Prospective Study on HIV-related Hodgkin Lymphoma

• Status: Unknown status
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Standard therapy for HIV-related Hodgkin lymphoma (HIV-HL) has not been defined. This trial was initiated to investigate a risk adapted treatment strategy in patients (pts) with HIV-HL as established in HIV-negative patients with HL.

Treatment schedule:

• Early stage favorable Hodgkin Lymphoma (HL): 2 cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) plus 30 Gy involved field (IF) radiation

• Early stage unfavorable HL: 4 cycles of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPP)-baseline or 4 cycles of ABVD plus 30 Gy IF radiation

• Advanced HL: 8 cycles of BEACOPP-baseline. BEACOPP should be replaced by ABVD in pts with far advanced HIV-infection. After the completion of chemotherapy sites of initial bulky disease (those at least 5 cm in diameter) and residual tumor larger than 2.5 cm in diameter receive 30 Gy of irradiation.

• Primary outcome measure: tolerability, treatment-related mortality

• Secondary outcome measure: complete remission rate, progression-free survival (PFS), overall survival (OS).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Harlachinger Krebshilfe e.V.
• Collaborator: Deutsche AIDS Gesellschaft e.V.
• Treatments: Bleomycin; Cyclophosphamide; Dacarbazine; Doxorubicin; Etoposide; Etoposide phosphate; Liposomal doxorubicin; Prednisone; Procarbazine; Vinblastine; Vincristine

Criteria

Inclusion Criteria:

• age 18 - 75 years

• proven infection with HIV 1 (Elisa and Western Blot)

• histology-proven newly diagnosed Hodgkin lymphoma

• written, informed consent.

Exclusion Criteria:

• severe cardiac, hepatic or pulmonary insufficiency

• severe renal insufficiency (creatinine > 2,0 mg/dl) not caused by lymphoma

• bone marrow failure, not caused by lymphoma or HAART (neutrophils < 1000/µl, platelets < 70.000/µl)

• uncontrolled infection

• uncontrolled drug addiction or psychiatric disease

• pregnancy or lactation period

• prior chemotherapy of Hodgkin lymphoma

• life expectancy < 6 weeks

• HIV-related wasting-syndrome

• active secondary malignancy with cervix carcinoma in situ, basalioma and Kaposi's sarcoma being excepted