong

Collaborator

Source ClinicalTrials.gov

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