NCT00008151

Brief Summary

RATIONALE: Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Peripheral stem cell or bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy used to kill cancer cells. PURPOSE: Phase II trial to study the effectiveness of gemtuzumab ozogamicin combined with fludarabine and total-body irradiation followed by donor peripheral stem cell or bone marrow transplantation in treating patients who have advanced acute myeloid leukemia or myelodysplastic syndrome.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Oct 2000

Shorter than P25 for phase_2 leukemia

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

October 1, 2000

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2001

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2002

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

March 25, 2004

Completed
Last Updated

April 2, 2010

Status Verified

March 1, 2010

Enrollment Period

1.7 years

First QC Date

January 6, 2001

Last Update Submit

March 31, 2010

Conditions

LeukemiaMyelodysplastic Syndromes

Keywords

recurrent childhood acute myeloid leukemiarecurrent adult acute myeloid leukemiarefractory anemia with excess blastsrefractory anemia with excess blasts in transformationde novo myelodysplastic syndromespreviously treated myelodysplastic syndromessecondary myelodysplastic syndromeschildhood myelodysplastic syndromes

Interventions

cyclosporineDRUG
fludarabine phosphateDRUG
gemtuzumab ozogamicinDRUG
methotrexateDRUG
mycophenolate mofetilDRUG
allogeneic bone marrow transplantationPROCEDURE
peripheral blood stem cell transplantationPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Diagnosis of recurrent or refractory acute myeloid leukemia CD33 positive Greater than 5% morphologically identified blasts in the marrow OR Diagnosis of myelodysplastic syndrome CD33 positive Greater than 5% morphologically identified blasts in the marrow (refractory anemia with excess blasts (RAEB) and RAEB in transformation) Must have donor who meets the following criteria: HLA-A, B, C, DRB1 and DQB1 identical or mismatched for no more than 1 allelic or cross-reactive antigen Under 75 years of age PATIENT CHARACTERISTICS: Age: Any age Performance status: Not specified Life expectancy: Not specified Hematopoietic: WBC no greater than 30,000/mm3 (leukophereses or hydroxyurea allowed) Hepatic: Bilirubin no greater than 2 times upper limit of normal No synthetic dysfunction No severe cirrhosis Renal: Not specified Cardiovascular: No symptomatic coronary artery disease No cardiac failure requiring therapy Pulmonary: DLCO at least 35% OR Receiving supplementary continuous oxygen Other: No uncontrolled infection No other diseases that would severely limit life expectancy Not pregnant or nursing Fertile patients must use effective contraception during and for 1 year after study PRIOR CONCURRENT THERAPY: No post-transplant growth factors during and for 1 month after mycophenolate mofetil administration

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

Sponsors & Collaborators

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

MeSH Terms

Conditions

LeukemiaMyelodysplastic SyndromesLeukemia, Myeloid, AcuteAnemia, Refractory, with Excess of Blasts

Interventions

Cyclosporinefludarabine phosphateGemtuzumabMethotrexateMycophenolic AcidPeripheral Blood Stem Cell TransplantationRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow DiseasesLeukemia, MyeloidAnemia, RefractoryAnemia

Intervention Hierarchy (Ancestors)

CyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsCalicheamicinsAminoglycosidesGlycosidesCarbohydratesAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulinsAminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipidsHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Eric Sievers, MD

    Fred Hutchinson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 6, 2001

First Posted

March 25, 2004

Study Start

October 1, 2000

Primary Completion

July 1, 2002

Study Completion

July 1, 2002

Last Updated

April 2, 2010

Record last verified: 2010-03

Locations

US(1)