A Phase II Study of Allo-HCT for B-Cell NHL Using Zevalin, Fludarabine and Melphalan (NCT00577278) | Clinical Trial Compass
CompletedPhase 2
A Phase II Study of Allo-HCT for B-Cell NHL Using Zevalin, Fludarabine and Melphalan
United States41 participantsStarted 2007-10-03
Plain-language summary
RATIONALE: Giving monoclonal antibody therapy, radioimmunotherapy, and chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the stem cells from a related donor that do not exactly match the patient's blood, are infused into the patient, they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus and sirolimus before and after transplant may stop this from happening.
PURPOSE: This phase II trial is studying the side effects and how well giving indium In 111 ibritumomab tiuxetan and yttrium y 90 ibritumomab tiuxetan together with rituximab, fludarabine, melphalan, and donor stem cell transplant works in treating patients with B-cell non-Hodgkin lymphoma.
Who can participate
Age range18 Years – 69 Years
SexALL
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Inclusion Criteria:
* 6/6/human leukocyte antigen (HLA) matched sibling donor or related donor, or acceptable matched unrelated donor
* Biopsy (Bx) proven diagnosis of LG (including small lymphocytic lymphoma \[SLL\]/chronic lymphocytic leukemia \[CLL\], lymphoplasmacytic lymphoma, marginal zone, mucosa-associated lymphoid tissue \[MALT\] lymphoma and follicular lymphoma \[FL\] grade 1 and 2), IG (FL grade 3 and DLCL) or MCL NHL
* Prior demonstrated monoclonal CD20+ malignant B-Cell population in lymph nodes and/or BM Bx specimen
* LG NHL; must have relapsed after achieving a complete response (CR) or partial response (PR) to prior therapy or have never responded to prior therapy, including chemotherapy and/or MAb therapy
* MCL NHL in any disease state
* Other aggressive B-cell lymphomas (excluding Burkitt lymphoma or Burkitt-like lymphoma) having had at least one relapse or having been refractory to chemotherapy
* Bone marrow (BM) aspiration and Bx ( =\< 42 days prior to imaging dose) which show \< 25% lymphomatous involvement of total cellularity; in CLL, peripheral lymphocyte count \< 5000/mm\^3
* Salvage chemotherapy/MAbs to reduce BM lymphomatous involvement and reduce disease bulk allowed
* Normal renal function test with serum creatinine of =\< 1.5 mg/dl, or a creatinine clearance of \>= 60 ml/min
* Adequate pulmonary function as measured by forced expiratory volume in one second (FEV1) \> 65% of predicted measured, or a diffusing capacity of carbon monoxide (DLCO) \>…
What they're measuring
1
Relapse/Progression Rate at Two Years
Timeframe: From the initial treatment to the last disease assessment, up to two years