Acute Lymphoblastic Leukemia, in RelapsePhase 1/2HEM-iSMART ANCT05740449

HEM-iSMART-A: Decitabine / Venetoclax and Navitoclax in Pediatric Patients With Relapsed or Refractory Hematological Malignancies

A Phase 1/2 study testing Decitabine, Venetoclax and Navitoclax in people with Acute Lymphoblastic Leukemia, in Relapse and Lymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) Recurrent, run by Princess Maxima Center for Pediatric Oncology at 1 site in Netherlands.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

Who is it for?: Ages 1 year to 21 years
Conditions the study is for: Acute Lymphoblastic Leukemia, in Relapse, Lymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) Recurrent, Lymphoblastic Lymphoma (Precursor T-Lymphoblastic Lymphoma/Leukaemia) Recurrent
What is being tested?: Decitabine, Venetoclax and Navitoclax
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteNetherlands
Study dates: 1 Oct 2023to 1 Oct 2029
Phase: Phase 1/2
Are there results?: None posted in the registry

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 1 year to 21 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Children between 4 years and 18 years of age at the time of first diagnosis and less than 21 years at the time of inclusion. Children must have a body weight ≥ 20 kg.
Performance status: Karnofsky performance status (for patients >12 years of age) or Lansky Play score (for patients ≤12 years of age) ≥ 50% (Appendix I).
Written informed consent from parents/legal representative, patient, and age-appropriate assent before any study specific screening procedures are conducted, according to local, regional or national guidelines.
For all oral medications patients must be able to comfortably swallow capsules (except for those for which an oral solution is available or dissolving of tablets is allowed based on investigator brochure (IB); nasogastric or gastrostomy feeding tube administration is allowed only if indicated).
Patients must have had advanced molecular profiling and flow-cytometric analysis of their recurrent or refractory disease at a time-point before the first inclusion into this trial (see section 9.1 of this protocol for detailed description of the molecular diagnostics required). Drug response profiling and methylation is highly recommended but not mandatory. Patients with advanced molecular profiling at diagnosis may be allowed to be included after discussion with the sponsor.
Adequate organ function:

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RENAL AND HEPATIC FUNCTION (Assessed within 48 hours prior to C1D1) :
Serum creatinine ≤ 1.5 x upper limit of normal (ULN) for age or calculated creatinine clearance as per the Schwartz formula or radioisotope glomerular filtration rate ≥ 60 mL/min/1.73 m2.
Direct bilirubin ≤ 2 x ULN (≤ 3.0 × ULN for patients with Gilbert's syndrome).
Alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) ≤ 5 x ULN; AST/serum glutamic oxaloacetic transaminase/SGOT ≤ 5 x ULN. Note: Patients with hepatic disfunction related to the underling disease can be eligible even if they do not fulfill the aforementioned values for hepatic transaminases. In these cases, patients need to be discussed with the sponsor to confirm the eligibility.
CARDIAC FUNCTION:
Shortening fraction (SF) >29% (>35% for children < 3 years) and/or left ventricular ejection fraction (LVEF) ≥50% at baseline, as determined by echocardiography or MUGA.
Absence of QTcF prolongation (QTc prolongation is defined as >450 msec on baseline ECG, using the Friedericia correction), or other clinically significant ventricular or atrial arrhythmia.

Who cannot join

Pregnancy or positive pregnancy test (urine or serum) in females of childbearing potential. Pregnancy test must be performed within 7 days prior to C1D1.
Sexually active participants not willing to use highly effective contraceptive method (pearl index <1) as defined in CTFG HMA 2020 (Appendix II) during trial participation and until 6 months after end of antileukemic therapy.
Breast feeding.
Impairment of gastrointestinal (GI) function or GI disease that may significantly alter drug absorption of oral drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, or malabsorption syndrome) in case of oral IMPs.
Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to the study drugs, or drugs chemically related to study treatment or excipients that contraindicate their participation, including conventional chemotherapeutics (i.e. cytarabine and cyclophosphamide when applicable, intrathecal agents) and corticoids.
Known active viral hepatitis or known human immunodeficiency virus (HIV) infection or any other uncontrolled infection.

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Severe concomitant disease that does not allow treatment according to the protocol at the investigator's discretion.
Subjects unwilling or unable to comply with the study procedures.
Patients who have previously received decitabine can not participate.
Patients who have previously received venetoclax or navitoclax separately can be eligible for this sub-study.
Patients who have consumed grapefruit, grapefruit products, Seville oranges (Including marmalade containing Seville oranges) or starfruit within 72 hours prior to the first dose of study drug
Patients who have received strong and moderate CYP3A4 inhibitors/inducers within 7 days prior to the first dose of study drug (also see Appendix VI of the Master Protocol).
Current use of a prohibited medication or herbal preparation or requires any of these medications during the study. See Section 7, Appendix III and or details. In general, CYP3A4 inhibitors/Pgp inhibitors, moderate or strong inducers of CYP3A4 or drugs inducing QTc changes (prolongation of the QT interval or inducing Torsade de Points) are not permitted.
Unresolved toxicity greater than NCI CTCAE v 5.0 ≥ grade 2 from previous anti-cancer therapy, including major surgery, except those that in the opinion of the investigator are not clinically relevant given the known safety/toxicity profile of the study treatment (e.g., alopecia and/or peripheral neuropathy related to platinum or vinca alkaloid based chemotherapy) (Common Terminology Criteria for Adverse Events (CTCAE) (cancer.gov).
Active acute graft versus host disease (GvHD) of any grade or chronic GvHD of grade 2 or higher. Patients receiving any agent to treat or prevent GvHD post bone marrow transplant are not eligible for this trial.
Received immunosuppression post allogenic HSCT within one moth of study entry.
Wash-out periods of prior medication:
CHEMOTHERAPY: At least 7 days must have elapsed since the completion of cytotoxic therapy, with the exception of hydroxyurea, 6-mercaptopurine, oral methotrexate and steroids which are permitted up until 48 hours prior to initiating protocol therapy. Patients may have received intrathecal therapy (IT) at any time prior to study entry.
RADIOTHERAPY: Radiotherapy (non-palliative) within 21 days prior to the first dose of drug. Palliative radiation in past 21 days is allowed.
HEMATOPOIETIC STEM CELL TRANSPLANTATION:
Autologous HSCT within 2 months prior to the first study drug dose.
Allogeneic HSCT within 3 months prior to the first study drug dose.
IMMUNOTHERAPY: At least 42 days must have elapsed after the completion of any type of immunotherapy other than monoclonal antibodies (e.g. CAR-T therapy)
MONOCLONAL ANTIBODIES AND INVESTIGATIONAL DRUGS: At least 21 days or 5 times the half-life (whichever is shorter) from prior treatment with monoclonal antibodies or any investigational drug under investigation must have elapsed before the first study drug.
SURGERY: Major surgery within 21 days of the first dose. Gastrostomy, ventriculo-peritoneal shunt, endoscopic ventriculostomy, tumor biopsy and insertion of central venous access devices are not considered major surgery.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

Princess Máxima Center for Pediatric Oncology
Utrecht, 3584CS

Other trials in Netherlands

About this study

Official title: International Proof of Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory HEMatological Malignancies in Children, Subprotocol A: Decitabine / Venetoclax and Navitoclax in Pediatric Patients With Relapsed or Refractory Hematological Malignancies

HEM-iSMART is a master protocol which investigates multiple investigational medicinal products in children, adolescents and young adults (AYA) with relapsed/refractory (R/R) ALL and LBL. Sub-protocol A is a phase I/II trial evaluating the safety and efficacy of Decitabine / Venetoclax and Navitoclax in children and AYA with R/R pediatric ALL/LBL

Read the detailed description

HEM-iSMART is a master protocol with sub-protocols. The overarching objective is that introducing targeted therapy using a biomarker driven approach for treatment stratification may improve the outcome of children with R/R acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) It is characterized by a shared framework that allows for the investigation of multiple IMPs and generate pivotal safety and efficacy evidence within the sub-protocols to establish and define the benefits and risks of new treatments for children with R/R leukemia.

Sub-protocol A within HEM-iSMART, is a phase I/II, multicenter, international, open-label clinical trial designed to evaluate the safety, tolerability, pharmacokinetics (PK) and efficacy of decitabine, venetoclax and navitoclax in children, adolescents and young with R/R ALL and LBL. The epigenetic approach may improve outcome for patients whose tumor lack molecular alterations.

Conditions: Acute Lymphoblastic Leukemia, in Relapse, Lymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) Recurrent, Lymphoblastic Lymphoma (Precursor T-Lymphoblastic Lymphoma/Leukaemia) Recurrent, Lymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) Refractory, Lymphoblastic Lymphoma (Precursor T-Lymphoblastic Lymphoma/Leukaemia) Refractory
Being tested: Decitabine, Venetoclax, Navitoclax, intrathecal chemotherapy
Keywords: Acute lymphoblastic leukemia, Lymphoblastic lymphoma, Epigentic approach, decitabine, navitoclax, venetoclax, Relapse, Refractory, Children, Adolescents, Young adults
Medical subject headings: Precursor Cell Lymphoblastic Leukemia-Lymphoma, Precursor B-Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Recurrence, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

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

DecitabineDrug
intravenous
VenetoclaxDrug
oral
NavitoclaxDrug
oral
intrathecal chemotherapyDrug
IT: Methotrexate +/- prednisone/hydrocortisone/cytarabine according to the degree of central nervous involvement

Study groups in NCT05740449
Study group	Role	What they receive
sub-study A - Epigenetic approach	Experimental	Decitabine / Venetoclax and Navitoclax. Each cycle lasts 28 days. Cycle 1: Decitabine is given 10 mg/m2 intravenous, once a day on 5 consecutive days (Day 1 - 5), venetoclax 400 mg adult equivalent dose, once a day, Day 1 - Day 28 orally, with a ramp-up dose on day 1 and navitoclax once a day, Day 3 - 28 orally depending on the weight of the patient (dose level 1). Cycle 2: Decitabine is given 10 mg/m2 intravenous, once a day on 5 consecutive days (Day 1 - 5), venetoclax 400 mg adult equivalent dose, once a day, Day 1 - Day 28 orally and navitoclax once a day, Day 1 - 28 orally depending on the weight of the patient (dose level 1). Patients in dose level 2: will receive decitabine 20 mg/m2 intravenous once a day on 5 consecutive days (Day 1 - 5). Patients in dose level -1: will receive venetoclax 200 mg adult equivalent dose, once a day, Day 1 - Day 28 orally. All patients receive age adapted intrathecal chemnotherapy. Receives: Drug: Decitabine; Drug: Venetoclax; Drug: Navitoclax; Drug: intrathecal chemotherapy

What is being measured

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

Phase I: Maximum tolerated dose (MTD) / Recommended phase 2 dose (RP2D)
Defined as the highest dose level tested at which 0/6 or 1/6 patients experiences dose limiting toxicities (DLT) during course 1 with at least 2 patients experiencing DLT at the next higher dose.
Measured: 3 years
Phase II: Best overall response rate (ORR)
For patients with leukemia: CR and MRD response after 1 cycle of treatment. This includes determination of CR, CRp, CRi and minimal residual disease (MRD) negativity rate in patients suffering from overt morphological relapse of T-ALL at time of enrolment (morphological disease (M2/M3)), and the MRD negativity rate in those that entered with high-MRD levels but in morphological CR. These results will together be presented as a composite endpoint Overall Response rate (ORR). MRD negativity will be defined as ≤1x10-4 as generated by multi-parameter flow cytometry.
For patients with lymphoma: Response in LBL patients is defined as CR, PR, minor response (MR) as defined in International pediatric NHL response criteria. In case of bone-marrow involvement MRD will be taken into account.
Measured: 6 years

Secondary outcomes (7)

Overall survival (OS)
Defined as time from C1D1 until death of any cause.
Measured: 7 years
Event-free survival (EFS)
Defined as time from C1D1 to the first event (subsequent relapse after CR (including molecular reappearance), death of any cause, failure to achieve remission (CR, CRp or CRi), or secondary malignancy).
Measured: 7 years
Cumulative incidence of relapse (CIR)
Estimate of the risk, that a patient will develop a relapse over a specified period of time.
Measured: 7 years
Number of patients proceeding to hematopoietic stem cell transplantation (HSCT) after the experimental therapy.
The rate of those proceeding to subsequent allogenic HSCT
Measured: 7 years
Cumulative overall response rate (ORR)
Defined as the CR, CRp, CRi and MRD negativity rates after more than 1 cycle of treatment
Measured: 7 years
Rate of dose limiting toxicities (DLTs)
Number of participants with dose limiting toxicities (DLTs)
Measured: 7 years
Peak plasma concentration (Cmax)
Estimation of decitabine, venetoclax and navitoclax Cmax
Measured: 6 years

Timeline

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

1 Oct 20231 Oct 2029

First posted23 Feb 2023
Study start1 Oct 2023 (estimated)
Primary completion1 Oct 2029 (estimated)
Study completion1 Oct 2029 (estimated)

Why it stopped: Company stopped development and production of one of the IMP's.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Acute Lymphoblastic Leukemia, in RelapseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05740449
Sponsor's protocol ID: 2022-501865-29-00
Acronym: HEM-iSMART A
Status last verified: Jun 2024
First submitted: 13 Feb 2023
Last updated: 21 Jun 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: All individual participant data will be used to generate a publication

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: International Proof of Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory HEMatological Malignancies in Children, Subprotocol A: Decitabine / Venetoclax and Navitoclax in Pediatric Patients With Relapsed or Refractory Hematological Malignancies
ClinicalTrials.gov ID: NCT05740449
Acronym / sponsor ID: HEM-iSMART A / 2022-501865-29-00
Conditions: Acute Lymphoblastic Leukemia, in Relapse, Lymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) Recurrent, Lymphoblastic Lymphoma (Precursor T-Lymphoblastic Lymphoma/Leukaemia) Recurrent, Lymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) Refractory, Lymphoblastic Lymphoma (Precursor T-Lymphoblastic Lymphoma/Leukaemia) Refractory
Keywords: Acute lymphoblastic leukemia, Lymphoblastic lymphoma, Epigentic approach, decitabine, navitoclax, venetoclax, Relapse, Refractory
Phase: Phase 1/2
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Company stopped development and production of one of the IMP's.
Enrolment: 0 participants (actual)
Lead sponsor: Princess Maxima Center for Pediatric OncologyUniversity, hospital or other
Collaborators: Innovative Therapies For Children with Cancer Consortium, IBFM, Fight Kids Cancer
Study start: 1 Oct 2023 (estimated)
Primary completion: 1 Oct 2029 (estimated)
Study completion: 1 Oct 2029 (estimated)
First posted: 23 Feb 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
sub-study A - Epigenetic approach	Experimental	Drug: Decitabine, Drug: Venetoclax, Drug: Navitoclax, Drug: intrathecal chemotherapyDecitabine / Venetoclax and Navitoclax. Each cycle lasts 28 days. Cycle 1: Decitabine is given 10 mg/m2 intravenous, once a day on 5 consecutive days (Day 1 - 5), venetoclax 400 mg adult equivalent dose, once a day, Day 1 - Day 28 orally, with a ramp-up dose on day 1 and navitoclax once a day, Day 3 - 28 orally depending on the weight of the patient (dose level 1). Cycle 2: Decitabine is given 10 mg/m2 intravenous, once a day on 5 consecutive days (Day 1 - 5), venetoclax 400 mg adult equivalent dose, once a day, Day 1 - Day 28 orally and navitoclax once a day, Day 1 - 28 orally depending on the weight of the patient (dose level 1). Patients in dose level 2: will receive decitabine 20 mg/m2 intravenous once a day on 5 consecutive days (Day 1 - 5). Patients in dose level -1: will receive venetoclax 200 mg adult equivalent dose, once a day, Day 1 - Day 28 orally. All patients receive age adapted intrathecal chemnotherapy.

Who may qualify

Ages: 1 year to 21 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (13 listed)

Children between 4 years and 18 years of age at the time of first diagnosis and less than 21 years at the time of inclusion. Children must have a body weight ≥ 20 kg.
Performance status: Karnofsky performance status (for patients >12 years of age) or Lansky Play score (for patients ≤12 years of age) ≥ 50% (Appendix I).
Written informed consent from parents/legal representative, patient, and age-appropriate assent before any study specific screening procedures are conducted, according to local, regional or national guidelines.
For all oral medications patients must be able to comfortably swallow capsules (except for those for which an oral solution is available or dissolving of tablets is allowed based on investigator brochure (IB); nasogastric or gastrostomy feeding tube administration is allowed only if indicated).
Patients must have had advanced molecular profiling and flow-cytometric analysis of their recurrent or refractory disease at a time-point before the first inclusion into this trial (see section 9.1 of this protocol for detailed description of the molecular diagnostics required). Drug response profiling and methylation is highly recommended but not mandatory. Patients with advanced molecular profiling at diagnosis may be allowed to be included after discussion with the sponsor.

Key exclusion criteria (25 listed)

Pregnancy or positive pregnancy test (urine or serum) in females of childbearing potential. Pregnancy test must be performed within 7 days prior to C1D1.
Sexually active participants not willing to use highly effective contraceptive method (pearl index <1) as defined in CTFG HMA 2020 (Appendix II) during trial participation and until 6 months after end of antileukemic therapy.
Breast feeding.
Impairment of gastrointestinal (GI) function or GI disease that may significantly alter drug absorption of oral drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, or malabsorption syndrome) in case of oral IMPs.
Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to the study drugs, or drugs chemically related to study treatment or excipients that contraindicate their participation, including conventional chemotherapeutics (i.e. cytarabine and cyclophosphamide when applicable, intrathecal agents) and corticoids.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Decitabineintravenous	Drug	sub-study A - Epigenetic approach
Venetoclaxoral	Drug	sub-study A - Epigenetic approach
Navitoclaxoral	Drug	sub-study A - Epigenetic approach
intrathecal chemotherapyIT: Methotrexate +/- prednisone/hydrocortisone/cytarabine according to the degree of central nervous involvement	Drug	sub-study A - Epigenetic approach

Primary outcome

Phase I: Maximum tolerated dose (MTD) / Recommended phase 2 dose (RP2D)
Time frame: 3 years
Defined as the highest dose level tested at which 0/6 or 1/6 patients experiences dose limiting toxicities (DLT) during course 1 with at least 2 patients experiencing DLT at the next higher dose.
Phase II: Best overall response rate (ORR)
Time frame: 6 years
For patients with leukemia: CR and MRD response after 1 cycle of treatment. This includes determination of CR, CRp, CRi and minimal residual disease (MRD) negativity rate in patients suffering from overt morphological relapse of T-ALL at time of enrolment (morphological disease (M2/M3)), and the MRD negativity rate in those that entered with high-MRD levels but in morphological CR. These results will together be presented as a composite endpoint Overall Response rate (ORR). MRD negativity will be defined as ≤1x10-4 as generated by multi-parameter flow cytometry. For patients with lymphoma: Response in LBL patients is defined as CR, PR, minor response (MR) as defined in International pediatric NHL response criteria. In case of bone-marrow involvement MRD will be taken into account.

7 secondary outcomes

Overall survival (OS)
Time frame: 7 years
Event-free survival (EFS)
Time frame: 7 years
Cumulative incidence of relapse (CIR)
Time frame: 7 years
Number of patients proceeding to hematopoietic stem cell transplantation (HSCT) after the experimental therapy.
Time frame: 7 years
Cumulative overall response rate (ORR)
Time frame: 7 years
Rate of dose limiting toxicities (DLTs)
Time frame: 7 years
Peak plasma concentration (Cmax)
Time frame: 6 years

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
Individual participant dataSharing planned: Yes. All individual participant data will be used to generate a publication

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michel Zwaan, Prof. Dr. study chair

Princess Maxima Center for Pediatric Oncology

Andrej Lissat, MD, PhD principal investigator

Charité

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 13 inclusion and 25 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: withdrawn, as of the sponsor's last update on 21 Jun 2024. 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 Netherlands. 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?

The study was withdrawn before enrolling participants, so there are no results.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase I: Maximum tolerated dose (MTD) / Recommended phase 2 dose (RP2D) (time frame: 3 years). The study lists 2 primary outcomes in all. 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 NCT05740449.

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 21 Jun 2024.