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interferon-a-2a

Phase 3

Lymphoma | Small molecule | Oncology |Roche Holding AG|Last Updated: Sep 8, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment313

FDA Designations

No designations recorded

Clinical trial landscape

interferon-a-2a · 1 trial · 1 indication

Phase 3 1
NCT01609010A Study of MabThera/Rituxan (Rituximab) Alone and in Combination With Roferon-A in Patients With Follicular or Other CD20+ Low-Grade (Indolent) LymphomaLymphoma
COMPLETED313 Analytics
PHASE3COMPLETED
A Study of MabThera/Rituxan (Rituximab) Alone and in Combination With Roferon-A in Patients With Follicular or Other CD20+ Low-Grade (Indolent) Lymphoma
LymphomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Treatment Failure - Percentage of Participants With an Event
Baseline (BL), Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period

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.

Treatment Failure - Time to Event
BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period

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

Secondary Endpoints

Percentage of Participants Achieving Complete Response (CR), Unconfirmed CR (CRu), or Partial Response (PR)
Weeks 10 and 16
Percentage of Participants Achieving CR or CRu
Weeks 10 and 16
Duration of Response - Percentage of Participants With an Event
BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
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.
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.

Interventions

NameTypeDescription
rituximabDRUG375 mg/m2 rituximab i.v. weekly for 4 weeks
interferon-a-2aDRUG3 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
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites31

Inclusion Criteria: * 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 ch...

Countries:DenmarkNorwaySweden
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Competitive Landscape -Lymphoma 338 trials

Top 20 of 66 competitors

CompanyTickerTrialsLead PhaseDrugs
Regeneron Pharmaceuticals, Inc.REGN7PHASE3Odronextamab, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine
Eli Lilly and CompanyLLY12PHASE3Pirtobrutinib, Idelalisib, Bendamustine, Rituximab
AstraZeneca PLCAZN14PHASE3Surovatamig, R-CHOP, R-CVP, BR
Merck & Co., Inc.MRK16PHASE3Nemtabrutinib, Fludarabine, Cyclophosphamide, Bendamustine, Rituximab
AbbVie, Inc.ABBV11PHASE3Venetoclax
Novartis AG Sponsored ADRNVS8PHASE3Tisagenlecleucel, Lenalidomide and rituximab in 28-day cycles for up to 12 cycles, Rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone or prednisolone in 21-day cycles for 6 to 8 cycles, Lymphodepleting chemotherapy
Incyte CorporationINCY16PHASE3Tafasitamab, Lenalidomide
BeOne Medicines Ltd. Sponsored ADRONC20PHASE3BGB-16673, Bendamustine, Rituximab, Methylprednisolone, Chlorambucil
Gilead Sciences, Inc.GILD7PHASE3Axicabtagene Ciloleucel, Cyclophosphamide, Fludarabine, Lenalidomide, Rituximab
Genmab A/S Sponsored ADRGMAB18PHASE3Epcoritamab, Rituximab, Lenalidomide
Bristol-Myers Squibb CompanyBMY17PHASE3Golcadomide, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine
Johnson & JohnsonJNJ11PHASE3Ibrutinib
Pfizer Inc.PFE4PHASE3Brentuximab vedotin, Rituximab, Lenalidomide
Nurix Therapeutics, Inc.NRIX6PHASE3NX-5948, Pirtobrutinib
ADC Therapeutics LtdADCT4PHASE3Loncastuximab Tesirine, Rituximab, Gemcitabine, Oxaliplatin
Corvus Pharmaceuticals, Inc.CRVS2PHASE3Soquelitinib, Belinostat, Pralatrexate
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
HUTCHMED (China) Limited Sponsored ADRHCM2PHASE3HMPL-760, R-GemOx
Nuvalent, Inc. Class ANUVL1PHASE3Neladalkib, Alectinib
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK6PHASE2Brentuximab Vedotin, Cyclophosphamide, Doxorubicin, Prednisone
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Frequently asked questions about interferon-a-2a

What is interferon-a-2a used for in lymphoma?

Interferon-a-2a is used for the treatment of lymphoma, specifically in patients with follicular or other CD20+ low-grade (indolent) lymphoma. It is being studied in combination with rituximab (MabThera/Rituxan) in a Phase 3 clinical trial. The drug is administered to adult patients aged 18 years and older.

What does interferon-a-2a target?

Interferon-a-2a is a small molecule that targets the immune system to fight cancer cells. It works by modulating the body's immune response, helping to slow or stop the growth of lymphoma cells. The drug is being evaluated in combination with rituximab, which targets the CD20 protein on B-cells, for the treatment of low-grade lymphoma.

Who makes interferon-a-2a?

Interferon-a-2a is developed by Roche Holding AG, a multinational healthcare company. The company's stock is traded under the ticker symbol RHHBY. Roche is conducting clinical trials to evaluate the drug's efficacy in treating lymphoma, particularly in combination with rituximab.

What phase is interferon-a-2a in?

Interferon-a-2a is in Phase 3 clinical development for the treatment of lymphoma. The drug is currently being studied in a Phase 3 trial that has been completed. It is an investigational drug and has not yet been approved for this indication. The trial enrolled 313 patients with follicular or other CD20+ low-grade lymphoma.

What clinical trials is interferon-a-2a in?

Interferon-a-2a is being studied in clinical trial NCT01609010, a Phase 3 study titled 'A Study of MabThera/Rituxan (Rituximab) Alone and in Combination With Roferon-A in Patients With Follicular or Other CD20+ Low-Grade (Indolent) Lymphoma.' The trial was conducted in Denmark, Norway, and Sweden, enrolled 313 patients, and has been completed.

Is interferon-a-2a the same as Roferon-A?

Yes, interferon-a-2a is also known as Roferon-A. In the clinical trial NCT01609010, the drug is referred to as Roferon-A, which is the brand name for interferon-a-2a. The trial evaluates the combination of Roferon-A with rituximab for the treatment of follicular or other CD20+ low-grade lymphoma.