Lymphoma, Non-HodgkinNCT00001301
Chronic and Late Effects of Non-Hodgkin's Lymphoma and Its Treatment in Long Term Survivors
An observational study of Lymphoma, Non-Hodgkin, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Non-Hodgkin's lymphoma has been studied in the Pediatric Branch for at least 20 years, during which time a number of different treatment protocols have been used. Approximately 110 patients have apparently been cured of their lymphoma. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lymphoma, Non-Hodgkin
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 1992to Apr 2000
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Patients with a histologic diagnosis of small noncleaved cell (undifferentiated) (SNCL), lymphoblastic (LL), and large cell lymphoma (LCL) who were treated according to National Cancer Institute Pediatric Branch non-Hodgkin's lymphoma protocols 74-0, 75-6, 76-5, 77-04, 85-C-67, and 89-C-41A, and who have been in continuous remission for one year or longer following completion of treatment.
Patients who have relapsed and been successfully re-treated are not excluded, except for patients with lymphoblastic lymphoma who have been re-treated according to acute lymphoblastic leukemia protocols.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
About this study
Non-Hodgkin's lymphoma has been studied in the Pediatric Branch for at least 20 years, during which time a number of different treatment protocols have been used. Approximately 110 patients have apparently been cured of their lymphoma. The present protocol has no therapeutic component, but is designed to document the late effects that may have been encountered by our patients, either as a consequence of the disease or its treatment. In essence, patients who consent to participate will be asked a series of questions pertaining to the quality of their life and possible medical problems that they may be encountering. In addition, they will receive a complete physical examination and undergo non-invasive investigations designed to identify the presence of unsuspected late effects. Investigators in the Eye Clinic, Dental Clinic, Audiology, Cardiology and Endocrinology departments will participate in the protocol. As a part of the study, blood samples will be obtained to investigate the possibility that predisposing genetic factors may be identifiable in the patients normal cells (e.g., p53 mutations, evidence of DNA instability). If such abnormalities are detected, blood samples from family members will also be examined to determine whether the defect was inherited.
Read the detailed description
Non-Hodgkin's lymphoma has been studied in the Pediatric Branch for at least 20 years, during which time a number of different treatment protocols have been used. Approximately 110 patients have apparently been cured of their lymphoma. The present protocol has no therapeutic component, but is designed to document the late effects that may have been encountered by our patients, either as a consequence of the disease or its treatment. In essence, patients who consent to participate will be asked a series of questions pertaining to the quality of their life and possible medical problems that they may be encountering. In addition, they will receive a complete physical examination and undergo non-invasive investigations designed to identify the presence of unsuspected late effects. Investigators in the Eye Clinic, Dental Clinic, Audiology, Cardiology and Endocrinology departments will participate in the protocol. As a part of the study, blood samples will be obtained to investigate the possibility that predisposing genetic factors may be identifiable in the patients normal cells (e.g., p53 mutations, evidence of DNA instability). If such abnormalities are detected, blood samples from family members will also be examined to determine whether the defect was inherited.
- Conditions
- Lymphoma, Non-Hodgkin
- Keywords
- Adverse Effects, Burkitt's Lymphoma, Diffuse Large Cell Lymphoma, Extended Remission, Health Status, Lymphoblastic Lymphoma, Molecular Studies
- Medical subject headings
- Lymphoma, Non-Hodgkin, Burkitt Lymphoma, Lymphoma, Large B-Cell, Diffuse, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startAug 1992
- Study completionApr 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lymphoma, Non-HodgkinStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Enrolment
- 107 participants
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001301
- Sponsor's protocol ID
- 920242
- Other IDs
- 92-C-0242
- Status last verified
- Jun 1999
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Ziegler JL, DeVita VT, Graw RG Jr, Herzig G, Leventhal BG, Levine AS, Pomeroy TC. Combined modality treatment of American Burkitt's lymphoma. Cancer. 1976 Dec;38(6):2225-31. doi: 10.1002/1097-0142(197612)38:63.0.co;2-f.
PubMed 1036716Appelbaum FR, Deisseroth AB, Graw RG Jr, Herzig GP, Levine AS, Magrath IT, Pizzo PA, Poplack DG, Ziegler JL. Prolonged complete remission following high dose chemotherapy of Burkitt's lymphoma in relapse. Cancer. 1978 Mar;41(3):1059-63. doi: 10.1002/1097-0142(197803)41:33.0.co;2-n.
PubMed 638947Magrath IT, Janus C, Edwards BK, Spiegel R, Jaffe ES, Berard CW, Miliauskas J, Morris K, Barnwell R. An effective therapy for both undifferentiated (including Burkitt's) lymphomas and lymphoblastic lymphomas in children and young adults. Blood. 1984 May;63(5):1102-11.
PubMed 6546890
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic and Late Effects of Non-Hodgkin's Lymphoma and Its Treatment in Long Term Survivors
- ClinicalTrials.gov ID
- NCT00001301
- Acronym / sponsor ID
- 920242
- Conditions
- Lymphoma, Non-Hodgkin
- Keywords
- Adverse Effects, Burkitt's Lymphoma, Diffuse Large Cell Lymphoma, Extended Remission, Health Status, Lymphoblastic Lymphoma, Molecular Studies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Aug 1992
- Study completion
- Apr 2000
- First posted
- 10 Dec 2002 (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.
Non-Hodgkin's lymphoma has been studied in the Pediatric Branch for at least 20 years, during which time a number of different treatment protocols have been used. Approximately 110 patients have apparently been cured of their lymphoma. The present protocol has no therapeutic component, but is designed to document the late effects that may have been encountered by our patients, either as a consequence of the disease or its treatment. In essence, patients who consent to participate will be asked a series of questions pertaining to the quality of their life and possible medical problems that they may be encountering. In addition, they will receive a complete physical examination and undergo non-invasive investigations designed to identify the presence of unsuspected late effects. Investigators in the Eye Clinic, Dental Clinic, Audiology, Cardiology and Endocrinology departments will participate in the protocol. As a part of the study, blood samples will be obtained to investigate the possibility that predisposing genetic factors may be identifiable in the patients normal cells (e.g., p53 mutations, evidence of DNA instability). If such abnormalities are detected, blood samples from family members will also be examined to determine whether the defect was inherited.
Detailed description
Non-Hodgkin's lymphoma has been studied in the Pediatric Branch for at least 20 years, during which time a number of different treatment protocols have been used. Approximately 110 patients have apparently been cured of their lymphoma. The present protocol has no therapeutic component, but is designed to document the late effects that may have been encountered by our patients, either as a consequence of the disease or its treatment. In essence, patients who consent to participate will be asked a series of questions pertaining to the quality of their life and possible medical problems that they may be encountering. In addition, they will receive a complete physical examination and undergo non-invasive investigations designed to identify the presence of unsuspected late effects. Investigators in the Eye Clinic, Dental Clinic, Audiology, Cardiology and Endocrinology departments will participate in the protocol. As a part of the study, blood samples will be obtained to investigate the possibility that predisposing genetic factors may be identifiable in the patients normal cells (e.g., p53 mutations, evidence of DNA instability). If such abnormalities are detected, blood samples from family members will also be examined to determine whether the defect was inherited.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 4 Mar 2008.
- Background: PubMed 1036716Ziegler JL, DeVita VT, Graw RG Jr, Herzig G, Leventhal BG, Levine AS, Pomeroy TC. Combined modality treatment of American Burkitt's lymphoma. Cancer. 1976 Dec;38(6):2225-31. doi: 10.1002/1097-0142(197612)38:63.0.co;2-f.
- Background: PubMed 638947Appelbaum FR, Deisseroth AB, Graw RG Jr, Herzig GP, Levine AS, Magrath IT, Pizzo PA, Poplack DG, Ziegler JL. Prolonged complete remission following high dose chemotherapy of Burkitt's lymphoma in relapse. Cancer. 1978 Mar;41(3):1059-63. doi: 10.1002/1097-0142(197803)41:33.0.co;2-n.
- Background: PubMed 6546890Magrath IT, Janus C, Edwards BK, Spiegel R, Jaffe ES, Berard CW, Miliauskas J, Morris K, Barnwell R. An effective therapy for both undifferentiated (including Burkitt's) lymphomas and lymphoblastic lymphomas in children and young adults. Blood. 1984 May;63(5):1102-11.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Lymphoma, Non-Hodgkin, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. 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 States. 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?
On the ClinicalTrials.gov record for NCT00001301, which also lists 3 linked publications.
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 4 Mar 2008.