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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00410982
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 69 Years
Healthy Volunteers
Not accepted

Interventions

  • Busulfan — DRUG
    Day -10 = 32 mg/m\^2 Intravenous Test Dose; Days -8 thru -5 = 105 mg/m\^2 Intravenous
  • Gemcitabine — DRUG
    Day -8 = 75 mg/m\^2 Intravenous bolus; Day -3 = 75 mg/m\^2 Intravenous bolus.
  • Melphalan — DRUG
    Day -3 and Day -2 = 60 mg/m\^2 Intravenous.
  • Hematopoietic Cell Transplantation — OTHER
    Infusion of stem cells on Day 0.
  • Rituximab for Patients with B-Cell Malignancies — DRUG
    375 mg/m\^2 Intravenous on Days 1 and 8.
  • Palifermin — DRUG
    60 microgram/kg by vein on Days -13 to -11 and Days 0, +1, +2

Study Details

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.

Key Dates

Start date
Dec 31, 2006
Status verified
Sep 2012
Primary completion
Sep 30, 2012
Completion
Sep 30, 2012

Study Design

Enrollment
145 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Gemcitabine + Busulfan + Melphalan + HCT
    HCT = Hematopoietic Cell Transplantation

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of Gemcitabine with Busulfan + Melphalan [ Time Frame: Baseline to Day 100 post transplant, up to 115 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
UT MD Anderson Cancer CenterHoustonTexas77030-

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