Study of OFATUMUMAB as Part of the Scheme of Reduced Intensity Conditioning in High Risk Non-Hodgkin Lymphoma B Patients

• Status: Completed
• Trial end date: 2020-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is rate of acute graft-versus-host disease II-IV measured at day +365according to conventional criteria (Przepiorka et al. 1995) in patients with high risk non-Hodgkin lymphoma B subjects with Allogeneic Stem Cell Transplant

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
• Treatments: Antibodies, Monoclonal; Ofatumumab

Criteria

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.