NCT00005892

Brief Summary

OBJECTIVES: I. Determine the effectiveness of moderate dose cyclophosphamide and radiotherapy in terms of improving survival and reducing the morbidity following allogeneic bone marrow transplantation in patients with myelodysplastic syndrome and acute leukemia related to Fanconi's anemia.

Trial Health

80
On Track

Trial Health Score

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

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2000

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2000

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 5, 2000

Completed
Last Updated

June 24, 2005

Status Verified

July 1, 2004

First QC Date

June 2, 2000

Last Update Submit

June 23, 2005

Conditions

Fanconi's AnemiaMyelodysplastic SyndromesLeukemia, Nonlymphocytic, AcuteLeukemia, Lymphocytic, Acute

Keywords

Fanconi's anemiaacute leukemiaacute lymphocytic leukemiaacute myeloid leukemiaacute undifferentiated leukemiaadult acute lymphoblastic leukemiaadult acute lymphoblastic leukemia in remissionadult acute myeloid leukemiaadult acute myeloid leukemia in remissionaplastic anemiachildhood acute lymphoblastic leukemiachildhood acute lymphoblastic leukemia in remissionchildhood acute myeloid leukemiachildhood acute myeloid leukemia in remissionde novo myelodysplastic syndromehematologic disordershematopoietic/lymphoid cancerleukemiamyelodysplastic syndromeoncologic disorderspreviously treated myelodysplastic syndromerare diseasesecondary myelodysplastic syndrome

Interventions

cyclophosphamideDRUG
Allogeneic Bone Marrow TransplantationPROCEDURE

Eligibility Criteria

Age0 Years - 54 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
* Diagnosis of Fanconi's anemia with the family history and typical phenotype including: Short stature Hypoplastic radii Skin pigmentation Renal anomalies Chromosomal fragility * Evidence of Fanconi's myelodysplastic syndrome Bone marrow dysplasia of all 3 marrow cell lines AND Clonal cytogenetic abnormalities demonstrable in marrow cells * First complete remission following therapy for Fanconi's acute leukemia allowed * Must have related histocompatible donor No evidence of excessive in vitro chromosome fragility typical of Fanconi's anemia Normal CBC and bone marrow

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Fairview University Medical Center

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Fanconi AnemiaMyelodysplastic SyndromesLeukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Biphenotypic, AcuteAnemia, AplasticHematologic DiseasesHematologic NeoplasmsLeukemiaRare Diseases

Interventions

Cyclophosphamide

Condition Hierarchy (Ancestors)

Anemia, Hypoplastic, CongenitalAnemiaHemic and Lymphatic DiseasesCongenital Bone Marrow Failure SyndromesBone Marrow Failure DisordersBone Marrow DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDNA Repair-Deficiency DisordersMetabolic DiseasesNutritional and Metabolic DiseasesLeukemia, MyeloidNeoplasms by Histologic TypeNeoplasmsLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms by SiteDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Study Officials

  • Daniel J. Weisdorf

    Fairview University Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 2, 2000

First Posted

June 5, 2000

Study Start

March 1, 2000

Last Updated

June 24, 2005

Record last verified: 2004-07

Locations

US(1)