Clinical trial · Interventional
Immunotherapy Using Cyclosporine, Interferon Gamma, and Interleukin-2 After High-Dose Myeloablative Chemotherapy With Autologous Stem Cell Transplantation in Treating Patients With Refractory or Relapsed Hodgkin's Lymphoma
A Phase II/III Study of Immunomodulation After High Dose Myeloablative Therapy With Autologous Stem Cell Rescue for Refractory/Relapsed Hodgkin 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)
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with autologous stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Giving immunotherapy using cyclosporine, interferon gamma, and interleukin-2 after stem cell transplantation may help the transplanted cells make an immune response and kill any remaining cancer cells. It is not yet known whether high-dose chemotherapy followed by autologous stem cell transplantation is more effective with or without immunotherapy. PURPOSE: This randomized phase II/III trial is studying how well high-dose chemotherapy followed by autologous stem cell transplantation, cyclosporine, interferon gamma, and interleukin-2 works and compares it to high-dose chemotherapy followed by autologous stem cell transplantation only in treating patients with refractory or relapsed Hodgkin's lymphoma.
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 (11)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aldesleukin | Biological | Aldesleukin | ALIAS |
| autologous bone marrow transplantation | Procedure | — | UNRESOLVED |
| bone marrow ablation with stem cell support | Procedure | — | UNRESOLVED |
| carmustine | Drug | Carmustine | ALIAS |
| cyclosporine | Drug | — | UNRESOLVED |
| cytarabine | Drug | Cytarabine | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Hyperfractionated Involved-Field Radiotion-immunotherapy
- description
- Completed prior salvage induction therapy and have not received full tissue tolerance from prior radiotherapy may receive hyperfractionated involved-field radiotherapy twice daily for 7 days. HIGH-DOSE PREPARATIVE REGIMEN: Beginning within 7 days after radiotherapy, carmustine IV over 3 hours on day -6; etoposide IV over 1 hour and cytarabine IV over 1 hour on days -5 to -2; and melphalan IV over 30 minutes on day -1. ASCT: Autologous bone marrow or peripheral blood stem cell transplantation on day 0. Filgrastim (oral or IV) beginning on day 1 and continuing until blood counts recover. IMMUNOTHERAPY: Cyclosporine IV twice daily beginning on day 0 and continuing until the completion of the course of recombinant interferon gamma and interleukin-2. When sufficiently recovered, Aldesleukin once daily for 18 days.
- interventionNames
- Biological: aldesleukin
- Biological: filgrastim
- Biological: recombinant interferon gamma
- Drug: carmustine
- Drug: cyclosporine
- Drug: cytarabine
- Drug: etoposide
- Drug: melphalan
- Procedure: autologous bone marrow transplantation
- Procedure: bone marrow ablation with stem cell support
- Procedure: peripheral blood stem cell transplantation
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 30 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of Hodgkin's lymphoma * Histologically confirmed at original diagnosis AND at relapse or disease progression * Relapsed or refractory to conventional therapy * No recurrence without B symptoms or bulky disease at least 1 year after completion of minimal systemic therapy defined by either of the following: * Stage IA/IIA with nodal disease previously treated with radiotherapy only * Stage IA/IIA with nodal disease previously treated with less than 3 courses of standard dose chemotherapy * Concurrently enrolled on the COG-AHOD00P1 salvage chemotherapy study OR received other appropriate salvage therapy (e.g., ifosfamide and vinorelbine) PATIENT CHARACTERISTICS: Age * Under 30 Performance status * ECOG 0-2 (for adults) * Lansky 50-100% (for children) Life expectancy * At least 2 months Hematopoietic * Absolute neutrophil count at least 500/mm\^3 Hepatic * Bilirubin no greater than 1.5 times normal * SGPT less than 2.5 times normal Renal * Creatinine no greater than 1.5 times normal OR * Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min/1.73 m\^2 Cardiovascular * Shortening fraction at least 27% by echocardiogram OR * Ejection fraction at least 50% by MUGA Pulmonary * No evidence of dyspnea at rest * No exercise intolerance * DLCO at least 50% (patients 8 years of age and over) Other * Not pregnant or nursing * Negative pregnancy test * No concurrent serious illness PRIOR CONCURRENT THERAPY: Biologic therapy * Recovered from prior immunotherapy * At least 1 week since prior antineoplastic biologic agents * More than 1 week since prior growth factors * No prior stem cell transplantation * No other concurrent immunomodulating agents Chemotherapy * See Disease Characteristics * More than 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered * No other concurrent anticancer chemotherapy Endocrine therapy * No concurrent steroids, including dexamethasone as an antiemetic Radiotherapy * See Disease Characteristics * Recovered from prior radiotherapy Surgery * Not specified Other * No concurrent participation in another COG therapeutic study
References
Publications (1)
- RESULTChen AR, Hutchison R, Hess A, et al.: Clinical outcomes of patients with recurrent/refractory Hodgkin disease receiving cyclosporine, interferon-, and interleukin-2 immunotherapy to induce auto-reactivity after autologous stem cell transplantation with BEAM: a COG study. [Abstract] Blood 110 (11): A-1896, 2007.