Clinical trial · Interventional
Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease
- 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)
Primary: To assess the toxicity of chemotherapy with ABVD (doxorubicin / bleomycin / vinblastine / dacarbazine) when given with filgrastim ( granulocyte colony-stimulating factor; G-CSF ) in patients with underlying HIV infection and Hodgkin's disease; to observe the efficacy of ABVD and G-CSF in reducing tumor burden in HIV-infected patients with Hodgkin's disease. Secondary: To determine the durability of tumor response to ABVD plus G-CSF over the 2-year study period; to observe the incidence of bacterial and opportunistic infections in HIV-infected patients with Hodgkin's disease receiving this regimen; to document quality of life of patients receiving this regimen. Addition of granulocyte colony-stimulating factor may prevent neutropenia caused by chemotherapy, allowing more timely administration of chemotherapy and improved response.
Conditions
Conditions (2)
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 Infections | — | UNRESOLVED | — |
| Hodgkin's Disease | Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bleomycin sulfate | Drug | Bleomycin | ALIAS |
| Dacarbazine | Drug | Dacarbazine | ALIAS |
| Doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| Filgrastim | Drug | Filgrastim | ALIAS |
| Vinblastine sulfate | Drug | Vinblastine | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
Show eligibility criteria text
Inclusion Criteria Concurrent Medication: Required: * PCP prophylaxis consisting of Bactrim, aerosolized pentamidine, or dapsone. Recommended: * Antiemetic therapy within 30 minutes of chemotherapy. Allowed: * Antiretroviral medication after two cycles of chemotherapy, provided the patient has not experienced grade 3 neutropenia while on chemotherapy or on previous antiretroviral therapy. * Acetaminophen and/or nonsteroidal anti-inflammatory agents. * Bone marrow-suppressive agents, such as ganciclovir, Fansidar, Bactrim, and dapsone. * Maintenance therapy for chronic opportunistic infection. Concurrent Treatment: Allowed: * Cranial irradiation (2400 rads) for patients with CNS involvement. Patients must have: * Documented HIV infection or diagnosis of AIDS. * Hodgkin's disease. * Consent of parent or guardian and have care directly supervised by a pediatric oncologist if under 18 years of age. Prior Medication: Allowed: * Maintenance therapy for opportunistic infections. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Second primary cancer other than Kaposi's sarcoma that does not require systemic therapy, nonmelanomatous skin cancer, Bowen's disease, or carcinoma in situ of the cervix. * Acute, active bacterial or opportunistic infection requiring ongoing therapy if such therapy has been initiated within the past 2 weeks. * Known hypersensitivity (e.g., anaphylactoid reaction, bronchospasm) to E. coli-derived proteins. Prior Medication: Excluded: * Prior chemotherapy for Hodgkin's disease. * Antiretroviral therapy within 2 weeks prior to study entry. Prior Treatment: Excluded: * Prior radiotherapy for Hodgkin's disease.
References
Publications (2)
- BACKGROUNDLevine AM, Li P, Cheung T, Tulpule A, Von Roenn J, Nathwani BN, Ratner L. Chemotherapy consisting of doxorubicin, bleomycin, vinblastine, and dacarbazine with granulocyte-colony-stimulating factor in HIV-infected patients with newly diagnosed Hodgkin's disease: a prospective, multi-institutional AIDS clinical trials group study (ACTG 149). J Acquir Immune Defic Syndr. 2000 Aug 15;24(5):444-50. doi: 10.1097/00126334-200008150-00009. PMID 11035615
- BACKGROUNDLevine AM, et al. Prospective, multicenter phase II trial of ABVD chemotherapy with G-CSF in HIV-infected patients with Hodgkin's disease (HD): AIDS Clincial Trials Group (ACTG) Study 149. Proc Annu Meet Am Soc Clin Oncol. 1997;16:A194