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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004729-29 | EudraCT Number |
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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
In addition to above:
Rate of progression-free survival (PFS) at 12, 24, 36 and 60 months post-transplant defined as the time between the infusion of progenitors and the disease progression or death. Patients alive or in complete remission will be censored at the time of last follow up
Transplant-related mortality (TRM) at 12, 24, 36 and 60 months after transplantation, defined as any death not caused directly by lymphoma (any death caused by complications related to transplantation).
Overall survival (OS) defined as the time between infusion of progenitors and the patient's death from any cause. Alive Patients will be censored at the time of last follow-up
Incidence of chronic graft versus host disease (GVHD) wide at 1 and 5 years according to conventional criteria (Atkinson et al. 1989) and Filipovich et al. (BBMT, 2005).
Rate of event-free survival (DFS) defined as time interval between diagnosis of lymphoma and lymphoma progression or relapse or death if the above does not occur.
Successful graft implantation: is defined as:
Reconstitution of the immune system: lymphocyte count populations CD20, CD3, CD4 and CD8 and immunoglobulinemia serum (days +100, 180, 360, 18 months and 24 months).
intercurrent infections. All sorts of infections (viral, fungal and bacterial)will be recorded
Safety assessment by the standards of Common Terminology Criteria for adverse events v. 4.0
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ofatumumab | Experimental | Ofatumumab as part of the reduced intensity conditioning regimen (RIC) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ofatumumab | Drug | Ofatumumab as part of the reduced intensity conditioning regimen (RIC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of acute grade II-IV graft-versus-host disease at 1 year | According to conventional criteria. This endpoint will be descriptively reported. Confidence intervals (95% bounds) will be provided. The rate will be analyzed in all patients enrolled at the clinical trial and that no major violation has been produced. | 5 years follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| To analyze the complete response rate after treatment. Further secondary outcomes as described in study summary | To analyze the complete response rate after treatment | 5 years follow up |
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Inclusion Criteria:
Subjects who have given their informed consent before any study-specific procedures
Histopathological diagnostic of NHL cell B CD 20 + B of different histologic subtypes:
High risk CD +20 Lymphoma having at least one of the following characteristics:
Age between 18 and 65 years
ECOG between 0 to 1 (Appendix III).
Subjects who are HBgAG negative, anti-HBc positive and HBV DNA negative may be include in the study but must undergo HBV DNA monitoring
Adequate lung Function
Cardiac ejection greater than 40% as measured by scintigraphy or echocardiography.
Adequate renal and hepatic function defined by the following biochemical parameters
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.
Availability of a histocompatible donor (9 to 10/10 loci) family or unrelated
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:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Dolores Caballero, MD | Hospital Clinico de Salamanca | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Vall d'Hebron | Barcelona | Spain | ||||
| Hospital Reina Sofia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38167647 | Derived | Cabrero M, Lopez-Corral L, Jarque I, de la Cruz-Vicente F, Perez-Lopez E, Valcarcel D, Sanz J, Espigado I, Orti G, Martin-Calvo C, de la Serna J, Caballero D; Grupo Espanol de Trasplante Hematopoyetico (GETH) and Grupo Espanol de Linfomas y Trasplante Autologo (GELTAMO). Ofatumumab as part of reduced intensity conditioning in high risk B-cell lymphoma patients: final long-term analysis from a prospective multicenter Phase-II Trial. Bone Marrow Transplant. 2024 Mar;59(3):359-365. doi: 10.1038/s41409-023-02171-5. Epub 2024 Jan 2. |
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| Córdoba |
| Spain |
| H.U. 12 de Octubre, | Madrid | Spain |
| H.U. Gregorio Marañón, | Madrid | Spain |
| H.U. La Paz | Madrid | Spain |
| Complejo Hospitalario Carlos Haya | Málaga | 29010 | Spain |
| H. Morales Meseguer. | Murcia | Spain |
| H. Clinico de Salamanca | Salamanca | Spain |
| Hospital Virgen del Rocío | Seville | 41013 | Spain |
| H. La Fe | Valencia | Spain |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D004194 | Disease |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C527517 | ofatumumab |
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