Acute Lymphoblastic LeukemiaPhase 1NCT03571321
Ruxolitinib and Chemotherapy in Adolescents and Young Adults With Ph-like Acute Lymphoblastic Leukemia
A Phase 1 study testing Ruxolitinib, Cyclophosphamide and Cytarabine in people with Acute Lymphoblastic Leukemia and ALL, Childhood, run by University of Chicago at 2 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia, ALL, Childhood, ALL
- What is being tested?
- Ruxolitinib, Cyclophosphamide and Cytarabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 May 2019to 5 Sep 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 1 recruiting
- Recruiting
University of Chicago Medical Center
Chicago, Illinois, 60637
Howie Weiner, (773) 702-2084, hweiner@medicine.bsd.uchicago.edu
Wendy Stock, MD
- Active, not recruiting
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
Official title: 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)
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).
- Conditions
- Acute Lymphoblastic Leukemia, ALL, Childhood, ALL
- Being tested
- Ruxolitinib, Cyclophosphamide, Cytarabine, Mercaptopurine, Vincristine
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RuxolitinibDrug
Also called Jakafi
Participants will receive one of 3 doses [taken by mouth] (30 mg, 40 mg, or 50 mg) depending on when they are enrolled to the study.
Remission consolidation regimen:
- Days 1-14 and 29-43
Interim maintenance regimen:
- Days 1-14 and 29-43
Delayed Intensification regimen:
- Days 1-14 and 29-43
CyclophosphamideDrug
Remission consolidation regimen:
- 1000 mg/m2 by intravenous infusion (IV) on Day 1 and Day 29
Delayed Intensification regimen:
- 1000 mg/m2 IV on Day 29
CytarabineDrug
Remission consolidation regimen:
- 75 mg/m2/day IV or subcutaneously (SC) on Days 1-4 (i.e., 4 doses), 8-11, 29-32, and 36-39
Delayed Intensification regimen:
- 75 mg/m2/day IV or SC on Days 29-32 and 36-39
MercaptopurineDrug
Taken by mouth.
Remission consolidation regimen:
- 60 mg/m2 on Days 1-14 and 29-42
Maintenance Therapy:
- 75 mg/m2 on Days 1-84
VincristineDrug
Remission consolidation regimen:
- 1.5 mg/m2 (maximum 2 mg) IV once per week on Days 15, 22, 43, and 50
Interim maintenance regimen:
- 1.5 mg/m2 (maximum 2 mg) IV on Days 1, 11, 21, 31, and 41
Delayed Intensification regimen:
- 1.5 mg/m2 (maximum 2 mg) IV on Days 1, 8, 15, 43, and 50
Maintenance Therapy:
- 1.5 mg/m2 (maximum 2 mg) IV on Days 1, 29, and 57
PegaspargaseDrug
Remission consolidation regimen:
- 2500 IU/m2 given by intramuscular (IM) injection or IV on Days 15 and 43
Interim maintenance regimen:
- 2500 IU/m2 IM or IV on Days 2 and 22
Delayed Intensification regimen:
- 2500 IU/m2 IM or IV on Day 4 (OR Day 5 OR Day 6) AND Day 43.
RituximabDrug
For patients that have cluster of differentiation antigen 20 positive (CD20+) disease only.
Remission consolidation regimen:
- 375 mg/m2 IV on Days 1, 8, 29 and 36
Interim maintenance regimen:
- 375 mg/m2 IV on Days 1 and 11
Delayed Intensification regimen:
- 375 mg/m2 IV on Days 1 and 8
Methotrexate (Intrathecal Administration)Drug
Drug is given through a needle which is inserted in one of the spaces between the bones in the lower back (intrathecal [IT] administration).
Remission consolidation regimen:
- 15 mg on Days 1, 8, 15, and 22
Interim maintenance regimen:
- 15 mg on Days 1 and 31
Delayed Intensification regimen:
- 15 mg on Days 1, 29, and 36
Maintenance Therapy:
- 15 mg on Day 1
- 15 mg on Day 29 (First 4 courses only)
Methotrexate (Intravenous Administration)Drug
Interim maintenance regimen:
- 100 mg/m2 IV on Days 1, 11, 21, 31, and 41
DexamethasoneDrug
Taken by mouth or given by IV infusion.
Delayed Intensification regimen:
- 10 mg/m2 per day (divided into 2 doses) on Days 1-7 and 15-21
Maintenance Therapy:
- 6 mg/m2 per day (divided into 2 doses) on Days 1-5, 29-33, and 57-61
DoxorubicinDrug
Delayed Intensification regimen:
- 25 mg/m2 IV on Days 1, 8, 15
ThioguanineDrug
Taken by mouth at least 1 hour after evening meal.
Delayed Intensification regimen:
- 60 mg/m2 on Days 29-42
Methotrexate Oral ProductDrug
Taken by mouth.
Maintenance Therapy:
- 20 mg/m2 weekly (on Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78)
- Not given on Day 29 of first 4 courses (on days when IT Methotrexate is given]
| Study group | Role | What they receive |
|---|---|---|
| Ruxolitinib | Experimental | Participants will receive ruxolitinib in addition to standard chemotherapy.
Standard Chemotherapy Consists of:
* Remission consolidation therapy (lasting 8 weeks)
* Interim Maintenance (lasting 8 weeks)
* Delayed Intensification (lasting 8 weeks
* Maintenance Therapy (12 week courses/84 day cycles lasting 2-3 years)
Prior to study entry, patients must have completed a 4-drug induction therapy regimen with intrathecal chemotherapy (modified Berlin-Frankfurt-Münster (aBFM) regimen or equivalent) as per the institution standard of care. Receives: Drug: Ruxolitinib; Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Mercaptopurine; Drug: Vincristine; Drug: Pegaspargase; Drug: Rituximab; Drug: Methotrexate (Intrathecal Administration); Drug: Methotrexate (Intravenous Administration); Drug: Dexamethasone; Drug: Doxorubicin; Drug: Thioguanine; Drug: Methotrexate Oral Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of adding ruxolitinib to a standard-of-care pediatric-based chemotherapy regimen in adolescents and young adult patients as determined by rate of side effects seen when combination is given
Determined by rate of side effects seen when combination is given
Measured: 24 weeks
Secondary outcomes (3)
Rate of participants that are minimal residual disease (MRD) negative at end of induction therapy
Measured: 4 weeks
Overall survival rate
Measured: 2 years
Event-free survival rate
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2018
- Study start28 May 2019
- Primary completion1 Sep 2026 (estimated)
- Study completion5 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Incyte Corporation
- Responsible party
- Sponsor
- Investigators
- Wendy Stock, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03571321
- Sponsor's protocol ID
- IRB17-1110
- Status last verified
- Jan 2026
- First submitted
- 22 Jun 2018
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT03571321
- Acronym / sponsor ID
- IRB17-1110
- Conditions
- Acute Lymphoblastic Leukemia, ALL, Childhood, ALL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Incyte Corporation
- Study start
- 28 May 2019 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 5 Sep 2027 (estimated)
- First posted
- 27 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ruxolitinib | Experimental | Drug: Ruxolitinib, Drug: Cyclophosphamide, Drug: Cytarabine, Drug: Mercaptopurine, Drug: Vincristine, Drug: Pegaspargase, Drug: Rituximab, Drug: Methotrexate (Intrathecal Administration), Drug: Methotrexate (Intravenous Administration), Drug: Dexamethasone, Drug: Doxorubicin, Drug: Thioguanine, Drug: Methotrexate Oral ProductParticipants will receive ruxolitinib in addition to standard chemotherapy. Standard Chemotherapy Consists of: * Remission consolidation therapy (lasting 8 weeks) * Interim Maintenance (lasting 8 weeks) * Delayed Intensification (lasting 8 weeks * Maintenance Therapy (12 week courses/84 day cycles lasting 2-3 years) Prior to study entry, patients must have completed a 4-drug induction therapy regimen with intrathecal chemotherapy (modified Berlin-Frankfurt-Münster (aBFM) regimen or equivalent) as per the institution standard of care. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (21 listed)
- 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:
- SH2B adaptor protein 3 (SH2B3) deletions
- Interleukin-7 receptor subunit alpha (IL7RA) mutations
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RuxolitinibAlso: JakafiParticipants will receive one of 3 doses [taken by mouth] (30 mg, 40 mg, or 50 mg) depending on when they are enrolled to the study. Remission consolidation regimen: * Days 1-14 and 29-43 Interim maintenance regimen: * Days 1-14 and 29-43 Delayed Intensification regimen: * Days 1-14 and 29-43 | Drug | Ruxolitinib |
| CyclophosphamideRemission consolidation regimen: * 1000 mg/m2 by intravenous infusion (IV) on Day 1 and Day 29 Delayed Intensification regimen: * 1000 mg/m2 IV on Day 29 | Drug | Ruxolitinib |
| CytarabineRemission consolidation regimen: * 75 mg/m2/day IV or subcutaneously (SC) on Days 1-4 (i.e., 4 doses), 8-11, 29-32, and 36-39 Delayed Intensification regimen: * 75 mg/m2/day IV or SC on Days 29-32 and 36-39 | Drug | Ruxolitinib |
| MercaptopurineTaken by mouth. Remission consolidation regimen: * 60 mg/m2 on Days 1-14 and 29-42 Maintenance Therapy: * 75 mg/m2 on Days 1-84 | Drug | Ruxolitinib |
| VincristineRemission consolidation regimen: * 1.5 mg/m2 (maximum 2 mg) IV once per week on Days 15, 22, 43, and 50 Interim maintenance regimen: * 1.5 mg/m2 (maximum 2 mg) IV on Days 1, 11, 21, 31, and 41 Delayed Intensification regimen: * 1.5 mg/m2 (maximum 2 mg) IV on Days 1, 8, 15, 43, and 50 Maintenance Therapy: * 1.5 mg/m2 (maximum 2 mg) IV on Days 1, 29, and 57 | Drug | Ruxolitinib |
| PegaspargaseRemission consolidation regimen: * 2500 IU/m2 given by intramuscular (IM) injection or IV on Days 15 and 43 Interim maintenance regimen: * 2500 IU/m2 IM or IV on Days 2 and 22 Delayed Intensification regimen: * 2500 IU/m2 IM or IV on Day 4 (OR Day 5 OR Day 6) AND Day 43. | Drug | Ruxolitinib |
| RituximabFor patients that have cluster of differentiation antigen 20 positive (CD20+) disease only. Remission consolidation regimen: * 375 mg/m2 IV on Days 1, 8, 29 and 36 Interim maintenance regimen: * 375 mg/m2 IV on Days 1 and 11 Delayed Intensification regimen: * 375 mg/m2 IV on Days 1 and 8 | Drug | Ruxolitinib |
| Methotrexate (Intrathecal Administration)Drug is given through a needle which is inserted in one of the spaces between the bones in the lower back (intrathecal [IT] administration). Remission consolidation regimen: * 15 mg on Days 1, 8, 15, and 22 Interim maintenance regimen: * 15 mg on Days 1 and 31 Delayed Intensification regimen: * 15 mg on Days 1, 29, and 36 Maintenance Therapy: * 15 mg on Day 1 * 15 mg on Day 29 (First 4 courses only) | Drug | Ruxolitinib |
| Methotrexate (Intravenous Administration)Interim maintenance regimen: * 100 mg/m2 IV on Days 1, 11, 21, 31, and 41 | Drug | Ruxolitinib |
| DexamethasoneTaken by mouth or given by IV infusion. Delayed Intensification regimen: * 10 mg/m2 per day (divided into 2 doses) on Days 1-7 and 15-21 Maintenance Therapy: * 6 mg/m2 per day (divided into 2 doses) on Days 1-5, 29-33, and 57-61 | Drug | Ruxolitinib |
| DoxorubicinDelayed Intensification regimen: * 25 mg/m2 IV on Days 1, 8, 15 | Drug | Ruxolitinib |
| ThioguanineTaken by mouth at least 1 hour after evening meal. Delayed Intensification regimen: * 60 mg/m2 on Days 29-42 | Drug | Ruxolitinib |
| Methotrexate Oral ProductTaken by mouth. Maintenance Therapy: * 20 mg/m2 weekly (on Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78) * Not given on Day 29 of first 4 courses (on days when IT Methotrexate is given] | Drug | Ruxolitinib |
Primary outcome
Feasibility of adding ruxolitinib to a standard-of-care pediatric-based chemotherapy regimen in adolescents and young adult patients as determined by rate of side effects seen when combination is given
Time frame: 24 weeks
Determined by rate of side effects seen when combination is given
3 secondary outcomes
Rate of participants that are minimal residual disease (MRD) negative at end of induction therapy
Time frame: 4 weeks
Overall survival rate
Time frame: 2 years
Event-free survival rate
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wendy Stock, MD principal investigator
University of Chicago
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ruxolitinib, Cyclophosphamide and Cytarabine in people with Acute Lymphoblastic Leukemia and ALL, Childhood, run by University of Chicago at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Office (1-855-702-8222, cancerclinicaltrials@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of adding ruxolitinib to a standard-of-care pediatric-based chemotherapy regimen in adolescents and young adult patients as determined by rate of side effects seen when combination is given (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.