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Completed

NCT Number: NCT00413036

A Study of Revlimid in the Treatment of Non-Hodgkin's Lymphoma

Subjects who qualify will receive oral lenalidomide daily on days 1-21 of every 28 day cycle. Treatment will continue until disease progression, or unacceptable adverse events develop

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Key information

Conditions

Lymphoma, Non-Hodgkin's Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

London Health Science Center, London, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Key Inclusion criteria

  • Biopsy proven aggressive non-hodgkin's lymphoma
  • Follicular center lymphoma Grade 3.
  • Diffuse large B-cell lymphoma.
  • Mantle cell lymphoma.
  • Transformed lymphoma.
  • Relapsed or refractory to previous therapy for lymphoma
  • At least one prior combination chemotherapy regime
  • Measurable disease on cross sectional imaging that is at least 2 cm in the longest diameter
  • Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1 or 2
  • Willing to follow the pregnancy precautions

Key Exclusion criteria

  • Any of the following laboratory abnormalities.
  • Absolute neutrophil count (ANC) < 1,500 cells/mm^3 (1.5*10^9/L).
  • Platelet count < 60,000/mm^3 (60*10^9/L).
  • Calculated creatinine clearance of <50mL/min
  • Serum glutamic oxaloacetic transaminase/aspartate aminotransferase (SGOT/AST) or Serum glutamic pyruvic transaminase/Alanine transaminase (SGPT/ALT) 5.0 times upper limit of normal (ULN).
  • Serum total bilirubin > 2.0 mg/dL (34 µmol/L)/conjugated bilirubin >0.8mg/dL.
  • Subjects who are candidates for and willing to undergo an autologous stem cell transplant.
  • History of active Central Nervous System (CNS) lymphoma within the previous 6 months
  • History of other malignancies within the past year
  • Positive Human immunodeficiency virus (HIV) or active Hepatitis B or C

Treatment and study plan

Lenalidomide

Drug

once daily oral capsule

Other names: Revlimid

Primary outcomes

  1. Participants Categorized by Best Response as Determined by Central Review

    Time frame: Up to 1459 days

    Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definitions, refer to Cheson article.

    • Complete Response(CR): Complete disappearance of all detectable disease and disease-related symptoms if present before therapy; normalization of lab abnormalities assignable to NHL. If bone marrow involved before treatment, must be cleared on repeat biopsy.
    • Complete Response Unconfirmed(CRu): CR, with one of the following: 1)residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters(SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2)indeterminate bone marrow.
    • Partial Response(PR): >50% decrease in 6 largest nodes or nodal masses. Nodes selected according to Cheson.
    • Stable Disease(SD): Less than PR, but not progressive disease.
    • Progressive Disease(PD): Appearance of new lesion during/end of therapy; >=50% increase from lowest measurement in SPD.

Secondary outcomes

  1. Duration of Response as Determined by Central Review

    Time frame: Up to 1459 days

    Kaplan-Meier estimates for the duration of response were calculated for responders and defined as the time from at least a partial response (PR) to progression of disease (PD) or death due to Non-Hodgkin's lymphoma.

    For response assessment criteria (per Cheson, 1999) see the primary outcome measure in this results posting.

  2. Time to Progression as Determined by Central Review

    Time frame: Up to 1459 days

    Kaplan-Meier estimate of time-to-progression is calculated as time from the start of study drug therapy to the first observation of disease progression.

    Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definition of progressive disease, refer to Cheson article.

    • Progressive Disease(PD): Appearance of new lesion during/end of therapy; >=50% increase from lowest measurement in SPD.

  3. Progression-free Survival as Determined by Central Review

    Time frame: Up to 1459 days

    Kaplan-Meier estimate of progression-free survival is defined as start of study drug therapy to the first observation of progressive disease or death due to any cause, whichever comes first.

    Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definition of progressive disease, refer to Cheson article.

    • Progressive Disease(PD): Appearance of new lesion during/end of therapy; >=50% increase from lowest measurement in SPD.

  4. Proportion of Participants Who Experienced Stable Disease or Better as Determined by Central Review

    Time frame: Up to 1459 days

    Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definitions, refer to Cheson article.

    • Complete Response(CR): Complete disappearance of all detectable disease and disease-related symptoms if present before therapy; normalization of lab abnormalities assignable to NHL. If bone marrow involved before treatment, must be cleared on repeat biopsy.
    • Complete Response Unconfirmed(CRu): CR, with one of the following: 1)residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters(SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2)indeterminate bone marrow.
    • Partial Response(PR): >50% decrease in 6 largest nodes or nodal masses. Nodes selected according to Cheson.
    • Stable Disease(SD): Less than PR, but not progressive disease.

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study title

A Phase II, Multicenter, Single-Arm, Open-Label Study To Evaluate The Safety And Efficacy Of Single-Agent Lenalidomide (Revlimid®, CC-5013) in Subjects With Relapsed Or Refractory Aggressive Non-Hodgkin's Lymphoma

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Dec 19, 2006
Registry last updated
Mar 1, 2017

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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