Completed

A Phase II Trial Combining Gemtuzumab Ozogamicin (Mylotarg) With Cyclosporine for the Treatment of Relapsed Acute Myeloid Leukemia in Adults Over Age 60

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What is being tested

Data Collection

Who is being recruted

Hematologic Diseases
+3

+ Leukemia
+ Leukemia, Myeloid
Over 60 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: May 2004
See protocol details

Summary

Principal SponsorFred Hutchinson Cancer Center
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: May 1, 2004Actual date on which the first participant was enrolled.

OBJECTIVES: Primary * Determine the efficacy of gemtuzumab ozogamicin and cyclosporine, in terms of the complete remission rate, in older patients with relapsed acute myeloid leukemia. * Determine the toxicity and pharmacokinetics of this regimen in these patients. Secondary * Correlate clinical response with laboratory studies of drug susceptibility in patients treated with this regimen. OUTLINE: Patients receive cyclosporine IV continuously over 72 hours on days 1-3 and 15-17. Eight hours after initiation of each cyclosporine infusion, patients receive gemtuzumab ozogamicin IV over 2 hours on days 1 and 15. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed for survival. PROJECTED ACCRUAL: A total of 25-50 patients will be accrued for this study within 3 years.

Official TitleA Phase II Trial Combining Gemtuzumab Ozogamicin (Mylotarg) With Cyclosporine for the Treatment of Relapsed Acute Myeloid Leukemia in Adults Over Age 60 
NCT00089050
Principal SponsorFred Hutchinson Cancer Center
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 60 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Hematologic Diseases
Leukemia
Leukemia, Myeloid
Neoplasms
Neoplasms by Histologic Type
Leukemia, Myeloid, Acute
Criteria

DISEASE CHARACTERISTICS: * Morphologically confirmed acute myeloid leukemia (AML) by bone marrow aspirate * More than 20% blasts by morphologic criteria * Relapsed disease ≥ 3 months after prior complete remission * Blasts CD33-positive by flow cytometry * No primary hematologic disorder that preceded initial presentation with AML * No documented secondary AML related to prior chemotherapy or toxin exposure * No acute promyelocytic leukemia (FAB M3) * Not a candidate for transplant therapy * No active CNS leukemia PATIENT CHARACTERISTICS: Age * 60 and over Performance status * Karnofsky 70-100% Life expectancy * Not specified Hematopoietic * WBC ≤ 30,000/mm\^3 (hydroxyurea allowed) Hepatic * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST or ALT ≤ 1.5 times ULN Renal * Creatinine ≤ 1.5 mg/dL Other * HIV negative * No uncontrolled infection PRIOR CONCURRENT THERAPY: Biologic therapy * Not planning hematopoietic stem cell transplantation immediately after study therapy Chemotherapy * See Disease Characteristics * See Hematopoietic Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * More than 1 month since prior investigational agents * No other concurrent anticancer therapy * No administration of any of the following for 24 hours after cyclosporine administration: * Diltiazem * Verapamil * Erythromycin * Clarithromycin * Metoclopramide * Phenytoin * Rifampin * Phenobarbital * Aminoglycosides * Amphotericin B * Vancomycin * Cimetidine * Ranitidine * Trimethoprim/sulfamethoxazole * Ketoconazole * Fluconazole * Itraconazole * Voriconazole * Carbamazepine

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Fred Hutchinson Cancer Research CenterSeattle, United StatesSee the location
CompletedOne Study Center
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