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Salvage chemotherapy followed by autoSCT for relapsed HIV associated lymphoma

Salvage chemotherapy followed by autoSCT for relapsed HIV associated lymphoma - Salvage chemotherpy for HIV associated lymphoma

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001181
Enrollment
20
Registered
2008-06-10
Start date
2008-06-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed or refractory HIV associated lymphoma

Interventions

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=2
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

Sponsors

International Medical Center of JAPAN
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion criteria for salvage regimen; 1)HIV positive 2)refractory to first line chemotherapy or relapsed non-Hodgkin's lymphoma 3)ECOG PS0-4 4)Well controlled HIV rirul load with HAART 5)Written informed consent sheet must be obtained before entry to the trial Inclusion criteria for autologous peripheral blood stem cell transplantation; 1)More than 2x10E6/kg of CD34-positive cells were collected 2)Patients who achieved PR or CR after the salvage regimen 3)Age:15=< <60 4)ECOG PS0-2 5)HIV virus load should be well controlled with HAART 6)No active opportunistic infection 7)Written informed consent sheet must be obtained

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
2year over all survival

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactShotaro Hagiwara

International Medical Center of JAPAN Division of Hematology

shagiwar@imcj.hosp.go.jp

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026