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Gemcitabine Plus Busulfan, Melphalan and Hematopoietic Cell Transplant for Advanced Lymphoid Malignancies

NCT00410982 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2016-06-03

No results posted yet for this study

Summary

The goal of this clinical research study is to find the highest tolerated dose of gemcitabine that can be given with busulfan and melphalan. The safety of this drug combination will also be studied.

Conditions

Interventions

DRUG

Busulfan

Day -10 = 32 mg/m\^2 Intravenous Test Dose; Days -8 thru -5 = 105 mg/m\^2 Intravenous

DRUG

Gemcitabine

Day -8 = 75 mg/m\^2 Intravenous bolus; Day -3 = 75 mg/m\^2 Intravenous bolus.

DRUG

Melphalan

Day -3 and Day -2 = 60 mg/m\^2 Intravenous.

OTHER

Hematopoietic Cell Transplantation

Infusion of stem cells on Day 0.

DRUG

Rituximab for Patients with B-Cell Malignancies

375 mg/m\^2 Intravenous on Days 1 and 8.

DRUG

Palifermin

60 microgram/kg by vein on Days -13 to -11 and Days 0, +1, +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
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2012-09-30
Completion
2012-09-30

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 NCT00410982 on ClinicalTrials.gov