NCT00022321

Brief Summary

RATIONALE: Monoclonal antibodies such as gemtuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Randomized phase II trial to study the effectiveness of gemtuzumab in treating patients who have myelodysplastic syndrome.

Trial Health

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Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 10, 2001

Completed
22 days until next milestone

Study Start

First participant enrolled

September 1, 2001

Completed
2.4 years until next milestone

First Posted

Study publicly available on registry

January 14, 2004

Completed
Last Updated

December 19, 2013

Status Verified

June 1, 2002

First QC Date

August 10, 2001

Last Update Submit

December 18, 2013

Conditions

Myelodysplastic Syndromes

Keywords

refractory anemiarefractory anemia with ringed sideroblastsrefractory anemia with excess blastsrefractory anemia with excess blasts in transformationde novo myelodysplastic syndromes

Interventions

gemtuzumab ozogamicinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed myelodysplastic syndrome (MDS) Refractory anemia (RA) RA with ringed sideroblasts RA with excessive blasts (RAEB) RAEB in transformation (stable disease for at least 2 months) No chromosomal abnormalities including t(8;21), inv(16), or t(15;17) No chronic myelomonocytic leukemia proliferative type (WBC greater than 12,000/mm3) No known CNS involvement with MDS blast progression International Prognostic Scoring System (IPSS) score at least 1.5 PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin less than 1.5 mg/dL Renal: Creatinine less than 2.0 mg/dL Cardiovascular: No severe cardiac disease Pulmonary: No severe pulmonary disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 1 year after study HIV negative No other prior active malignancy except basal cell or squamous cell skin cancer No uncontrolled infections PRIOR CONCURRENT THERAPY: Biologic therapy: No prior stem cell transplantation No prior anti-CD33 antibodies At least 4 weeks since prior hematopoietic growth factors, epoetin alfa, or cytokine therapy Chemotherapy: No prior chemotherapy for MDS or other malignancy No concurrent cytotoxic chemotherapy Endocrine therapy: At least 4 weeks since prior systemic steroids except topical or inhaled steroids No concurrent systemic steroids except topical or inhaled steroids Radiotherapy: No prior radiotherapy for MDS or other malignancy Surgery: No prior organ transplantation Other: At least 4 weeks since prior immunosuppressive therapy At least 4 weeks since prior investigational agents No concurrent immunosuppressive therapy No other concurrent investigational agents

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

Sponsors & Collaborators

Study Sites (1)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

MeSH Terms

Conditions

Myelodysplastic SyndromesAnemia, RefractoryAnemia, Refractory, with Excess of Blasts

Interventions

Gemtuzumab

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesAnemia

Intervention Hierarchy (Ancestors)

CalicheamicinsAminoglycosidesGlycosidesCarbohydratesAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Gary J. Schiller, MD

    Jonsson Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 10, 2001

First Posted

January 14, 2004

Study Start

September 1, 2001

Last Updated

December 19, 2013

Record last verified: 2002-06

Locations

US(1)