NCT01683123

Brief Summary

Analyze the results of conditioning with once-daily dose intravenous busulfan and fludarabine in patients undergoing HLA identical sibling Allogeneic HSCT for myeloid malignancies.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
143

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2007

Longer than P75 for all trials

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

July 1, 2007

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 11, 2012

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

March 17, 2022

Status Verified

March 1, 2022

Enrollment Period

3.9 years

First QC Date

September 7, 2012

Last Update Submit

March 16, 2022

Conditions

Acute Myeloid LeukemiaMyelodysplastic SyndromeMyeloproliferative DisordersChronic Myeloid Leukemia

Keywords

Allogeneic HSCTBusulfanFludarabina

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with myeloid malignancies submitted to allogeneic HSCT with an HLA identical sibling donor

You may qualify if:

  • Acute Myeloid Leukemia
  • Myelodysplastic Syndrome
  • Myeloproliferative Disorders
  • Chronic Myeloid Leukemia

You may not qualify if:

  • Performance status ECOG\>2
  • Cardiomyopathy (LVEF \<39%)
  • Pulmonary dysfunction (DLCO\<39%)
  • Hepatic dysfunction Grade \>1
  • Renal dysfunction Grade \>1 (Creatinine \> 1.6 mg/dl)
  • HIV infection
  • Other active neoplasm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteMyelodysplastic SyndromesMyeloproliferative DisordersLeukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Javier De la Serna, MD

    Grupo Espanol de trasplantes hematopoyeticos y terapia celular

    PRINCIPAL INVESTIGATOR

  • Guillermo Sanz, MD

    Grupo Espanol de trasplantes hematopoyeticos y terapia celular

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2012

First Posted

September 11, 2012

Study Start

July 1, 2007

Primary Completion

June 1, 2011

Study Completion

October 1, 2012

Last Updated

March 17, 2022

Record last verified: 2022-03