TheranosticTrials.org

Clinical Trial · NCT00577278

A Phase II Study of Allo-HCT for B-Cell NHL Using Zevalin, Fludarabine and Melphalan

Overview

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.

Sponsor

City of Hope Medical Center

Phase

Phase 2

Contacts

Matthew Mei, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT00577278

Drug / Compound

ibritumomab tiuxetan

Isotope(s):
Target(s):
  • cd20
Ligand Class: Antibodies
Chelator: tiuxetan

ibritumomab tiuxetan

Isotope(s):
Target(s):
  • cd20
Ligand Class: Antibodies
Chelator: tiuxetan

Eligibility

Inclusion

  • Involved field External Beam Therapy (EBT) to area excluding lung, heat, liver, and kidney allowed, but evaluated on a case-by-case basis
  • 6/6/human leukocyte antigen (HLA) matched sibling donor or related donor, or acceptable matched unrelated donor
  • 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
  • Other aggressive B-cell lymphomas (excluding Burkitt lymphoma or Burkitt-like lymphoma) having had at least one relapse or having been refractory to chemotherapy
  • No active Central Nervous System (CNS) disease or prior history of CNS disease
  • 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
  • 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) \>= 50% of predicted measured
  • 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
  • Prior demonstrated monoclonal CD20+ malignant B-Cell population in lymph nodes and/or BM Bx specimen
  • 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
  • MCL NHL in any disease state
  • Adequate liver function tests with a bilirubin of =\< 1.5 x normal and serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) =\< 2 x normal

Exclusion

  • Prior radioimmunotherapy (RIT)
  • Prior AHSCT; but prior aHSCT is allowed; prior fractionated total body irradiation (FTBI) in the conditioning regimen will be evaluated on an individual basis
  • Total peripheral lymphocyte count \> 5,000/mm\^3 if SLL/CLL
  • DONOR: Identical twin
  • Burkitt lymphoma or Burkitt-like lymphoma