Hodgkin's DiseaseNCT00648037
Rituximab (Rituxan) for the Prevention of EBV-LPD Epstein Barr Virus (EBV) Lymphoproliferative Disorder Post T Cell Depleted Unrelated and HLA Mis-matched Related HSCT
A study testing Rituximab in people with Hodgkin's Disease and Leukemia, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hodgkin's Disease, Leukemia, Myelodysplastic Syndrome
- What is being tested?
- Rituximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Dec 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Pilot Trial of Rituximab (Rituxan) for the Prevention of EBV-LPD Post T Cell Depleted Unrelated and HLA Mis-matched Related HSCT
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.
- Being tested
- Rituximab
- Keywords
- RITUXIMAB, Lymphoma
- Medical subject headings
- Hodgkin Disease, Leukemia, Myelodysplastic Syndromes, Lymphoma, Non-Hodgkin, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Rituximab | Experimental | Patients following a T cell depleted HLA-mis-matched related or unrelated hematopoietic stem cell transplant (HSCT) will be treated with monthly Rituximab. Receives: Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months post transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hodgkin's DiseaseStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Trudy Small, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00648037
- Sponsor's protocol ID
- 01-118
- Status last verified
- Dec 2015
- First submitted
- 27 Mar 2008
- Last updated
- 1 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of Rituximab (Rituxan) for the Prevention of EBV-LPD Post T Cell Depleted Unrelated and HLA Mis-matched Related HSCT
- ClinicalTrials.gov ID
- NCT00648037
- Acronym / sponsor ID
- 01-118
- Keywords
- RITUXIMAB, Lymphoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 1 Apr 2008 (estimated)
- Results
- Posted 1 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rituximab | Experimental | Drug: RituximabPatients following a T cell depleted HLA-mis-matched related or unrelated hematopoietic stem cell transplant (HSCT) will be treated with monthly Rituximab. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RituximabRituximab 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. | Drug | Rituximab |
Primary outcome
Safety of Rituximab Prophylaxis
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Trudy Small, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rituximab in people with Hodgkin's Disease and Leukemia, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of Rituximab Prophylaxis (time frame: 3 months post transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2016.