Status:
TERMINATED
R-ABVD vs ABVD-RT in Early Stage Hodgkin's Lymphoma
Lead Sponsor:
Fondazione Michelangelo
Conditions:
Hodgkin Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Combined modality therapy has then emerged as the standard of care for limited-stage Hodgkin's lymphoma and doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) chemotherapy that is devoid of a...
Detailed Description
Limited-stage Hodgkin lymphoma is a highly curable disease, with expected long-term disease-free and overall survival rates close to 90% and 95%, respectively. This success has come at a cost of long-...
Eligibility Criteria
Inclusion
- History of histologically confirmed classical Hodgkin lymphoma (cHL)
- Limited-stage disease defined as stage I or IIA with no areas of bulky disease
- Measurable disease according to the Cheson criteria
- Age \>=18 years
- Adequate bone marrow reserve (ANC \>= 1,500/uL, Platelet \> 100,000/uL)
- LVEF \>= 50% by MUGA scan or echocardiogram
- Serum creatinine \< 2 mg/dl, serum bilirubin \< 2 mg/dl, AST or ALT \<2x ULN
- Bi-dimensionally measurable disease
- Use of effective means of contraception
- Signed informed consent form
Exclusion
- Lymphocyte predominant HL
- Prior chemotherapy or radiation therapy
- Severe pulmonary disease as judged by the PI including COPD and asthma
- Presence of CNS lymphoma
- Concomitant malignancies or previous malignancies (exception made for adequately treated basal or squamous cell carcinoma of the skin)
- Active infection requiring treatment with intravenous therapy
- Known HIV infection
- Active hepatitis B or C
- Pregnancy or lactation and women of child bearing age who are not practicing adequate contraception
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2019
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT00992030
Start Date
September 1 2009
End Date
March 1 2019
Last Update
August 19 2021
Active Locations (11)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
2
Ospedali Riuniti Umberto I
Ancona, Italy, 60020
3
Ospedali Riuniti
Bergamo, Italy, 24100
4
Policlinico S. Orsola Malpighi
Bologna, Italy, 40138