MAGIC AML - Multiarm, Multicenter, RAndomized, Molecularly-GuIded Controlled Trial of Personalized Treatment Strategy - of Acute Myeloid Leukemia

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Medical University Of Lodz

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

23 Oct 2024 → ongoing

Decision date (initial)

2024-04-29

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Polish Medical Research Agency

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

Comparison of efficacy (measured as event-free survival; EFS) of induction treatment including:

(i) cladribine in combination with daunorubicin, cytosine arabinoside and gemtuzumab ozogamicin (DAC+GO protocol) in CBF-AML patients compared to induction therapy according to DAC protocol;

(ii) cladribine in combination with daunorubicin, cytosine arabinoside and midostaurin (DAC+M protocol) in AML patients with FLT3 gene mutations compared to induction treatment according to the DA+M protocol;

(iii) venetoclax in combination with cladribine, daunorubicin and cytosine arabinoside (DAC+Ven protocol) compared to DAC protocol plus placebo in other AML patients

Secondary objectives 11

1. Comparison of patients achieving composite complete remission with no measurable residual disease (CR+CRh MRD-) between treatment and control groups for each arm
2. Comparison of OS between study and control groups for each arm
3. Comparison of RFS between study and control groups for each arm
4. Comparison of CIR between treatment and control groups for each arm
5. Comparison of the percentage of patients experiencing CR between the study and control groups for each arm
6. Comparison of the percentage of patients experiencing CRh between the study and control groups for each arm
7. Comparison of the percentage of patients experiencing cCR between the study and control groups for each arm
8. Comparison of the percentage of patients who did not achieve a response between the study and control groups for each arm
9. Comparison of the percentage of patients experiencing ED between the study and control groups for each arm
10. Comparison of the percentage of patients undergoing allogeneic transplantation between the study and control groups for each arm
11. Assessment of quality of life as measured by the EORTC QLQ-C30 questionnaire at baseline and after the first induction

Conditions and MedDRA coding

Acute Myeloid Leucaemia

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Acute Myeloid Leukemia diagnosed according to the WHO 2016 criteria
2. Age ≥ 18 and ≤65 years
3. General condition according to the ECOG scale ≤ 2
4. HCT-CI comorbidity index score ≤ 3
5. Informed, written consent to participate in the study
6. Consent to the use of effective contraception during the study with the use of contraception in both women and men
7. Negative serum or urine pregnancy test in women of childbearing age

Exclusion criteria 8

1. Acute Promyelocytic Leukemia
2. Pregnancy and breastfeeding
3. Other active cancer disease
4. HIV infection
5. Active infection with hepatitis B or C virus
6. Organ failure which is a contraindication to the use of intensive chemotherapy
7. Known hypersensitivity to any of the preparations used in the treatment
8. Other not described above abnormalities that exclude the patient from the study based on the Investigator's assessment

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Event Free Survival (EFS)

Secondary endpoints 11

1. Complex complete remission with no measurable residual disease (CR+CRh+CRi MRD-)
2. Overall survival (OS)
3. Relapse-free survival (RFS)
4. Cumulative Relapse Rate (CIR)
5. Proportion of patients experiencing complete remission (CR)
6. Proportion of Remission with partial haematological recovery (CRh) or remission with incomplete hematopoietic regeneration (CRi)
7. Proportion of patients who did not achieve a response (NR)
8. Percentage of patients experiencing early death (ED)
9. Percentage of patients undergoing allogeneic transplantation
10. EORTC QLQ-C30 score
11. Proportion of patients experiencing a composite complete remission (cCR)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 1

Auxiliary 5

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Medical University Of Lodz

Sponsor organisation

Medical University Of Lodz

Address

Al. Tadeusza Kosciuszki 4

City

Lodz

Postcode

90-419

Country

Poland

Scientific contact point

Organisation

Medical University Of Lodz

Contact name

Clinical Trial Support Unit

Public contact point

Organisation

Medical University Of Lodz

Contact name

Clinical Trial Support Unit

Locations

1 EU/EEA country · 18 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications