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New treatment option for Previously Untreated Relapsed Refractory Acute Myeloid Leukemia
Official title Study of Biomarker-Based Treatment of Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT03013998
What this study is testing
What is Samalizumab (BAML-16-001-S1)?
Samalizumab (BAML-16-001-S1) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for previously untreated relapsed refractory acute myeloid leukemia.
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 screening and multi-sub-study Phase 1b/2 trial will establish a method for genomic screening followed by assigning and accruing simultaneously to a multi-study "Master Protocol (BAML-16-001-M1)." The specific subtype of acute myeloid leukemia will determine which sub-study, within this protocol, a participant will be assigned to evaluate investigational therapies or combinations with the ultimate goal of advancing new targeted therapies for approval. The study also includes a marker negative sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies.
- Phase 2: a mid-size study of how well it works
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
- Adults, age 60 years or older at the time of diagnosis unless in a specific known cytogenetic and genomic group for which treatment in Group A, B, or...
- Patients must be able to understand and provide written informed consent
- Cohort - Group A: Patients must have previously untreated acute myeloid leukemia (AML) according to the WHO classification with no prior treatment...
- Cohort - Group B: Patients must have relapsed or refractory AML according to the WHO classification. For study purposes, refractory AML is defined as...
- Cohort - Group C: For select sites which are not part of the Beat AML core sites. These sites will only participate in select sub-studies. Patients...
You likely can't join if
- Acute promyelocytic leukemia
- Clinically active central nervous system (CNS) involvement by AML. A patient may be considered eligible if CNS leukemia is showing response to...
- Signs of leukostasis requiring urgent therapy
- Disseminated intravascular coagulopathy with active bleeding or signs of thrombosis
- Patients with psychological, familial, social, or geographic factors that otherwise preclude them from giving informed consent, following the...
- Any other significant medical condition, including psychiatric illness or laboratory abnormality, that would preclude the patient participating in...
See the full eligibility criteria
Who can join
- Adults, age 60 years or older at the time of diagnosis unless in a specific known cytogenetic and genomic group for which treatment in Group A, B, or C is allowed by the sub-study where age 18 and older is allowed. In...
- Patients must be able to understand and provide written informed consent
- Cohort - Group A: Patients must have previously untreated acute myeloid leukemia (AML) according to the WHO classification with no prior treatment other than hydroxyurea. Patients with myeloid malignancies [e.g...
- Cohort - Group B: Patients must have relapsed or refractory AML according to the WHO classification. For study purposes, refractory AML is defined as failure to ever achieve a complete response (CR) or recurrence of AML...
- Cohort - Group C: For select sites which are not part of the Beat AML core sites. These sites will only participate in select sub-studies. Patients in this group will enroll under the Beat AML M1 Master protocol with...
What rules you out
- Acute promyelocytic leukemia
- Clinically active central nervous system (CNS) involvement by AML. A patient may be considered eligible if CNS leukemia is showing response to treatment at study entry and should continue to receive intrathecal therapy...
- Signs of leukostasis requiring urgent therapy
- Disseminated intravascular coagulopathy with active bleeding or signs of thrombosis
- Patients with psychological, familial, social, or geographic factors that otherwise preclude them from giving informed consent, following the protocol (including failure to collect genomics samples for screening), or...
- Any other significant medical condition, including psychiatric illness or laboratory abnormality, that would preclude the patient participating in the trial or would confound the interpretation of the results of the...
- Patients, age 60 years or older at the time of diagnosis with untreated AML according to the International Consensus Classification (ICC) 2022 guidelines, that have NPM1 mutated or MLL rearranged disease and who are not...
- Patients must be able to understand and provide written informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
- Aspartate aminotransferase (AST) \< 5 x upper limit of normal (ULN), alanine aminotransferase (ALT) \< 5 x ULN, and total bilirubin \< 2 x ULN (except for patients with known or suspected Gilbert's syndrome and with...
- Adequate renal function as defined by calculated creatinine clearance ≥ 60 mL/min for the local laboratory.
- Females must be non-child bearing, postmenopausal, surgically sterile or meet certain criteria if of childbearing potential. Males must adhere to criteria if with females of child bearing potentia
- Patients must have previously untreated AML with no prior treatment other than hydroxyurea. No chemotherapy for AML outside of hydroxyurea for treatment of leukostasis or ATRA for initially suspected APL (that is ruled...
- If the patient has co-morbid illness or malignancy, life expectancy attributed to this must be greater than 2 years. BAML-16-001-S17 - Exclusion Criteria:
- Isolated myeloid sarcoma (meaning, patients must have blood or marrow involvement with AML to enter the study).
- Acute promyelocytic leukemia (FAB M3).
- Favorable risk cytogenetics [Core Binding Factor (CBF) AML].
- Active central nervous system (CNS) involvement by AML.
- Signs of leukostasis requiring urgent therapy.
- Patients with WBC ≥ 25,000/μl. (Patients must have WBC \< 25,000/μl to begin therapy and Hydroxyurea may be used to obtain this level).
- Patients willing and able to receive intensive induction chemotherapy.
- Disseminated intravascular coagulopathy with active bleeding or signs of thrombosis.
- Patients with psychological, familial, social, or geographic factors that otherwise preclude them from giving informed consent, following the protocol, or potentially hamper compliance with study treatment and follow-up.
- Any other significant medical condition, including psychiatric illness or laboratory abnormality, that would preclude the patient participating in the trial or would confound the interpretation of the results of the...
- Known active Human Immunodeficiency Virus (HIV), active hepatitis B or active hepatitis C infection.
- Patients with the following will be excluded: uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, myocardial...
- As infection is a common feature of AML, patients with active infection are permitted to enroll provided that the infection is under control. Patients with uncontrolled infection shall not be enrolled until infection is...
- Patients who have received an investigational agent (for any indication) within 5 half-lives of the agent and until toxicity from this has resolved to grade 1 or less; if the half-life of the agent is unknown, patients...
- Patients with QTcF (Fridericia) \> 450 ms for male patients and \> 468 for female patients; patients with right, left, or partial bundle branch blocks or pacemaker that may confound interpretation of this reading are...
- Written Informed Consent must be obtained from the patient prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).
- Patient is ≥18 years of age at the time of obtaining informed consent.
- Patient is refractory to or relapsed after multiple AML therapies (with or without HSCT). and have exhausted all reasonable therapies expected to produce benefit unless the patient declines or is ineligible for these.
- Group 1: Patient must have a confirmed FLT3-ITD or FLT3-TKD mutation by central laboratory testing. Group 2: Patient must have a documented SF3B1, SRSF2, U2AF1, or ZRSR2 pathogenic mutation by local lab sequencing.
- For Group 1 only: Patients must have previously been treated with Gilteritinib with failure to stop disease progression, or not met the criteria for treatment with Gilteritinib in the opinion of the Investigator or...
- Patients have a life expectancy of at least 3 months in the opinion of the Investigator.
- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- Patient must meet the following criteria as indicated on the clinical laboratory tests:
- Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × upper limit of normal (ULN).
- Serum total bilirubin ≤1.5 × ULN unless due to Gilbert's disease where a maximum total bilirubin level of 4.0 mg/dL is acceptable.
- Estimated glomerular filtration rate (eGFR) of \> \>40 mL/min as calculated by the Modification of Diet in Renal Disease equation.
- Females must be non-child bearing, postmenopausal, surgically sterile or meet certain criteria if of childbearing potential.
- Males must adhere to criteria if with females of child bearing potential BAML-16-001-S21 - Exclusion Criteria:
- Diagnosis of isolated myeloid sarcoma (meaning, patients must have blood or marrow involvement with AML).
- Acute promyelocytic leukemia (FAB M3).
- Active central nervous system (CNS) involvement by AML.
- Clinical signs/symptoms of leukostasis requiring urgent therapy.
- Known active infection with Human Immunodeficiency Virus (HIV), hepatitis B or hepatitis C. Patients with a history of positive serology for hepatitis B or C require a negative Polymerase chain reaction (PCR) test for...
- Disseminated intravascular coagulopathy with active, unmanageable bleeding or signs of thrombosis.
- Patients who have received an investigational agent (for any indication) within 5 half-lives of the agent; if the half-life of the agent is unknown, patients must wait 1 week prior to first dose of study treatment. An...
- Systemic chemotherapy or radiation therapy within 1 week prior to starting protocol with the exception of hydroxyurea, which is allowed to control white blood cell counts.
- Female patients who are pregnant or lactating.
- Patients with QTcF \> 470 msec that cannot be corrected with electrolyte replacement, hydration, or medication modifications.
- Patients with psychological, familial, social, or geographic factors, other significant medical condition, laboratory abnormality that otherwise preclude them from giving informed consent, following the protocol...
- Patients with the following will be excluded: uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, myocardial...
- Infection is a common feature of AML, as such patients with active infection are permitted to enroll provided that the infection is under control in the opinion of the Investigator. Patients with uncontrolled infection...
- ≥ 60 years at time of AML diagnosis
- Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2
- Aspartate aminotransferase (AST) \< 2.5 x upper limit of normal (ULN), alanine aminotransferase (ALT) \< 2.5 x ULN, and total bilirubin \< 1.5 x ULN (except for patients with known Gilbert's syndrome) for the local...
- Adequate renal function as defined by calculated creatinine clearance \> 40 mL/min per the local laboratory
- Patients must be able to understand and provide written informed consent.
- Females must be non-child bearing, postmenopausal, surgically sterile or meet certain criteria if of childbearing potential.
- Males must adhere to criteria if with females of child bearing potential
- No prior chemotherapy for leukemia, except hydroxyurea to control leukocytosis and ATRA for initially suspected APL, which is permitted. [Prior therapy for myelodysplastic syndrome (MDS) or myeloproliferative neoplasm...
- If the patient has co-morbid illness or malignancy, life expectancy attributed to this must be greater than 2 years. BAML-16-001-S24 - Exclusion Criteria:
- Patients able and willing to receive intensive induction chemotherapy for underlying AML.
- Isolated myeloid sarcoma (meaning, patients must have blood or marrow involvement with AML to enter the study).
- Acute promyelocytic leukemia.
- Known active central nervous system (CNS) involvement by AML.
- Clinical signs/symptoms of leukostasis requiring urgent therapy.
- Known active Human Immunodeficiency Virus (HIV), active hepatitis B or active hepatitis C infection.
- Disseminated intravascular coagulopathy with active bleeding or signs of thrombosis.
- Patients who have received an investigational agent (for any indication) within 5 half-lives of the agent; if the half-life of the agent is unknown, patients must wait 1 week prior to first dose of study treatment. An...
- Systemic antineoplastic therapy (for any indication) within 5 half-lives or radiation therapy within 1 week prior to starting protocol except for hydroxyurea, which is allowed to control white blood cell counts.
- Patients with psychological, familial, social, or geographic factors, other significant medical condition, laboratory abnormality that otherwise preclude them from giving informed consent, following the protocol...
- Patients with the following will be excluded: uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, myocardial...
- As infection is a common feature of AML, patients with active infection are permitted to enroll provided that the infection is under control. Patients with uncontrolled infection shall not be enrolled until infection is...
- Patients who require treatment with concomitant drugs that are strong inducers of cytochrome P450 (CYP) 3A.
- Patients who require treatment with concomitant drugs that are strong inhibitors or inducers of P-glycoprotein (P-gp) with the exception of drugs that are considered absolutely essential for the care of the patient.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Los Angeles, California, United States
- San Francisco, California, United States
- Denver, Colorado, United States
- Gainesville, Florida, United States
- Jacksonville, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Fairway, Kansas, United States
- Baltimore, Maryland, United States
- Rochester, Minnesota, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Cincinnati, Ohio, United States
- Columbus, Ohio, United States
- Portland, Oregon, United States
- Pittsburgh, Pennsylvania, United States
- Dallas, Texas, United States
- Salt Lake City, Utah, 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Los Angeles, California, United States; San Francisco, California, United States; Denver, Colorado, United States; Gainesville, Florida, United States; Jacksonville, Florida, United States and 13 more location(s). 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.