| Eligibility |
Inclusion Criteria:
1. Subjects who have given their informed consent before any study-specific procedures
2. Histopathological diagnostic of NHL cell B CD 20 + B of different histologic subtypes:
3. High risk CD +20 Lymphoma having at least one of the following characteristics:
- Less than a partial remission after two courses of treatment
- Relapse after autologous peripheral blood stem cell (PBSCT)
- Evidence of measurable disease (With CT and PET or PET / CT) three months after
PBSCT
- Hematopoietic precursors improper count in patients with relapsed or partial
remission after two treatment lines that prevent the realization of a PBSCT.
- Patients after first relapse in RP after two lines of treatment in whom the
probability of freedom from progression per year is very low due to risk factors
such as: first CR less than 12 months after PBSCT low SLP, etc..
4. Age between 18 and 65 years
5. ECOG between 0 to 1 (Appendix III).
6. Subjects who are HBgAG negative, anti-HBc positive and HBV DNA negative may be include
in the study but must undergo HBV DNA monitoring
7. Adequate lung Function
8. Cardiac ejection greater than 40% as measured by scintigraphy or echocardiography.
9. Adequate renal and hepatic function defined by the following biochemical parameters
10. The disease status prior to transplantation had to be in place in accordance with the
criteria of Revised Response Criteria for Malignant Lymphoma, Cheson 2007. CT and PET
or PET / CT.
11. Availability of a histocompatible donor (9 to 10/10 loci) family or unrelated
12. Adults with ability to procreate must commit to use an effective method of birth
control during the study treatment and at least 6 months.
Exclusion Criteria:
1. Refractory disease at the time of transplantation
2. Progressive disease at the time of transplantation.
3. ECOG=2
4. Lymphoma associated with infection with human immunodeficiency virus (HIV).
5. Test positive for HIV.
6. Presence of anti-murine antibodies (HAMA) or (HACA).
7. Treatment with any marketed or experimental drug administered not in a period between
5 terminal half-lives of clearance of therapy or 4 weeks before enrollment
8. Participation in another interventional clinical trial.
9. Prior treatment with anti-CD20 monoclonal antibody or alemtuzumab within 3 months
prior to start of therapy. This is generally required and may be excluded as
applicable.
10. Hepatitis B positive serology
11. Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg.
12. Positive serology for hepatitis C (HC) defined as a positive test for HCAb.
13. Active liver or biliary disease (with exception of Gilbert's disease, cholelithiasis,
metastases).
14. Other past or current malignancy.
15. Chronic infectious disease that requires ongoing treatment with systemic antibiotics,
antifungal or antiviral drugs
16. History of cerebrovascular disease active in the last 6 months or event with
significant symptoms or sequelae.
17. Clinically significant heart disease, such as unstable angina, acute myocardial
infarction in the six months prior to inclusion, congestive heart failure (grades
III-IV NYHA) and arrhythmia unless it is controlled by treatment, except for premature
or disorders Mild driving.
18. Concurrent medical disorder, uncontrolled and important, such as kidney disease,
liver, digestive, endocrine, pulmonary, neurological, brain, psychiatric, or which in
the opinion of the investigator may represent a risk to the patient
19. Pregnancy or breastfeeding
20. Women of childbearing potential, including those whose last menstrual period was one
year prior to screening.
21. Men unable or unwilling to use contraception
22. Patients with hypersensitivity to fludarabine, melphalan, thiotepa, tacrolimus,
sirolimus and / or any excipients.
|
