Lymphoblastic LymphomaLBL-CISL-1NCT01813344
Hyper-CVAD Treatment in Lymphoblastic Lymphoma
An observational study of Lymphoblastic Lymphoma, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
Treatment outcomes of lymphoblastic lymphoma (LBL) have improved by the use of the regimens for acute lymphoblastic leukemia. Hyper-CVAD is one of the most effective treatments with high remission rate in acute lymphoblastic leukemia (ALL) and LBL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoblastic Lymphoma
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2012to Jun 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult lymphoblast lymphoma patients treated with hyper-CVAD regimen in Korea
Who may be able to join
- age over 18 at diagnosis
- Pathologically proven lymphoblastic lymphoma
Who cannot join
- proven HIV infection
- pretreatment with other regimens
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Ajou Universtiy School of Medicine
Suwon, Kyeonggi, 443-721
Geum Sook Jeong, MS, +82-31-219-5990, geumsook@ajou.ac.kr
About this study
Official title: The Clinical Outcomes of Hyper-CVAD Treatment in Lymphoblastic Lymphoma
Treatment outcomes of lymphoblastic lymphoma (LBL) have improved by the use of the regimens for acute lymphoblastic leukemia. Hyper-CVAD is one of the most effective treatments with high remission rate in acute lymphoblastic leukemia (ALL) and LBL. However, the treatment outcome of hyper-CVAD in LBL has reported only in small number of patients from single institution. The investigators conducted this study to evaluate the hyper-CVAD regimen based treatment in LBL.
Read the detailed description
We will analyze treatment outcome of lymphoblastic lymphoma patients treated with hyper-CVAD regimen from 13 institutions in Korea. In all patients, hyper-CVAD was initial treatment. After achievement of response, patients either underwent hematopoietic stem cell transplantation (HSCT) or consolidation with hyper-CVAD.
- Conditions
- Lymphoblastic Lymphoma
- Keywords
- Adult lymphoblastic lymphoma, Hyper-CVAD, first-line treatment
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 3-year
Progression free survival
Measured: 3-year
Secondary outcomes (1)
Response Rate
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2013 (estimated)
- Study startJan 2012
- Primary completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoblastic LymphomaStudies 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
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seong Hyun Jeong, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01813344
- Sponsor's protocol ID
- LBL-CISL-1
- Acronym
- LBL-CISL-1
- Status last verified
- Mar 2013
- First submitted
- 13 Mar 2013
- Last updated
- 19 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Outcomes of Hyper-CVAD Treatment in Lymphoblastic Lymphoma
- ClinicalTrials.gov ID
- NCT01813344
- Acronym / sponsor ID
- LBL-CISL-1 / LBL-CISL-1
- Conditions
- Lymphoblastic Lymphoma
- Keywords
- Adult lymphoblastic lymphoma, Hyper-CVAD, first-line treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2013 (estimated)
- First posted
- 19 Mar 2013 (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.
Treatment outcomes of lymphoblastic lymphoma (LBL) have improved by the use of the regimens for acute lymphoblastic leukemia. Hyper-CVAD is one of the most effective treatments with high remission rate in acute lymphoblastic leukemia (ALL) and LBL. However, the treatment outcome of hyper-CVAD in LBL has reported only in small number of patients from single institution. The investigators conducted this study to evaluate the hyper-CVAD regimen based treatment in LBL.
Detailed description
We will analyze treatment outcome of lymphoblastic lymphoma patients treated with hyper-CVAD regimen from 13 institutions in Korea. In all patients, hyper-CVAD was initial treatment. After achievement of response, patients either underwent hematopoietic stem cell transplantation (HSCT) or consolidation with hyper-CVAD.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult lymphoblast lymphoma patients treated with hyper-CVAD regimen in Korea
Key inclusion criteria (2 listed)
- age over 18 at diagnosis
- Pathologically proven lymphoblastic lymphoma
Key exclusion criteria (2 listed)
- proven HIV infection
- pretreatment with other regimens
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
Overall survival
Time frame: 3-year
Progression free survival
Time frame: 3-year
1 secondary outcome
Response Rate
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2013.
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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.
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 Lymphoblastic Lymphoma, run by Ajou University School of Medicine at 1 site in South Korea.
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 2 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: status not confirmed, as of the sponsor's last update on 19 Mar 2013. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seong Hyun Jeong, MD (+82-31-219-5989, seonghyunmd@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 3-year). 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 19 Mar 2013.