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Study With Intravenous Busulfan And Fludarabine Myeloablative Conditioning Regimen For HLA Identical Sibling Donor HSCT (BUFLU)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Grupo Espanol de trasplantes hematopoyeticos y terapia celular
ClinicalTrials.gov Identifier:
NCT01683123
First received: September 7, 2012
Last updated: September 10, 2012
Last verified: September 2012
History of Changes
  Purpose

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


Condition
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Myeloproliferative Disorders
Chronic Myeloid Leukemia

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Phase 2 Study With Intravenous Busulfan And Fludarabine Myeloablative Conditioning For HLA Identical Sibling Allogeneic HSCT In Myeloid Malignancies. Retrospective Analysis.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Grupo Espanol de trasplantes hematopoyeticos y terapia celular:

Enrollment: 143
Study Start Date: July 2007
Estimated Study Completion Date: October 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Detailed Description:

In this study the investigators evaluate a conditioning regimen consisting in Fludarabine 40 mg/m2 once daily i.v in 60 min. on days -6 to -3 (total dose 160 mg/m2), followed by Busulfan 3,2 mg/kg once daily i.v. in 180 min. in the same days (total dose 12,8 mg/kg). No busulfan pharmacokinetic monitoring is performed. Graft versus host disease prophylaxis consists in the combination of cyclosporine and methotrexate. Graft products obtained from bone marrow or peripheral blood of HLA identical sibling donors are not manipulated in their cellular content before transplantation. Blood products were leukocyte depleted and irradiated before transfusion. Supportive care, including seizure prophylaxis, isolation measures, antiemetics, antimicrobial agents and growth factors use are followed according to standard procedures.

The main objectives are to record data regarding engraftment, regimen related toxicity and outcome in different patient populations according to age, disease type, disease status at HSCT and comorbidities.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01683123

Sponsors and Collaborators
Grupo Espanol de trasplantes hematopoyeticos y terapia celular
Investigators
Principal Investigator: Javier De la Serna, MD Grupo Espanol de trasplantes hematopoyeticos y terapia celular
Study Chair: Guillermo Sanz, MD Grupo Espanol de trasplantes hematopoyeticos y terapia celular
  More Information

No publications provided

Responsible Party: Grupo Espanol de trasplantes hematopoyeticos y terapia celular
ClinicalTrials.gov Identifier: NCT01683123     History of Changes
Other Study ID Numbers: get-buf-2010-02
Study First Received: September 7, 2012
Last Updated: September 10, 2012
Health Authority: Spain: Ministry of Health and Consumption

Keywords provided by Grupo Espanol de trasplantes hematopoyeticos y terapia celular:
Allogeneic HSCT
Busulfan
Fludarabina

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Myelodysplastic Syndromes
Preleukemia
Myeloproliferative Disorders
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
 Busulfan
Fludarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Myeloablative Agonists

ClinicalTrials.gov processed this record on May 19, 2013