Phase 3
Completed N=43
Zevalin-beam for Aggressive Lymphoma
Source: ClinicalTrials.gov NCT00491491 ↗Enrolled (actual)
43
Serious AEs
2.3%
Results posted
Aug 2020
Primary outcomePrimary: Overall Survival — 91; 62 percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The study hypothesis is that the addition of zevalin radioimmunotherapy to the conditioning regimen given prior to BEAM high-dose chemotherapy and autologous stem cell transplantation in patients with aggressive lymphoma will reduced disease recurrence rate and improve overall and disease-free survival.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
91; 62 | — |
| SECONDARY Progression-free Survival |
59; 37 | — |
| SECONDARY Clinical Response |
22; 20 | — |
| SECONDARY Hematopoietic Recovery |
10; 11 | — |
| SECONDARY Grade III Toxicity |
3; 4; 6; 1; 13; 16 | — |
| SECONDARY Secondary Malignancies |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with CD20 positive diffuse large B-cell lymphoma as confirmed by a pathological biopsy report.
- Patients who are candidates for autologous stem-cell transplantation due to primary refractory or first relapse of disease.
- Patients must have chemo-sensitive disease achieving at least partial response (Cheson 2007 criteria) to last chemotherapy.
- Age ≥ 18 years and age ≤ 70
- Patients with adequate autologous stem cell collection for transplantation (target ≥ 2.5 x 106 CD34+ cells/kg).
- Patients must sign written informed consent.
- Adequate birth control in fertile patients.
- All prior chemotherapy completed at least three weeks before study treatment.
- Marrow involvement less than 25% at transplantation, no limitation on blood counts (low platelet count allowed).
- Negative HIV antibody.
Exclusion Criteria
- 1. Chemo-refractory disease as determined by less than partial response (Cheson 2007 Criteria) to last chemotherapy.
- Two or more relapses after initial response to induction chemotherapy.
- High-grade transformation from earlier diagnosis of low-grade lymphoma. Patients with "De Novo" Transformed DLBCL, defined as DLBCL only on lymph node biopsy and a discordant marrow with para-trabecular small cells at first diagnosis of lymphoma, are eligible if adherent all other selection criteria.
- Bilirubin > 3.0 mg/dl, transaminases > 3 times upper normal limit.
- Creatinine > 2.0 mg/dl.
- ECOG Performance status > 2.
- Uncontrolled infection.
- Pregnancy or lactation.
- Abnormal lung diffusion capacity (DLCO 5 years in relation to this prior malignance. The 5-year exclusion rule does not apply to-non melanoma skin tumors and in situ cervical cancer.
- Pleural effusion or ascites > 1 liter.
- Known hypersensitivity to rituximab.
- Psychiatric conditions/disease that impair the ability to give informed consent or to adequately co-operate.
- Prior radioimmunotherapy.
- Prior autologous or allogeneic HSCT.
- Active evidence of Hepatitis B or C infection; Hepatitis B surface antigen positive.
- Patients who have had prior radiation to the lung will be excluded from the study, although mediastinal irradiation will be permitted if minimal lung is in the treatment volume.
- Patients who have received >500cGy radiation to the kidneys will be excluded from the study.
Data sourced from ClinicalTrials.gov (NCT00491491). 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.