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R/R AMLPhase 1/2FLAsH-IV-AMLNCT07766850

Addition of Hydroxyurea to Fludarabine, Cytarabine, Idarubicin and Venetoclax Salvage Therapy for Adults With Relapsed or Refractory Acute Myeloid Leukemia

A Phase 1/2 study testing Hydroxycarbamid in people with R/R AML, run by Christer C Nilsson at 1 site in Sweden.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study is evaluating a new treatment approach for adults with acute myeloid leukemia (AML) that has either returned after previous treatment or has not responded to treatment. Outcomes for these patients are often poor, and there is a need for more effective therapies. Read more about this study

Who is it for?
Ages 18 to 74 years
Conditions the study is for
R/R AML
What is being tested?
Hydroxycarbamid
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteSweden
Study dates
Oct 2026to Sep 2034
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A diagnosis of either:
  • Refractory AML defined as having > 10% bone marrow blasts after induction with one cycle of intensive chemotherapy or no CR after two cycles of chemotherapy.
  • Relapsed disease (including extramedullary disease) according to the 2022 ELN criteria (see appendix A).
  • MRD relapse defined as evidence of measurable (minimal) residual disease (MRD) at a level of ≥5%, as determined by either molecular assays or multiparameter flow cytometry.
  • Age 18 years or older.
  • ECOG Performance Status ≤ 2.
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  • Adequate renal and hepatic functions as indicated by the following laboratory values:
  • Creatinine clearance ≥ 30 mL/min calculated by the Cockcroft Gault formula.
  • Serum bilirubin ≤ 3 x upper limit of normal (ULN), unless due to Gilbert's syndrome.
  • Alanine aminotransferase (ALAT) ≤ 5 x ULN.
  • Considered fit for intensive chemotherapy.
  • Male patients must use a latex condom during any sexual contact with women of childbearing potential, even if they have undergone a successful vasectomy and must agree to avoid fathering a child (while on therapy and for 6 months after the final study drug administration). In addition, their female partners of childbearing potential must use a highly effective method of birth control.
  • Male patient must not donate sperm starting at screening and throughout the study period and for 6 months after the final study drug administration.
  • Female patients of nonchildbearing potential must be postmenopausal (defined as at least 1 year without any menses), documented surgically sterile prior to screening.
  • Female patients of childbearing potential must agree to avoid pregnancy during the study and for 6 months after the final study drug administration and have a negative urine or serum pregnancy test at screening, and if heterosexually active, agree to consistently apply one highly effective method of birth control in combination to a barrier method for the duration of the study and for 6 months after the final study drug administration.
  • The subject has given their written consent to participate in the trial.
  • Patient is capable of giving informed consent.

Who cannot join

  • Acute promyelocytic leukemia.
  • WBC ≥30; pretreatment with HU to reduce the level of WBC <30 is allowed in part B/phase II of the trial.
  • TP53 double hit mutation / biallelic TP53 inactivation.
  • CNS leukemia.
  • Relapse within 3 months from the date of allo-HCT.
  • Uncontrolled infection.
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  • ECOG Performance Status > 2.
  • Major organ failure precluding administration of planned chemotherapy
  • Cardiac dysfunction as defined by:
  • Myocardial infarction within the last 3 months of study entry, or
  • Reduced left ventricular function with an ejection fraction < 50% as measured by echocardiogram (will only be performed when clinically suspected) or
  • Unstable angina or
  • New York Heart Association (NYHA) grade III or IV congestive heart failure (see appendix C) or
  • Severe cardiac arrhythmias
  • Age 75 years or older.
  • Known intolerance to any of the chemotherapeutic drugs in the protocol.
  • Positive pregnancy test.
  • Lactating female or female of childbearing potential not using adequate contraception.
  • Known inherited bone marrow failure syndromes (e.g., Fanconi anemia, Dyskeratosis congenita and related telomeropathies (e.g., TERT, TERC, DKC1 mutations).
  • Patients with a history of non-compliance to medical regimens or who are considered unreliable with respect to compliance.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Christer C Nilsson, Md PhD contact

08-123 800 00

christer.c.nilsson@regionstockholm.se

Sweden1 site

  • Medical Unit Hematology, Karolinska University Hospital

    Stockholm

    Merja Jansson, +46 8 123 827 08, merja.jansson@regionstockholm.se

    Christer C Nilsson, MD PhD

Other trials in Sweden

About this study

Official title: FLAsH-IV-AML: A Phase I/II Multi-center Study to Assess the Tolerability and Efficacy of the Addition of Hydroxyurea to Salvage Treatment With Fludarabine, Ara-C, Idarubicin and Venetoclax for Adults With Relapsed or Refractory Acute Myeloid Leukemia

This study is evaluating a new treatment approach for adults with acute myeloid leukemia (AML) that has either returned after previous treatment or has not responded to treatment. Outcomes for these patients are often poor, and there is a need for more effective therapies.

The study is investigating whether adding hydroxyurea to a combination of established AML medicines (fludarabine, cytarabine, idarubicin, and venetoclax) is safe and tolerable and can improve treatment results. Laboratory studies suggest that hydroxyurea may help leukemia cells become more sensitive to treatment and may increase the effectiveness of chemotherapy.

Read more

The study is being conducted in two parts. In the first part, researchers will determine the safest and most appropriate dose of hydroxyurea when given together with the study treatment. In the second part, researchers will evaluate whether adding hydroxyurea improves treatment outcomes, including the length of time patients remain free from disease progression, relapse, or death.

The overall goal of the study is to determine whether adding hydroxyurea to standard treatment for relapsed or refractory AML is safe and may improve patient outcomes.

Conditions
R/R AML
Being tested
Hydroxycarbamid
Keywords
Hydroxyurea, FLAG-Ida, Venetoclax

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HydroxycarbamidDrug

    Also called Hydroxyurea

    Hydroxyurea 500-1000 mg administered 1 hour before each infusion of cytarabine.

Study groups in NCT07766850
Study groupRoleWhat they receive
Hydroxyurea added to fludarabine, ara-C, idarubicin and venetoclaxExperimentalHydroxyurea added to fludarabine, ara-C, idarubicin and venetoclax
Receives: Drug: Hydroxycarbamid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1-year EFS

    Defined as event-free-survial from the time from initiation of study treatment to the first occurrence of treatment failure, hematologic relapse from CR/CRi, or death from any cause.

    Measured: From initiation of study treatment to the first occurrence of treatment failure, hematologic relapse after CR/CRi, or death from any cause, whichever occurs first, assessed up to 365 days.

Secondary outcomes (9)

  1. Safety and tolerability: incidence and severity of treatment-emergent adverse events

    Frequency, nature and severity of non-hematological toxicities, including potential ara-C or fludarabine related neurological or dermatological adverse events.

    Measured: From registration in the study until 60 days after the last dose of treatment.

  2. Overall survival (OS)

    Overall survival (OS), defined as the time from initiation of study treatment to death from any cause, with survival estimates reported at 1 and 2 years after initiation of study treatment.

    Measured: From initiation of study treatment through 2 years of follow-up.

  3. 2-year event-free survival (EFS)

    Time from initiation of study treatment to the first occurrence of treatment failure, hematologic relapse after CR/CRi, or death from any cause, whichever occurs first.

    Measured: From initiation of study treatment through 2 years of follow-up.

  4. Relapse-free survival (RFS)

    Overall survival (OS), defined as the time from initiation of study treatment to the date of death from any cause or hematologic relapse from CR/CRi, with survival estimates reported at 1 and 2 years after initiation of study treatment.

    Measured: From initiation of study treatment through 2 years of follow-up.

  5. Cumulative incidence of hematologic relapse

    Cumulative incidence of hematologic relapse after achievement of CR/CRi, reported at 1 and 2 years. Death without prior relapse will be treated as a competing risk.

    Measured: From initiation of study treatment through 2 years of follow-up.

  6. Response rate

    Proportion of patients achieving complete remission (CR), complete remission with incomplete hematologic recovery (CRi), morphologic leukemia-free state (MLFS), partial remission (PR) and minimal residual disease (MRD) negativity.

    Measured: At response assessment after Cycle 1 (between Day 25 and Day 35 from the start of Cycle 1).

  7. Time to hematopoietic recovery

    Time to hematopoietic recovery (ANC 0.5 and 1.0 x 109/L; platelets 50 and 100 x 109/L) after each chemotherapy treatment cycle, defined as the time from the start of the cycle until recovery.

    Measured: From the start of each treatment cycle until hematopoietic recovery. Treatment cycles are of variable duration, with no predefined cycle length; the subsequent cycle is initiated only after hematopoietic recovery.

  8. Rate of patients bridged to allo-HCT

    Proportion of patients undergoing allogeneic hematopoietic cell transplantation.

    Measured: From treatment initiation until allogeneic hematopoietic cell transplantation, relapse/progression, death, or 2 years of follow-up, whichever occurs first.

  9. Early mortality (30-day and 60-day mortality)

    Proportion of patients who die from any cause within 30 and 60 days after initiation of study treatment.

    Measured: 30 and 60 days after initiation of study treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionJun 2029 (estimated)
  4. Study completionSep 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
A non-randomized open label phase I/II multi-center study
Masking
None (open label)
Enrolment
26 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07766850
Sponsor's protocol ID
FLAsH-IV-AML
Acronym
FLAsH-IV-AML
Status last verified
Aug 2026
First submitted
12 Jun 2026
Last updated
17 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD Sharing Statement: Individual participant data (IPD) will not be shared. Justification: The study is an early-phase investigator-initiated clinical trial in a rare and high-risk patient population. Due to the small sample size, detailed molecular data, and potential risk of re-identification despite de-identification, individual participant data will not be made publicly available.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Hydroxycarbamid in people with R/R AML, run by Christer C Nilsson at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Christer C Nilsson, Md PhD (08-123 800 00, christer.c.nilsson@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1-year EFS (time frame: From initiation of study treatment to the first occurrence of treatment failure, hematologic relapse after CR/CRi, or death from any cause, whichever occurs first, assessed up to 365 days.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07766850.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.

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