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Anti-Human CD45 Monoclonal Antibodies in Patients With Advanced Leukemia Prior to Allogeneic Stem Cell Transplantation

NCT00057005 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2020-01-18

No results posted yet for this study

Summary

Participants in this study have a hematologic malignancy which is a disorder in the bone marrow that affects the body's ability to create blood. Participants might benefit from receiving an allogeneic stem cell transplant (meaning the cells come from a donor). The participants donor is a family member. Stem cells are cells in the bone marrow and blood that can form a whole new blood system.

Conditions

Interventions

DRUG

CAMPATH-1H

Day-8 through Day-6 according to institutional SOPs

DRUG

Anti-CD45

Day-5 400 μg/kg

DRUG

Ara-C

day-7 through day-5 3000 mg/m2 q 12h

DRUG

Cyclophosphamide

Day-7 through Day-6 45 mg/kg

DRUG

Mesna

Days -7 and -6 45 mg/kg divided into 5 doses

RADIATION

Total Body Irradiation

150 cGy x 2 (5/6 matched related) 180 cGy x 2 (5/6 matched unrelated)

Sponsors & Collaborators

  • The Methodist Hospital Research Institute

    collaborator OTHER

  • Center for Cell and Gene Therapy, Baylor College of Medicine

    collaborator OTHER

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Malcolm K Brenner, MD · Baylor College of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-02-28
Primary Completion
2009-10-31
Completion
2009-10-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT00057005 on ClinicalTrials.gov