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Health Condition(s) or Problem
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Lymphoma
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Lay Summary
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RATIONALE: Giving combination chemotherapy and total-body irradiation before a peripheral
stem cell transplant that uses the patient's or a donor's stem cells, helps stop both the
growth of cancer cells and the patient's immune system from rejecting the stem cells. When
the stem cells are infused into the patient they may help the patient's bone marrow make
stem cells, red blood cells, white blood cells, and platelets. Giving combination
chemotherapy and total-body irradiation followed by a stem cell transplant may be an
effective treatment for anaplastic large cell lymphoma.
PURPOSE: This clinical trial is studying how well combination chemotherapy followed by stem
cell transplant works in treating young patients with progressive or relapsed anaplastic
large cell lymphoma.
(from ClinicalTrials.gov)
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Who can enter the trial
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DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed anaplastic large cell lymphoma (ALCL)
- Progressive disease OR first relapse
- No second or subsequent relapse of ALCL
- Slides available for national central pathology review
- Availability of 1 of the following (for allogeneic stem cell transplantation only):
- HLA-identical matched sibling donor
- 10/10 HLA-matched nonsibling donor (related or unrelated)
- 9/10 HLA-matched nonsibling donor (1-antigen-mismatched related or unrelated
donor)
- < 9/10 HLA-mismatched donor (related or unrelated)
- Stem cells may be obtained from unmanipulated bone marrow or peripheral
blood stem cells after filgrastim (G-CSF) stimulation
PATIENT CHARACTERISTICS:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Adequate hepatic, renal, and cardiac function
- No HIV infection or AIDS
- No severe immunodeficiency
- No other prior malignancy
- No pre-existing disease or condition prohibiting study treatment
PRIOR CONCURRENT THERAPY:
- At least 2 months since prior chemotherapy or radiotherapy
- No significant pretreatment for first relapse
- No prior organ transplantation
- No concurrent participation in another clinical trial
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Who cannot enter the trial
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DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed anaplastic large cell lymphoma (ALCL)
- Progressive disease OR first relapse
- No second or subsequent relapse of ALCL
- Slides available for national central pathology review
- Availability of 1 of the following (for allogeneic stem cell transplantation only):
- HLA-identical matched sibling donor
- 10/10 HLA-matched nonsibling donor (related or unrelated)
- 9/10 HLA-matched nonsibling donor (1-antigen-mismatched related or unrelated
donor)
- < 9/10 HLA-mismatched donor (related or unrelated)
- Stem cells may be obtained from unmanipulated bone marrow or peripheral
blood stem cells after filgrastim (G-CSF) stimulation
PATIENT CHARACTERISTICS:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Adequate hepatic, renal, and cardiac function
- No HIV infection or AIDS
- No severe immunodeficiency
- No other prior malignancy
- No pre-existing disease or condition prohibiting study treatment
PRIOR CONCURRENT THERAPY:
- At least 2 months since prior chemotherapy or radiotherapy
- No significant pretreatment for first relapse
- No prior organ transplantation
- No concurrent participation in another clinical trial
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What will happen
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Biological; anti-thymocyte globulin; Drug; busulfan; Drug; carboplatin; Drug; carmustine; Drug; cyclosporine; Drug; cytarabine; Drug; dexamethasone; Drug; etoposide phosphate; Drug; idarubicin; Drug; ifosfamide; Drug; leucovorin calcium; Drug; lomustine; Drug; melphalan; Drug; methotrexate; Drug; mitoxantrone hydrochloride; Drug; prednisolone; Drug; thiotepa; Drug; vinblastine sulfate; Drug; vindesine; Procedure; allogeneic hematopoietic stem cell transplantation; Procedure; autologous hematopoietic stem cell transplantation; Procedure; peripheral blood stem cell transplantation; Radiation; total-body irradiation
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Primary aim
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Event-free survival as measured by the Kaplan-Meier method
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Secondary Aim
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Proportion of patients who are treated on protocol among all patients who meet the inclusion criteria; No; Overall survival; No; Acute and long term toxicity; Yes; Rate of acute and chronic graft-vs-host disease in patients with allogeneic stem cell transplantation; No; Treatment related mortality; No
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Participant Information Sheet
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Sorry, not currently available
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Website
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http://cancer.gov/clinicaltrials/EICNHL-ALCL-RELAPSE
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Recruitment Status
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Not Recruiting
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Nation
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England, Northern Ireland, Scotland, Wales
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Location
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Birmingham, Bristol, Cambridge, Leeds, Leicester, Liverpool, London, Manchester, Newcastle upon Tyne, Nottingham, Oxford, Sheffield, Southampton, Sutton, Belfast, Aberdeen, Edinburgh, Glasgow, Cardiff
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