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OpenTrials
Completed

NCT Number: NCT01609010

A Study of MabThera/Rituxan (Rituximab) Alone and in Combination With Roferon-A 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.

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Key information

Conditions

Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Copenhagen, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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

Exclusion criteria

  • 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

Treatment and study plan

Rituximab

Drug

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

Other names: MabThera, Rituxan

interferon-a-2a

Drug

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

Other names: Roferon-A

Primary outcomes

  1. 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

    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.

  2. Treatment Failure - Time to Event

    Time frame: 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 outcomes

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

    Time frame: Weeks 10 and 16

    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.

  2. Percentage of Participants Achieving CR or CRu

    Time frame: Weeks 10 and 16

    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.

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

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

    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.

  4. Duration of Response

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

    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.

  5. Disease Progression - Percentage of Participants With an Event

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

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

  6. Time to Disease Progression

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

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

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

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

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

  8. Overall Survival

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

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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Collaborators

  • Nordic Lymphoma Group

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2011
Study completion
2011
First posted
May 31, 2012
Registry last updated
Sep 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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