CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 70 enrolled
Drug / intervention
Zevalin Radioimmunotherapy +4 moredrug
Likely dose
90Y Zevalin 0.2-0.3-0.4 mCi/kg (escalating single dose) with rituximab 250 mg/m² on days 1 and 8, fludarabine 30 mg/m²/day for 3 days, and cyclophosphamide 750 mg/m²/day for 3 daysAI-extracted
Key inclusion· 7
  • Relapsed, refractory, or high-risk CD-20-positive B-cell NHL or CLL (including Richter's transformation or high-risk chromosomal abnormalities in CLL)
  • Measurable disease
  • Age 18-70 years with expected survival ≥3 months
  • ECOG performance status 0-2
Key exclusion· 6
  • Prior myeloablative therapies or radioimmunotherapy
  • Prior external beam radiation therapy to >25% of active bone marrow
  • Prior therapy with 90Y Zevalin or Campath
  • CNS lymphoma, HIV, or HTLV-1 positivity

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00048737
NCT00048737Phase 2Completed

Safety and Efficacy of 90Y Zevalin in Nonmyeloablative Transplantation for Lymphoid Malignancies

M.D. Anderson Cancer Center·interventional·Posted Nov 8, 2002·Updated Jun 13, 2013

In Brief

A Phase 2 clinical trial evaluating Zevalin Radioimmunotherapy, Rituximab, and 3 other interventions for Lymphoma and Leukemia. Completed, enrolled 70 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to see if low intensity chemotherapy given together with the new drug 90Y Zevalin, followed by a transplant of blood or marrow stem cells from a donor can increase the length of remission in patients with leukemia and lymphoma. The safety of this treatment will also be studied.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma, Leukemia
CountriesUnited States
CollaboratorsBiogen

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 8, 2002
Enrollment StartOct 1, 2002
Primary CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 9.2 yearsPosted 23.7 years ago

Interventions

Zevalin Radioimmunotherapydrug

Escalating single dose of 90Y Zevalin 0.2-0.3-0.4 mCi/kg

Rituximabdrug

250 mg/m\^2 on day 1 and day 8

Fludarabinedrug

30 mg/m\^2/day for 3 days

Cyclophosphamidedrug

750 mg/m\^2/day for 3 days, given on the same days as fludarabine, at 4-hour intervals

Allogeneic Stem Cell Transplantationprocedure

Allogeneic stem cell transplantation 2 days after chemotherapy