TheranosticTrials.org

Clinical Trial · NCT01538472

Y Zevalin and BEAM in Autologous Stem Cell Transplantation (ASCT) for Lymphoma

Overview

The goal of this clinical research study is to see if high-dose chemotherapy (BEAM) and rituximab, given together with the new drug 90Y Zevalin, followed by a transplant of blood or marrow stem cells is safe. Another goal is to learn if this treatment can help decrease the chances of the cancer coming back.

Sponsor

MD Anderson Cancer Center

Phase

Phase 1/2

Contacts

Issa F. Khouri, MD,BS (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT01538472

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

  • 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).
  • 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.
  • 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.
  • If patients had prior radiation, this should have not involved more than 25% of the bone marrow.
  • Patients determined to have \<10% bone marrow involvement with lymphoma within four weeks before stem cell collection as defined by bilateral aspirates and biopsies.
  • Prestudy performance status of 0, 1, or 2 according to the World Health Organization (WHO).
  • 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
  • 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.
  • No prior radioimmunoconjugate therapy.
  • Relapsed CD20-positive B-cell non-Hodgkin's lymphoma (NHL) (demonstrated in lymph nodes or bone marrow), chemosensitive (at least Partial Remission (PR)).
  • Female patients included must not be pregnant or lactating.

Exclusion

  • Presence of central nervous system (CNS) lymphoma.
  • Patients with abnormal renal function: serum creatinine \> 1.6 mg/dl
  • Cardiac ejection fraction (EF) \< 50% by 2-D Echogram.
  • Corrected carbon monoxide diffusion in the lung (DLCO) \<50% and forced expiratory volume in 1 second (FEV1) or forced vital capacity (FVC) \< 50% predicted.
  • Abnormal cytogenetics, filter in situ hybridization (FISH) (-5, -7, 11q23)
  • Serious nonmalignant disease or infection which, in the opinion of the investigator and/or the sponsor, would compromise other protocol objectives.
  • Pleural effusions.
  • Prior radioimmunotherapy.
  • Patients with human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS)-related lymphoma.
  • 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
  • Patients who have received prior external beam radiation therapy to \>25% of active bone marrow (involved field or regional).
  • Patients with abnormal liver function: total bilirubin \> 1.5 mg/dl
  • Prior radiation to lungs.
  • Patients with chronic lymphocytic lymphoma.