Low Grade LymphomaPhase 2NCT00144092
HDCT and Stem Cell Transplantation for Mantle Cell and Relapsed Low Grade Non-hodgkin's Lymphoma
A Phase 2 study testing stem cell source in people with Low Grade Lymphoma, run by Alberta Health services at 1 site in Canada.
Trial summary
Low grade lymphoma patients receive R-ICE reinduction therapy followed by allogeneic stem cell transplanation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Grade Lymphoma
- What is being tested?
- stem cell source
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- May 2001to Jun 2010
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- indolent histology lymphomas after relapse 1 or 2 LVEF > 50% Creatinine < 150 umol/L bilirubin < 30 umol/L wbc >3.5X10^9/L platelets >100X10^9/L other medical condition as controlled
Who cannot join
- pregnant lactating HIV positive CNS involvement by lymphoma other malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Dose Chemotherapy and Autologous or Allogeneic Blood Stem Cell Transplantation for Mantle Cell and Relapsed Low Grade Non-hodgkin's Lymphoma
Low grade lymphoma patients receive R-ICE reinduction therapy followed by allogeneic stem cell transplanation.
Read the detailed description
Low grade lymphoma patients receive R-ICE reinduction therapy followed by allogeneic stem cell transplanation if they have an HLA matched sibling, or an autologous transplant if they do not.
- Conditions
- Low Grade Lymphoma
- Being tested
- stem cell source
- Keywords
- autologous and allogeneic stem cell transplantation, low grade lymphoma, mantle cell
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stem cell sourceProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility
mortality
overall survival
event free survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startMay 2001
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Grade 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alberta Health services
- Sponsor type
- University, hospital or other
- Investigators
- Doug Stewart, Principal investigator, Alberta Cancer Board - TBCC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00144092
- Sponsor's protocol ID
- 147
- Other IDs
- 15841
- Status last verified
- Aug 2011
- First submitted
- 1 Sep 2005
- Last updated
- 21 Nov 2011
- Results posted
- No
Publications
Stewart DA, Duan Q, Carlson L, Russell JA, Bahlis NJ, Duggan P, Hasegawa W, Voralia M. A prospective phase II study of RICE re-induction, then high-dose fludarabine and busulfan, followed by autologous or allogeneic blood stem cell transplantation for indolent b-cell lymphoma. Clin Lymphoma Myeloma Leuk. 2011 Dec;11(6):475-82. doi: 10.1016/j.clml.2011.06.012. Epub 2011 Aug 10.
PubMed 21831743
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Dose Chemotherapy and Autologous or Allogeneic Blood Stem Cell Transplantation for Mantle Cell and Relapsed Low Grade Non-hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00144092
- Acronym / sponsor ID
- 147
- Conditions
- Low Grade Lymphoma
- Keywords
- autologous and allogeneic stem cell transplantation, low grade lymphoma, mantle cell
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Alberta Health servicesUniversity, hospital or other
- Study start
- May 2001
- Study completion
- Jun 2010 (actual)
- First posted
- 5 Sep 2005 (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.
Low grade lymphoma patients receive R-ICE reinduction therapy followed by allogeneic stem cell transplanation.
Detailed description
Low grade lymphoma patients receive R-ICE reinduction therapy followed by allogeneic stem cell transplanation if they have an HLA matched sibling, or an autologous transplant if they do not.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- indolent histology lymphomas after relapse 1 or 2 LVEF > 50% Creatinine < 150 umol/L bilirubin < 30 umol/L wbc >3.5X10^9/L platelets >100X10^9/L other medical condition as controlled
Key exclusion criteria (1 listed)
- pregnant lactating HIV positive CNS involvement by lymphoma other malignancy
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 |
|---|---|---|
| stem cell source | Procedure or surgery | – |
Primary outcome
feasibility
mortality
overall survival
event free survival
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 21 Nov 2011.
- Derived from this study: PubMed 21831743Stewart DA, Duan Q, Carlson L, Russell JA, Bahlis NJ, Duggan P, Hasegawa W, Voralia M. A prospective phase II study of RICE re-induction, then high-dose fludarabine and busulfan, followed by autologous or allogeneic blood stem cell transplantation for indolent b-cell lymphoma. Clin Lymphoma Myeloma Leuk. 2011 Dec;11(6):475-82. doi: 10.1016/j.clml.2011.06.012. Epub 2011 Aug 10.
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Radiotherapy 12Gy in 6 Fractions For Orbital Lymphoma
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Low Dose Radiation as Bridging Therapy in Relapsed B-Cell Non-Hodgkin Lymphoma
DLBCL - Diffuse Large B Cell Lymphoma, High-grade B-cell Lymphoma
RecruitingObservational study
Quality Of Life On Elderly Patients With Low Grade Non-Hodgkin Lymphoma
Low Grade Non-Hodgkin's Lymphoma, Adult
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.
Doug Stewart principal investigator
Alberta Cancer Board - TBCC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing stem cell source in people with Low Grade Lymphoma, run by Alberta Health services at 1 site in Canada.
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 21 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 Canada. 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 phase mean?
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?
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?
feasibility. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00144092, which also lists 1 linked publication.
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 21 Nov 2011.