RecruitingPhase 1

Ruxolitinib and Chemotherapy in Adolescents and Young Adults With Ph-like Acute Lymphoblastic Leukemia

Phase I Trial of Ruxolitinib in Combination With a Pediatric Based-regimen for Adolescents and Young Adults (AYAs) With Ph-like Acute Lymphoblastic Leukemia (ALL)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 39 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether adding ruxolitinib to standard chemotherapy is safe and can be tolerated. It is for people ages 18 to 39 with newly diagnosed Ph-like acute lymphoblastic leukemia (ALL), a type of blood cancer.

This study will test if adding ruxolitinib to standard multi-drug chemotherapy regimen will be safe and tolerated in adolescents and young adults with newly diagnosed Ph-like acute lymphoblastic leukemia (ALL).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 to 39.
  • Have newly diagnosed B-precursor ALL, a cancer of immature B blood cells, confirmed by tests.
  • Have tests showing the Ph-like pattern and a gene change that can be targeted through the JAK pathway, which helps control cell growth.
  • Finish the first four-drug chemotherapy treatment, including chemotherapy into the fluid around the brain and spinal cord, before starting ruxolitinib. No other past leukemia treatment is allowed except certain emergency treatments.
  • Be able to care for yourself and be up and about at least half of your waking hours.
  • Have a platelet count above 25,000 and liver and kidney test results within the study’s limits. Platelets help blood clot.
  • Agree to use birth control or not have sex before joining and during the study if you are a man or a woman who can become pregnant.
  • Be able to understand the study and sign a consent form.

Who can't join

  • Receiving another experimental drug.
  • Have another active cancer, except non-melanoma skin cancer. Cancer treated at least 3 years ago with no disease since then is not considered active.
  • Have had an allergic reaction to drugs similar to ruxolitinib or other study drugs.
  • Recently used medicines that strongly affect a liver enzyme called CYP3A4, which helps break down drugs. The study team must check the required waiting time.
  • Have an uncontrolled illness, such as an infection or certain heart problems, or mental health or social issues that would keep you from following study requirements.
  • Are pregnant. Breastfeeding must stop if you receive ruxolitinib.
  • Have Down syndrome.
  • Have Burkitt-type leukemia or Philadelphia chromosome-positive ALL (Ph+ ALL) at diagnosis.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Newly diagnosed de novo B-precursor acute lymphoblastic leukemia (ALL) as determined by World Health Organization (WHO) criteria. Patients must have unequivocal diagnosis of precursor B ALL. This includes an institutional immunophenotyping report that is to assign B-lineage or T-lineage. * "Ph-like" signature, as determined by low density micro-array (LDA) card * Jak-targetable genetic signature as defined by any of the following: * Cytokine receptor-like factor 2 (CRLF2) rearranged (JAK2 mutant or wild-type) * JAK2 or erythropoietin receptor (EPOR) fusions. * Other JAK pathway alterations at the discretion of the principle investigator including, but not limited to: * SH2B adaptor protein 3 (SH2B3) deletions * Interleukin-7 receptor subunit alpha (IL7RA) mutations * Prior therapy * Prior to starting ruxolitinib, patients must have completed a 4-drug induction regimen with intrathecal chemotherapy (modified aBFM regimen or equivalent) as per the institutional standard of care. Recommended induction treatment is outlined in Section 5.1.2. * No additional prior therapy for acute leukemia except emergency therapy (corticosteroids or hydroxyurea) for blast cell crisis, superior vena cava syndrome, or renal failure due to leukemic infiltration of the kidneys. When indicated, leukapheresis or exchange transfusion is recommended to reduce the white blood cell count (WBC). * Screening may occur at any point prior to or during induction therapy * Age ≥ 18 years and \< 40 years. Because this is specifically a study of the adolescent and young adult population and no adverse event data are currently available on the use of this pediatric-based chemotherapy regimen in patients ≥ 40 years of age, older adults are excluded from this study, but may be eligible for future trials. * Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky ≥ 60%) * Platelet count \> 25,000/uL. * Patients must have normal organ function as defined below: * total bilirubin ≤ 2 mg/dL * aspartate aminotransferase (AST) / alanine aminotransferase (ALT) ≤ 2.5 × institutional upper limit of normal * creatinine within normal institutional limits OR creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal. * Because the therapeutic agents used in this study are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Patients who are receiving any other investigational agent. * Patients with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for ≥ 3 years. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to ruxolitinib or other agents used in study. * Use of any potent cytochrome P450 (CYP) 3A4 inhibitor or inducer within 5 half-lives before the first dose of the study drug. Potent inhibitors of CYP3A4 include systemic ketoconazole, posaconazole, voriconazole, clarithromycin, itraconazole, nefazodone, and telithromycin. At the fluconazole dose of 200mg daily used this regimen, there is minimal inhibition of CYP3A4 \[36\] and therefore fluconazole is not prohibited on this trial and no dose modifications should be made in the presence of fluconazole. 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 Physicians' Desk Reference may also provide this information. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant women are excluded from this study because ruxolitinib is a class C agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ruxolitinib breastfeeding should be discontinued if the mother is treated with ruxolitinib. These potential risks may also apply to other agents used in this study. * Down Syndrome due to the likelihood of excessive toxicity resulting. These patients should be treated in consultation with a pediatric oncologist. * Burkitt type leukemia * Ph+ ALL at time of diagnosis

Study sites (2)

IL

TX