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STUDY AGORA-1 / ALFA 2100: Phase 2 on the combinaison of Gemtuzumab Ozogamicin witk gilteritinib in adult patients with acute myeloid leukemia (AML) with a relapsed or refractory FLT3 mutation.
EU CTIS ID: 2023-504176-25-00
What this study is testing
Stage 1 - Safety of the addition of gilteritinib to the AGORA treatment platform The primary objective of the first stage is to evaluate the safety of combining gilteritinib with the GO-cytarabine AGORA platform in patients with FLT3-ITD and/or FLT3-TKD mutated R/R AML, through occurrence of dose-limiting toxicity (DLT). Stage 2 - Event-free survival (EFS) The primary objective of the second extension stage is to evaluate the efficacy of combining gilteritinib with the GO-cytarabine AGORA platform in patients with FLT3-ITD and/or FLT3-TKD mutated R/R AML through event-free survival (EFS).
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients aged 18 years old or more
- Confirmed diagnosis of R/R AML positive for CD33 antigen as determined locally by immunophenotyping according to routine practice, defined as: - AML refractory to 1 or 2 intensive chemotherapy courses or a treatment by hypomethylating agents (HMAs) - Or AML in first hematologic relapse or progression after front-line therapy, including intensive chemotherapy or hypomethylating agents (HMAs). - Previous treatments with FLT3 inhibitors (other than gilteritinib) are allowed - R/R AML secondary to a prior chemotherapy or radiotherapy for another cancer (tAML) could be included.
- Presence of a FLT3-ITD mutation (allelic ratio ≥0.05 at last evaluation)* or a FLT3 TKD mutation
- Patient with no contraindication to gemtuzumab ozogamicin (GO), cytarabine and gilteritinib
- ECOG performance status ≤2
- AST and ALT ≤ 2.5 x upper the limit of normal (ULN) and/or total and direct serum bilirubin ≤ 1.5 x ULN unless considered due to leukemia
You likely can't join if
- Acute promyelocytic leukemia or AML with BCR-ABL1 gene fusion
- Uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate treatment)
- Active known HBV or HCV hepatitis or positive HIV serology
- Concurrent therapy with any other investigational agent or cytotoxic drug, within 28 days before starting treatment. Only hydroxyurea ± dexamethasone is permitted for the control of blood counts
- Current use or anticipated requirement for drugs that are known strong inducers of CYP3 A4/5
- Current use or anticipated requirement for drugs that are known as strong inhibitors or inducers of P glycoprotein (P-gp), as mentioned in the appendix 14 of the protocol, with the exception of drugs that are considered absolutely essential for the care of the subject
See the full eligibility criteria
- Patients aged 18 years old or more
- Confirmed diagnosis of R/R AML positive for CD33 antigen as determined locally by immunophenotyping according to routine practice, defined as: - AML refractory to 1 or 2 intensive chemotherapy courses or a treatment by hypomethylating agents (HMAs) - Or AML in first hematologic relapse or progression after front-line therapy, including intensive chemotherapy or hypomethylating agents (HMAs). - Previous treatments with FLT3 inhibitors (other than gilteritinib) are allowed - R/R AML secondary to a prior chemotherapy or radiotherapy for another cancer (tAML) could be included.
- Presence of a FLT3-ITD mutation (allelic ratio ≥0.05 at last evaluation)* or a FLT3 TKD mutation
- Patient with no contraindication to gemtuzumab ozogamicin (GO), cytarabine and gilteritinib
- ECOG performance status ≤2
- AST and ALT ≤ 2.5 x upper the limit of normal (ULN) and/or total and direct serum bilirubin ≤ 1.5 x ULN unless considered due to leukemia
- Estimated glomerular filtration rate (GFR) ≥ 50 mL/min according to the formula usually used by the investigator
- Acute promyelocytic leukemia or AML with BCR-ABL1 gene fusion
- Uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate treatment)
- Active known HBV or HCV hepatitis or positive HIV serology
- Concurrent therapy with any other investigational agent or cytotoxic drug, within 28 days before starting treatment. Only hydroxyurea ± dexamethasone is permitted for the control of blood counts
- Current use or anticipated requirement for drugs that are known strong inducers of CYP3 A4/5
- Current use or anticipated requirement for drugs that are known as strong inhibitors or inducers of P glycoprotein (P-gp), as mentioned in the appendix 14 of the protocol, with the exception of drugs that are considered absolutely essential for the care of the subject
- Current use or anticipated treatment with concomitant drugs that target 5HT1R or 5HT2BR receptors or sigma non-specific receptor, as mentioned in the appendix 15 of the protocol, with exception of drugs that are considered absolutely essential for the care of the subject
- Known malabsorption syndrome or other condition that may significantly impair absorption of oral study medications
- Any of concurrent severe and/or uncontrolled medical condition, which could compromise participation in the study
- Patient currently receiving one or more inadvisable or prohibited treatments described in section 6.4.2 of the protocol.
- Secondary AML (sAML) defined by a history of prior myelodysplastic syndrome (MDS) or myeloproliferative syndrome (MPN) including chronic myelomonocytic leukemia (CMML)
- Patient ineligible for an intensive chemotherapy.
- Patient with contraindications to the administration of gemtuzumab ozogamicin (GO), cytarabine and gilteritinib. Refer to the SPCs of the molecules mentioned concerning the contraindications, special warnings, precautions for use, dose modifications in the event of toxicity, contraception and monitoring of patients and drugs prohibited or to be used with caution.
- Proven central nervous system leukemic involvement
- Prior allogeneic HSCT within the last 6 months and/or history of acute GVHD of grade >1
- Prior treatment with gemtuzumab ozogamicin within the last 3 months preceding the initiation of the treatment in the present clinical trial
- Uncontrolled or active malignant disease within prior 12 months (excluding cutaneous basal cell carcinoma, “in-situ” carcinoma of the cervix or breast, or other local malignancy excised)
- Uncontrolled or significant cardiovascular history or symptoms
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.