Lymphoma, FollicularNCT03087929
Follow-up Trial of Rituximab Interferon Transplant Trial: Study Drug-Rituximab and Alpha Interferon
An observational study of Lymphoma, Follicular, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
A previous phase II trial entitled Treatment of Follicular non-Hodgkin's Lymphoma with High Dose Therapy and Stem Cell Support Followed by Consolidative Immunotherapy with Rituximab and Alpha Interferon was conducted at the Odette Cancer Centre between 2005 and 2012. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lymphoma, Follicular
- What is being tested?
- Follow up
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 20 Sep 2013to 15 Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Twelve patients with low grade follicular lymphoma who consented to long term follow-up and were previously treated with high dose therapy and autologous stem cell transplant with rituximab and alpha interferon as part of the phase II trial Treatment of Follicular Non-Hodgkin's Lymphoma with High Dose Therapy and Stem Cell Support Followed by Consolidative Immunotherapy with Rituximab and Alpha Interferon.
Who may be able to join
- Patients with 1-2 relapses of WHO Classification follicle centre NHL grade 1-2/3. Patients must have achieved at least a PR to previous treatment.
- Central pathology review before registration
- Ann Arbor stage III or IV
- Measurable disease: defined as clinically or radiologically documented disease with at least one site bidimensionally measurable using clinical exam, CT or MRI performed in the 3 weeks prior to study enrollment.
- ECOG performance status of <2.
- Patients may have received not more than 1 prior course (4 infusions) of rituximab. Timing from last dose of rituximab must exceed 6 months prior to registration. Patients must have demonstrated at least a PR to rituximab if previously administered.
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- Patient consent according to institutional and university human experimentation committee requirements
- Adequate Renal, hepatic and hematopoietic function test unless the abnormal values are thought to be due to involvement with lymphoma as defined by:
- Hb> 85
- ANC >1000/mm3
- Platelets >100,000/mm3
- Serum/Total Bilirubin >=2 SI units
- AST/ALT <2x Upper Limit of Normal
Who cannot join
- Positive serology for HIV
- Uncontrolled Infection
- Pregnancy
- CNS Metastases
- History of Psychiatric Disorder
- Other Malignancy (except nonmelanoma skin cancer)
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- Serious non-malignant disease (e.g., congestive heart failure, or active uncontrolled bacterial, viral, or fungal infections), or other conditions, which, in the opinion of the investigator and/or the sponsor, would compromise other protocol objectives.
- Major surgery, other than diagnostic surgery, within four weeks.
- Presence of anti-murine antibody (HAMA) reactivity. These laboratory results must be available prior to receiving treatment for those patients
- who have received prior murine proteins or patients who have allergies to murine proteins.
- New York Heart Association Class III or IV heart disease (see Appendix H, Clinical Evaluation of Functional Capacity of Patients with Heart Disease in Relation to Ordinary Physical Activity) or myocardial infarction within the past six months.
- Treatment with an investigational drug within 30 days or five half-lives (of the study drug with the longest half-life) prior to entry into the study, which ever is longer.
- Previous chemotherapy, immunotherapy, radiotherapy, or investigational therapy for the treatment of other malignancy except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix within the last 5 years.
- History of allergic reactions to compounds chemically related to Rituximab.
- Refusal to practice contraception if of reproductive potential.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Sunnybrook Health Sciences Centre, Odette Cancer Centre
Toronto, Ontario, M4N 3M5
About this study
Official title: Phase II Follow-up Trial of Rituximab Interferon Transplant Trial: Study Drug-Rituximab and Alpha Interferon
A previous phase II trial entitled Treatment of Follicular non-Hodgkin's Lymphoma with High Dose Therapy and Stem Cell Support Followed by Consolidative Immunotherapy with Rituximab and Alpha Interferon was conducted at the Odette Cancer Centre between 2005 and 2012. The primary objectives of this previous trial was to assess progression free survival and overall survival. Of the 36 patients in this trial, approximately 18 remain in remission. In this new follow up trial, follow up data will prospectively be collected on patients who provide informed consent to do so.
- Conditions
- Lymphoma, Follicular
- Being tested
- Follow up
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow upOther
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Patients who had previously undergone high dose therapy with stem cell support followed by consolidation with Rituximab and alpha-interferon as part of the trial Treatment of Follicular non-Hodgkin's Lymphoma with High Dose Therapy and Stem Cell Support Followed by Consolidative Immunotherapy with Rituximab and Alpha Interferon. The patients in this arm have consented to long-term follow up. Receives: Other: Follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Number of months from date of enrollment to date of death or last follow-up, whichever comes first.
Measured: through study completion, up to 15 years
Progression-free survival
Number of months from date of enrollment to date of progression. Progression is defined as a greater than or equal to 50% increase in the sum of the product of measurable lesions. Appearance of new lesions will also constitute progressive disease.
Measured: through study completion, up to 15 years
Event-free survival
Number of months from date of enrollment to date of an event. An event is defined as death, disease progression, transformation, or development of secondary malignancy.
Measured: through study completion, up to 15 years
Secondary outcomes (2)
Adverse events possibly or probably related to transplant
Adverse events include second malignancies, myelodysplastic syndrome (MDS), hypogammaglobulinemia, and pulmonary fibrosis. This outcome measurement is descriptive.
Measured: through study completion, up to 15 years
Minimal Residual Disease
This exploratory endpoint is used to evaluate the detection of recurrent lymphoma in peripheral blood DNA. It is measured as real-time quantitative polymerase chain reaction (RQ-PCR) and is expressed as a percent of detection per 100,000 cells at each follow-up time point.
Measured: through study completion, up to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2017
- Study start20 Sep 2013
- Primary completion15 Mar 2017
- Study completion15 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, FollicularStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Neil Berinstein, Sunnybrook Health Sciences Centre
- Investigators
- Neil Berinstein, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03087929
- Sponsor's protocol ID
- Rituxan INF II
- Status last verified
- Mar 2017
- First submitted
- 10 Feb 2017
- Last updated
- 23 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Follow-up Trial of Rituximab Interferon Transplant Trial: Study Drug-Rituximab and Alpha Interferon
- ClinicalTrials.gov ID
- NCT03087929
- Acronym / sponsor ID
- Rituxan INF II
- Conditions
- Lymphoma, Follicular
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 20 Sep 2013 (actual)
- Primary completion
- 15 Mar 2017 (actual)
- Study completion
- 15 Mar 2017 (actual)
- First posted
- 23 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A previous phase II trial entitled Treatment of Follicular non-Hodgkin's Lymphoma with High Dose Therapy and Stem Cell Support Followed by Consolidative Immunotherapy with Rituximab and Alpha Interferon was conducted at the Odette Cancer Centre between 2005 and 2012. The primary objectives of this previous trial was to assess progression free survival and overall survival. Of the 36 patients in this trial, approximately 18 remain in remission. In this new follow up trial, follow up data will prospectively be collected on patients who provide informed consent to do so.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | – | Other: Follow upPatients who had previously undergone high dose therapy with stem cell support followed by consolidation with Rituximab and alpha-interferon as part of the trial Treatment of Follicular non-Hodgkin's Lymphoma with High Dose Therapy and Stem Cell Support Followed by Consolidative Immunotherapy with Rituximab and Alpha Interferon. The patients in this arm have consented to long-term follow up. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Twelve patients with low grade follicular lymphoma who consented to long term follow-up and were previously treated with high dose therapy and autologous stem cell transplant with rituximab and alpha interferon as part of the phase II trial Treatment of Follicular Non-Hodgkin's Lymphoma with High Dose Therapy and Stem Cell Support Followed by Consolidative Immunotherapy with Rituximab and Alpha Interferon.
Key inclusion criteria (13 listed)
- Patients with 1-2 relapses of WHO Classification follicle centre NHL grade 1-2/3. Patients must have achieved at least a PR to previous treatment.
- Central pathology review before registration
- Ann Arbor stage III or IV
- Measurable disease: defined as clinically or radiologically documented disease with at least one site bidimensionally measurable using clinical exam, CT or MRI performed in the 3 weeks prior to study enrollment.
- ECOG performance status of <2.
Key exclusion criteria (15 listed)
- Positive serology for HIV
- Uncontrolled Infection
- Pregnancy
- CNS Metastases
- History of Psychiatric Disorder
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 |
|---|---|---|
| Follow up | Other | Treatment Arm |
Primary outcome
Overall survival
Time frame: through study completion, up to 15 years
Number of months from date of enrollment to date of death or last follow-up, whichever comes first.
Progression-free survival
Time frame: through study completion, up to 15 years
Number of months from date of enrollment to date of progression. Progression is defined as a greater than or equal to 50% increase in the sum of the product of measurable lesions. Appearance of new lesions will also constitute progressive disease.
Event-free survival
Time frame: through study completion, up to 15 years
Number of months from date of enrollment to date of an event. An event is defined as death, disease progression, transformation, or development of secondary malignancy.
2 secondary outcomes
Adverse events possibly or probably related to transplant
Time frame: through study completion, up to 15 years
Minimal Residual Disease
Time frame: through study completion, up to 15 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2017.
- Individual participant dataSharing planned: No
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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.
Neil Berinstein, MD principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma, Follicular, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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 13 inclusion and 15 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 23 Mar 2017. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall survival (time frame: through study completion, up to 15 years). The study lists 3 primary outcomes in all. 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 23 Mar 2017.