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Chemotherapy Followed By Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory AIDS-Related Lymphoma

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ClinicalTrials.gov Identifier: NCT00005824
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : February 3, 2016
National Cancer Institute (NCI)
Information provided by:
AIDS Malignancy Consortium

June 2, 2000
January 27, 2003
February 3, 2016
November 2000
July 2004   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00005824 on ClinicalTrials.gov Archive Site
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Chemotherapy Followed By Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory AIDS-Related Lymphoma
Pilot Study of the Safety and Feasibility of Autologous Peripheral Blood Stem Cell Transplantation for Patients With Relapsed AIDS-Related Lymphoma

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.


  • Determine the safety and tolerability of intensive chemotherapy and autologous peripheral blood stem cell transplantation in patients with recurrent or refractory AIDS-related lymphoma.
  • Determine the response and response duration in these patients treated with this regimen.
  • Determine the effect of this treatment regimen on HIV RNA and CD4 cells in these patients.

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.

Phase 2
Masking: None (Open Label)
Primary Purpose: Treatment
  • Biological: filgrastim
  • Drug: busulfan
  • Drug: cyclophosphamide
  • Procedure: peripheral blood stem cell transplantation
Not Provided
Spitzer TR, Ambinder RF, Lee JY, Kaplan LD, Wachsman W, Straus DJ, Aboulafia DM, Scadden DT. Dose-reduced busulfan, cyclophosphamide, and autologous stem cell transplantation for human immunodeficiency virus-associated lymphoma: AIDS Malignancy Consortium study 020. Biol Blood Marrow Transplant. 2008 Jan;14(1):59-66.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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April 2006
July 2004   (Final data collection date for primary outcome measure)


  • Intermediate- or high-grade non-Hodgkin's lymphoma or Hodgkin's disease

    • Failed to achieve complete remission with initial therapy OR
    • Relapsed after initial therapy
  • May be in complete remission after salvage therapy
  • Sensitive to most recent chemotherapy

    • Improvement of at least 25% in bidimensional tumor measurements OR
    • Improvement in evaluable disease sustained over 4 weeks
  • Measurable or evaluable disease
  • HIV-1 positive
  • CD4 greater than 50 cells/mm^3 (unless not receiving optimal antiretroviral therapy)
  • HIV RNA less than 110,000 copies/mL (unless not receiving optimal antiretroviral therapy)
  • No active leptomeningeal or parenchymal CNS involvement NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.



  • Physiologic 18 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • Not specified


  • Absolute neutrophil count greater than 1,000/mm^3


  • AST no greater than 3 times upper limit of normal
  • Bilirubin no greater than 2.0 mg/dL (unless receiving indinavir)


  • Creatinine no greater than 2.0 mg/dL


  • No history of cardiac disease
  • LVEF at least 45%


  • No history of symptomatic pulmonary disease
  • DLCO at least 60%


  • No active opportunistic infections
  • No cytomegalovirus retinitis or pneumonitis requiring maintenance therapy
  • No sensitivity to E. coli-derived products
  • Not pregnant
  • Negative pregnancy test


Biologic therapy:

  • Not specified


  • See Disease Characteristics
  • At least 1 week since prior chemotherapy

Endocrine therapy:

  • Not specified


  • Not specified


  • Not specified


  • Chronic suppressive therapy for infection allowed
Sexes Eligible for Study: All
18 Years to 120 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
CDR0000067835 ( Other Identifier: NCI )
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AIDS Malignancy Consortium
National Cancer Institute (NCI)
Study Chair: David T. Scadden, MD Massachusetts General Hospital
AIDS Malignancy Consortium
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP