NCT00506857

Brief Summary

Objectives:

  1. 1.To determine the relative toxicities, engraftment potential, kinetics of engraftment, degree of chimerism and disease control achieved with the combination of fludarabine and busulfan at different dose levels and different dose schedules in patients undergoing allogeneic stem cell transplant (SCT).
  2. 2.Determine pharmacokinetics, and toxicity of intravenous busulfan given at equal total dose levels given four times daily, or once daily.
  3. 3.In vivo determination of fludarabine inhibitory effects on DNA repair.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2003

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 25, 2007

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
7 months until next milestone

Results Posted

Study results publicly available

February 28, 2012

Completed
Last Updated

February 28, 2012

Status Verified

January 1, 2012

Enrollment Period

7.8 years

First QC Date

July 23, 2007

Results QC Date

January 24, 2012

Last Update Submit

January 24, 2012

Conditions

Hematologic Malignancies

Keywords

Hematologic MalignanciesBlood And Marrow TransplantationLeukemiaMDSLymphomaMyelomaFludarabineFludaraFludarabine PhosphateBusulfanBusulfexMyleranProgenitor Cell TransplantationGranulocyte colony stimulating factorG-CSFApheresisBlood cell infusion

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose (MTD)

    Continual reassessment method (four times a day) used to determine an MTD, with a target toxicity probability of 20%, where "toxicity" is defined as grade 3 or 4 conventional toxicity \[National Cancer Institute Common Toxicity Criteria (NCI-CTC)\]. Participant evaluation in a cohort with each modality is 30 days.

    1 month

Secondary Outcomes (1)

  • Number of Participants With Graft Versus Host Disease (GVHD)

    5 years

Study Arms (1)

Busulfan + Fludarabine

EXPERIMENTAL

Busulfan starting 0.8 mg/kg by vein (IV) every 6 hours for 12 doses; Fludarabine 30 mg/m\^2 IV daily for 4 days.

Drug: BusulfanDrug: Fludarabine

Interventions

BusulfanDRUG

Starting Dose 0.8 mg/kg by vein every 6 hours x 12 doses.

Also known as: Busulfex, Myleran
Busulfan + Fludarabine
FludarabineDRUG

30 mg/m\^2 by vein daily x 4 days.

Also known as: Fludarabine phosphate, Fludara
Busulfan + Fludarabine

Eligibility Criteria

AgeUp to 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Less than physiologic 75 years of age.
  • Interferon resistant late chronic phase CML not eligible for a protocol of higher priority.
  • Accelerated/Blastic Phase CML.
  • Acute leukemia or Intermediate to High Risk MDS according to the IPPS.
  • Any Lymphoma or Myeloma beyond CR1 ineligible for a protocol of higher priority.
  • Patients must have an HLA compatible donor willing to donate either peripheral blood or bone marrow progenitor cells.
  • Both patients and donor must sign written informed consents.

You may not qualify if:

  • Uncontrolled infection
  • Bilirubin \>3.0
  • Creatinine \>2.5
  • Performance Status \>Zubrod 2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Hematologic NeoplasmsLeukemiaLymphomaNeoplasms, Plasma Cell

Interventions

Busulfanfludarabinefludarabine phosphate

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Butylene GlycolsGlycolsAlcoholsOrganic ChemicalsMesylatesAlkanesulfonatesAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsSulfonic AcidsSulfur AcidsSulfur Compounds

Results Point of Contact

Title
Richard E. Champlin/Professor
Organization
UT MD Anderson Cancer Center
ytdinh@mdanderson.org

Study Officials

  • Richard E. Champlin, MD, BS

    UT MD Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2007

First Posted

July 25, 2007

Study Start

November 1, 2003

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

February 28, 2012

Results First Posted

February 28, 2012

Record last verified: 2012-01

Locations

US(1)