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Treatment of Older Adults With Acute Lymphoblastic Leukemia

NCT00973752 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-03-30

Study results available
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Summary

The purpose of this study is to determine the safety and effectiveness of a multi-drug regimen (which includes prednisone, vincristine, cytarabine, doxorubicin, 6 mercaptopurine, and methotrexate) which is considered standard treatment for children and young adults with acute lymphoblastic leukemia (ALL), in combination with PEG-asparaginase and clofarabine to treat older adults with ALL. PEG-asparaginase has been used in chemotherapy treatment regimens for both children and adults with ALL. Clofarabine has been used in chemotherapy treatment regimens for children with ALL and has been shown to decrease the number of leukemia cells. Participants with leukemia that has an abnormal chromosome, called the Philadelphia chromosome, will also be given imatinib.

Conditions

Interventions

DRUG

Prednisone

Orally during Induction, Consolidation 1, CNS, Consolidation 2, and Continuation therapy.

DRUG

Vincristine

Intravenously during Induction, CNS, Consolidation 2 and Continuation Therapy

DRUG

Doxorubicin

Intravenously during Induction, CNS, and Consolidation 2 therapy

DRUG

PEG-asparaginase

Intravenously during Induction, Consolidation 1, CNS, and Consolidation 2 therapy

DRUG

Cytarabine

Intrathecally during Induction and CNS therapy

DRUG

Methotrexate

Intrathecally during Induction, CNS, and Continuation Therapy

DRUG

Imatinib

Orally during Induction, Consolidation 1, CNS, Consolidation 2 and Continuation Therapy

DRUG

Clofarabine

Intravenously during Consolidation 1 Therapy

DRUG

6 Mercaptopurine

Orally during CNS, Consolidation 2 and Continuation Therapy

Sponsors & Collaborators

Principal Investigators

  • Amir Fathi, MD · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
51 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2014-12-31
Completion
2016-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00973752 on ClinicalTrials.gov