Relapsed/Refractory Acute Lymphoblastic LeukemiaNCT02783651
An Study of Patients With Ph- Chromosome-negative Relapsed or Refractory Acute Lymphoblastic Leukemia in the US
An observational study of Relapsed/Refractory Acute Lymphoblastic Leukemia, run by Amgen at 19 sites in United States.
Trial summary
A retrospective chart review study of Philadelphia chromosome-negative R/R ALL patients in the US. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Relapsed/Refractory Acute Lymphoblastic Leukemia
- What is being tested?
- Other
- How many people
- 212 participants
- Where
- 19 sitesUnited States
- Study dates
- 30 Jun 2016to 31 Mar 2020
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients initiating treatment for Philadelphia chromosome-negative (Ph-) R/R ALL between January 2013 and March 2019 at participating clinical sites in the US
Who may be able to join
- -Medical records of patients initiating treatment for Ph- R/R ALL at participating clinical centers in the US between January 2013 and March 2019 will be eligible for inclusion.
Who cannot join
- Medical records of patients with Ph+ ALL will be excluded.
- If informed consent is required, medical records of patients who do not provide informed consent will be excluded.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Research Site
Ames, Iowa, 50010
Research Site
Austin, Texas, 78701
Research Site
Baltimore, Maryland, 21201
Research Site
Baltimore, Maryland, 21287
Research Site
Buffalo, New York, 14263
Research Site
Chicago, Illinois, 60612
Research Site
Cincinnati, Ohio, 45229
Research Site
Cleveland, Ohio, 44106
Research Site
Detroit, Michigan, 48201
Research Site
Duarte, California, 91010
Research Site
Hackensack, New Jersey, 07601
Research Site
Los Angeles, California, 90089
Research Site
New Orleans, Louisiana, 70112
Research Site
New York, New York, 10065
Research Site
Philadelphia, Pennsylvania, 19104
Research Site
Philadelphia, Pennsylvania, 19107
Research Site
Seattle, Washington, 98109-1023
Research Site
Tucson, Arizona, 85719
Research Site
Winston-Salem, North Carolina, 27157
About this study
Official title: An Observational Study of Patients With Philadelphia Chromosome-negative Relapsed or Refractory Acute Lymphoblastic Leukemia in the US
A retrospective chart review study of Philadelphia chromosome-negative R/R ALL patients in the US.
- Being tested
- Other
- 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.
OtherOther
No intervention other than routine medical care
| Study group | Role | What they receive |
|---|---|---|
| No treatment 1 | It is planned to have 20-30 sites participating on the trial for chart review of approximately 200-235 patients initiating treatment for Philadelphia chromosome-negative (Ph-) Relapsed or Refractory (R/R) Acute Lymphoblastic Leukemia (ALL) between January 2013 and March 2019. Receives: Other: Other | |
| No Treatment 2 | Initial record abstraction will occur at study site with subsequent reviews occurring at the site every 3 months thereafter until study conclusion on March 2020. Receives: Other: Other |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment patterns in patients with Ph- R/R ALL
Measured: 86 months
Drug utilization in patients with Ph- R/R ALL
Measured: 86 months
Healthcare resource utilization in patients with Ph- R/R ALL
Measured: 86 months
Secondary outcomes (6)
Receipt of allogeneic stem cell transplantation following salvage treatment
Measured: 86 Months
Incidence of selected adverse events including cytokine release syndrome, neurologic events, any events resulting in hospitalizations, and other serious adverse events.
Measured: 86 Months
Best response to salvage treatment (chemotherapy or blinatumomab) within 8 weeks and within 12 weeks of initiation of salvage treatment.
Measured: 12 Weeks
MRD status within 12 weeks of initiation of salvage treatment
Measured: 12 Weeks
Overall survival from the time of initiation of salvage treatment
Measured: 86 Months
RFS from time remission achieved with salvage treatment
Measured: 86 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2016 (estimated)
- Study start30 Jun 2016
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by AmgenThe 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02783651
- Sponsor's protocol ID
- 20150253
- Status last verified
- Apr 2020
- First submitted
- 11 May 2016
- Last updated
- 27 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Patients With Philadelphia Chromosome-negative Relapsed or Refractory Acute Lymphoblastic Leukemia in the US
- ClinicalTrials.gov ID
- NCT02783651
- Acronym / sponsor ID
- 20150253
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2016 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 26 May 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.
A retrospective chart review study of Philadelphia chromosome-negative R/R ALL patients in the US.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No treatment 1 | – | Other: OtherIt is planned to have 20-30 sites participating on the trial for chart review of approximately 200-235 patients initiating treatment for Philadelphia chromosome-negative (Ph-) Relapsed or Refractory (R/R) Acute Lymphoblastic Leukemia (ALL) between January 2013 and March 2019. |
| No Treatment 2 | – | Other: OtherInitial record abstraction will occur at study site with subsequent reviews occurring at the site every 3 months thereafter until study conclusion on March 2020. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients initiating treatment for Philadelphia chromosome-negative (Ph-) R/R ALL between January 2013 and March 2019 at participating clinical sites in the US
Key inclusion criteria (1 listed)
- -Medical records of patients initiating treatment for Ph- R/R ALL at participating clinical centers in the US between January 2013 and March 2019 will be eligible for inclusion.
Key exclusion criteria (2 listed)
- Medical records of patients with Ph+ ALL will be excluded.
- If informed consent is required, medical records of patients who do not provide informed consent will be excluded.
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 |
|---|---|---|
| OtherNo intervention other than routine medical care | Other | No Treatment 2, No treatment 1 |
Primary outcome
Treatment patterns in patients with Ph- R/R ALL
Time frame: 86 months
Drug utilization in patients with Ph- R/R ALL
Time frame: 86 months
Healthcare resource utilization in patients with Ph- R/R ALL
Time frame: 86 months
6 secondary outcomes
Receipt of allogeneic stem cell transplantation following salvage treatment
Time frame: 86 Months
Incidence of selected adverse events including cytokine release syndrome, neurologic events, any events resulting in hospitalizations, and other serious adverse events.
Time frame: 86 Months
Best response to salvage treatment (chemotherapy or blinatumomab) within 8 weeks and within 12 weeks of initiation of salvage treatment.
Time frame: 12 Weeks
MRD status within 12 weeks of initiation of salvage treatment
Time frame: 12 Weeks
Overall survival from the time of initiation of salvage treatment
Time frame: 86 Months
RFS from time remission achieved with salvage treatment
Time frame: 86 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2020.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
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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.
MD study director
Amgen
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsed/Refractory Acute Lymphoblastic Leukemia, run by Amgen at 19 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 27 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Treatment patterns in patients with Ph- R/R ALL (time frame: 86 months). The study lists 3 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 27 Apr 2020.