Acute T Cell LeukemiaPhase 1/2NCT03613428
Ruxolitinib Plus LVP in Patients With R/R ETP-ALL
A Phase 1/2 study testing Ruxolitinib, Vincristine and Prednisone in people with Acute T Cell Leukemia, run by Sichuan University.
Trial summary
To determine the maximum tolerated dose (MTD), if present, and dose schedule of ruxolitinib in combination with L-ASP, vincristine, and prednisone (LVP) in patients with relapsed-and-refractory (R/R) early T precursor acute lymphocytic leukemia (ETP-ALL). Read more about this study
- Who is it for?
- Ages 13 to 75 years
- Conditions the study is for
- Acute T Cell Leukemia
- What is being tested?
- Ruxolitinib, Vincristine and Prednisone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2018to 30 Mar 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 13 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects with early T-precursor ALL, with any of the following:
- refractory to primary induction therapy or refractory to salvage therapy,
- in untreated first relapse with first remission duration <12 months
- in untreated second or greater relapse
- relapse at any time after allogeneic HSCT
- Subject has received intensive combination chemotherapy for the treatment of ALL for initial treatment or subsequent salvage therapy.
- Greater than 5% blasts in the bone marrow
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Who cannot join
- Malignancy other than ALL within 5 years before recruitment, except for adequately treated selected cancers without evidence of disease
- Current relevant central nervous system (CNS) pathology or known or suspected CNS involvement
- Isolated extramedullary disease
- Current autoimmune disease or history of autoimmune disease with potential CNS involvement
- Autologous HSCT within 6 weeks or allogeneic HSCT within 12 weeks before blinatumomab treatment, or eligibility for allogeneic HSCT at the time of enrollment
- Active acute grade 2 to 4 graft versus host disease (GvHD) according to Glucksberg et al (1974) criteria that required systemic treatment to prevent or treat GvHD 2 weeks before blinatumomab treatment
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- Known exclusion criteria to investigator choice of SOC chemotherapy (per package insert)
- Cancer chemotherapy or radiotherapy with 2 weeks, or immunotherapy (included CD19 therapy) within 4 weeks of protocol-specified therapy
- Abnormal laboratory values (alanine or aspartate transaminase [ALT or AST] or alkaline phosphatase [ALP] ≥ 5 × upper limit of normal [ULN]; total bilirubin or creatinine ≥ 1.5 × ULN), or calculated creatinine clearance < 60 mL/min.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Phase I/II Study of Ruxolitinib Plus L-asparaginase, Vincristine, and Prednisone in Adult Patients With Relapsed or Refractory Early T Precursor Acute Lymphocytic Leukemia
To determine the maximum tolerated dose (MTD), if present, and dose schedule of ruxolitinib in combination with L-ASP, vincristine, and prednisone (LVP) in patients with relapsed-and-refractory (R/R) early T precursor acute lymphocytic leukemia (ETP-ALL). Once determined, the purpose of this study will be to determine the efficacy of ruxolitinib in combination with LVP in patients with R/R ETP-ALL.
- Conditions
- Acute T Cell Leukemia
- Being tested
- Ruxolitinib, Vincristine, Prednisone
- Medical subject headings
- Precursor T-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 JAK1/JAK2 inhibitor
Dose escalation up to 80 mg administered orally
VincristineDrug
Also called Oncovin
1.4 mg/m2 i.v. weekly for 4 weeks
PrednisoneDrug
Also called steroid
1 mg/kg orally 5 consecutive days per week for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| ruxolitinib, vincristine, prednisone | Experimental | Open label dosing cohorts will evaluate oral ruxolitinib (doses ranging from 10 - 80 mg) in combination with vincristine (1.4 mg/m2) and oral prednisone (1 mg/kg, 5 days a week for 4 weeks). Receives: Drug: Ruxolitinib; Drug: Vincristine; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish optimal dose of ruxolitinib
Determine maximum tolerated dose (MTD) of ruxolitinib
Measured: Upon completion of a 28 day treatment cycle
Secondary outcomes (3)
Evaluate safety by assessing toxicities
Evaluate safety by assessing possible toxicities of thrombocytopenia, neutropenia, serum creatinine, total bilirubin, diarrhea, and/or vomiting.
Measured: Upon completion of a 28 day treatment cycle
Overall response
Measured: At the end of Cycle 2 (each cycle is 60 days)
Complete response
Measured: At the end of Cycle 2 (each cycle is 60 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start1 Dec 2018 (estimated)
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute T Cell LeukemiaStudies of the same condition, open and under way.
- More trials run by Sichuan UniversityThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label dosing cohorts will evaluate oral ruxolinitib (doses ranging from 10 - 80 mg) in combination with vincristine (1.4 mg/m2) and oral prednisone (1 mg/kg, 5 days a week for 4 weeks).
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie Ji, Sichuan University
- Investigators
- Jie Ji, MD, Principal investigator, West Chinia Hospital, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03613428
- Sponsor's protocol ID
- HX-ETP-01
- Status last verified
- Aug 2018
- First submitted
- 16 Jul 2018
- Last updated
- 3 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Ruxolitinib Plus L-asparaginase, Vincristine, and Prednisone in Adult Patients With Relapsed or Refractory Early T Precursor Acute Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT03613428
- Acronym / sponsor ID
- HX-ETP-01
- Conditions
- Acute T Cell Leukemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Sichuan UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (estimated)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Mar 2021 (estimated)
- First posted
- 3 Aug 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.
To determine the maximum tolerated dose (MTD), if present, and dose schedule of ruxolitinib in combination with L-ASP, vincristine, and prednisone (LVP) in patients with relapsed-and-refractory (R/R) early T precursor acute lymphocytic leukemia (ETP-ALL). Once determined, the purpose of this study will be to determine the efficacy of ruxolitinib in combination with LVP in patients with R/R ETP-ALL.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label dosing cohorts will evaluate oral ruxolinitib (doses ranging from 10 - 80 mg) in combination with vincristine (1.4 mg/m2) and oral prednisone (1 mg/kg, 5 days a week for 4 weeks).
| Arm | Type | Receives |
|---|---|---|
| ruxolitinib, vincristine, prednisone | Experimental | Drug: Ruxolitinib, Drug: Vincristine, Drug: PrednisoneOpen label dosing cohorts will evaluate oral ruxolitinib (doses ranging from 10 - 80 mg) in combination with vincristine (1.4 mg/m2) and oral prednisone (1 mg/kg, 5 days a week for 4 weeks). |
Who may qualify
- Ages
- 13 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects with early T-precursor ALL, with any of the following:
- Subject has received intensive combination chemotherapy for the treatment of ALL for initial treatment or subsequent salvage therapy.
- Greater than 5% blasts in the bone marrow
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Key exclusion criteria (9 listed)
- Malignancy other than ALL within 5 years before recruitment, except for adequately treated selected cancers without evidence of disease
- Current relevant central nervous system (CNS) pathology or known or suspected CNS involvement
- Isolated extramedullary disease
- Current autoimmune disease or history of autoimmune disease with potential CNS involvement
- Autologous HSCT within 6 weeks or allogeneic HSCT within 12 weeks before blinatumomab treatment, or eligibility for allogeneic HSCT at the time of enrollment
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: JAK1/JAK2 inhibitorDose escalation up to 80 mg administered orally | Drug | ruxolitinib, vincristine, prednisone |
| VincristineAlso: Oncovin1.4 mg/m2 i.v. weekly for 4 weeks | Drug | ruxolitinib, vincristine, prednisone |
| PrednisoneAlso: steroid1 mg/kg orally 5 consecutive days per week for 4 weeks. | Drug | ruxolitinib, vincristine, prednisone |
Primary outcome
Establish optimal dose of ruxolitinib
Time frame: Upon completion of a 28 day treatment cycle
Determine maximum tolerated dose (MTD) of ruxolitinib
3 secondary outcomes
Evaluate safety by assessing toxicities
Time frame: Upon completion of a 28 day treatment cycle
Overall response
Time frame: At the end of Cycle 2 (each cycle is 60 days)
Complete response
Time frame: At the end of Cycle 2 (each cycle is 60 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
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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. This study is not recruiting at the moment.
Jie Ji, MD principal investigator
West Chinia Hospital, Sichuan University
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ruxolitinib, Vincristine and Prednisone in people with Acute T Cell Leukemia, run by Sichuan University.
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 8 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 3 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jie Ji, MD (86-18980605802, jieji@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish optimal dose of ruxolitinib (time frame: Upon completion of a 28 day treatment cycle). 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 3 Aug 2018.