Clinical trial · Interventional
Combination Chemotherapy Followed By Antiviral Therapy and Interferon Alfa in Treating Patients With HTLV-1-Related Adult T-Cell Leukemia/Lymphoma
Phase II Trial Of Induction Therapy With EPOCH Chemotherapy And Maintenance Therapy With Combivir/Interferon ALPHA-2a For HTLV-1 Associated T-Cell Non-Hodgkin's 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)
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Antiviral therapy may kill viruses such as HTLV-1 that can cause cancer. Interferon alfa may interfere with the growth of cancer cells. Combining chemotherapy with antiviral drugs and interferon alfa may be effective in treating adult T-cell leukemia/lymphoma. PURPOSE: Phase II trial to determine the effectiveness of combination chemotherapy followed by antiviral therapy and interferon alfa in treating patients who have adult T-cell leukemia/lymphoma caused by HTLV-1.
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 |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| lamivudine | Drug | — | UNRESOLVED |
| prednisone | Drug | Prednisone | ALIAS |
| recombinant interferon alfa | Biological | — | UNRESOLVED |
| vincristine sulfate | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Efficacy
- timeFrame
- 60 days
- measure
- Duration of response
- timeFrame
- 3 years
- measure
- Effects on markers of virus replication and expression and immune function
- timeFrame
- 5 years
- measure
- Toxicity
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed HTLV-1-associated adult T-cell leukemia/lymphoma (ATLL) * Previously treated ATLL allowed * CD3-positive * Documented HTLV-1 infection by serologic assay (ELISA, Western blot) * Measurable or evaluable disease PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 50-100% Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count greater than 1,000/mm\^3\* * Platelet count greater than 75,000/mm\^3\* NOTE: \*Unless cytopenia is secondary to ATLL Hepatic: * Transaminase less than 7 times upper limit of normal * Bilirubin less than 2.0 mg/dL (unless secondary to hepatic infiltration with lymphoma or isolated indirect hyperbilirubinemia associated with indinavir) Renal: * Creatinine less than 2.0 mg/dL (unless due to lymphoma) Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after study completion * No active opportunistic infection requiring acute therapy * No untreated thyroid disease * No autoimmune disease * No uncontrolled significant psychiatric disease * No other concurrent malignancy except carcinoma in situ of the cervix or non-metastatic nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 24 hours since prior hematologic growth factors Chemotherapy: * Not specified Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified Other: * Concurrent chronic therapy with potentially myelosuppressive agents allowed * Other concurrent antiretroviral therapy for HIV, hepatitis B, or hepatitis C infection (or other indication) allowed at investigator's discretion for patients receiving therapy prior to study initiation
References
Publications (1)
- RESULTRatner L, Harrington W, Feng X, Grant C, Jacobson S, Noy A, Sparano J, Lee J, Ambinder R, Campbell N, Lairmore M; AIDS Malignancy Consortium. Human T cell leukemia virus reactivation with progression of adult T-cell leukemia-lymphoma. PLoS One. 2009;4(2):e4420. doi: 10.1371/journal.pone.0004420. Epub 2009 Feb 10. PMID 19204798