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Status:

UNKNOWN

Rituximab, Fludarabine, Cyclophosphamide, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Relapsed B-Cell Non-Hodgkin's Lymphoma

Lead Sponsor:

Technical University of Munich

Conditions:

Lymphoma

Eligibility:

All Genders

50-75 years

Phase:

PHASE1

PHASE2

Brief Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them o...

Detailed Description

OBJECTIVES: Primary * Determine the dose-limiting toxicity and maximum tolerated dose of rituximab and yttrium Y 90 (\^90Y) ibritumomab tiuxetan when administered with rituximab as radioimmunotherap...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed CD20-positive B-cell non-Hodgkin's lymphoma (NHL), including any of the following subtypes:
  • Indolent NHL, including any of the following:
  • Follicular
  • Lymphoplasmacytoid
  • Marginal zone
  • Mantle cell NHL
  • Transformed B-cell NHL
  • In at least first relapse with an indication for systemic antineoplastic treatment, as defined by the following:
  • Local or constitutional (B-) symptoms
  • Hypersplenism due to splenic involvement
  • Bulky disease (\> 7.5 cm in diameter)
  • Impending medical problems derived from rapid disease progression within the past 6 months, as defined by an observed or anticipated \> 50% increase in the sum of the areas calculated from multiplying the greatest perpendicular diameters of each lesion
  • Measurable lesions of lymphoma infiltration
  • Medically ineligible for high-dose treatment followed by autologous stem cell support
  • Adequate bone marrow cellularity (\> 15% of marrow area covered by hematopoiesis)
  • No CNS, leptomeningeal, spinal cord, or testes lymphoma involvement
  • No lymphoma lesion mandating emergency radiotherapy
  • No clinical, cytological, cytogenetic, or histopathologic indication of myelodysplastic syndrome
  • If there is bone marrow infiltration detected prior to chemoimmunotherapy, patient must undergo a repeat bone marrow biopsy prior to planned treatment with radioimmunotherapy to verify the level of bone marrow infiltration is \< 25%
  • PATIENT CHARACTERISTICS:
  • ECOG performance status 0-2
  • Life expectancy ≥ 3 months
  • Absolute neutrophil count \> 1,500/mm³
  • Platelet count \> 150,000/mm³
  • Hemoglobin \> 9 g/dL
  • Creatinine \< 1.5 times upper limit of normal (ULN)
  • Bilirubin \< 2 times ULN
  • ALT and AST \< 2 times ULN
  • Albumin \> 2.5 g/dL
  • INR \< 1.5
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 12 months after completion of study treatment
  • No concurrent severe and/or uncontrolled medical disease that would preclude study compliance, including any of the following:
  • Uncontrolled diabetes
  • Congestive heart failure
  • Chronic renal disease
  • Active uncontrolled infection
  • No bleeding risks or disorders, including any of the following:
  • CNS abnormalities suggesting an increased susceptibility for hemorrhage, including recent history of stroke as demonstrated by cranial contrast-enhanced CT scan
  • Severe arrhythmia or uncontrolled hypertension
  • Myocardial infarction within the past 6 months
  • Diabetic retinopathy with history of symptomatic hemorrhage
  • Known and potentially active gastrointestinal bleeding foci
  • Concurrent anticoagulant medication that must be continued even with platelet count \< 20,000/mm³ (e.g., following mitral valve replacement, anti-phospholipid syndrome, or recurrent venous thromboembolism)
  • Other congenital or acquired hemorrhagic diatheses
  • No ongoing autoimmune hemolytic anemia
  • No known presence of anti-murine antibody reactivity
  • No known hypersensitivity to murine or chimeric antibodies or proteins
  • No known HIV infection
  • No psychiatric illness that would preclude study requirements
  • No other malignant disorder within the past 10 years except basal cell carcinoma of the skin or carcinoma in situ of the cervix
  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • Recovered from prior therapy
  • No more than 4 prior systemic anti-lymphoma regimens (including single-agent rituximab)
  • At least 2 months since prior systemic anti-lymphoma treatment (including single-agent rituximab)
  • No prior radioimmunotherapy
  • No prior autologous or allogeneic hematopoietic stem cell transplantation
  • No prior treatment with purine analogues that has not resulted in remission for \> 1 year
  • No prior anti-CD20 radioimmunoconjugate therapy
  • More than 5 years since prior radiotherapy to extensive fields covering lymph node regions on both sides of the diaphragm or \> 50% of the spinal column
  • More than 4 weeks since prior surgery
  • No concurrent oral anticoagulant therapy

Exclusion

    Key Trial Info

    Start Date :

    June 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    May 1 2013

    Estimated Enrollment :

    12 Patients enrolled

    Trial Details

    Trial ID

    NCT00397800

    Start Date

    June 1 2005

    End Date

    May 1 2013

    Last Update

    August 28 2012

    Active Locations (12)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (12 locations)

    1

    Medizinische Klinik, Klinikum Augsburg

    Augsburg, Germany, D-86156

    2

    Medizinische Klinik III - Universitaetsklinikum Erlangen

    Erlangen, Germany, D-91054

    3

    Universitaetsklinikum Goettingen

    Göttingen, Germany, D-37075

    4

    Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

    Lübeck, Germany, D-23538