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 Lymphoma
Conditions
Interventions
After the project was approved by the University Hospital Research Ethics Committee at Federal University of Juiz de Fora, CAAE number: 16011019.7.0000.5133, in 2019, the researcher in charge has impl
1.000 mg/m² of etoposide is intravenously administered at D-5, for 10 hours
2.000 mg/m²/day of cyclophosphamide is intravenously administered at D-4, D-3 and D-2. With respect to aHSCT, days are considered negative (D-1, D-2, and so on) until the date of the hematopoietic ste
from this date onwards, days are considered positive (D +1, D+2, and so on).
The study was conducted based on the traditional 3 + 3 dose escalation model in order to determine the lomustine dose-limi
SP8.473.654.412.052.005.030
M9591/3
Sponsors
Universidade Federal de Juiz de Fora
Universidade Federal de Juiz de Fora
Eligibility
Age
No minimum to 60 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess overall survival and disease-free survival in these patients that underwent LEC (lomustine, Etoposide and Cyclophosphamide) Protocol. | — |
Countries
Brazil
Contacts
Public ContactAbrahão Hallack Neto
Universidade Federal de Juiz de Fora
Outcome results
None listed