Acute Myeloid LeukemiaPhase 1/2NCT01853228
A Study of Decitabine (DACOGEN) in Sequential Administration With Cytarabine in Children With Relapsed or Refractory Acute Myeloid Leukemia
A Phase 1/2 study testing Phase1 and Phase 2: decitabine, Phase 1: cytarabine and Phase 2: cytarabine in people with Acute Myeloid Leukemia, run by Janssen Research & Development, LLC at 17 sites in 7 countries.
Trial summary
The purpose of this study is to examine the safety and efficacy of decitabine in sequential administration with cytarabine in children with relapsed or refractory acute myeloid leukemia (AML). Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Phase1 and Phase 2: decitabine, Phase 1: cytarabine and Phase 2: cytarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 17 sitesin 7 countries
- Study dates
- 22 Oct 2013to 28 Aug 2017
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Histological diagnosis of acute myeloid leukemia (AML) according to the World Health Organization (WHO) classification
- Diagnosis of AML which has relapsed or is refractory to standard of care and no curative therapy exists
- Karnofsky or Lansky score of at least 50
- Must be recovered from acute toxicity of any prior treatment
- Must have adequate organ function according to protocol-defined criteria
- Agrees to protocol-defined use of effective contraception
- Female participants of childbearing potential must have a negative serum or urine pregnancy test at Day 1 of Cycle 1
Who cannot join
- Prior treatment with decitabine or azacitidine
- Acute promyelocytic leukemia (M3 subtype in the French-American-British [FAB] classification system)
- CNS3 disease
- acute myeloid leukemia (AML) associated with congenital syndromes such as Down syndrome, Fanconi anemia, Bloom syndrome, Kostmann syndrome or Diamond-Blackfan anemia, or bone marrow failure associated with inherited syndromes
- White blood cell count greater than 40x10^9 cells/liter(L)
- Known allergies, hypersensitivity, or intolerance to decitabine or cytarabine or their excipients
Show all 14Show fewer
- Contraindications to the use of cytarabine per local prescribing information or prior adverse reactions to cytarabine which would prevent further use
- Currently enrolled in the treatment phase of an interventional investigational study
- Female who is pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 3 months after the last dose of study drug (however, the period after which it becomes safe to become pregnant after the last dose of treatment is not known)
- Male who plans to father a child while enrolled in this study or within 3 months after the last dose of study drug
- Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient or that could prevent, limit, or confound the protocol-specified assessments
- Any social or medical condition that in the investigator's opinion renders the participant unfit for study participation
- History of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease
- History of human immunodeficiency virus (HIV) antibody positive
Trial locations and contacts
17 sites in 7 countries.
17 sites in 7 countries
Germany4 sites
Study site
Essen
Study site
Hamburg
Study site
Hanover
Study site
Stuttgart
United Kingdom4 sites
Study site
Birmingham
Study site
Cambridge
Study site
Glasgow
Study site
Sutton
France3 sites
Study site
Paris
Study site
Toulouse
Study site
Vandœuvre-lès-Nancy
About this study
Official title: Phase 1-2 Safety and Efficacy Study of DACOGEN in Sequential Administration With Cytarabine in Children With Relapsed or Refractory Acute Myeloid Leukemia
The purpose of this study is to examine the safety and efficacy of decitabine in sequential administration with cytarabine in children with relapsed or refractory acute myeloid leukemia (AML).
Read the detailed description
This is an open-label (identity of assigned study drug will be known) study to evaluate safety, efficacy, and pharmacokinetics (study of what the body does to a drug) of decitabine in sequential administration with cytarabine in children with relapsed or refractory AML. The study will determine the maximum tolerated dose of cytarabine that can be given following decitabine (Phase 1) and the response rate to this combination (Phase 2). Participants may enter a continuation phase of single agent-decitabine infusions for as long as such treatment would be considered beneficial. Serial pharmacokinetic samples will be collected and safety and efficacy will be monitored throughout the study.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Phase1 and Phase 2: decitabine, Phase 1: cytarabine, Phase 2: cytarabine
- Keywords
- Acute myeloid leukemia, Relapsed or refractory acute myeloid leukemia, Children, Decitabine, DACOGEN, Cytarabine
- Medical subject headings
- Leukemia, Myeloid, Acute, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase1 and Phase 2: decitabineDrug
20 mg/m2 administered by intravenous infusion over 1 hour once daily for 5 consecutive days (Day 1 to Day 5 of 28-day cycle)
Phase 1: cytarabineDrug
1 g/m2, 2 g/m2, and 1.5 g/m2 dose levels administered by intravenous infusion over 4 hours daily for 5 consecutive days (Day 8 to Day 12 of 28-day cycle) for the determination of the maximum tolerated dose
Phase 2: cytarabineDrug
Phase 1 maximum tolerated dose administered by intravenous infusion over 4 hours daily for 5 consecutive days (Day 8 to Day 12 of 28-day cycle)
| Study group | Role | What they receive |
|---|---|---|
| Decitabine and cytarabine | Experimental | Not described Receives: Drug: Phase1 and Phase 2: decitabine; Drug: Phase 1: cytarabine; Drug: Phase 2: cytarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Maximum Tolerated Dose (MTD) of Cytarabine
The maximum tolerated dose (MTD) for cytarabine was based on the number of participants experiencing a dose-limiting toxicity (DLT) by the end of Cycle 1. A non-hematological DLT was defined as: any Grade >=3 toxicity that persists for greater than (>) 5 days or any Grade 2 toxicity that persists for >7 days and that is intolerable to the participant. A hematological DLT was defined as Grade 4 neutropenia or thrombocytopenia due to a hypoplastic bone marrow at Day 42, in the absence of malignant infiltration. The nominal duration of each cycle was 28 days. However, participants who had not experienced bone marrow recovery at Day 28 were followed up to Day 42. Failure of marrow recovery (improvement to Grade 3) by Day 42 was considered a DLT. The maximum duration of Cycle 1 was therefore 42 days.
Measured: Cycle 1 (42 days)
Phase 1 and 2: Total Clearance of Decitabine
Total clearance of drug after intravenously administration was calculated as: dose/area under the plasma concentration-time curve.
Measured: Cycle 1 (28 days) Day 5: pre-infusion, 0.5 hour during infusion, end of infusion and at 5 minute (min), 0.5 hour, 1 hour, and 2 hour after end of infusion
Phase 1 and 2: Volume of Distribution at Steady-State (Vss) of Decitabine
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.
Measured: Cycle 1 (28 days) Day 5: pre-infusion, 0.5 hour during infusion, end of infusion and at 5 min, 0.5 hour, 1 hour, and 2 hour after end of infusion
Phase 2: Percentage of Participants Who Achieved CR or CRi at Cycle 1 Day 28
Response rate (percentage of participants who achieved CR or CRi) was measured using international working group (IWG) criteria. Response rate is defined as complete remission (CR) or complete remission with incomplete blood count recovery (CRi) in children with relapsed or refractory acute myeloid leukemia. CRi is defined as morphologic CR with residual neutropenia (less than [<] 1,000/microliter) or thrombocytopenia <100,000/ microliter). CR is defined as morphologic leukemia-free state, with less than 5 percentage (%) blasts in aspirate sample with marrow spicules and with a count of greater than or equal to (>=) 200 nucleated cells, plus absolute neutrophil count (ANC) greater than (>) 1,000/ microliter, platelet count of >100,000/microliter and participant must be independent of transfusions for a minimum of 1 week before each marrow assessment.
Measured: Cycle 1 (28 days) Day 28
Phase 2: Percentage of Participants Who Achieved CR or CRi at Cycle 2 Day 28
Response rate (percentage of participants who achieved CR or CRi) was measured using international working group (IWG) criteria. Response rate is defined as complete remission (CR) or complete remission with incomplete blood count recovery (CRi) in children with relapsed or refractory acute myeloid leukemia. CRi is defined as morphologic CR with residual neutropenia (less than [<] 1,000/microliter) or thrombocytopenia <100,000/ microliter). CR is defined as morphologic leukemia-free state, with less than 5 percentage (%) blasts in aspirate sample with marrow spicules and with a count of greater than or equal to (>=) 200 nucleated cells, plus absolute neutrophil count (ANC) greater than (>) 1,000/ microliter, platelet count of >100,000/microliter and participant must be independent of transfusions for a minimum of 1 week before each marrow assessment.
Measured: Cycle 2 (28 days) Day 28
Phase 2: Percentage of Participants Who Achieved CR or CRi at End of Study Treatment
Response rate (percentage of participants who achieved CR or CRi) was measured using international working group (IWG) criteria. Response rate is defined as complete remission (CR) or complete remission with incomplete blood count recovery (CRi) in children with relapsed or refractory acute myeloid leukemia. CRi is defined as morphologic CR with residual neutropenia (less than [<] 1,000/microliter) or thrombocytopenia <100,000/ microliter). CR is defined as morphologic leukemia-free state, with less than 5 percentage (%) blasts in aspirate sample with marrow spicules and with a count of greater than or equal to (>=) 200 nucleated cells, plus absolute neutrophil count (ANC) greater than (>) 1,000/ microliter, platelet count of >100,000/microliter and participant must be independent of transfusions for a minimum of 1 week before each marrow assessment.
Measured: End of study treatment (approximately 3 years)
Secondary outcomes (7)
Phase 1 and 2: Maximum Plasma Concentration (Cmax) of Decitabine
Cmax is the maximum observed plasma concentration of Decitabine.
Measured: Cycle 1 (28 days) Day 5: pre-infusion, 0.5 hour during infusion, end of infusion and at 5 min, 0.5 hour, 1 hour, and 2 hour after end of infusion
Phase 1 and 2: Area Under the Plasma Concentration-Time Curve (AUC) of Decitabine
AUC is the area under the plasma concentration-time curve of decitabine.
Measured: Cycle 1 (28 days) Day 5: pre-infusion, 0.5 hour during infusion, end of infusion and at 5 min, 0.5 hour, 1 hour, and 2 hour after end of infusion
Phase 2: Duration of Response
Duration of response is defined as weeks from date of first response to date of first relapse or date of death.
Measured: From time of response to relapse, study completion/withdrawal, or death, whichever comes first, for up to approximately 3 years 10 months
Phase 2: Overall Response Rate
Overall response rate is defined as percentage of participants with complete remission (CR) +complete remission with incomplete blood count recovery (CRi)+partial remission (PR) per IWG Criteria. CRi: morphologic CR with residual neutropenia (less than [<] 1,000/microliter) or thrombocytopenia <100,000/microliter). CR is defined as morphologic leukemia-free state, with less than 5 percentage (%) blasts in aspirate sample with marrow spicules and with a count of greater than or equal to (>=) 200 nucleated cells, plus absolute neutrophil count (ANC) greater than (>) 1,000/ microliter platelet count of >100,000/microliter and participant must be independent of transfusions for a minimum of 1 week before each marrow assessment. PR: all the same hematologic values of a CR, but with a decrease of >=50% of the percentage of blasts to 5% to 25% in the bone marrow aspirate.
Measured: Up to approximately 3 years 10 months
Phase 1 and 2: Overall Survival (OS)
OS is defined as the time from the date of first dose of study drug to date of death from any cause. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant will be last known to be alive.
Measured: From enrollment to death or withdrawal, whichever comes first, for up to approximately 3 years 10 months
Phase 1 and 2: Event-Free Survival
Event free survival is defined as the time from first dose of study drug to relapse from CR, death, or second malignancy for participants who achieved CR. CR is defined as morphologic leukemia-free state, with less than 5 percentage (%) blasts in aspirate sample with marrow spicules and with a count of greater than or equal to (>=) 200 nucleated cells, plus absolute neutrophil count (ANC) greater than (>) 1,000/ microliter platelet count of >100,000/microliter and participant must be independent of transfusions for a minimum of 1 week before each marrow assessment.
Measured: From enrollment to progression/relapse, death, or withdrawal, whichever comes first, for up to approximately 3 years 10 months
Phase 1 and 2: Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs)
TEAEs are defined as adverse events with onset or worsening on or after date of first dose of study treatment. An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Measured: Approximately 3 years 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2013 (estimated)
- Study start22 Oct 2013
- Primary completion28 Aug 2017
- Study completion28 Aug 2017
Why it stopped: EMA/PDCO acknowledged that available results from this study do not support further clinical studies in relapsed/refractory AML paediatric patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe 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
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01853228
- Sponsor's protocol ID
- CR102071
- Other IDs
- DACOGENAML2004, 2013-000390-70
- Status last verified
- Mar 2019
- First submitted
- 10 May 2013
- Last updated
- 17 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1-2 Safety and Efficacy Study of DACOGEN in Sequential Administration With Cytarabine in Children With Relapsed or Refractory Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT01853228
- Acronym / sponsor ID
- CR102071
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Acute myeloid leukemia, Relapsed or refractory acute myeloid leukemia, Children, Decitabine, DACOGEN, Cytarabine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: EMA/PDCO acknowledged that available results from this study do not support further clinical studies in relapsed/refractory AML paediatric patients.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 22 Oct 2013 (actual)
- Primary completion
- 28 Aug 2017 (actual)
- Study completion
- 28 Aug 2017 (actual)
- First posted
- 14 May 2013 (estimated)
- Results
- Posted 17 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the safety and efficacy of decitabine in sequential administration with cytarabine in children with relapsed or refractory acute myeloid leukemia (AML).
Detailed description
This is an open-label (identity of assigned study drug will be known) study to evaluate safety, efficacy, and pharmacokinetics (study of what the body does to a drug) of decitabine in sequential administration with cytarabine in children with relapsed or refractory AML. The study will determine the maximum tolerated dose of cytarabine that can be given following decitabine (Phase 1) and the response rate to this combination (Phase 2). Participants may enter a continuation phase of single agent-decitabine infusions for as long as such treatment would be considered beneficial. Serial pharmacokinetic samples will be collected and safety and efficacy will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Decitabine and cytarabine | Experimental | Drug: Phase1 and Phase 2: decitabine, Drug: Phase 1: cytarabine, Drug: Phase 2: cytarabine |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Histological diagnosis of acute myeloid leukemia (AML) according to the World Health Organization (WHO) classification
- Diagnosis of AML which has relapsed or is refractory to standard of care and no curative therapy exists
- Karnofsky or Lansky score of at least 50
- Must be recovered from acute toxicity of any prior treatment
- Must have adequate organ function according to protocol-defined criteria
Key exclusion criteria (14 listed)
- Prior treatment with decitabine or azacitidine
- Acute promyelocytic leukemia (M3 subtype in the French-American-British [FAB] classification system)
- CNS3 disease
- acute myeloid leukemia (AML) associated with congenital syndromes such as Down syndrome, Fanconi anemia, Bloom syndrome, Kostmann syndrome or Diamond-Blackfan anemia, or bone marrow failure associated with inherited syndromes
- White blood cell count greater than 40x10^9 cells/liter(L)
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 |
|---|---|---|
| Phase1 and Phase 2: decitabine20 mg/m2 administered by intravenous infusion over 1 hour once daily for 5 consecutive days (Day 1 to Day 5 of 28-day cycle) | Drug | Decitabine and cytarabine |
| Phase 1: cytarabine1 g/m2, 2 g/m2, and 1.5 g/m2 dose levels administered by intravenous infusion over 4 hours daily for 5 consecutive days (Day 8 to Day 12 of 28-day cycle) for the determination of the maximum tolerated dose | Drug | Decitabine and cytarabine |
| Phase 2: cytarabinePhase 1 maximum tolerated dose administered by intravenous infusion over 4 hours daily for 5 consecutive days (Day 8 to Day 12 of 28-day cycle) | Drug | Decitabine and cytarabine |
Primary outcome
Phase 1: Maximum Tolerated Dose (MTD) of Cytarabine
Time frame: Cycle 1 (42 days)
The maximum tolerated dose (MTD) for cytarabine was based on the number of participants experiencing a dose-limiting toxicity (DLT) by the end of Cycle 1. A non-hematological DLT was defined as: any Grade >=3 toxicity that persists for greater than (>) 5 days or any Grade 2 toxicity that persists for >7 days and that is intolerable to the participant. A hematological DLT was defined as Grade 4 neutropenia or thrombocytopenia due to a hypoplastic bone marrow at Day 42, in the absence of malignant infiltration. The nominal duration of each cycle was 28 days. However, participants who had not experienced bone marrow recovery at Day 28 were followed up to Day 42. Failure of marrow recovery (improvement to Grade 3) by Day 42 was considered a DLT. The maximum duration of Cycle 1 was therefore 42 days.
Phase 1 and 2: Total Clearance of Decitabine
Time frame: Cycle 1 (28 days) Day 5: pre-infusion, 0.5 hour during infusion, end of infusion and at 5 minute (min), 0.5 hour, 1 hour, and 2 hour after end of infusion
Total clearance of drug after intravenously administration was calculated as: dose/area under the plasma concentration-time curve.
Phase 1 and 2: Volume of Distribution at Steady-State (Vss) of Decitabine
Time frame: Cycle 1 (28 days) Day 5: pre-infusion, 0.5 hour during infusion, end of infusion and at 5 min, 0.5 hour, 1 hour, and 2 hour after end of infusion
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.
Phase 2: Percentage of Participants Who Achieved CR or CRi at Cycle 1 Day 28
Time frame: Cycle 1 (28 days) Day 28
Response rate (percentage of participants who achieved CR or CRi) was measured using international working group (IWG) criteria. Response rate is defined as complete remission (CR) or complete remission with incomplete blood count recovery (CRi) in children with relapsed or refractory acute myeloid leukemia. CRi is defined as morphologic CR with residual neutropenia (less than [<] 1,000/microliter) or thrombocytopenia <100,000/ microliter). CR is defined as morphologic leukemia-free state, with less than 5 percentage (%) blasts in aspirate sample with marrow spicules and with a count of greater than or equal to (>=) 200 nucleated cells, plus absolute neutrophil count (ANC) greater than (>) 1,000/ microliter, platelet count of >100,000/microliter and participant must be independent of transfusions for a minimum of 1 week before each marrow assessment.
Phase 2: Percentage of Participants Who Achieved CR or CRi at Cycle 2 Day 28
Time frame: Cycle 2 (28 days) Day 28
Response rate (percentage of participants who achieved CR or CRi) was measured using international working group (IWG) criteria. Response rate is defined as complete remission (CR) or complete remission with incomplete blood count recovery (CRi) in children with relapsed or refractory acute myeloid leukemia. CRi is defined as morphologic CR with residual neutropenia (less than [<] 1,000/microliter) or thrombocytopenia <100,000/ microliter). CR is defined as morphologic leukemia-free state, with less than 5 percentage (%) blasts in aspirate sample with marrow spicules and with a count of greater than or equal to (>=) 200 nucleated cells, plus absolute neutrophil count (ANC) greater than (>) 1,000/ microliter, platelet count of >100,000/microliter and participant must be independent of transfusions for a minimum of 1 week before each marrow assessment.
Phase 2: Percentage of Participants Who Achieved CR or CRi at End of Study Treatment
Time frame: End of study treatment (approximately 3 years)
Response rate (percentage of participants who achieved CR or CRi) was measured using international working group (IWG) criteria. Response rate is defined as complete remission (CR) or complete remission with incomplete blood count recovery (CRi) in children with relapsed or refractory acute myeloid leukemia. CRi is defined as morphologic CR with residual neutropenia (less than [<] 1,000/microliter) or thrombocytopenia <100,000/ microliter). CR is defined as morphologic leukemia-free state, with less than 5 percentage (%) blasts in aspirate sample with marrow spicules and with a count of greater than or equal to (>=) 200 nucleated cells, plus absolute neutrophil count (ANC) greater than (>) 1,000/ microliter, platelet count of >100,000/microliter and participant must be independent of transfusions for a minimum of 1 week before each marrow assessment.
7 secondary outcomes
Phase 1 and 2: Maximum Plasma Concentration (Cmax) of Decitabine
Time frame: Cycle 1 (28 days) Day 5: pre-infusion, 0.5 hour during infusion, end of infusion and at 5 min, 0.5 hour, 1 hour, and 2 hour after end of infusion
Phase 1 and 2: Area Under the Plasma Concentration-Time Curve (AUC) of Decitabine
Time frame: Cycle 1 (28 days) Day 5: pre-infusion, 0.5 hour during infusion, end of infusion and at 5 min, 0.5 hour, 1 hour, and 2 hour after end of infusion
Phase 2: Duration of Response
Time frame: From time of response to relapse, study completion/withdrawal, or death, whichever comes first, for up to approximately 3 years 10 months
Phase 2: Overall Response Rate
Time frame: Up to approximately 3 years 10 months
Phase 1 and 2: Overall Survival (OS)
Time frame: From enrollment to death or withdrawal, whichever comes first, for up to approximately 3 years 10 months
Phase 1 and 2: Event-Free Survival
Time frame: From enrollment to progression/relapse, death, or withdrawal, whichever comes first, for up to approximately 3 years 10 months
Phase 1 and 2: Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs)
Time frame: Approximately 3 years 10 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
17 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 Phase1 and Phase 2: decitabine, Phase 1: cytarabine and Phase 2: cytarabine in people with Acute Myeloid Leukemia, run by Janssen Research & Development, LLC at 17 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 7 inclusion and 14 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: stopped early, as of the sponsor's last update on 17 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Germany, United Kingdom, France, Spain, Belgium 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?
Yes. Results are posted in the registry (first posted 17 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Phase 1: Maximum Tolerated Dose (MTD) of Cytarabine (time frame: Cycle 1 (42 days)). The study lists 6 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 17 Jun 2019.