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Status:

COMPLETED

Chemotherapy Before Autologous Stem Cell Transplantation +/- Rituximab in Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma

Lead Sponsor:

NCIC Clinical Trials Group

Conditions:

Lymphoma

Eligibility:

All Genders

16-65 years

Phase:

PHASE3

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as dexamethasone, cisplatin, gemcitabine, and cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining c...

Detailed Description

OBJECTIVES: Salvage therapy Primary * Compare the response rate and transplantation rate in patients with relapsed or refractory aggressive non-Hodgkin's lymphoma when treated with salvage chemothe...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed aggressive non-Hodgkin's lymphoma of 1 of the following subtypes:
  • Diffuse large cell lymphoma (includes primary mediastinal B-cell lymphoma and T-cell-rich B-cell lymphoma)
  • Prior indolent lymphoma (e.g., follicular center cell lymphoma; marginal zone lymphoma, including extranodal mucosa-associated lymphoid tissue \[MALT\] lymphoma; and lymphoplasmacytoid lymphoma) with transformation to diffuse large B-cell lymphoma at relapse
  • Must be histologically confirmed
  • No transformed lymphoma at diagnosis with subsequent indolent histology without transformation at relapse
  • Peripheral T-cell lymphoma
  • Anaplastic large cell lymphoma
  • Small noncleaved Burkitt-like lymphoma
  • T-cell or B-cell lineage confirmed by immunohistochemistry
  • Clinically or radiologically documented disease meeting either of the following criteria:
  • Measurable disease, defined as at least 1 bidimensionally measurable site of disease using clinical exam, CT scan, or MRI
  • Lymph nodes must be \> 1.5 cm by physical exam or CT scan
  • Other non-nodal lesions must be ≥ 1.0 cm by physical exam, CT scan, or MRI
  • Bone lesions are not considered measurable
  • Evaluable disease, defined as only nonmeasurable disease, including any of the following:
  • Marrow infiltration
  • Cytology-confirmed ascites or effusions
  • Bony involvement
  • Enlarged liver or spleen
  • Unidimensionally measurable intrathoracic or abdominal masses
  • Previously treated with 1, and only 1, chemotherapy regimen including an anthracycline and excluding cisplatin, cytarabine, and gemcitabine
  • No uncontrolled CNS involvement by lymphoma
  • No CNS disease at time of relapse
  • CNS disease diagnosed at initial presentation allowed provided a complete response for CNS disease was achieved and maintained
  • PATIENT CHARACTERISTICS:
  • Age
  • 16 to 65
  • Performance status
  • ECOG 0-3
  • Life expectancy
  • At least 12 weeks
  • Hematopoietic
  • Absolute granulocyte count ≥ 1,000/mm\^3
  • Platelet count ≥ 75,000/mm\^3
  • Hepatic
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST or ALT ≤ 2.5 times ULN (5 times ULN if liver involvement with lymphoma)
  • Hepatitis B status known (for patients with a history of hepatitis B or who are at high risk of hepatitis B infection)
  • Renal
  • Creatinine ≤ 1.5 times ULN
  • Cardiovascular
  • No significant cardiac dysfunction or cardiovascular disease
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Willing to complete quality of life questionnaires
  • HIV negative
  • No active, uncontrolled bacterial, fungal, or viral infection
  • No other malignancy within the past 5 years except adequately treated basal cell skin cancer or carcinoma in situ of the cervix
  • No other concurrent serious illness or medical condition that would preclude study participation
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • See Chemotherapy
  • Prior rituximab allowed
  • Chemotherapy
  • See Disease Characteristics
  • At least 4 weeks since prior IV chemotherapy
  • No prior high-dose chemotherapy with stem cell transplantation
  • Endocrine therapy
  • No concurrent corticosteroids except for physiologic replacement
  • Radiotherapy
  • At least 4 weeks since prior radiotherapy and recovered
  • Exceptions may be made for low-dose, non-myelosuppressive radiotherapy
  • No prior radiotherapy to more than 25% of functioning bone marrow
  • Involved-field radiotherapy may be given to areas of bulky disease at relapse (≥ 5 cm) after stem cell transplantation, according to the center's policy
  • Surgery
  • At least 2 weeks since prior major surgery
  • Other
  • No other concurrent anticancer therapy
  • No other concurrent experimental agents

Exclusion

    Key Trial Info

    Start Date :

    August 27 2003

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    December 1 2018

    Estimated Enrollment :

    849 Patients enrolled

    Trial Details

    Trial ID

    NCT00078949

    Start Date

    August 27 2003

    End Date

    December 1 2018

    Last Update

    August 23 2023

    Active Locations (27)

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

    Page 1 of 7 (27 locations)

    1

    Rush-Presbyterian-St. Luke's Medical Centre

    Chicago, Illinois, United States, 60612

    2

    Indiana University Medical Center

    Indianapolis, Indiana, United States, 46202

    3

    Hackensack University Medical Center

    Hackensack, New Jersey, United States, 07601

    4

    University of Cincinnati, Barrett Cancer Centre

    Cincinnati, Ohio, United States, 45219