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Clinical Trials/ACTRN12612001045808
ACTRN12612001045808Active, not recruitingPhase 3

A Phase 3 open-label randomized study tocompare the efficacy and safety of rituximabplus lenalidomide versus rituximab pluschemotherapy followed by rituximab in subjectswith previously untreated follicular lymphoma

The Lymphoma academic research organisation0 sites775 target enrollmentStarted: October 2, 2012Last updated:
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Conditions

Trial Snapshot

Phase
Phase 3
Status
Active, not recruiting
Sponsor
Enrollment
775
Study OverviewStudy DesignEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Randomised controlled trial
Primary Purpose
Treatment
Masking
Open (masking not used)

Eligibility Criteria

Ages
18 Years to o limit (—)
Sex
All

Inclusion Criteria

  • •1. Histologically confirmed CD20+ follicular lymphoma grade 1, 2 or 3a as assessed by the investigators:
  • •2. Have no prior systemic treatment for lymphoma.
  • •3. Must be in need of treatment as evidenced by at least one of the following criteria:
  • •Bulky disease defined as:
  • •-a nodal or extranodal (except spleen) mass > 7cm in its
  • •greater diameter or,
  • •-involvement of at least 3 nodal or extranodal sites (each
  • •with a diameter greater than >3 cm)
  • •Presence of at least one of the following B symptoms:
  • •-fever (>38 degrees Celcius) of unclear etiology
  • •-night sweats
  • •-weight loss greater than 10% within the prior 6 months
  • •Symptomatic splenomegaly
  • •Compression syndrome (ureteral, orbital, gastrointestinal)
  • •Any one of the following cytopenias due to lymphoma:
  • •-hemoglobin < 10g/dL (6.25 mmol/L)
  • •-platelets <100 x 10^9/L , or
  • •-absolute neutrophil count (ANC) < 1.5 x 10^9/L
  • •Pleural or peritoneal serous effusion (irrespective of cell
  • •LDH> upper limit of normal (ULN) or beta 2 microglobulin > ULN
  • •4. Bi-dimensionally measurable disease with at least one mass lesion > 2cm that was not previously irradiated.
  • •5. Stage II, III or IV disease.
  • •6. Must be > or = to 18 years and sign an informed consent.
  • •7. Performance status less than or equal to 2 on the ECOG scale.
  • •8. Adequate hematological function (unless abnormalities are related to lymphoma infiltration of the bone marrow) within 28 days prior to signing informed consent, including:
  • •-Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/L
  • •-Platelet count greater than or equal to 75 x 10^9/L
  • •-Hemoglobin greater than or equal to 8.0 g/dl (5 mmol/L)
  • •9. Must be able to adhere to the study visit schedule and other protocol requirements.
  • •10. Females of childbearing potential (FCBP) receiving lenalidomide must:
  • •-Have two negative pregnancy tests as verified by the study
  • •doctor prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after end of study therapy. This applies even if the subject practices complete abstinence from heterosexual contact.
  • •-Either commit to complete abstinence from heterosexual
  • •contact(which must be reviewed on a monthly basis) or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting study drug, during the study therapy (including dose interruptions), and for 28 days after discontinuation of study therapy.
  • •11. Male patients receiving lenalidomide must:
  • •Must practice complete abstinence or agree to use a condom
  • •during sexual contact with a pregnant female or a female of
  • •childbearing potential while participating in the study, during
  • •dose interruptions and for at least 28 days following study
  • •drug discontinuation, even if he has undergone a successful
  • •Agree to not donate semen during study drug therapy and for 28 days after discontinuation of study drug therapy.
  • •12. All patients receiving lenalidomide must:
  • •Have an understanding that the study drug could have a potential teratogenic risk.
  • •Agree to abstain from donating blood while taking study drug therapy and for 28 days after discontinuation of study drug therapy.
  • •Agree not to share study medication with another person.
  • •Agree to be counseled about pregnancy precautions and risk of fetal exposure
  • •Females must agree to abstain from breastfeeding during study participation and for at least 28 days after study drug
  • •discontinuation.
  • •13. For all patien

Exclusion Criteria

  • •1. Clinical evidence of transformed lymphoma by investigator assessment.
  • •2. Grade 3b follicular lymphoma.
  • •3. Patients taking corticosteroids during the last 4 weeks, unless administered at a dose equivalent to < 10 mg/day prednisolone (over these 4 weeks).
  • •4. Major surgery (excluding lymph node biopsy) within 28 days prior to signing informed consent.
  • •5. Seropositive for or active viral infection with hepatitis B virus (HBV):
  • •-HBsAg positive
  • •-HBsAg negative, anti-HBs positive and/or anti-HBc positive and detectable viral DNA
  • •-Patients who are HBsAg negative, anti-HBs positive and/or anti HBc positive but viral DNA negative are eligible
  • •-Patients who are seropositive due to a history of hepatitis B vaccine are eligible.
  • •6. Known seropositive for, or active infection hepatitis C virus (HCV).
  • •7. Known seropositive for, or active viral infection with human immunodeficiency virus (HIV).
  • •8. Life expectancy < 6 months.
  • •9. Known sensitivity or allergy to murine products.
  • •10. Prior history of malignancies, other than follicular lymphoma, unless the subject has been free of the disease for greater than or equal to 10 years. Exceptions include a history of previously treated:
  • •a. Localized non-melanoma skin cancer
  • •b. Carcinoma in situ of the cervix
  • •11. Prior use of lenalidomide.
  • •12. Neuropathy > Grade 1.
  • •13. Presence or history of CNS involvement by lymphoma.
  • •14. Patients who are at a high risk for a thromboembolic event and are not willing to take venous thromboembolic (VTE) prophylaxis.
  • •15. Any of the following laboratory abnormalities:
  • •-serum aspartate transaminase (AST/SGOT) or alanine
  • •transaminase (ALT/SGPT) > 3x upper limit of normal (ULN),
  • •except in patients with documented liver or pancreatic
  • •involvement by lymphoma
  • •-total bilirubin > 2.0 mg/dl (34 µmol/L) except in cases of Gilberts Syndrome and documented liver involvement by lymphoma
  • •-creatinine clearance of < 30 mL/min
  • •16. Uncontrolled intercurrent illness.
  • •17. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
  • •18. Pregnant or lactating females.
  • •19. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study, or which confounds the ability to interpret data from the study.

Investigators

Sponsor
The Lymphoma academic research organisation

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