Non-Hodgkins LymphomaNCT00301288
A Retrospective Study of Toxicity and Outcome of High Dose Chemotherapy With Autologous Stem Cell Transplant in Patients With Non-Hodgkin Lymphoma (NHL).
An observational study of Non-Hodgkins Lymphoma, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Patients with aggressive Non-Hodgkin-lymphoma treated at first diagnosis with chemotherapy alone or combined chemo-radiotherapy can achieve high response rates. However, patients with relapsed lymphoma still have a poor prognosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkins Lymphoma
- What is being tested?
- Autologous stem cell transplant
- Type of treatment
- Surgery or procedure
- How many people
- 152 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Start not givento not given
- 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: 152 participants with Non-Hodgkin's Lymphoma who have received an autologous stem cell trandplant in the past and have written informed consent.
Who may be able to join
- a) Age over 18 b) Patients with Non-Hodgkin's Lymphoma who have received an autologous stem cell transplant in the past.
- Informed written consent
Who cannot join
- a) Medical or psychiatric conditions that compromise the patient's ability to give informed consent b) HIV positive or AIDS related lymphoma
Trial locations and contacts
1 site in 1 country.
About this study
Patients with aggressive Non-Hodgkin-lymphoma treated at first diagnosis with chemotherapy alone or combined chemo-radiotherapy can achieve high response rates. However, patients with relapsed lymphoma still have a poor prognosis. High dose chemotherapy (HDCT) followed by autologous stem cell transplantation (ASCT) is the treatment of choice for these patients. An ASCT allows patients to receive much higher doses of chemotherapy than usual, to improve the chances of curing the disease. The high-dose of chemotherapy destroys the cells in the patients bone marrow and then the patients own cells from either the bone marrow or peripheral blood are used to rescue the patient from intensive treatment. High-dose chemotherapy with autologous stem cell (either bone marrow or peripheral blood) transplantation is used in the treatment of Intermediate/High grade NHL with poor risk disease and in second remission at the Royal Marsden Hospital.
The purpose of the present analysis is to determine independent prognostic factors correlated with the long-term outcome of patients with NHL who received an ASCT between January 1991 and June 2005. Accrual of eligible patients currently under follow-up will be performed in clinic at the time of next appointment. All patients accrued will give informed consent to participate in the study for retrospective case note review, after discussion with a study investigator and after receiving a study information sheet. The results of the analysis will be published in a peer-reviewed medical journal. This will include patients treated at the royal Marsden Hospital only.
- Conditions
- Non-Hodgkins Lymphoma
- Being tested
- Autologous stem cell transplant
- 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.
Autologous stem cell transplantProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkins LymphomaStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe 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
- Time perspective
- Retrospective
- Enrolment
- 152 participants
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Investigators
- David Cunningham, FRCP, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00301288
- Sponsor's protocol ID
- 2657
- Status last verified
- Jan 2010
- First submitted
- 9 Mar 2006
- Last updated
- 12 Jan 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study of Toxicity and Outcome of High Dose Chemotherapy With Autologous Stem Cell Transplant in Patients With Non-Hodgkin Lymphoma (NHL).
- ClinicalTrials.gov ID
- NCT00301288
- Acronym / sponsor ID
- 2657
- Conditions
- Non-Hodgkins Lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- First posted
- 10 Mar 2006 (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.
Patients with aggressive Non-Hodgkin-lymphoma treated at first diagnosis with chemotherapy alone or combined chemo-radiotherapy can achieve high response rates. However, patients with relapsed lymphoma still have a poor prognosis. High dose chemotherapy (HDCT) followed by autologous stem cell transplantation (ASCT) is the treatment of choice for these patients. An ASCT allows patients to receive much higher doses of chemotherapy than usual, to improve the chances of curing the disease. The high-dose of chemotherapy destroys the cells in the patients bone marrow and then the patients own cells from either the bone marrow or peripheral blood are used to rescue the patient from intensive treatment. High-dose chemotherapy with autologous stem cell (either bone marrow or peripheral blood) transplantation is used in the treatment of Intermediate/High grade NHL with poor risk disease and in second remission at the Royal Marsden Hospital.
The purpose of the present analysis is to determine independent prognostic factors correlated with the long-term outcome of patients with NHL who received an ASCT between January 1991 and June 2005. Accrual of eligible patients currently under follow-up will be performed in clinic at the time of next appointment. All patients accrued will give informed consent to participate in the study for retrospective case note review, after discussion with a study investigator and after receiving a study information sheet. The results of the analysis will be published in a peer-reviewed medical journal. This will include patients treated at the royal Marsden Hospital only.
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
- 152 participants with Non-Hodgkin's Lymphoma who have received an autologous stem cell trandplant in the past and have written informed consent.
Key inclusion criteria (2 listed)
- a) Age over 18 b) Patients with Non-Hodgkin's Lymphoma who have received an autologous stem cell transplant in the past.
- Informed written consent
Key exclusion criteria (1 listed)
- a) Medical or psychiatric conditions that compromise the patient's ability to give informed consent b) HIV positive or AIDS related lymphoma
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 |
|---|---|---|
| Autologous stem cell transplant | Procedure or surgery | – |
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 12 Jan 2010.
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Non-Hodgkin Lymphoma
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.
David Cunningham, FRCP principal investigator
Royal Marsden NHS Foundation Trust
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 Non-Hodgkins Lymphoma, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
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 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 12 Jan 2010. 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 United Kingdom. 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 12 Jan 2010.