Prospective Study on HIV-related Hodgkin Lymphoma

Harlachinger Krebshilfe e.V.

Status and phase: Unknown; Phase 2

Conditions: HIV-associated Hodgkin Lymphoma

Treatments: Drug: Cyclophosphamide; Drug: Vinblastine; Drug: Prednisone; Drug: Vincristine; Drug: Etoposide; Drug: Procarbazine; Drug: Bleomycin; Drug: Doxorubicin; Drug: Dacarbazine

Study type: Interventional

Funder types: Other

Identifiers

NCT01468740

HIV-HL 2004

Details and patient eligibility

About

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).

Enrollment: 130 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)