An interventional study of Rituximab in Hodgkin's Disease, Leukemia and Myelodysplastic Syndrome, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2016-02-01.
Sponsored by Memorial Sloan Kettering Cancer Center · Not applicable, Interventional, and Treatment
The purpose of this study is to determine if we can prevent Epstein Barr Virus lymphomas by the monthly administration of an (antibody) protein against B lymphocytes called Rituximab. Although this medicine has been approved by the Food and Drug Administration to treat patients with other types of lymphomas, and has been used to treat a small number of patients with EBV lymphomas and other types of B-cell leukemias, it has not been approved to try and prevent EBV-lymphomas. Use of Rituximab to try to prevent EBV-lymphomas is therefore experimental.
885 studies on the registry are indexed under Hodgkin Disease; 132 are open to participants now.
This study's enrollment of 26 is below the median of 44 across 726 interventional studies indexed under Hodgkin Disease.
Browse Hodgkin Disease studies →Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.
Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients following a T cell depleted HLA-mis-matched related or unrelated hematopoietic stem cell transplant (HSCT) will be treated with monthly Rituximab.
Drug: Rituximab
Rituximab 375 mg/m\^2 starting approximately 1 month post transplant (no later than day 45), and continuing monthly until the CD4 cell count is \> 200 cells/ul or a maximum of 6 doses have been given.
Safety of Rituximab Prophylaxis
The following stopping rules will be employed to determine that the risks of graft failure, severe GvHD, treatment-related mortality, infection, and EBV-LPD in study patients are not increased over expected. In addition, patients will be removed from study if they develop irreversible non-hematologic Grade III toxicity or any Grade IV toxicity felt to be related or possibly related to study drug.
Time frame: 3 months post transplant
| Milestone | Rituximab Prophylaxis in TCD Unrelated or HLA Mismatched HSCT |
|---|---|
| Started | 26 |
| Completed | 10 |
| Not completed | 16 |
| Withdrew: Not treated | 1 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Adverse event | 11 |
| Withdrew: Relapse | 2 |
| Withdrew: Other | 1 |
The following stopping rules will be employed to determine that the risks of graft failure, severe GvHD, treatment-related mortality, infection, and EBV-LPD in study patients are not increased over expected. In addition, patients will be removed from study if they develop irreversible non-hematologic Grade III toxicity or any Grade IV toxicity felt to be related or possibly related to study drug.
| participants | Rituximab Prophylaxis in TCD Unrelated or HLA Mismatched HSCT |
|---|---|
| Safety of Rituximab Prophylaxis | 23 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Rituximab Prophylaxis in TCD Unrelated or HLA Mismatched HSCT | — | 6/26 (23.1%) | 23/26 (88.5%) |
| Event | Rituximab Prophylaxis in TCD Unrelated or HLA Mismatched HSCT |
|---|---|
| Infection w.out neutropeniaInfections and infestations | 4/26 |
| Infection with grade 3/4 neutInfections and infestations | 1/26 |
| Neutrophils/granInfections and infestations | 1/26 |
| Pericardial effusionCardiac disorders | 1/26 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 1/26 |
| Event | Rituximab Prophylaxis in TCD Unrelated or HLA Mismatched HSCT |
|---|---|
| LeukocytesInvestigations | 18/26 |
| LymphopeniaInvestigations | 18/26 |
| Hemoglobin (Hgb)Investigations | 15/26 |
| Neutrophils/granInvestigations | 12/26 |
| PlateletsInvestigations | 11/26 |
| SGPT (ALT)Investigations | 10/26 |
| HypocalcemiaMetabolism and nutrition disorders | 7/26 |
| HypokalemiaMetabolism and nutrition disorders | 7/26 |
| Infection w.out neutropeniaInfections and infestations | 7/26 |
| Alkaline phosphataseInvestigations | 5/26 |
| Age, Categorical(Participants) | Rituximab Prophylaxis in TCD Unrelated or HLA Mismatched HSCT |
|---|---|
| <=18 years | 9 |
| Between 18 and 65 years | 16 |
| >=65 years | 1 |
| Sex: Female, Male(Participants) | Rituximab Prophylaxis in TCD Unrelated or HLA Mismatched HSCT |
|---|---|
| Female | 9 |
| Male | 17 |
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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Memorial Sloan Kettering Cancer Center