Clinical trial · Interventional
Chemotherapy With or Without Radiation, Low and Intermediate Risk Hodgkins Lymphoma, TXCH-HD-12A
Immune Reconstitution and Biomarker Identification in Patients With Newly Diagnosed Low and Intermediate Risk Hodgkins Lymphoma Receiving Chemotherapy With or Without Radiation Therapy: TXCH-HD-12A
- 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)
Subjects have a type of cancer called Hodgkin Disease (HD), a cancer of the lymph system. The lymph system is made up of tissue throughout the body that makes and stores infection-fighting cells. HD is one of the most treatable childhood cancers. The standard treatment for HD involves chemotherapy (treatment with anti-cancer drugs) and radiation therapy (the use of high-dose x-rays to get rid of cancer cells). Although they are cured from their cancer, some patients experience negative side effects from treatment later in life. These kinds of side effects are often referred to as late effects. This can include problems with growth, problems with some organ functions, and sometimes second cancers. These types of effects can be associated with either chemotherapy or radiation therapy. The investigators are therefore designing studies to minimize or prevent these late effects. It is thought that if some patients can be successfully treated without radiation, those patients might experience fewer late side effects. Some patients, however, do not respond as well to the first stages of treatment (slow early responders). Slow early responders are considered to be at higher risk for relapse. This study also looks at whether these kinds of patients will benefit from additional chemotherapy. The purpose of this study is to look at how the immune system recovers and at how certain T-cells in the blood behave after receiving chemotherapy with or without radiation. The investigators also want to identify if bio-markers (special proteins in blood and in cancer) relate to the response of HD to study treatment.
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 |
|---|---|---|---|
| Hodgkin Disease | Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ABVE-PC | Drug | — | UNRESOLVED |
| DECA | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Rapid Early Responders
- description
- All patients will have initial treatment utilizing ABVE-PC x2 cycles. Those patients with rapid early response (RER) determined by FDG-PET/CT scan after two cycles of ABVE-PC will receive two more cycles of ABVE-PC. If subsequent PET/CT scan indicates a complete response (CR), therapy will stop and regular follow-up will begin. If the subsequent PET/CT for RER patients indicates a partial response, those patients will undergo IFRT.
- interventionNames
- Drug: ABVE-PC
- type
- EXPERIMENTAL
- label
- Slow Early Responders
- description
- All patients will have initial treatment utilizing ABVE-PC x2 cycles. Those patients determined to have a slow early response (SER) determined by PET/CT scan after two cycles of ABVE-PC will receive 2 courses of DECA. If after PET/CT, the patient has a partial or complete response, then 2 additional courses of ABVE-PC will be given. If subsequent PET/CT scan indicates PR or CR, those patients will then undergo IFRT. If stable or progressive disease is found at either PET/CT scan, the patient will be taken off-study and follow up will begin.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: Patients with newly diagnosed, histologically confirmed Hodgkin Lymphoma (HD) who meet the following criteria: * Stage IA and IB (non-bulky nodular lymphocyte predominant) * Stage IIA and IIB * Stage IIIA * Stage IVA Exclusion Criteria: * Patients with Stage IA-IIA non-bulky lymphocyte predominant histology * Patients who have received previous chemotherapy or radiation therapy (does NOT include steroids). * Patients with symptomatic cardiac failure unrelieved by medical therapy or evidence of significant cardiac dysfunction by echocardiogram (shortening fraction \<27%). * Patients with severe renal disease (i.e. Measured or estimated creatinine clearance or radioisotope GFR \<= 70 ml/min/1.73 m2). * Patients with pre-existing severe restrictive pulmonary disease (FVC less than 60% of predicted). * Patients with severe hepatic disease (direct bilirubin greater than 3 mg/dl or AST greater than 500 IU/L). * Known HIV positivity * Patients with a Karnofsky performance score \<70% or Lansky score \<70%. * Female patients who are pregnant or breast feeding.
References
Publications (0)
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