Zevalin-Containing Nonmyeloablative Conditioning for Stem Cell Transplantation (SCT)
Leukemia, Lymphoma
About this trial
This is an interventional treatment trial for Leukemia focused on measuring Leukemia, Chronic lymphocytic leukemia, Lymphoma, CD20+ lymphoid malignancies, Diffuse large B-cell lymphoma, Allogeneic transplantation, Rituximab, Rituxan, In ibritumomab, Y ibritumomab, Zevalin, Fludarabine Phosphate, Fludara, Bendamustine Hydrochloride, Bendamustine HCL, CEP-18083, SDX-105, Treanda, Stem Cell Transplantation, Planar Scintigraphy, Spect Scan, Single Photon Emission-Computed Tomography, CT Scan, Computed Tomography, G-CSF, Filgrastim, Neupogen, Thymoglobulin, ATG, Antithymocyte Globulin, Methotrexate, Mycophenolate, MMF, Mycophenolate Mofetil, CellCept, Tacrolimus, Prograf
Eligibility Criteria
Inclusion Criteria:
- 18 to 70 years of age.
- Patients with the following CD20+ lymphoid malignancies who are eligible for allogeneic transplantation: a. Relapsed or refractory follicular lymphoma; b. Relapsed or refractory or high risk mantle cell lymphoma (hi ki67; blastic); c. Recurrent or refractory marginal zone; d. Recurrent or refractory CLL/small lymphocytic lymphoma; e. Double-hit lymphoma; f. Diffuse large B cell lymphoma; g. Richter's patients; or h. Refractory or recurrent Burkitts.
- Patients who meet criterion #2 or have any of the following are eligible: a. Less than PR to salvage chemotherapy; b. Kinetic failure; c. Having received more than 3 lines of therapy; d. Failure to mobilize autologous stem cell; e. 10% or more marrow involvement; f. 6 months post autologous stem cell transplant.
- Patients must have a fully-matched related donor or a matched unrelated donor identified. Double cord (at least 4/6 matched) can be used if no adult matched donor is available.
- Performance score of at least 80% by Karnofsky or 0 to 2 ECOG.
- Left ventricular EF >/= 45% with no uncontrolled arrythmias or symptomatic heart disease.
- FEV1, FVC >/= 60% and corrected DLCO >/= 60%.
- Serum creatinine </=1.6 mg/dL. Serum bilirubin < 2 mg/dL (unless due to Gilbert's Syndrome).
- SGPT < 2 X upper limit of normal.
- Men and women of reproductive potential must agree to follow accepted birth control methods (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
- Negative Beta HCG test within 30 days in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization). Pregnancy testing is not required for post-menopausal or surgically sterilized women.
Exclusion Criteria:
- Patient with active CNS involvement with lymphoid malignancy.
- Known infection with HIV, HTLV-I, Hepatitis B, or Hepatitis C.
- Patients with other malignancies diagnosed within 2 years prior to study registration. Skin squamous or basal cell carcinoma are exceptions.
- Active bacterial, viral or fungal infections.
- History of stroke within 6 months prior to study registration.
- A prior allogeneic stem cell transplant.
- Patient has received other investigational drugs within 3 weeks before study registration.
- Presence of circulating malignant lymphoid cells or bone marrow with lymphoma that constituted more than 25% of the cellular elements.
- Serious nonmalignant or malignant disease or psychiatric illness, which, in the opinion of the investigator would compromise protocol objectives or interfere with participation.
- Patients who are breast-feeding.
Sites / Locations
- University of Texas MD Anderson Cancer Center
Arms of the Study
Arm 1
Experimental
Yttrium-90 Ibritumomab + Chemo
Day -22 and -14, Rituximab 250 mg/m2 preceding 111In Ibritumomab and (90Y) ibritumomab tiuxetan administration, respectively. Day -22, -21 to -16, Imaging, repeated 3-6 hours later (including Single Photon Emission-Computed Tomography/Computed Tomography (SPECT/CT) scan of the abdomen). Day -14, (90Y) ibritumomab tiuxetan administration. Day -5, -4 and -3, Fludarabine and Bendamustine following Stem Cell Transplant (SCT) and CT. Fludarabine 30 mg/m2 intravenously followed by Bendamustine 130 mg/m2 intravenously. All patients receive Graft Versus Host Disease (GvHD) prophylaxis, infections disease prophylaxis, growth factors, blood and platelet transfusion and other supportive treatment.