Hodgkin's Disease, Leukemia, Myelodysplastic Syndrome, Non-Hodgkin's Lymphoma
Conditions
Keywords
RITUXIMAB, Lymphoma
Brief summary
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.
Interventions
DRUGRituximab
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.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patient must be a recipient of aT cell depleted unrelated or HLA mis-matched related HSCT for the treatment of a malignancy or immunodeficiency disease. * Patients must have an ANC \> or = to 1500 cells/ul on the day of first treatment. * Patients with acute or chronic leukemia, or MDS prior to transplant must be in remission defined as \<5% blasts in the bone marrow. * Patient with must be in remission. * Patient must be Hepatitis B surface antigen negative pre transplant. * Patients must have adequate cardiac function defined as a left ventricular ejection fraction at rest of \>50% documented pre-transplant. * Patient may be of either gender and of any ethnic background. * Patient may be of any age. There is no upper age restriction. * Patients or their guardians must be able to understand the nature and risk of the proposed study and be able to sign consent.
Exclusion criteria
* Karnofsky score \<70% * Female patients who are pregnant or lactating. * Evidence of EBV-LPD or circulating EBV copy number \>1000. * Active uncontrolled bacterial or fungal infection. * Prior history of Hepatitis B infection or Hepatitis B surface antigen positivity pre transplant. * HIV-1,2 sero-positive patients. * Patients or guardians not signing informed consent. * Patients with prior allergic reaction to Rituximab or other murine monoclonal antibody. * Patients taking other investigational agents under another protocol unless discussed and approved in advance by Genentech and the IDEC Therapeutic Director.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Rituximab Prophylaxis | 3 months post transplant | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rituximab Prophylaxis in TCD Unrelated or HLA Mismatched HSCT To determine the safety of Rituximab prophylaxis in patients following TCD unrelated or HLA mismatched related HSCT | 26 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 11 |
| Overall Study | Not Treated | 1 |
| Overall Study | Other | 1 |
| Overall Study | Relapse | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Rituximab Prophylaxis in TCD Unrelated or HLA Mismatched HSCT |
|---|---|
| Age, Categorical <=18 years | 9 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 23 / 26 |
| serious Total, serious adverse events | 6 / 26 |
Outcome results
Primary
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
Population: Please see Adverse Event section for more details.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rituximab Prophylaxis in TCD Unrelated or HLA Mismatched HSCT | Safety of Rituximab Prophylaxis | 23 participants |