Clinical trial · Interventional
Prospective Study on HIV-related Hodgkin Lymphoma
A Prospective Multicenter Study on HIV-associated Hodgkin Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HIV-associated Hodgkin Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bleomycin | Drug | Bleomycin | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Dacarbazine | Drug | Dacarbazine | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Prednisone | Drug | Prednisone | ALIAS |
| Procarbazine | Drug | Procarbazine | ALIAS |
| Vinblastine | Drug | Vinblastine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Number of patients with World Health Organization (WHO) grade 3 and grade 4 toxicity
- timeFrame
- 30 days after termination of chemotherapy or radiotherapy
- measure
- Treatment related mortality
- timeFrame
- 30 days after termination of chemotherapy or radiotherapy
Secondary outcomes (3)
- measure
- Overall Survival
- timeFrame
- 12 months and 24 months after termination of chemotherapy or radiotherapy
- measure
- Progression-free survival
- timeFrame
- 12 months and 24 months after termination of chemotherapy or radiotherapy
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available