Clinical trial for Acute Myeloid Leukemia
Official title Pemigatinib After Chemotherapy for the Treatment of Newly Diagnosed Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT04659616
What this study is testing
What is Cytarabine?
Cytarabine is a standard chemotherapy medicine being studied in this trial as part of a treatment plan for acute myeloid leukemia. It is designed to stop cancer cells from dividing and growing.
Also referred to as Ara-C.
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
- This study aims to find the best dose of pemigatinib and see if it helps treat the disease after standard chemotherapy.
- Who it's for
- People who have just been diagnosed with acute myeloid leukemia.
- What's involved
- Participants will receive standard chemotherapy first, followed by the study drug pemigatinib, which blocks a specific protein that may help leukemia cells grow.
- Time commitment
- The source text does not specify the total duration or number of visits required.
- Phase 1: an early, usually small safety study
- Time commitment: about 24 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- PRE-SCREENING Ability to understand and the willingness to sign a written informed consent document
- PRE-SCREENING Age \>= 18 years at time of informed consent. Both men and women of all races and ethnic groups will be included
- PRE-SCREENING Participants must consent to a bone marrow aspirate/biopsy that will be collected prior to start of planned 7+3 induction therapy.
- TREATMENT Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- t(9;11)(p21.3;q23.3); MLLT3-KMT2A
You likely can't join if
- PRE-SCREENING EXCLUSION CRITERIA: Diagnosis of acute promyelocytic leukemia (APL, or AML M3 subtype) per WHO classification
- PRE-SCREENING EXCLUSION CRITERIA: AML with FLT3 mutations that qualify for standard of care treatment with 7+3 and midostaurin (e.g.
- PRE-SCREENING EXCLUSION CRITERIA: Favorable risk AML: inv(16), t(8;21), NPM1 mutations without FLT3-ITD, or in-frame mutations (mono- or biallelic)...
- PRE-SCREENING EXCLUSION CRITERIA: Any cancer-directed therapy within 2 weeks prior to starting planned 7+3 induction regimen, with the exception of...
- PRE-SCREENING EXCLUSION CRITERIA: Prior receipt of a selective FGFR inhibitor
- PRE-SCREENING EXCLUSION CRITERIA: Known liver disease
See the full eligibility criteria
Who can join
- PRE-SCREENING Ability to understand and the willingness to sign a written informed consent document
- PRE-SCREENING Age \>= 18 years at time of informed consent. Both men and women of all races and ethnic groups will be included
- PRE-SCREENING Participants must consent to a bone marrow aspirate/biopsy that will be collected prior to start of planned 7+3 induction therapy.
- TREATMENT Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- t(9;11)(p21.3;q23.3); MLLT3-KMT2A
- Cytogenetic abnormalities not classified as favorable
- t(6;9)(p23;q34.1); DEK-NUP214
- t(v;11q23.3); KMT2A rearranged
- t(9;22)(q34.1;q11.2); BCR-ABL1
- inv(3)(q21.3q26.2) or t(3;3)(q21.3;q26.2); GATA2,MECOM(EVI1)
- -5 or del(5q); -7; -17/abn(17p)
- Complex karyotype - defined as three or more unrelated chromosome abnormalities in the absence of 1 of the WHO-designated recurring translocations or inversions, that is, t(8;21), inv(16) or t(16;16), t(9;11)...
- Monosomal karyotype - defined by the presence of 1 single monosomy (excluding loss of X or Y) in association with at least 1 additional monosomy or structural chromosome abnormality (excluding core-binding factor AML)
- Mutated RUNX1 (without favorable risk cytogenetics/mutations)
- Mutated BCOR (without favorable risk cytogenetics/mutations)
- Mutated EZH2 (without favorable risk cytogenetics/mutations)
- Mutated ASXL1 (without favorable risk cytogenetics/mutations)
- Mutated SF3B1 (without favorable risk cytogenetics/mutations)
- Mutated SRSF2 (without favorable risk cytogenetics/mutations)
- Mutated STAG2 (without favorable risk cytogenetics/mutations)
- Mutated U2AF1, (without favorable risk cytogenetics/mutations)
- Mutated ZRSR2 (without favorable risk cytogenetics/mutations)
- Mutated TP53 (mono- or biallelic) at a variant allele fraction of at least 10%
- TREATMENT Serum creatinine clearance \>= 30 mL/min (as calculated by Cockcroft-Gault formula) (on or by day 8 of induction therapy, prior to starting pemigatinib)
- TREATMENT Serum phosphate within institutional upper limit of normal (ULN) or can be corrected with supplementation/ phosphate binders to be within institutional ULN (on or by day 8 of induction therapy, prior to...
- TREATMENT Serum electrolytes within institutional ULN: potassium, calcium (total, or corrected for serum albumin in case of hypoalbuminemia) and magnesium.
- TREATMENT Total serum bilirubin =\< 3 x ULN (on or by day 8 of induction therapy, prior to starting pemigatinib)
- TREATMENT Serum aspartate transaminase (AST) and/or alanine transaminase (ALT) =\< 3 x ULN (on or by day 8 of induction therapy, prior to starting pemigatinib)
- TREATMENT Participants must consent to standard of care bone marrow aspirate/biopsies during treatment.
- TREATMENT Female participants of childbearing potential must agree to use effective contraception (2 forms of contraception or abstinence) from the screening visit until 6 months following the last dose of study...
- TREATMENT Male patients of childbearing potential having intercourse with females of childbearing potential must agree to abstain from heterosexual intercourse or have their partner use 2 forms of contraception from the...
What rules you out
- PRE-SCREENING EXCLUSION CRITERIA: Diagnosis of acute promyelocytic leukemia (APL, or AML M3 subtype) per WHO classification
- PRE-SCREENING EXCLUSION CRITERIA: AML with FLT3 mutations that qualify for standard of care treatment with 7+3 and midostaurin (e.g. FLT3 ITD or TKD with allelic ratio \> 0.05)
- PRE-SCREENING EXCLUSION CRITERIA: Favorable risk AML: inv(16), t(8;21), NPM1 mutations without FLT3-ITD, or in-frame mutations (mono- or biallelic) affecting the basic leucine zipper region of CEBPA
- PRE-SCREENING EXCLUSION CRITERIA: Any cancer-directed therapy within 2 weeks prior to starting planned 7+3 induction regimen, with the exception of hydroxyurea, which is allowed to control white blood cell count, or...
- PRE-SCREENING EXCLUSION CRITERIA: Prior receipt of a selective FGFR inhibitor
- PRE-SCREENING EXCLUSION CRITERIA: Known liver disease
- PRE-SCREENING EXCLUSION CRITERIA: History of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of soft tissues
- Except for commonly observed calcifications in soft tissues such as the skin, kidney tendon, or vessels due to injury, disease, or aging in the absence of systemic mineral imbalance)
- PRE-SCREENING EXCLUSION CRITERIA: History of hypovitaminosis D being actively treated with supraphysiologic doses (e.g., 50,000 IU/weekly) to replenish the deficiency.
- PRE-SCREENING EXCLUSION CRITERIA: Untreated human immunodeficiency virus (HIV) or active hepatitis C detectable by PCR, or chronic hepatitis B
- Individuals positive for hepatitis B core antibody who are receiving intravenous immunoglobulin (IVIg) are eligible if HepB PCR is negative
- PRE-SCREENING EXCLUSION CRITERIA: History of cerebrovascular accident or intracranial hemorrhage within 2 months of enrollment
- PRE-SCREENING EXCLUSION CRITERIA: Unwillingness to receive infusion of blood products
- PRE-SCREENING EXCLUSION CRITERIA: Inability to take oral medication
- PRE-SCREENING EXCLUSION CRITERIA: Gastrointestinal condition/disorders that may raise gastric and/or small intestinal pH that could interfere with absorption, metabolism, or excretion of pemigatinib
- PRE-SCREENING EXCLUSION CRITERIA: Known history and/or current evidence of ectopic mineralization/calcification, including (but not limited to): soft tissue, kidneys, intestine, myocardia, or lung, excepting calcified...
- PRE-SCREENING EXCLUSION CRITERIA: Concurrent active malignancy with expected survival of \< 1 year
- PRE-SCREENING EXCLUSION CRITERIA: Active central nervous system involvement with AML
- TREATMENT EXCLUSION CRITERIA: Clinically significant coagulation abnormality (e.g., disseminated intravascular coagulation) that is present on or by day 8 of induction therapy prior to starting pemigatinib
- TREATMENT EXCLUSION CRITERIA: Clinically significant or uncontrolled cardiac disease, including unstable angina, acute myocardial infarction within 6 months from day 1 of planned induction therapy, New York Heart...
- A screening QT interval by Fridericia's Correction Formula (QTcF) interval \> 480 ms will result in exclusion.
- For participants with an intraventricular conduction delay (QRS interval \> 120 ms), the JTc interval may be used in place of the QTc with approval from Sponsor-Investigator.
- TREATMENT EXCLUSION CRITERIA: Left ventricular ejection fraction (LVEF) by echocardiogram \< 45% prior to initiating pemigatinib
- TREATMENT EXCLUSION CRITERIA: Active infection that is not well-controlled by antibacterial or antiviral therapy
- TREATMENT EXCLUSION CRITERIA: Current use of prohibited medications including use of any potent CYP3A4 inducers within 14 days or five half-lives (whichever is longer) before the first dose of study drug.
- Use of CYP3A4 inhibitors should be avoided but, if medically necessary, is permitted with a dose reduction of study drug
- Use of moderate CYP3A4 inhibitors are permitted.
- Based on the low overall bioavailability of topical ketoconazole, there are no restrictions on topical ketoconazole
- TREATMENT EXCLUSION CRITERIA: Current use of prohibited medication
- TREATMENT EXCLUSION CRITERIA: Hypersensitivity to pemigatinib, or its excipients, when administered alone
- TREATMENT EXCLUSION CRITERIA: Current evidence of corneal disorder/keratopathy, including (but not limited to): bullous/band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjunctivitis, etc., as...
- TREATMENT EXCLUSION CRITERIA: Pregnancy or breastfeeding at the time of enrollment
- TREATMENT EXCLUSION CRITERIA: Any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the participant or compliance with the protocol
- TREATMENT EXCLUSION CRITERIA: Active central nervous system involvement with AML
- TREATMENT EXCLUSION CRITERIA: Patients with FLT mutations
The study team makes the final eligibility decision.
Where it is enrolling
- Portland, Oregon, United States
- Dallas, 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, but confirm specifics with the study team.
How long does this study last?
The study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Portland, Oregon, United States; Dallas, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.