Tolerated dose of Lomustine used in combination with Etoposide and Cyclophosphamide in conditioning regimen for hematopoietic stem cell transplantation in lymphoma patients
- Conditions
- The participants are patients with lymphoma (Hodgkin's disease and NonHodgkins lymphoma) who are chemosensitive and have indication for hematopoietic stem cell transplantation (as refractoriness) - thus, they will be submitted to this new protocol (LEC-Lomustine, Etoposide and Cyclophosphamide) with evaluation of the maximum tolerated dose of Lomustine.Descriptors: Hodgkins LymphomaNonhodgkins LymphomaM9590/3
- Registration Number
- RBR-10bj7s98
- Lead Sponsor
- niversidade Federal de Juiz de Fora
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
The study will include patients chemosensitive with LH and LNH younger than 60 years, who present performance status higher than 70% Karnofsky and normal cardiac function ejection fraction > 50%, who do not have chronic respiratory disease expiratory volume in one second > 50%, who have normal liver and kidney function, who are in partial or full disease remission, who present creatinine level lower than 2.0 mg/dL at the beginning of conditioning, and who tested negative for human immunodeficiency virus and hepatitis. All study participants will be eligible to aHSCT therefore, they will meet the criteria presented above.
Patients who do not meet the established inclusion criteria or who do not agree to participate or not sign the free and informed consent form.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Finding the effective and non toxic (secure) lomustine dose for aHSCT conditioning; establishing an effective alternative treatment for patients with chemosensitive Hodgkin’s and non-Hodgkin’s lymphoma; identifying the main toxicities of the drug treatment and proving the effectiveness of the protocol due to the fact that the previous drug used named Carmustine is not available in Brazil.<br>
- Secondary Outcome Measures
Name Time Method To assess overall survival and disease-free survival in these patients that underwent LEC (lomustine, Etoposide and Cyclophosphamide) Protocol.