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New treatment option for B-cell Acute Lymphoblastic Leukemia
Official title ABL001 + Dasatinib + Prednisone + Blinatumomab in BCR-ABL+ B-ALL or CML
ClinicalTrials.gov ID: NCT03595917
What this study is testing
What is ABL001?
ABL001 is an investigational medicine, given as an once-daily, being studied as a potential treatment for b-cell acute lymphoblastic 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 research study is evaluating a drug called ABL001 taken in combination with dasatinib (Sprycel®) and prednisone (a steroid) as a possible treatment for B-cell Acute Lymphoblastic Leukemia that is BCR-ABL positive (BCR-ABL+ B-ALL) or Chronic Myeloid Leukemia (CML) in lymphoid blast crisis. BCR-ABL+ B-ALL is also called Philadelphia chromosome positive Acute Lymphoblastic Leukemia (Ph+ ALL).
- 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 18 and older
You may be able to join if
- Participants must meet the following criteria on screening examination to be eligible to participate in the study:
- Participants must have cytopathologically confirmed CD19+ BCR-ABL1+ acute leukemia (B-cell ALL, mixed phenotype acute leukemia, or CML in lymphoid...
- BCR-ABL1 positive status may be confirmed by FISH, karyotype analysis, or molecular testing for p210 (b2a2 or b3a2) or p190 (e1a2) transcripts.
- Patients with asymptomatic central nervous system (CNS) disease are eligible and may be treated concurrently with intrathecal chemotherapy.
- Dose escalation: Participants must NOT be suitable for or willing to receive standard intensive induction chemotherapy.
You likely can't join if
- For dose escalation only: Participants suitable for and willing to receive standard intensive induction chemotherapy.
- Patients with a known ABL T315I mutation are excluded. ABL kinase mutation analysis is not recommended for newly diagnosed patient. ABL kinase...
- Prior treatment of ALL or CML with dasatinib or ASCIMINIB. Prior receipt of other TKIs and chemotherapy for the treatment of ALL or CML is permitted.
- Any TKI therapy must be discontinued for 5 half-lives prior to initiation of protocol therapy.
- Patient may not have received other chemotherapy, including antibody-based therapy, within 2 weeks of the initiation of protocol therapy with the...
- Participants who are receiving any other investigational agents for conditions other than ALL must have discontinued those agents 2 weeks prior to...
See the full eligibility criteria
Who can join
- Participants must meet the following criteria on screening examination to be eligible to participate in the study:
- Participants must have cytopathologically confirmed CD19+ BCR-ABL1+ acute leukemia (B-cell ALL, mixed phenotype acute leukemia, or CML in lymphoid blast crisis with ≥ 5% lymphoblasts.)22
- BCR-ABL1 positive status may be confirmed by FISH, karyotype analysis, or molecular testing for p210 (b2a2 or b3a2) or p190 (e1a2) transcripts.
- Patients with asymptomatic central nervous system (CNS) disease are eligible and may be treated concurrently with intrathecal chemotherapy.
- Dose escalation: Participants must NOT be suitable for or willing to receive standard intensive induction chemotherapy.
- Dose expansion: Participants aged 18 years and older will be eligible regardless of suitability for intensive induction chemotherapy. The following groups are not considered suitable for standard intensive induction...
- Participants who have not received standard intensive induction chemotherapy and are aged ≥ 50 years.
- Participants who have not received standard intensive induction chemotherapy and are aged 18 to 49 years and unfit due to co-morbidity or other factors to receive intensive chemotherapy. Specific criteria that would...
- Severe cardiac comorbidity (congestive heart failure or documented cardiomyopathy with EF ≤50%).
- Severe pulmonary comorbidity (documented pulmonary disease with DLCO ≤ 65% or FEV1 ≤ 65%, or dyspnea at rest, or requiring oxygen).
- ECOG performance status of 2 due to medical conditions unrelated to leukemia.
- Any other comorbidity that the physician judges to be incompatible with intensive cytotoxic chemotherapy.
- Participants aged ≥ 18 years with disease that is relapsed or refractory to 1 or more cycles of standard intensive induction chemotherapy.
- ECOG performance status 0-3 (Appendix A). ECOG value of 3 is allowed after documented discussion with PI, if poor performance status is attributed to underlying disease.
- Participants must have normal organ function as defined below:
- Creatinine ≤ 1.5x institutional upper limit of normal.
- Amylase and lipase values ≤ 3.0x institutional upper limit of normal.
- Alkaline phosphatase ≤ 2.5x institutional upper limit of normal (unless considered to be not of hepatic origin) (any level permitted), and/or unless felt to be clearly related to disease where ≤ 5x institutional upper...
- AST(SGOT)/ALT(SGPT) ≤ 3x institutional upper limit of normal unless felt to be clearly related to disease where ≤ 5x institutional upper limit of normal is permitted, after discussion with the overall PI.
- Total bilirubin - ≤1.5x institutional upper limit of normal (≤ 3x upper limit of normal in patients with known or suspected Gilbert's syndrome). The effects of ASCIMINIB on the developing human fetus are unknown. For...
- Women of child-bearing potential must agree to use highly effective methods of contraception during dosing and for 30 days after study treatment. Should a woman become pregnant or suspect she is pregnant while she or...
- Allowable methods of birth control:
- Total abstinence (when this is in line with the preferred and usual lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post ovulation methods) and withdrawal are not acceptable...
- Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only...
- Male sterilization (at least 6 months prior to screening). The vasectomized male partner should be the sole partner for that subject.
- Use of oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable how well it...
- Sexually active males must use a condom during intercourse while taking the drug and for 30 days after stopping treatment and should not father a child in this period. A condom is required to be used also by...
What rules you out
- For dose escalation only: Participants suitable for and willing to receive standard intensive induction chemotherapy.
- Patients with a known ABL T315I mutation are excluded. ABL kinase mutation analysis is not recommended for newly diagnosed patient. ABL kinase mutation analysis is recommended for patients with relapsed disease or CML...
- Prior treatment of ALL or CML with dasatinib or ASCIMINIB. Prior receipt of other TKIs and chemotherapy for the treatment of ALL or CML is permitted.
- Any TKI therapy must be discontinued for 5 half-lives prior to initiation of protocol therapy.
- Patient may not have received other chemotherapy, including antibody-based therapy, within 2 weeks of the initiation of protocol therapy with the exception of steroids, hydroxyurea, ATRA, and/or intrathecal chemotherapy.
- Participants who are receiving any other investigational agents for conditions other than ALL must have discontinued those agents 2 weeks prior to the start of study treatment.
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome). Patients...
- History of prior or concurrent malignancy requiring current treatment and/or whose natural history has the potential to interfere with the safety or how well it works assessment of the investigational regimen. Indolent...
- Acute or chronic liver disease (including known active hepatitis B and C infections). Screening for hepatitis is not required. Patients with known treated or past exposure viral hepatitis may participate after...
- History of pulmonary arterial hypertension.
- Significant pleural effusions leading to respiratory compromise and need for intervention (i.e. thoracentesis).
- Alcohol abuse requiring medical treatment.
- Participants with a history of or current acute pancreatitis, chronic pancreatitis, or any ongoing pancreatic disease.
- Known human immunodeficiency virus (HIV). Screening is not required.
- History of a serious bleeding disorder unrelated to ALL.
- It is suggested that participants receiving treatment with medications that meet one of the following criteria discontinue the relevant drug prior to the start of treatment with ASCIMINIB and for the duration of the...
- Strong inducers of CYP3A4/5.
- Moderate and strong inhibitors CYP3A4/5.
- CYP3A4/5, CYP2C8 and CYP2C9 substrates with narrow therapeutic index. All other substrates of the enzymes should be used with caution.
- H2 antagonists/proton-pump inhibitors.
- Grapefruit products are not permitted while on study.
- Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated list such as http://medicine.iupui.edu/clinpharm/ddis/table.aspx; medical reference texts such as the...
- Corrected QT interval (QTc) of \> 480 milliseconds (ms) on baseline electrocardiogram (ECG) (using corrected QT interval per institutional standard).
- Major surgery within 2 weeks before the first dose of ASCIMINIB.
- Uncontrolled intercurrent illness including, but not limited to:
- Uncontrolled infection.
- Unstable cardiovascular condition including symptomatic congestive heart failure (NYHA class 3 or 4), unstable angina pectoris, ongoing clinically significant cardiac arrhythmia uncontrolled by medication, and...
- Psychiatric illness/social situations that would limit compliance with study requirements.
- Currently requiring supplemental oxygen, mechanical ventilation, vasopressors, and/or hemodialysis (life-support).
- History of significant congenital or acquired bleeding disorder unrelated to cancer.
- Unable to comply with an oral regimen.
- Are pregnant or nursing at the time of screening. Pregnant women are excluded from this study because ASCIMINIB is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but...
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- Buffalo, New York, 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 Chicago, Illinois, United States; Boston, Massachusetts, United States; Buffalo, New York, 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.