Chemotherapy With or Without Radiation, Low and Intermediate Risk Hodgkins Lymphoma, TXCH-HD-12A (TXCH-HD-12A)
Hodgkin Disease
About this trial
This is an interventional treatment trial for Hodgkin Disease focused on measuring Hodgkin's Lymphoma, ABVE-PC, doxorubicin, bleomycin, vincristine, etoposide, prednisone, cyclophosphamide, DECA, decadron, cisplatin, cytarabine, Radiation
Eligibility Criteria
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.
Sites / Locations
- Texas Children's Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Rapid Early Responders
Slow Early Responders
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.
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.