B-cell Precursor Acute Lymphoblastic Leukemia (ALL)NCT02303522
Historical Data Analysis of Complete Remission in Children With R/R Acute Lymphoblastic Leukemia (ALL)
An observational study of B-cell Precursor Acute Lymphoblastic Leukemia (ALL), run by Amgen at 3 sites in 3 countries.
Trial summary
An historical data comparator study for children with relapsed/refactory acute lymphoblastic leukemia (ALL). Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- B-cell Precursor Acute Lymphoblastic Leukemia (ALL)
- What is being tested?
- Other: not applicable - observational study
- How many people
- 207 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 9 Dec 2014to 22 Jan 2015
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)
Who may be able to join
- Pediatric (age less than 18 years) patients with relapsed or refractory B-cell precursor ALL, specifically those with
- 2nd or later relapse after chemotherapy (with no prior transplantation),
- Relapse after HSCT, or
- Refractory disease
- Had treatment for relapsed or refractory disease between 2005-2012
- Has data available on ALL treatment, including number of salvage treatments, response status after therapies, and HSCT
Who cannot join
- No CNS involvement at relapse
- No previous treatment with blinatumomab
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: A Retrospective Pooled Analysis of Complete Remission Among Pediatric Patients With Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia (ALL)
An historical data comparator study for children with relapsed/refactory acute lymphoblastic leukemia (ALL).
Read the detailed description
A retrospective observational study reviewing historical complete remission for pediatric patients who had either relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL)
- Being tested
- Other: not applicable - observational study
- Keywords
- ALL, pediatric, leukemia, childhood, lymphoblastic, lymphoma, acute, Precursor Cell
- Medical subject headings
- Leukemia, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other: not applicable - observational studyOther
No intervention exists as this is a retrospective observational study
| Study group | Role | What they receive |
|---|---|---|
| All subjects | All subjects will be included in a unique cohort Receives: Other: Other: not applicable - observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematological Complete Remission (CR)
To estimate hematological Complete Remission (CR) in pediatric patients with relapsed or refractory B-cell precursor Acute Lymphoblastic Leukemia (ALL)
Measured: Approx. 1 year
Secondary outcomes (5)
Overall survival
OS following salvage therapy: defined as time to death.
Measured: Approx. 1 year
Molecular CR
Defined as MRD <10-4 measured either by PCR or flow cytometry.
Measured: Approx. 1 year
Relapse Free Survival (RFS)
Defined as time to relapse or death.
Measured: Approx. 1 year
Time to hematological CR
Defined as time to unequivocal detection of >5% leukemia cells in bone marrow as measured by cytological, microscopic assessment, presence of circulating leukemia blasts, or extramedullary leukemia
Measured: Approx. 1 year
Receipt of HSCT after salvage treatment
Defined as the receipt of HSCT after chemotherapy or a previously failed HSCT.
Measured: Approx. 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2014 (estimated)
- Study start9 Dec 2014
- Primary completion22 Jan 2015
- Study completion22 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell Precursor Acute Lymphoblastic Leukemia (ALL)Studies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 207 participants (estimated)
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
- NCT02303522
- Sponsor's protocol ID
- 20120299
- Status last verified
- May 2020
- First submitted
- 6 Nov 2014
- Last updated
- 6 May 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Pooled Analysis of Complete Remission Among Pediatric Patients With Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia (ALL)
- ClinicalTrials.gov ID
- NCT02303522
- Acronym / sponsor ID
- 20120299
- Keywords
- ALL, pediatric, leukemia, childhood, lymphoblastic, lymphoma, acute, Precursor Cell
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 207 participants (estimated)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 9 Dec 2014 (actual)
- Primary completion
- 22 Jan 2015 (actual)
- Study completion
- 22 Jan 2015 (actual)
- First posted
- 1 Dec 2014 (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.
An historical data comparator study for children with relapsed/refactory acute lymphoblastic leukemia (ALL).
Detailed description
A retrospective observational study reviewing historical complete remission for pediatric patients who had either relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects | – | Other: Other: not applicable - observational studyAll subjects will be included in a unique cohort |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)
Key inclusion criteria (6 listed)
- Pediatric (age less than 18 years) patients with relapsed or refractory B-cell precursor ALL, specifically those with
- 2nd or later relapse after chemotherapy (with no prior transplantation),
- Relapse after HSCT, or
- Refractory disease
- Had treatment for relapsed or refractory disease between 2005-2012
Key exclusion criteria (2 listed)
- No CNS involvement at relapse
- No previous treatment with blinatumomab
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 |
|---|---|---|
| Other: not applicable - observational studyNo intervention exists as this is a retrospective observational study | Other | All subjects |
Primary outcome
Hematological Complete Remission (CR)
Time frame: Approx. 1 year
To estimate hematological Complete Remission (CR) in pediatric patients with relapsed or refractory B-cell precursor Acute Lymphoblastic Leukemia (ALL)
5 secondary outcomes
Overall survival
Time frame: Approx. 1 year
Molecular CR
Time frame: Approx. 1 year
Relapse Free Survival (RFS)
Time frame: Approx. 1 year
Time to hematological CR
Time frame: Approx. 1 year
Receipt of HSCT after salvage treatment
Time frame: Approx. 1 year
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 6 May 2020.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
Related trials for B-cell Precursor Acute Lymphoblastic Leukemia (ALL)
Recruiting
A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
B-All, Acute Lymphoblastic Leukemia
RecruitingPhase 1
A Phase I Dose Finding Study of MB-CART2219.1
Lymphoma, CLL
RecruitingPhase 1
Anti-CRLF2-R/TSLPR Chimeric Antigen Receptor T Cells (TSLPR-CART) in Participants With Recurrent or Refractory CRLF2-R/TSLPR-Overexpressing B-Cell Acute Lymphoblastic Leukemia (B-ALL)
B-All, Acute Lymphoblastic Leukemia
RecruitingObservational study
HPC Offered for PRESERVE Expansion
Bone Marrow Transplant (BMT)
Not yet recruiting
Busulfan-Based Versus TBI-Based Conditioning for Adult ALL-CR2 Allo-HSCT
Acute Lymphoblastic Leukemia, Hematopoietic Stem Cell Transplantation
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
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of B-cell Precursor Acute Lymphoblastic Leukemia (ALL), run by Amgen at 3 sites in 3 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 6 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 6 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Austria, Germany, Italy. 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?
Hematological Complete Remission (CR) (time frame: Approx. 1 year). 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 6 May 2020.