Salvage chemotherapy followed by autoSCT for relapsed HIV associated lymphoma

UMIN ID: UMIN000001181

Registered date:10/06/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Relapsed or refractory HIV associated lymphoma
• Date of first enrollment: 2008/06/01
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Salvage regimen; etoposide60mg/m2 div for 2hrs day1-4 mPSL500mg div for 30min day1-5 carboplatin100mg/m2 cont.div day1-4 AraC2g/m2 div for 3hrs day5 Rituximab375mg div day1 for a case with CD20 positive 1course=21days, 1-4courses Peripheral blood stem cells should be collected after 1-4 course using G-CSF Patients who achieved PR or CR after 1-4courses of salvage regimen, should be treated with MEAM regimen followed by autologous peripheral blood stem cell transplantation. More than 2x10E6/kg of CD34-posiive cells should be infused on day0. MEAM regimen; MCNU300mg/m2 div for 1hr day-6 etoposide200mg/m2 div for 3hrs day-5~-3 AraC200mg/m2 div for 3 hrs day-5~-3 L-PAM140mg/m2 bolus iv day-2

Outcome(s)

• Primary Outcome: 2year over all survival
• Secondary Outcome: survival at 100 days after transplantation, CR rate, therapy related toxicity, the number of collected stem cells, the rate of engraftment, the number of CD4 positive cells, the quantity of HIV-virus

Key inclusion & exclusion criteria

• Age minimum: 15years-old
• Age maximum: 60years-old
• Gender: Male and Female
• Exclude criteria: Exclusion criteria for salvage regimen 1)Organ dysfunction a)EF<40% by cardiac sonography b)PaO2<50mmHg or SaO2<90% c)serumCr>3.0mg/dl d)Total-bilirubin>3.0mg/dl or ALT>five times upper limit of the institutional normal value 2)Serious active infection Exclusion criteria for PBSCT 1)Organ dysfunction a)EF<50% by cardiac sonography b)PaO2<60mmHg c)serumCr>2.0mg/dl d)Total-bilirubin>2.0mg/dl or ALT>twice of upper limit of the institutional normal value 2)Uncontrollable HIV virus load and resistant to HAART 3)Uncontrollable diabetes which is resistant to insulin 4)Uncontrollable hypertension 5)Intractable and active infection 6)Intractable invasion of lymphoma to CNS 7)Pregnant or possible pregnant women or breast feeding

Related Information

• Primary Sponsor: International Medical Center of JAPAN
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare