Clinical trial NCT00482053 (phase 2, status: terminated)
Conditions: lymphoma, b-cell, lymphoma, non-hodgkin, diffuse large b-cell lymphoma (dlbcl), malignant lymphoma, non-hodgkin
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: rituximab, carmustine, etoposide, filgrastim, anti-thymocyte globulin (atg), cyclosporine, mycophenolate mofetil (mmf), cyclophosphamide, acetaminophen, diphenhydramine, hydrocortisone, methylprednisolone
SMILES: ClCCN(CCCl)P1(=O)NCCCO1, ClCCNC(=O)N(CCCl)N=O, OCCOCCN1CCN(CC1)C(C1=CC=CC=C1)C1=CC=C(Cl)C=C1, N[C@@H](CCCNC(N)=N)C(O)=O, CC[C@@H]1NC(=O)[C@H]([C@H](O)[C@H](C)C\C=C\C)N(C)C(=O)[C@H](C(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](NC(=O)[C@H](CC(C)C)N(C)C(=O)CN(C)C1=O)C(C)C, COC(=O)\C=C\C(O)=O, ClCCN(CCCl)P1(=O)NCCCO1, CC1=CC(O)=CC(C)=C1Cl, CN(C)CCOC(C1=CC=CC=C1)C1=CC=CC=C1, [O-][N+]1=C(S)C=CC=C1, [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@]12C
Reason stopped: 
    low accrual
  
Eligibility criteria:

        INCLUSION CRITERIA

          -  Age 18 to 70 years.

          -  Histologically-proven diffuse large B-cell lymphoma (DLBCL) by the World Health
             Organization (WHO) classification.

          -  Relapse after achieving initial remission or failure to achieve initial remission.
             Patients with residual radiographic abnormalities after primary therapy are eligible
             if abnormalities are postive by fluorodeoxyglucose (FDG)-positron emission tomography
             (PET) (FDG-PET).

          -  Receipt of 2 cycles of second-line therapy and FDG-PET positive per Stanford (central)
             review. FDG-PET to be done 2 weeks after cycle 2 of second line chemotherapy.

          -  Eastern Cooperative Oncology Group (ECOG) performance status < 2

          -  Matched related or unrelated donor identified and available

          -  Bone marrow biopsy and cytogenetic analysis within 8 weeks of registration

          -  Pretreatment serum bilirubin < 2 x the institutional upper limit of normal (ULN)

          -  Serum creatinine < 2 x the institutional ULN and measured or estimated creatinine
             clearance > 60 mL/min by the following formula (all tests must be performed within 28
             days prior to registration):

               -  Estimated Creatinine Clearance = (140 age) x weight (kg) x 0.85 if female 72 x
                  serum creatinine (mg/dL).

          -  EKG within 42 days prior to registration with no significant abnormalities suggestive
             of active cardiac disease

          -  Patients must have a radionuclide ejection fraction within 42 days of registration. If
             the ejection fraction is < 40%, the patient will not be eligible. If the ejection
             fraction is 40-50%, the patient will have a cardiology consult.

          -  Corrected diffusion capacity > 55%.

          -  Sexually active males are advised to use an accepted and effective method of birth
             control

          -  Women of child-bearing potential are advised to use an accepted and effective method
             of birth control

          -  Patients must sign and give written informed consent in accordance with institutional
             and federal guidelines. Patients must be informed of the investigational nature of
             this study.

        EXCLUSION CRITERIA

          -  Known allergy to etoposide or a history of Grade 3 hemorrhagic cystitis with
             cyclophosphamide

          -  Greater than Grade 2 sensory or motor peripheral neuropathy from prior vinca alkaloid
             use

          -  Requiring therapy for coronary artery disease, cardiomyopathy, dysrhythmia, or
             congestive heart failure

          -  Known to be human immunodeficiency virus (HIV)-positive. The antibody test for HIV
             must be performed within 42 days of registration.

          -  Prior chemotherapy other than corticosteroids administered within 2 weeks of the
             initiation of protocol therapy.

          -  Prior malignancy, except adequately treated basal cell or squamous cell skin cancer,
             in situ cervical cancer or other cancer for which the patients has been disease-free
             for five years.

          -  Prior diagnosis of non-Hodgkin's lymphoma

          -  Active infection requiring oral or intravenous antibiotics

          -  Prior autologous or allogeneic hematopoietic cell transplantation

          -  Prior radioimmunotherapy

          -  Pregnant

          -  Lactating

        DONOR ELIGIBILITY

          -  Related or unrelated HLA-identical donors who are in good health and have no
             contra-indication to donation

          -  No contra-indication for the donor to collection by apheresis of mononuclear cells
             mobilized by G-CSF at a dose of 16 µg/kg of body weight.

          -  Donors will be evaluated with a full history and physical examination.

          -  Virology testing including HIV; cytomegalovirus (CMV); Epstein-Barr virus (EBV); human
             T-lymphotropic virus (HTLV); rapid plasma reagin (RPR); Hepatitis A, B and C be
             performed within 30 days of donation.

          -  Prospective donors will be screened for CMV seroreactivity and seronegative donors
             will be utilized if available.

          -  If more than one human leukocyte antigen (HLA)-matched related donor exists, then the
             donor will be selected on the basis of CD31 allotype.