search
Back to results

Chronic and Late Effects of Non-Hodgkin's Lymphoma and Its Treatment in Long Term Survivors

Primary Purpose

Lymphoma, Non-Hodgkin

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Lymphoma, Non-Hodgkin focused on measuring Adverse Effects, Burkitt's Lymphoma, Diffuse Large Cell Lymphoma, Extended Remission, Health Status, Lymphoblastic Lymphoma, Molecular Studies

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Cancer Institute (NCI)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00001301
Brief Title
Chronic and Late Effects of Non-Hodgkin's Lymphoma and Its Treatment in Long Term Survivors
Official Title
Chronic and Late Effects of Non-Hodgkin's Lymphoma and Its Treatment in Long Term Survivors
Study Type
Observational

2. Study Status

Record Verification Date
June 1999
Overall Recruitment Status
Completed
Study Start Date
August 1992 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2000 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Non-Hodgkin
Keywords
Adverse Effects, Burkitt's Lymphoma, Diffuse Large Cell Lymphoma, Extended Remission, Health Status, Lymphoblastic Lymphoma, Molecular Studies

7. Study Design

Enrollment
107 (false)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
National Cancer Institute (NCI)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
1036716
Citation
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.
Results Reference
background
PubMed Identifier
638947
Citation
Appelbaum 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.
Results Reference
background
PubMed Identifier
6546890
Citation
Magrath 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.
Results Reference
background

Learn more about this trial

Chronic and Late Effects of Non-Hodgkin's Lymphoma and Its Treatment in Long Term Survivors

We'll reach out to this number within 24 hrs