Acute Lymphoblastic LeukemiaNCT01470924
Acute Lymphoblastic Leukemia Relapse in Sweden 2003-2007
An observational study of Acute Lymphoblastic Leukemia, run by Region Örebro County at 1 site in Sweden.
Trial summary
A minority of patients with adult acute lymphoblastic leukemia (ALL) relapse are rescued. The aim of this population-based study was to assess the results of reinduction treatment and allogeneic stem cell transplantation (SCT) in second complete remission (CR) in Sweden 2003-2007. Read more about this study
- Who is it for?
- Ages 18 to 66 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- How many people
- 76 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2003to Jun 2011
- 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 18 to 66 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adults with relapsed ALL
Who may be able to join
- Adult patients with first relapse of ALL
Who cannot join
- patients with Burkitt leukemia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Curability Via Intensive Reinduction Chemotherapy and Stem Cell Transplantation in Young Adults With Relapsed Acute Lymphoblastic Leukemia in Sweden 2003-2007
A minority of patients with adult acute lymphoblastic leukemia (ALL) relapse are rescued. The aim of this population-based study was to assess the results of reinduction treatment and allogeneic stem cell transplantation (SCT) in second complete remission (CR) in Sweden 2003-2007.
Read the detailed description
This is a national, multicenter, prospective, population-based study of outcome among adult patients aged 19 to 65 years with ALL relapse diagnosed during 2003-2007 in Sweden. Most of the patients had primary treatment according to National guidelines for ALL as recommended by The Swedish Adult ALL Group (SVALL). The guidelines suggest two different treatment protocols for early relapses, and retreatment according to the initial therapy for late relapses, with the intention to proceed to allogeneic SCT in CR2 for eligible patients. The aim of the current study was to assess outcome among adult patients after first ALL relapse, and the utilization and efficacy of recommended protocols and of allogeneic SCT in this setting.
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- acute lymphoblastic leukemia, relapse, salvage, prognostic
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Recurrence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2011 (estimated)
- Study startJan 2003
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Piotr Kozlowski, Region Örebro County
- Investigators
- Piotr J Kozlowski, MD, Principal investigator, Region Örebro County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01470924
- Sponsor's protocol ID
- OLL-180361
- Status last verified
- Nov 2011
- First submitted
- 7 Nov 2011
- Last updated
- 11 Nov 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Curability Via Intensive Reinduction Chemotherapy and Stem Cell Transplantation in Young Adults With Relapsed Acute Lymphoblastic Leukemia in Sweden 2003-2007
- ClinicalTrials.gov ID
- NCT01470924
- Acronym / sponsor ID
- OLL-180361
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- acute lymphoblastic leukemia, relapse, salvage, prognostic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Study start
- Jan 2003
- Study completion
- Jun 2011 (actual)
- First posted
- 11 Nov 2011 (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 minority of patients with adult acute lymphoblastic leukemia (ALL) relapse are rescued. The aim of this population-based study was to assess the results of reinduction treatment and allogeneic stem cell transplantation (SCT) in second complete remission (CR) in Sweden 2003-2007.
Detailed description
This is a national, multicenter, prospective, population-based study of outcome among adult patients aged 19 to 65 years with ALL relapse diagnosed during 2003-2007 in Sweden. Most of the patients had primary treatment according to National guidelines for ALL as recommended by The Swedish Adult ALL Group (SVALL). The guidelines suggest two different treatment protocols for early relapses, and retreatment according to the initial therapy for late relapses, with the intention to proceed to allogeneic SCT in CR2 for eligible patients. The aim of the current study was to assess outcome among adult patients after first ALL relapse, and the utilization and efficacy of recommended protocols and of allogeneic SCT in this setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adults with relapsed ALL
Key inclusion criteria (1 listed)
- Adult patients with first relapse of ALL
Key exclusion criteria (1 listed)
- patients with Burkitt leukemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 11 Nov 2011.
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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.
Piotr J Kozlowski, MD principal investigator
Region Örebro County
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lymphoblastic Leukemia, run by Region Örebro County at 1 site in Sweden.
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 1 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 11 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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.
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 11 Nov 2011.