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Phase 2 Completed N=40 Treatment

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

Source: ClinicalTrials.gov NCT01538472 ↗
Enrolled (actual)
40
Serious AEs
17.5%
Results posted
Sep 2014
Primary outcomePrimary: Overall Survival Median — 1299 days

Summary

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Overall Survival Median
1299
PRIMARY
3-Year Overall Survival
78

Eligibility Criteria

Inclusion Criteria

  • Relapsed CD20-positive B-cell non-Hodgkin's lymphoma (NHL) (demonstrated in lymph nodes or bone marrow), chemosensitive (at least Partial Remission (PR)).
  • 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.
  • No prior radioimmunoconjugate therapy.
  • If patients had prior radiation, this should have not involved more than 25% of the bone marrow.
  • An IRB-approved signed informed consent.
  • Age: 18 to 65 years of age.
  • 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.
  • Patients determined to have 4*106 CD34+/kg
  • Prior radioimmunotherapy.
  • Presence of central nervous system (CNS) lymphoma.
  • Patients with chronic lymphocytic lymphoma.
  • Patients with human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS)-related lymphoma.
  • Patients with abnormal liver function: total bilirubin > 1.5 mg/dl
  • Patients with abnormal renal function: serum creatinine > 1.6 mg/dl
  • Patients who have received prior external beam radiation therapy to >25% of active bone marrow (involved field or regional).
  • Serious nonmalignant disease or infection which, in the opinion of the investigator and/or the sponsor, would compromise other protocol objectives.
  • Corrected carbon monoxide diffusion in the lung (DLCO) <50% and forced expiratory volume in 1 second (FEV1) or forced vital capacity (FVC) < 50% predicted.
  • Cardiac ejection fraction (EF) < 50% by 2-D Echogram.
  • Pleural effusions.
  • Prior radiation to lungs.
  • Abnormal cytogenetics, filter in situ hybridization (FISH) (-5, -7, 11q23)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01538472). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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