MedTrace Logo

High-Dose Gemcitabine, Busulfan and Melphalan for Patients With Refactory Hodgkin's Disease

NCT01200329 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2019-12-16

Study results available
· View outcomes & findings →

Summary

The goal of this clinical research study is to learn if the combination of gemcitabine, busulfan, and melphalan, when given before a stem cell transplant, can help to control refractory Hodgkin's disease. The safety of this study treatment will also be studied.

Conditions

Interventions

DRUG

Gemcitabine

2775 mg/m2 by vein over about 3 hours on days -8 and -3.

DRUG

Busulfan

32 mg/m2 test dose with PKs as outpatient and on day -10 as inpatient AUC 4,000 by vein over about 3 hours on days -8 to -5.

DRUG

Melphalan

60 mg/m2 by vein over about 30 minutes on days -3 and -2.

PROCEDURE

Stem Cell Transplantation

Infusion of stem cells on Day 0.

DRUG

Palifermin

60 mg/kg by vein over 30 seconds daily, Days -12 to -10 and Days 0 to 2.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Yago Nieto, MD, PHD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2018-12-06
Completion
2018-12-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT01200329 on ClinicalTrials.gov