Clinical trial NCT00281983 (phase 1/phase 2, status: completed)
Conditions: chronic lymphocytic leukemia
ICD codes: C91.11, C91.12, C91.10
Drugs: busulfan, cyclophosphamide, cyclosporine, fludarabine phosphate, methotrexate, mycophenolate mofetil
SMILES: CS(=O)(=O)OCCCCOS(C)(=O)=O, ClCCN(CCCl)P1(=O)NCCCO1, 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, NC1=NC(F)=NC2=C1N=CN2[C@@H]1O[C@H](CO)[C@@H](O)[C@@H]1O, CN(CC1=CN=C2N=C(N)N=C(N)C2=N1)C1=CC=C(C=C1)C(=O)N[C@@H](CCC(O)=O)C(O)=O, N[C@@H](CCCNC(N)=N)C(O)=O
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of B-cell chronic lymphocytic leukemia or lymphoplasmocytic lymphoma
             (Waldenstrom's macroglobulinemia)

               -  Must have poor prognostic features and low probability of successful
                  autografting, defined by one of the following criteria:

                    -  Progressive disease with unfavorable cytogenetics (deletion or mutation of
                       critical regions on chromosomes 11q and/or 17p [p53]; and/or unmutated
                       status of the immunoglobulin V_H gene region; and/or usage of the V_H 3-21
                       gene), defined as 1 of the following:

                         -  Doubling of lymphocyte count or nodal involvement within 3 months or
                            less

                         -  Progressive decline of platelet count and/or hemoglobin values defining
                            Binet stage C disease (or to 50% or less of baseline values within 3
                            months) not due to immune mechanisms

                         -  Symptomatic splenomegaly

                         -  Discomfort or imminent complications due to large tumor masses

                         -  B symptoms

                    -  Refractory disease or early relapse (within 12 months) after treatment with
                       a fludarabine-containing regimen

                    -  Relapsed after autologous stem cell transplant (SCT)

                    -  Insufficient stem cell harvest for intended autologous SCT

          -  Presence of a clonal CDR III rearrangement detected by polymerase chain reaction

          -  No Richter's syndrome

          -  HLA-identical sibling or unrelated donor available

        PATIENT CHARACTERISTICS:

          -  ECOG performance status ≤ 1

          -  Creatinine clearance > 60 mL/min

          -  SGOT, SGPT, and bilirubin < 2 times normal

          -  Normal cardiac function determined by ECG and echocardiographic examination

          -  Inspiratory vital capacity, FEV_1, and DLCO > 50% of predicted

          -  No serious localized or systemic infections

          -  No other concurrent malignant disease

          -  No impaired organ function

          -  No uncontrolled diabetes

          -  No uncontrolled hypertension

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  No HIV infection

          -  No hepatitis B or C infection

          -  No concurrent alcohol or drug abuse

          -  No dementia or altered mental status that would preclude giving informed consent

        PRIOR CONCURRENT THERAPY:

          -  Not specified