Precursor Cell Lymphoblastic Leukemia-LymphomaPhase 1/2ORBITNCT02973191
A Study to Determine Safety, Feasibility and Efficacy of JCAR015 in Adult Subjects With B-Cell Acute Lymphoblastic Leukemia
A Phase 1/2 study testing JCAR015 in people with Precursor Cell Lymphoblastic Leukemia-Lymphoma, run by Celgene at 18 sites in 7 countries.
Trial summary
This is a single-arm, multi-center, open-label, Phase 2 study to determine the efficacy and safety of JCAR015 in adult subjects with B-cell ALL. The study is divided into two sequential parts, Part A and Part B; subjects will be screened and will provide informed consent before initiating any study procedures in Part… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- What is being tested?
- JCAR015
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 18 sitesin 7 countries
- Study dates
- 20 Dec 2016to 24 Jan 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years at the time of signing the informed consent form
- Subject must understand and voluntarily sign an Informed consent form (ICF) prior to any study-related assessments/procedures being conducted
- Subject is willing and able to adhere to the study visit schedule and other protocol requirements
- Diagnosis of B-cell Acute Lymphoblastic Leukemia (ALL)
- Evidence of CD19 expression via flow cytometry (peripheral blood or bone marrow) or immunohistochemistry (bone marrow biopsy)
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
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- No contraindications to cyclophosphamide. This includes subjects with:
- hypersensitivity to cyclophosphamide, any of its metabolites
- acute infections
- bone marrow aplasia or bone marrow depression prior to treatment
- urinary tract infection
- acute urothelial toxicity from cytotoxic chemotherapy or radiation therapy
- urinary outflow obstruction
- obstruction
- Adequate organ function, defined as:
- Serum creatinine ≤ 1.5 × age-adjusted upper limit of normal (ULN) OR calculated creatinine clearance (Cockcroft and Gault) > 30 mL/min/1.73 m2 b. Alanine aminotransferase (ALT) ≤ 5 × ULN and direct bilirubin < 2.0 mg/dL (or < 3.0 mg/dL for subjects with leukemic infiltration of the liver) c. Adequate pulmonary function, defined as ≤ Grade 1 dyspnea and oxygen saturation (SaO2) ≥ 92% on room air d. Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) ≥ 40% as assessed by echocardiogram (ECHO) or multiple uptake gated acquisition (MUGA) performed within 1 month of signing the informed consent form
- Adequate central or peripheral vascular access for leukapheresis procedure. For subjects requiring central venous catheter (CVC) placement, a surgical consultation indicating subject eligibility for CVC placement is sufficient for enrollment.
- Subjects must agree to not donate blood, organs, sperm or semen, and egg cells for usage in other individuals without recipient knowledge about exposure to a genetically modified organ by the donor and having been informed about the potential risks associated with it at any point after receiving JCAR015 infusion.
- Females of childbearing potential (FCBP1) must:
- Have two negative pregnancy tests as verified by the Investigator (one negative serum beta human chorionic gonadotropin (ß-hCG) pregnancy test result within 7 days prior to the first dose of cytoreductive chemotherapy (Part A screening evaluation), and one negative serum or urine pregnancy test at the Part B screening evaluation prior to first JCAR015 infusion). She must agree to have another pregnancy test 90 days post final JCAR015 dose. This applies even if the subject practices true abstinence2 from heterosexual contact.
- Either commit to true abstinence2 from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use, and be able to comply with, effective contraception without interruption. Contraception methods must include 1 highly effective and 1 additional effective (barrier) method of contraception from at least 28 days prior to JCAR015 initial infusion and during the study therapy including dose interruptions. Cessation of contraception after this point should be discussed with a responsible physician. Note: Highly effective methods are defined as those that result in a low failure rate (ie, less than 1% per year) when used consistently and correctly. The following are examples of highly effective and additional effective methods of contraception:
- Intrauterine device (IUD)
- Hormonal (birth control pill, injections, implants)
- Tubal ligation
- Partner's vasectomy
- Male Condom (additional effective method)
- Diaphragm (additional effective method)
- Cervical Cap (additional effective method) c. Agree to abstain from breastfeeding during study participation and for at least 90 days after the last dose of JCAR015.
- Agree to use highly effective methods of contraception during the entire study period (Part A through 12 months after the final JCAR015 infusion).
- Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method during the entire study period (Part A through 12 months after the final JCAR015 infusion).
- Additional Cohort Specific Inclusion Criteria
- Inclusion Criteria (Cohorts 1-4) 1. Relapsed or refractory disease, defined as:
- First bone marrow relapse (prior Complete response (CR) duration < 18 months) or any subsequent bone marrow relapse from Complete response (CR), OR
- Any bone marrow relapse after allogeneic hematopoietic stem cell transplant (HSCT); subjects must be at least 2 months from HSCT at the time of signing the informed consent form and off immunosuppressant medication for at least 1 month at the time of signing the informed consent form (with the exception of low-dose steroids (≤ 20 mg prednisone or equivalent), and have no Graft versus host disease (GVHD), OR
- Refractory Acute Lymphoblastic Leukemia (ALL), defined by not having achieved a Complete response (CR) or Complete response with incomplete peripheral blood count recovery (CRi) after two attempts at remission induction using standard chemotherapy regimens, OR
- Philadelphia chromosome positive (Ph+) B-cell ALL if subjects are intolerant to, or ineligible for, Tyrosine kinase inhibitor (TKI) therapy, or have progressed after at least one line of TKI therapy.
- 2. Bone marrow with morphological evidence of disease (≥ 5% blasts by morphology).
- Inclusion Criteria [Ph(+) (Cohort 3)] All subjects must meet Inclusion criteria described for Cohort 1.
- Inclusion Criteria (Cohort 4 only) 1. Eligible for Cohorts 1-3 but investigator has decided to administer blinatumomab as standard ALL therapy rather than other alternatives listed after leukapheresis but prior to part B of therapy Inclusion Criteria (MRD Positive+ [Cohort 5])
- Inclusion criteria as for Cohorts 1 and 2, with the exception of:
- 1. Bone marrow without morphological evidence of disease characterized as ≤ 5% blasts by morphology, but with MRD detected by flow cytometry, or qPCR at a frequency of ≥ 1 x 10-4 following standard of care induction and consolidation therapy in CR1 or in any subsequent CR
- For subjects in whom MRD has been followed only by flow cytometry, a nucleic acid sample of the leukemia blasts of sufficient quality must be available to generate realtime quantitative PCR (RQ-PCR) primers.
- 4.2.2. Inclusion Criteria (Part B)
- 1. Completion of Part A and successful generation of a JCAR015 cell product 2. Results from bone marrow examination following Part A:
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- Group 1: Morphological evidence of disease (≥ 5% blasts by morphology)
- Group 2: Morphologic complete remission (bone marrow with < 5% blasts) with or without blood count recovery (CR or CRi) or a hypoplastic, aplastic, or "recovery" marrow at Day 42 of Part A 3. Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 2 4. Adequate organ function, defined as:
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- Serum creatinine ≤ 1.5 × age-adjusted ULN OR calculated creatinine clearance
- (Cockcroft and Gault) > 30 mL/min/1.73 m2
- ALT ≤ 5 × ULN (or ≤ 8 × ULN for subjects with leukemic infiltration of the liver) and direct bilirubin < 2.0 mg/dL (or < 3.0 mg/dL for subjects with leukemic infiltration of the liver)
- Adequate pulmonary function, defined as ≤ Grade 1 dyspnea and SaO2 ≥ 92% on room air 5. Females of childbearing potential and males who have partners of childbearing potential follow the same inclusion criteria as Part A.
Who cannot join
- Isolated extramedullary disease relapse
- Concomitant genetic syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or any other known bone marrow failure syndrome
- Burkitt's lymphoma/leukemia or chronic myelogenous leukemia (CML) lymphoid blast crisis (p210 BCR-ABL+)
- Prior malignancy, unless treated with curative intent and with no evidence of active disease present for > 5 years before signing the informed consent form, with the following exceptions:
- Subjects with Stage I breast cancer that has been completely and successfully treated, requiring no therapy or only anti-hormonal therapy b. Subjects with T1N0M0 or T2N0M0 colorectal cancer who have been completely and successfully resected and who are disease-free for > 2 years prior to screening c. Subjects with indolent prostate cancer, defined as clinical stage T1 or T2a, Gleason score ≤ 6, and prostate-specific antigen (PSA) < 10 ng/mL, requiring no therapy or only anti- hormonal therapy d. Subjects with a history of basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix, fully resected, and with no evidence of active disease
- Treatment with any prior gene therapy product
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- Active hepatitis B, active hepatitis C, or any human immunodeficiency virus (HIV) infection at the time of signing the informed consent form
- Systemic fungal, bacterial, viral, or other infection that is not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment) at the time of signing the informed consent form
- Presence of Grade II-IV (Glucksberg) or B-D (IBMTR) acute or extensive chronic GVHD at the time of signing the informed consent form
- Active C S involvement by malignancy, defined as CNS-3 per NCCN guidelines. Subjects with a history of Central nervous system (CNS) disease that has been effectively treated (defined as one documented negative CSF evaluation within 1 month prior to signing the informed consent form) will be eligible
- History of any one of the following cardiovascular conditions within the past 6 months of signing the informed consent form: Class III or IV heart failure as defined by the New York Heart Association (NYHA), cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease
- History or presence of clinically relevant CNS pathology such as epilepsy, generalized seizure disorder, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
- Participation in an investigational research study using an investigational agent within 30 days of signing the informed consent form, with the exception of investigational antiinfective agents (eg, antibacterial, antifungal, antiviral)
- History of treatment with a murine-derived biological product (unless subject has been shown to be negative for human anti-mouse antibodies [HAMA] prior to or during screening). Prior use of blinatumomab is permitted (provided there is evidence of CD19 expression per Part A Inclusion Criterion #4). Chimeric biological products (eg, rituximab) are not considered murine for the purpose of this protocol.
- Pregnant or nursing (lactating) women
- Use of prohibited medications:
- Steroids: Therapeutic doses of corticosteroids (defined as > 20 mg/day prednisone or equivalent) are prohibited within 7 days prior to leukapheresis. Physiologic replacement dosing of steroids (≤ 12 mg/m2/day hydrocortisone or equivalent [≤ 3 mg/m2/day prednisone or ≤ 0.45 mg/m2/day dexamethasone]) is allowed. Topical steroids and intrathecal steroids for CNS relapse prophylaxis are permitted.
- Allogeneic cellular therapy: Donor lymphocyte infusions (DLI) are prohibited within 4 weeks prior to leukapheresis c. GVHD therapies: Any drug used for GVHD within 4 weeks prior to leukapheresis, eg, calcineurin inhibitors, methotrexate or other chemotherapeutics, mycophenolate mofetil, rapamycin, thalidomide, immunosuppressive antibodies (such as anti-CD20 [rituximab], anti-TNFα, anti-IL-6, or anti-IL-6R) d. Chemotherapies: Salvage chemotherapy (eg, cytosine arabinoside > 100 mg/m2/day, anthracyclines, and cyclophosphamide) must be stopped at least 1 week prior to leukapheresis
- Treatment with alemtuzumab within 6 months prior to leukapheresis, or treatment with clofarabine or cladribine within 3 months prior to leukapheresis
- Uncontrolled medical, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol, as judged by the Investigator; or subject unwillingness or inability to follow the procedures required in the protocol 4.3.2. Exclusion Criteria (Part B)
- Subjects must not meet any of the following criteria prior to Part B to be considered eligible:
- Systemic fungal, bacterial, viral, or other infection that is not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
- Active CNS involvement by malignancy, defined as CNS-3 per NCCN guidelines. Subjects with a history of CNS disease that has been effectively treated (defined as one documented negative CSF evaluation within 1 month prior to signing the informed consent form) will be eligible
- Presence of clinically relevant CNS pathology such as epilepsy, generalized seizure disorder, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
- Presence of Grade II-IV (Glucksberg) or B-D (IBMTR) acute or extensive chronic GVHD
- Use of prohibited medications
- Female subjects that have a positive serum or urine pregnancy test, or are pregnant
Trial locations and contacts
18 sites in 7 countries.
18 sites in 7 countries
Germany6 sites
University of Cologne
Cologne, 50924
Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden
Dresden, 1307
Universitatsklinikum Frankfurt
Frankfurt, 60590
University of Munich Grosshadern
Grosshadern Campus, D-81377
University of Leipzig
Leipzig, 4103
Universitaetsklinikum Ulm
Ulm, 89081
Italy4 sites
USC Ematologia, Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, 24127
Istituto Clinico Humanitas - Istituti di Ricovero E Cura A Carattere Scientifico (IRCSS)
Milan, 20089
Universita La Sapienza
Roma, 00168
Azienda Ospedaliera Citta della Salute e della Scienza di Torino
Torino, 10126
Spain2 sites
ICO-Hospital Germans Trias i Pujol
Barcelona, 08916
Hospital Universitario de Salamanca
Salamanca, 37007
United Kingdom2 sites
Bristol Royal Infirmary, University of Bristol Foundation Trust
Bristol, BS2 8BJ
UCL Cancer Institute
London, WC1E 6BT
About this study
Official title: A Phase 2, Open-label, Multiple Cohort, Single-arm, Multi-center Trial to Determine the Safety, Feasibility and Efficacy of JCAR015 in Adult Subjects With B-cell Acute Lymphoblastic Leukemia.
This is a single-arm, multi-center, open-label, Phase 2 study to determine the efficacy and safety of JCAR015 in adult subjects with B-cell ALL. The study is divided into two sequential parts, Part A and Part B; subjects will be screened and will provide informed consent before initiating any study procedures in Part A of the study.
- Being tested
- JCAR015
- Keywords
- Leukemia, B-Cell Acute Lymphoblastic Leukemia, JCAR015
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JCAR015Drug
| Study group | Role | What they receive |
|---|---|---|
| JCAR015 administration | Experimental | Single dose of 1.0-3.0 mg/m^2 IV cyclophosphamide, JCAR015 Dose 1 1x10^6 Tcells/kg, JCAR015 Dose 2 3x10^6 Tcells/kg Receives: Drug: JCAR015 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
The primary efficacy endpoint (for Cohorts 1-4) is ORR as determined by an Independent Review Committee (IRC). The ORR is, defined as proportion of subjects with a best overall response of Complete response (CR) or Complete response with incomplete peripheral blood count recovery (CRi) from 28 days through 6 months after the final infusion of JCAR015 or the start of receiving another anti-cancer therapy whichever comes first.
Measured: Up to 6 months
Minimal residual disease (MRD)
Evaluate the proportion of subjects who achieve a MRD negative complete response (CR) and the duration of MRD negative status, if achieved, after JCAR015 administration.
Measured: Up to 90 days
Secondary outcomes (11)
Adverse Events (AEs)
Number participants with adverse events
Measured: Up to 2 years
Duration of Minimal residual disease (MRD) response
Time from Minimal Residual Disease (MRD) response until MRD recurrence, morphologic relapse, or death
Measured: Up to 24 months
Relapse-free survival (RFS)
Relapse-free survival (RFS) is defined as the interval from the first documentation of complete response (CR) or Complete response with incomplete peripheral blood count recovery (CRi) to the earlier date of relapse or death due to any cause.
Measured: Up to 24 months
Event-free survival (EFS)
Is defined as the time from the date of the first JCAR015 infusion to death from any cause, relapse, or treatment failure, whichever occurs first
Measured: Up to 24 months
Overall survival (OS)
Is defined as the time from the date of the first JCAR015 infusion to date of death due to any reason
Measured: Up to 24 months
Percent Minimal residual disease (MRD) negative
Percentage of subjects who achieve CR or CRi with an MRD-negative bone marrow, as assessed by IgH gene sequencing (or BCR-ABL qPCR or flow cytometry for Ph(+) ALL subjects)
Measured: Up to 24 months
Depth of Minimal residual disease (MRD) response
Improvement of response in patients with MRD+ ALLL
Measured: Up to 24 months
Duration of remission (DOR)
Is defined as the interval from the first documentation of CR or CRi to the earlier date of relapse or death due to ALL. The first documentation of CR or CRi is defined as the latest of all dates of required measurements to establish the response. Duration of remission (DOR) will be evaluated based on the IRC evaluations for subjects who achieve a CR or CRi.
Measured: Up to 24 months
Pharmacokinetics - Cmax
Maximum observed concentration in plasma
Measured: Up to 24 months
Pharmacokinetics- Tmax
Time to reach maximum observed concentration in plasma
Measured: Up to 24 months
Pharmacokinetics - AUC
Area under the plasma concentration-time curve
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2016 (estimated)
- Study start20 Dec 2016 (estimated)
- Primary completion25 Jun 2019 (estimated)
- Study completion24 Jan 2021 (estimated)
Why it stopped: Development of JCAR015 has been discontinued. No subjects were enrolled/treated under protocol JCAR015-ALL-001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Precursor Cell Lymphoblastic Leukemia-LymphomaStudies of the same condition, open and under way.
- More trials run by CelgeneThe 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
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Juno
- Responsible party
- Sponsor
- Investigators
- Jens Hasskarl, MD, Study director, Celgene Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02973191
- Sponsor's protocol ID
- JCAR015-ALL-001
- Acronym
- ORBIT
- Status last verified
- Apr 2017
- First submitted
- 22 Nov 2016
- Last updated
- 10 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-label, Multiple Cohort, Single-arm, Multi-center Trial to Determine the Safety, Feasibility and Efficacy of JCAR015 in Adult Subjects With B-cell Acute Lymphoblastic Leukemia.
- ClinicalTrials.gov ID
- NCT02973191
- Acronym / sponsor ID
- ORBIT / JCAR015-ALL-001
- Keywords
- Leukemia, B-Cell Acute Lymphoblastic Leukemia, JCAR015
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Development of JCAR015 has been discontinued. No subjects were enrolled/treated under protocol JCAR015-ALL-001
- Enrolment
- 0 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Collaborators
- Juno
- Study start
- 20 Dec 2016 (estimated)
- Primary completion
- 25 Jun 2019 (estimated)
- Study completion
- 24 Jan 2021 (estimated)
- First posted
- 25 Nov 2016 (estimated)
- 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 is a single-arm, multi-center, open-label, Phase 2 study to determine the efficacy and safety of JCAR015 in adult subjects with B-cell ALL. The study is divided into two sequential parts, Part A and Part B; subjects will be screened and will provide informed consent before initiating any study procedures in Part A of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JCAR015 administration | Experimental | Drug: JCAR015Single dose of 1.0-3.0 mg/m^2 IV cyclophosphamide, JCAR015 Dose 1 1x10^6 Tcells/kg, JCAR015 Dose 2 3x10^6 Tcells/kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (52 listed)
- Age ≥18 years at the time of signing the informed consent form
- Subject must understand and voluntarily sign an Informed consent form (ICF) prior to any study-related assessments/procedures being conducted
- Subject is willing and able to adhere to the study visit schedule and other protocol requirements
- Diagnosis of B-cell Acute Lymphoblastic Leukemia (ALL)
- Evidence of CD19 expression via flow cytometry (peripheral blood or bone marrow) or immunohistochemistry (bone marrow biopsy)
Key exclusion criteria (27 listed)
- Isolated extramedullary disease relapse
- Concomitant genetic syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or any other known bone marrow failure syndrome
- Burkitt's lymphoma/leukemia or chronic myelogenous leukemia (CML) lymphoid blast crisis (p210 BCR-ABL+)
- Prior malignancy, unless treated with curative intent and with no evidence of active disease present for > 5 years before signing the informed consent form, with the following exceptions:
- Treatment with any prior gene therapy 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 |
|---|---|---|
| JCAR015 | Drug | JCAR015 administration |
Primary outcome
Overall Response Rate (ORR)
Time frame: Up to 6 months
The primary efficacy endpoint (for Cohorts 1-4) is ORR as determined by an Independent Review Committee (IRC). The ORR is, defined as proportion of subjects with a best overall response of Complete response (CR) or Complete response with incomplete peripheral blood count recovery (CRi) from 28 days through 6 months after the final infusion of JCAR015 or the start of receiving another anti-cancer therapy whichever comes first.
Minimal residual disease (MRD)
Time frame: Up to 90 days
Evaluate the proportion of subjects who achieve a MRD negative complete response (CR) and the duration of MRD negative status, if achieved, after JCAR015 administration.
11 secondary outcomes
Adverse Events (AEs)
Time frame: Up to 2 years
Duration of Minimal residual disease (MRD) response
Time frame: Up to 24 months
Relapse-free survival (RFS)
Time frame: Up to 24 months
Event-free survival (EFS)
Time frame: Up to 24 months
Overall survival (OS)
Time frame: Up to 24 months
Percent Minimal residual disease (MRD) negative
Time frame: Up to 24 months
Depth of Minimal residual disease (MRD) response
Time frame: Up to 24 months
Duration of remission (DOR)
Time frame: Up to 24 months
Pharmacokinetics - Cmax
Time frame: Up to 24 months
Pharmacokinetics- Tmax
Time frame: Up to 24 months
Pharmacokinetics - AUC
Time frame: Up to 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
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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.
Jens Hasskarl, MD study director
Celgene Corporation
18 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing JCAR015 in people with Precursor Cell Lymphoblastic Leukemia-Lymphoma, run by Celgene at 18 sites in 7 countries.
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 52 inclusion and 27 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: withdrawn, as of the sponsor's last update on 10 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Germany, Italy, France, Spain, United Kingdom and 2 more countries. 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 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) (time frame: Up to 6 months). The study lists 2 primary outcomes in all. 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 10 Apr 2017.