Status:
COMPLETED
Chemotherapy With or Without Radiation, Low and Intermediate Risk Hodgkins Lymphoma, TXCH-HD-12A
Lead Sponsor:
Baylor College of Medicine
Conditions:
Hodgkin Disease
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
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 i...
Detailed Description
At first the subject will have 2 cycles of cancer drugs (Doxorubicin, Bleomycin, Vincristine, Etoposide, Prednisone, Cyclophosphamide). The doctors call this combination of cancer drugs ABVE-PC for sh...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 19 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 12 2019
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01858922
Start Date
December 19 2012
End Date
August 12 2019
Last Update
January 12 2024
Active Locations (1)
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1
Texas Children's Hospital
Houston, Texas, United States, 77030