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LymphomaPhase 3NCT01609010

A Study of MabThera/Rituxan (Rituximab) Alone and in Combination With Roferon-A in Patients With Follicular or Other CD20+ Low-Grade (Indolent) Lymphoma

A Phase 3 study testing rituximab and interferon-a-2a in people with Lymphoma, run by Hoffmann-La Roche at 31 sites in 3 countries.

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 randomized, open-label study will compare the efficacy and safety of MabThera/Rituxan (rituximab) alone, and in combination with Roferon-A (interferon alfa-2a) in patients with follicular or other CD20+ low-grade lymphoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma
What is being tested?
rituximab and interferon-a-2a
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
313 participants
Where
31 sitesin 3 countries
Study dates
Oct 2002to Jul 2011
Phase
Phase 3
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients >18 years of age
  • CD20+ low-grade (indolent) lymphoma of follicular and marginal zone type, small lymphocytic lymphoma without a B-CLL phenotype, or indolent lymphoma not otherwise specified
  • Stage II (with bulky disease), III, or IV lymphoma
  • No previous chemotherapy or a maximum of 6 months chlorambucil or cyclophosphamide
  • Indication for treatment: symptomatic enlarged lymph nodes, spleen or other lymphoma manifestations, progression >6 months of lymphadenopathy or splenomegaly, anemia or thrombocytopenia or decreased hemoglobin or platelets due to lymphoma, general symptoms (weight loss, night sweats or fever)
  • WHO performance status 0-2

Who cannot join

  • Prior treatment with rituximab or an interferon
  • B-CLL, mantle cell lymphoma, lymphoplasmacytic lymphoma (Waldenstroem's disease), or central nervous system lymphoma
  • Indolent lymphoma transformed into aggressive lymphoma
  • Indolent lymphoma with bulky tumor requiring urgent therapy
  • Prior malignancies, except non-melanoma skin tumors, in situ cervical cancer, or curative surgery >5 years ago
  • Positive for HIV infection
  • Uncontrolled asthma or allergy requiring corticosteroids

Trial locations and contacts

31 sites in 3 countries.

31 sites in 3 countries

Sweden22 sites

  • Study site

    Eskilstuna, 63188

  • Study site

    Falun, 79182

  • Study site

    Gothenburg, 41685

  • Study site

    Halmstad, 30185

  • Study site

    Huddinge, 14186

  • Study site

    Jönköping, 55185

  • Study site

    Karlstad, 65185

  • Study site

    Kristianstad, 29185

  • Study site

    Linköping, 58185

  • Study site

    Luleå, S-971 80

  • Study site

    Lund, 22185

  • Study site

    Malmö, 21401

  • Study site

    Örebro, 701 85

  • Study site

    Stockholm, 118 83

  • Study site

    Stockholm, 17176

  • Study site

    Sundsvall, 85186

  • Study site

    Uddevalla, 45180

  • Study site

    Umeå, 90185

  • Study site

    Uppsala, 75185

  • Study site

    Västerås, 72189

  • Study site

    Vaxjo, 35185

  • Study site

    Visby, 62184

Other trials in Sweden

Norway6 sites

  • Study site

    Bergen, 5021

  • Study site

    Oslo, 0379

  • Study site

    Oslo, 0407

  • Study site

    Stavanger, 4068

  • Study site

    Tromsø, 9038

  • Study site

    Trondheim, 7000

Other trials in Norway

Denmark3 sites

  • Study site

    Copenhagen, 2100

  • Study site

    Hillerød, 3400

  • Study site

    Roskilde, 4000

Other trials in Denmark

About this study

Official title: Rituximab (Mabthera®) as Single Agent and in Combination With Interferon Alfa-2a (Roferon-A®), a Phase-III Randomized Trial in Patients With Follicular or Other CD20+ Low-grade (Indolent) Lymphoma

This randomized, open-label study will compare the efficacy and safety of MabThera/Rituxan (rituximab) alone, and in combination with Roferon-A (interferon alfa-2a) in patients with follicular or other CD20+ low-grade lymphoma. Patients will be randomized to receive either MabThera/Rituxan 375 mg/m2 intravenously weekly for 4 weeks or Roferon-A 3 MIU/day subcutaneously in Week 1 followed by 4.5 MIU/day sc in Weeks 2-5 plus MabThera/Rituxan 375 mg/m2 weekly iv in Weeks 3-6. Patients who have a response will receive an additional cycle of treatment. The anticipated time on study treatment is up to 6 months.

Conditions
Lymphoma
Being tested
rituximab, interferon-a-2a
Medical subject headings
Lymphoma

What participants receive

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

  • rituximabDrug

    Also called MabThera, Rituxan

    375 mg/m2 rituximab i.v. weekly for 4 weeks

  • interferon-a-2aDrug

    Also called Roferon-A

    3 MIU/day interferon-a2a s.c. during Week 1, and 4.5 MIU/day s.c. 6 days per week during Weeks 2 through 5

Study groups in NCT01609010
Study groupRoleWhat they receive
Rituximab MonotherapyActive comparatorParticipants received 375 milligrams per square meter (mg/m2) rituximab intravenously (i.v.) weekly for 4 weeks. Participants achieving minor response (MR), partial response (PR), or completer response (CR) received a second cycle of treatment.
Receives: Drug: rituximab
Rituximab, InterferonExperimentalParticipants received 375 mg/m2 rituximab i.v. weekly for 4 weeks; and 3 million international units per day (MIU/day) interferon-a2a subcutaneously (s.c.) during Week 1, and 4.5 MIU/day s.c. 6 days per week during Weeks 2 through 5. Interferon-a2a was not administered on days of rituximab administration. Participants achieving MR, PR, or CR received a second cycle of treatment.
Receives: Drug: rituximab; Drug: interferon-a-2a

What is being measured

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

  1. Treatment Failure - Percentage of Participants With an Event

    Treatment failure was defined as an event of any of the following: progressive disease while receiving study treatment, death due to any cause, or the initiation of another type of treatment due to stable disease, progressive disease or relapse, or intolerance to study treatment.

    Measured: Baseline (BL), Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period

  2. Treatment Failure - Time to Event

    The median time, in months, between randomization and treatment failure event determined using Kaplan-Meier estimates.

    Measured: BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period

Secondary outcomes (8)

  1. Percentage of Participants Achieving Complete Response (CR), Unconfirmed CR (CRu), or Partial Response (PR)

    CR was defined as the complete disappearance of all previously detectable disease signs; the absence of palpable lymph nodes greater than (>) 1 centimeter (cm) or nodes >1.5 cm observed in computerized axial tomography (CAT) scan; and negative bone marrow pathology, if initially positive. CRu was defined as CR, except that bone marrow results were indeterminate. PR was defined as a decrease of greater than or equal to (≥) 50 percent (%) compared with the BL value in the sum of the products of the two largest perpendicular diameters in all measurable and evaluable lesions; and a ≥50% reduction of the size from BL if hepato-splenomegaly was present.

    Measured: Weeks 10 and 16

  2. Percentage of Participants Achieving CR or CRu

    CR was defined as the complete disappearance of all previously detectable disease signs; the absence of palpable lymph nodes >1 cm or nodes >1.5 cm observed in CATscan; and negative bone marrow pathology, if initially positive. CRu was defined as CR, except that bone marrow results were indeterminate.

    Measured: Weeks 10 and 16

  3. Duration of Response - Percentage of Participants With an Event

    Response duration was defined as the period between the date for first observation of CR, CRu or PR and the date of progressive disease (PD), censored observation or death of any cause. Response duration was also assessed for response defined as CR only. Response duration was calculated among responders (CR+CRu+PR) with cutoffs for follow-up applied.

    Measured: BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period

  4. Duration of Response

    The median time, in months, from the date of the first observation of CR, CRu, or PR and the date of progressive disease (PD), censored observation, or death due to any cause. PD was defined as an increase of >50% compared to BL in the sum of the product of the two largest perpendicular parameters of measurable lymphoma, or the occurrence of new lesions. One month=30.4 days. Response duration was calculated amongst responders (CR+CRu+PR) with cutoffs for follow-up applied.

    Measured: BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period

  5. Disease Progression - Percentage of Participants With an Event

    A disease progression event was defined as tumor progression or death due to any cause (or a censored observation).

    Measured: BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period

  6. Time to Disease Progression

    The median time, in months, from randomization to disease progression event assessed using Kaplan-Meier estimates. One month=30.4 days

    Measured: BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period

  7. Overall Survival (OS) - Percentage of Participants With an Event

    An overall survival event was defined as death due to any cause.

    Measured: BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period

  8. Overall Survival

    The median time, in months, from randomization to OS event assessed using Kaplan-Meier estimates. One month=30.4 days

    Measured: BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period

Timeline

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

  1. First posted31 May 2012 (estimated)
  2. Study startOct 2002
  3. Primary completionJul 2011
  4. Study completionJul 2011

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
313 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01609010
Sponsor's protocol ID
ML16865
Status last verified
Aug 2014
First submitted
29 May 2012
Last updated
8 Sep 2014

Publications

  • Kimby E, Ostenstad B, Brown P, Hagberg H, Erlanson M, Holte H, Linden O, Johansson AS, Ahlgren T, Wader K, Wahlin BE, Delabie J, Sundstrom C; Nordic Lymphoma Group (NLG). Two courses of four weekly infusions of rituximab with or without interferon-alpha2a: final results from a randomized phase III study in symptomatic indolent B-cell lymphomas. Leuk Lymphoma. 2015;56(9):2598-607. doi: 10.3109/10428194.2015.1014363. Epub 2015 Mar 11.

    PubMed 25686644

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing rituximab and interferon-a-2a in people with Lymphoma, run by Hoffmann-La Roche at 31 sites in 3 countries.

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 6 inclusion and 7 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 8 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in Sweden, Norway, Denmark. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jun 2014). 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?

Treatment Failure - Percentage of Participants With an Event (time frame: Baseline (BL), Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period). 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 NCT01609010, which also lists 1 linked publication.

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 8 Sep 2014.

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