A Phase 2 interventional study of filgrastim and busulfan in Lymphoma, sponsored by AIDS Malignancy Consortium. Completed at 2 sites in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2016-02-03.
Sponsored by AIDS Malignancy Consortium · Phase 2, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by peripheral stem cell transplantation in treating patients who have recurrent or refractory AIDS-related lymphoma.
OBJECTIVES:
OUTLINE: Patients receive mobilization chemotherapy consisting of cyclophosphamide IV over 2 hours followed 2 days later by daily filgrastim (G-CSF) subcutaneously (SC) until blood counts recover. Patients then undergo leukopheresis to collect CD34+ cells.
Patients receive conditioning chemotherapy consisting of oral busulfan every 6 hours on days -7, -6, -5, and -4 for a total of 14 doses and cyclophosphamide IV over 1 hour on days -3 and -2. Patients undergo autologous stem cell infusion on day 0. G-CSF is administered IV or SC daily beginning on day 1 and continuing until blood counts recover.
Patients are followed monthly for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 5-25 patients will be accrued for this study.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
Browse Lymphoma studies →AIDS Malignancy Consortium is the lead sponsor of 61 studies on the registry; 10 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 8 (80%) have results posted.
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DISEASE CHARACTERISTICS:
Intermediate- or high-grade non-Hodgkin's lymphoma or Hodgkin's disease
Sensitive to most recent chemotherapy
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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AIDS Malignancy Consortium