Prospective Study on HIV-related Hodgkin Lymphoma

Phase 2

• Conditions: HIV-associated Hodgkin Lymphoma

• Registration Number: NCT01468740
• Lead Sponsor: Harlachinger Krebshilfe e.V.

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2004-03
• Status Verified: 2011-11
• Study First Submitted: 2011-11-01
• Study First Submitted QC: 2011-11-07
• Last Update Submitted: 2011-11-07
• Study First Posted: 2011-11-09
• Last Update Posted: 2011-11-09
• Primary Completion: 2012-02
• Study Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of patients with World Health Organization (WHO) grade 3 and grade 4 toxicity	30 days after termination of chemotherapy or radiotherapy
Treatment related mortality	30 days after termination of chemotherapy or radiotherapy

Secondary Outcome Measures

Name	Time	Method
Overall Survival	12 months and 24 months after termination of chemotherapy or radiotherapy
Progression-free survival	12 months and 24 months after termination of chemotherapy or radiotherapy
Complete remission rate	30 days and 90 days after termination of chemotherapy or radiotherapy

Trial Locations

Locations (8)

Infektionsmedizinisches Zentrum Hamburg; 🇩🇪 Hamburg, Germany

Vivantes Auguste Victoria Klinikum; 🇩🇪 Berlin, Germany

Ärzteforum Seestrasse; 🇩🇪 Berlin, Germany

Harlaching Hospital; 🇩🇪 Munich, Germany

Asklepios Klinikum St. Georg; 🇩🇪 Hamburg, Germany

University of Cologne; 🇩🇪 Cologne, Germany

Universiy of Bonn; 🇩🇪 Bonn, Germany

University of Frankfurt; 🇩🇪 Frankfurt, Germany