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Phase 2 Haplotype Mismatched HSCT in Patients With Hematological Malignancies

NCT00593554 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2018-04-10

Study results available
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Summary

The purpose of this study is to determine if haplotype-mismatched HSCT is associated with an improvement in treatment-related mortality (TRM) rate at 6 months.

Conditions

Interventions

RADIATION

Total Body Irradiation

8 Gy on Day -9

DRUG

Thiotepa

5 mg/kg/d on Day -8 to -7

DRUG

Fludarabine

40 mg/m2/d on Day -6 to -3

BIOLOGICAL

Rabbit ATG

2.5 mg/kg/d on Day -5 to -2

DRUG

Palifermin

60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2

Sponsors & Collaborators

  • Sherif S. Farag

    lead OTHER

Principal Investigators

  • Sherif Farag, MD/PhD · Indiana University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-08-07
Primary Completion
2016-08-27
Completion
2017-07-28
FDA Drug
Yes

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 NCT00593554 on ClinicalTrials.gov