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New treatment option for Acute Myeloid Leukemia
Official title A Phase I Study Investigating the Combination of the Menin Inhibitor Ziftomenib With Venetoclax and Gemtuzumab in Pediatric Patients With Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT06448013
What this study is testing
What is Venetoclax?
Venetoclax is an investigational medicine, being studied as a potential treatment for acute myeloid leukemia.
Also referred to as ABT-199, GDC-0199.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To find the recommended dose of ziftomenib in combination with gemtuzumab ozogamicin and venetoclax that can be given to pediatric participants who have relapsed or refractory AML or MPAL.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 21
You may be able to join if
- Age ≥ 3 year to 21 years
- Karnofsky for children \>16yo and Lansky \<16yo.
- Relapsed/refractory AML, or MPAL with a myeloid phenotype.
- Evidence of leukemia (AML, MPAL with a myeloid phenotype) in the bone marrow as detected by morphology or molecular diagnostics.
- Presence of KMT2Ar, NUP98r, NPM1c, UBTF-ITD or other HOX pathway mutation.
You likely can't join if
- Participants who weigh less than 10kg.
- Participants with any concurrent uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place the patient at...
- The use of other chemotherapeutic agents or anti-leukemic agents is not permitted during study with the following exceptions (1) intrathecal...
- Participants with any severe gastrointestinal or metabolic condition which could interfere with the absorption of oral study medications.
- Participants with chronic liver disease.
- Participants with a concurrent active malignancy under treatment.
See the full eligibility criteria
- Age ≥ 3 year to 21 years
- Karnofsky for children \>16yo and Lansky \<16yo.
- Relapsed/refractory AML, or MPAL with a myeloid phenotype.
- Evidence of leukemia (AML, MPAL with a myeloid phenotype) in the bone marrow as detected by morphology or molecular diagnostics.
- Presence of KMT2Ar, NUP98r, NPM1c, UBTF-ITD or other HOX pathway mutation.
- WBC must be below 25,000/ƒÊL at time of enrollment. Participants may receive cytoreduction prior to enrollment.
- Baseline ejection fraction must be \> 40%.
- Adequate hepatic function (direct bilirubin \< 1.5x upper limit of normal (ULN) unless increase is due to Gilbert's disease or leukemic involvement, and AST and/or ALT \< 3x ULN unless considered due to leukemic...
- Adequate renal function (creatinine clearance ≥ 30 mL/min) unless related to disease.
- In the absence of rapidly proliferative disease, the interval from prior treatment to time of initiation will be at least 14 days for cytotoxic or non-cytotoxic (immunotherapy agent(s), or an interval of 5 half-lives of...
- 3 month washout prior from bone marrow transplantation.
- Unless surgically or biologically sterile: Women of childbearing potential must agree to adequate methods of contraception during the study and at least 3 months for males, and 6 months for females, after the last...
- Participants who weigh less than 10kg.
- Participants with any concurrent uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place the patient at unacceptable risk of study treatment.
- The use of other chemotherapeutic agents or anti-leukemic agents is not permitted during study with the following exceptions (1) intrathecal chemotherapy for prophylactic use or for controlled CNS leukemia. (2) use of...
- Participants with any severe gastrointestinal or metabolic condition which could interfere with the absorption of oral study medications.
- Participants with chronic liver disease.
- Participants with a concurrent active malignancy under treatment.
- Known active hepatitis B (HBV) or Hepatitis C (HCV) infection or known HIV infection.
- Female participants who are pregnant or breast-feeding.
- Participants has an active uncontrolled infection.
- Any of the following within the 6 months prior to study entry: myocardial infarction, uncontrolled/unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), life-threatening...
- Mean corrected QT interval by Fredericia's formula \>480 ms on triplicate 12-lead electrocardiograms performed within approximately 5 minutes of each other.
- History of or any concurrent condition, therapy, or laboratory abnormality that in the Investigator's opinion might confound the results of the study, interfere with the participant's participation for the full duration...
- Clinically active central nervous system (CNS) leukemia.
- The use of topical steroids for cutaneous graft-versus-host disease (GVHD) or stable systemic steroid doses less than or equal to 20 mg of prednisone daily are permitted.
- Participants with Grade \> 2 active acute GVHD, moderate or severe limited chronic GVHD, or extensive chronic GVHD of any severity.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
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, 3 years to 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.