Clinical trial NCT00078949 (phase 3, status: completed)
Conditions: lymphoma
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: cisplatin, cytarabine, dexamethasone, gemcitabine hydrochloride
SMILES: [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC, ClCCN(CCCl)P1(=O)NCCCO1, C[C@@H](O[C@H]1OCCN(CC2=NNC(=O)N2)[C@H]1C1=CC=C(F)C=C1)C1=CC(=CC(=C1)C(F)(F)F)C(F)(F)F, NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F
Eligibility criteria:

        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