Clinical trial NCT01538472 (phase 1/phase 2, status: completed)
Conditions: lymphoma
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: y zevalin, in zevalin, rituxan, bcnu, vp -16, ara-c, melphalan, g-csf
SMILES: [H][C@]12[C@H](OC(=O)C3=CC=CC=C3)[C@]3(O)C[C@H](OC(=O)[C@H](O)[C@@H](NC(=O)C4=CC=CC=C4)C4=CC=CC=C4)C(C)=C([C@@H](OC(C)=O)C(=O)[C@]1(C)[C@@H](O)C[C@H]1OC[C@@]21OC(C)=O)C3(C)C, ClCCNC(=O)N(CCCl)N=O, NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)[C@@H]1O, N[C@@H](CC1=CC=C(C=C1)N(CCCl)CCCl)C(O)=O, C(N1CCCNCCNCCCNCC1)C1=CC=C(CN2CCCNCCNCCCNCC2)C=C1
Eligibility criteria:

        Inclusion Criteria:

          1. Relapsed CD20-positive B-cell non-Hodgkin's lymphoma (NHL) (demonstrated in lymph
             nodes or bone marrow), chemosensitive (at least Partial Remission (PR)).

          2. No anti-cancer therapy started within three weeks, prior to study initiation, and
             fully recovered from all toxicities associated with prior surgery, radiation
             treatments, chemotherapy, or immunotherapy. No prior Rituximab within three weeks of
             starting therapy.

          3. No prior radioimmunoconjugate therapy.

          4. If patients had prior radiation, this should have not involved more than 25% of the
             bone marrow.

          5. An IRB-approved signed informed consent.

          6. Age: 18 to 65 years of age.

          7. Acceptable hematologic status within two weeks prior to patient registration,
             including: Absolute neutrophil count ([segmented neutrophils + bands] * total white
             blood count (WBC)) > 1,500/mm3. Platelet counts > 100,000/mm3.

          8. Patients determined to have <10% bone marrow involvement with lymphoma within four
             weeks before stem cell collection as defined by bilateral aspirates and biopsies.

          9. Prestudy performance status of 0, 1, or 2 according to the World Health Organization
             (WHO).

         10. Female patients included must not be pregnant or lactating.

         11. Men and women or reproductive potential who are following acceptable birth control
             methods (as determined by the treating physician, however abstinence is not an
             acceptable method).

         12. Patients who have previously been treated on Phase II drugs can be included if no
             long-term toxicity is expected, and the patient has been off the drug for four or more
             weeks with no significant post treatment toxicities observed

         13. Patients should have at least 4 * 106 CD34+/kg peripheral stem cells collected.
             Whenever possible, 1 to 2 * 106 CD34+/kg, for the first 10 patients and held for 1
             year in case of graft failure. If graft failure does not occur in the first 10
             patients, backup cells will not be required for subsequent patients.

        Exclusion Criteria:

          1. Patients with impaired bone marrow reserve, as indicated by one or more of the
             following: Prior myeloablative therapies with autologous bone marrow transplantation
             (ABMT) or peripheral blood stem cell (PBSC) rescue Platelet count < 100,000 cells/mm3
             Hypocellular bone marrow Marked reduction in bone marrow precursors of one or more
             cell lines (granulocytic, megakaryocytic, erythroid) History of failed stem cell
             collection of > 4*106 CD34+/kg

          2. Prior radioimmunotherapy.

          3. Presence of central nervous system (CNS) lymphoma.

          4. Patients with chronic lymphocytic lymphoma.

          5. Patients with human immunodeficiency virus (HIV) or acquired immune deficiency
             syndrome (AIDS)-related lymphoma.

          6. Patients with abnormal liver function: total bilirubin > 1.5 mg/dl

          7. Patients with abnormal renal function: serum creatinine > 1.6 mg/dl

          8. Patients who have received prior external beam radiation therapy to >25% of active
             bone marrow (involved field or regional).

          9. Serious nonmalignant disease or infection which, in the opinion of the investigator
             and/or the sponsor, would compromise other protocol objectives.

         10. Corrected carbon monoxide diffusion in the lung (DLCO) <50% and forced expiratory
             volume in 1 second (FEV1) or forced vital capacity (FVC) < 50% predicted.

         11. Cardiac ejection fraction (EF) < 50% by 2-D Echogram.

         12. Pleural effusions.

         13. Prior radiation to lungs.

         14. Abnormal cytogenetics, filter in situ hybridization (FISH) (-5, -7, 11q23)