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Follicular LymphomaPhase 2NCT03069248

Treatment of Follicular Lymphoma With High Dose Therapy and Stem Cell Support Followed by Rituximab and Alpha Interferon

A Phase 2 study testing Rituximab and Alpha Interferon in people with Follicular Lymphoma, run by Sunnybrook Health Sciences Centre at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a non-comparative, prospective, non-randomized single centre phase II clinical trial of Rituximab and alpha interferon immunotherapy following autologous stem cell transplant in patients with relapsed follicular lymphoma conducted at Toronto Sunnybrook Regional Cancer Centre/Sunnybrook and Women's Health… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Follicular Lymphoma
What is being tested?
Rituximab and Alpha Interferon
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteCanada
Study dates
1 Jun 2000to 17 Sep 2009
Phase
Phase 2
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
  • No healthy volunteers
  • Adult, Older adult

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 of rituximab must exceed 12 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

Other trials in Canada

About this study

Official title: Treatment of Follicular Non-Hodgkin's Lymphoma With High Dose Therapy and Stem Cell Support Followed by Consolidative Immunotherapy With Rituximab and Alpha Interferon

This is a non-comparative, prospective, non-randomized single centre phase II clinical trial of Rituximab and alpha interferon immunotherapy following autologous stem cell transplant in patients with relapsed follicular lymphoma conducted at Toronto Sunnybrook Regional Cancer Centre/Sunnybrook and Women's Health Sciences Centre.

Being tested
Rituximab, Alpha Interferon
Medical subject headings
Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03069248
Study groupRoleWhat they receive
treatment armExperimentalSalvage treatment with CHOP or DHAP followed by high dose therapy and stem cell support prior to consolidative immunotherapy with Rituximab and Alpha interferon. .
Receives: Drug: Rituximab; Drug: Alpha Interferon

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Survival (Overall survival)

    Overall survival

    Measured: From date of randomization until date of death or last follow-up, whichever comes first, assessed up to 116 months

  2. Survival (Progression free survival)

    Progression free survival

    Measured: From date of randomization until date of relapse or disease progression, assessed up to 116 months

Secondary outcomes (2)

  1. Toxicities (Possible transplant-related adverse events)

    Possible transplant-related adverse events such as secondary malignancies, hypogammaglobulinemia, and pulmonary fibrosis

    Measured: assessed semi-annually, from date of enrollment up to 116 months

  2. Minimal Residual Disease

    Occult disease by PCR analysis of the t(14;18) or of patient specific V(D)J rearrangements in peripheral blood, bone marrow and stem cell graft collections.

    Measured: assessed semi-annually, from date of enrollment up to 116 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2017
  2. Study start1 Jun 2000
  3. Primary completion17 Sep 2009
  4. Study completion17 Sep 2009

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03069248
Sponsor's protocol ID
089-2000
Status last verified
Feb 2017
First submitted
17 Feb 2017
Last updated
3 Mar 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rituximab and Alpha Interferon in people with Follicular Lymphoma, 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 9 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 3 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Survival (Overall survival) (time frame: From date of randomization until date of death or last follow-up, whichever comes first, assessed up to 116 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03069248.

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 3 Mar 2017.

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