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Phase II study of the addition of rituximab to dmCODOX-M/IVAC therapy for AIDS-related burkitt lymphoma

Phase II study of the addition of rituximab to dmCODOX-M/IVAC therapy for AIDS-related burkitt lymphoma - ABL-R trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000011661
Enrollment
26
Registered
2013-09-06
Start date
2013-09-10
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

AIDS-related burkitt lymphoma

Interventions

the addition of rituximab to dmCODOX-M/IVAC therapy

Sponsors

National Hospital Organization Nagoya Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. HIV infection positive 2. Previously untreated patients with histologically confirmed Burkitt lymphoma 3. Presence of mesurable lesions by computed tomography or Magnetic Resonance Imaging 4. Age 20-65 years 5. Performance status (ECOG) of 0 to 2, or PS 3 by burkitt lymphoma 6. No major organ dysfunction (1) White cell counts: more than or equal to 2000/uL or, neutrophil counts:more than or equal to 1200/uL , and platelet counts:more than or equal to 50000/uL. (2) AST(GOT):less than or equal to 100IU/U, ALT(GPT):less than or equal to 100IU/U, and serum bilirubin:less than or equal to 2.0 mg/dl (3) Serum creatinin:less than 1.5mg/dl (4) a left ventricular ejection fraction by echocardiography at least 50% (5) SpO2:more than or equal to 90 percent 7. Informed consented patients

Exclusion criteria

Exclusion criteria: 1. Pregnant or possible pregnant women 2. Other active malignancies except for Kaposi sarcoma 3. Severe complication Uncontrollable angina pectoris, myocardial infarction, or heart failure Uncontrollable active infection Uncontrollable diabetes Interstitial pneumonia or pulmonary fibrosis by chest-Xay Uncontrollable opportunistic disease of central nervous system Uncontrollable pleural effusion, ascites or fluid retention in third space Severe psychosis 4. Judged for inappropriate with other reasons

Design outcomes

Primary

MeasureTime frame
Two-year progression-free survival

Secondary

MeasureTime frame
Two-year overall survival, complete response rate, overall response rate, adversed effect, incidence of opportunistic disease, treatment-related mortality

Countries

Japan

Contacts

Public ContactYuki Kojima

National Hospital Organization Nagoya Medical Center Clinical Research Center

yukik@nnh.hosp.go.jp052-951-1111

Outcome results

None listed

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