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COMPLETEDPHASE1

Sirolimus in Combination With MEC in High Risk Myeloid Leukemias

A Prospective Single Institution Pilot Study Evaluating the Pharmacokinetics of Sirolimus in Combination With MEC (Mitoxantrone + Etoposide + Cytarabine) in Patients With High Risk Leukemias

NCT00780104•Abramson Cancer Center at Penn Medicine

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the side effects of sirolimus (rapamycin) given in combination with chemotherapy (Mitoxantrone + Etoposide + Cytarabine (MEC)) on high risk myeloid leukemias.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Must have histologic evidence of advanced myeloid leukemias defined as one of the following: primary refractory non-M3 AML; relapsed non-M3 AML; secondary AML; intermediate or poor prognosis de novo AML in patients who are \>= 60 years old
•\>= 18 years of age
•ECOG performance status of 0, 1
•Able to consume oral medication
•Initial laboratory values: creatinine \<= 2.0 mg/dL; total or direct bilirubin \<= 1.5/dL; SGPT(ALT) \<= 3xULN; negative pregnancy test for women with child-bearing potential
•Ejection fraction of \>= 45%

Exclusion Criteria

•Subjects with FAM B3
•Must not be receiving chemotherapy (except Hydroxyurea)
•Not receiving growth factors, except for erythropoietin
•Subjects with a "currently active" second malignancy other than non-melanoma skin cancers
•Subjects with uncontrolled high blood pressure, unstable angina, symptomatic congestive heart failure, MI within the last 6 months or uncontrolled cardiac arrhythmia
•Subjects taking diltiazem
•Subjects who require HIV protease inhibitors or those with AIDS-related illnesses
•No evidence of cerebellar dysfunction at baseline or during prior cytarabine therapy
•Not pregnant or breastfeeding
•Uncontrolled infection
+1 more criteria

Locations (1)

University of Pennsylvania Abramson Cancer Center

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

July 1, 2007

Primary Completion Date

January 1, 2010

Completion Date

June 1, 2010

Last Updated

July 12, 2019

Enrollment

ACTUAL participants

Conditions

Myeloid LeukemiasAMLLeukemiaCML

Interventions

Rapamycin, Mitoxantrone, Etoposide, Cytarabine

DRUG

Rapamycin + MEC

DRUG

Venetoclax for the Treatment of Patients With Relapsed Hairy Cell Leukemia

NCT06311227

Recurrent Hairy Cell LeukemiaRecurrent Hairy Cell Leukemia Variant

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RECRUITINGPHASE1

Phase I Study of HC-7366 for Acute Myeloid Leukemia

NCT06285890

Acute Myeloid Leukemia

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RECRUITING

Long-term Evaluation and Follow-up Care of Patients Treated With Stem Cell Transplants

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 12, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Sirolimus in Combination With MEC in High Risk Myeloid Leukemias

Inclusion Criteria

Exclusion Criteria

Venetoclax for the Treatment of Patients With Relapsed Hairy Cell Leukemia

Phase I Study of HC-7366 for Acute Myeloid Leukemia

Long-term Evaluation and Follow-up Care of Patients Treated With Stem Cell Transplants

Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma

VAC Regimen for AML Patients Who Failed to Response to VA Regimen

Study of Venetoclax Combined With Azacitidine Regimen in Newly Diagnosed T-ALL Patients