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

NCT01538472 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2014-09-11

Study results available
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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.

Conditions

Interventions

DRUG

Y Zevalin

Starting dose: 0.4 mCi/kg by vein after Rituxan infusion on Day -14.

DRUG

In Zevalin

Imaging dose: 5 mCi by vein following Rituxan infusion on Day -21.

DRUG

Rituxan

250 mg/m2 by vein on Day -21 and on Day -14. 1000 mg/m2 by vein on Days +1 and +8.

DRUG

BCNU

300 mg/m2 by vein on Day -6.

DRUG

VP -16

200 mg/m2 by vein every 12 hours on Days -5, -4, -3, and -2.

DRUG

Ara-C

200 mg/m2 by vein every 12 hours on Days -5, -4, -3,and -2.

DRUG

Melphalan

140 mg/m2 by vein on Day -1.

PROCEDURE

Stem Cell Infusion

Autologous stem cell infusion on Day 0.

DRUG

G-CSF

5 mg/kg by vein daily starting Day 0 till recovery of granulocytes of 4.0 x 109/L.

Sponsors & Collaborators

  • Biogen

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Issa F. Khouri, MD,BS · UT MD Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-09-30
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01538472 on ClinicalTrials.gov