Treatment of Older Adults With Acute Lymphoblastic Leukemia

February 10, 2017 updated by: Amir Fathi, Massachusetts General Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

  • This research study has stages of treatment as follows: 1) Induction 2) Consolidation 1 3) Stem cell of Bone Marrow Transplant (if the participant is eligible). If the participant does not have a transplant: 4) CNS Therapy 5) Consolidation 2 6) Continuation Therapy.
  • During all phases of study treatment, participants will have additional tests and procedures to monitor their health and for research purposes. These tests will include: physical exams, blood tests, bone marrow aspirate/biopsy and EKGs (electrocardiogram) and/or ECHOs (echo-cardiogram).
  • INDUCTION STAGE: This stage lasts for about one month. The study drugs and the way they are administered are as follows: Prednisone orally on days 1-21 for participants less than 60 and days 1-7 for participants 60 or greater; Vincristine intravenously on days 1, 8, 15 and 22; Doxorubicin intravenously on days 1 and 2; PEG-Asparaginase intravenously on days 7 and 21; Cytarabine intrathecally on day 1; Methotrexate intrathecally on day 29; Imatinib orally on days 14-29 if participant has the Philadelphia Chromosome.
  • After induction, if there is evidence of ALL in the spinal fluid, participants may need to receive more intrathecal therapy.
  • CONSOLIDATION 1 Therapy: This stage will last about one month. Participants will receive Consolidation 1 Therapy, regardless of whether or not their ALL is in full remission after Induction. The study drugs and the way they are administered are as follows: Prednisone orally days 1-5; Clofarabine intravenously days 1-5; PEG-Asparaginase intravenously days 1 and 15; Imatinib continues orally for participants with the Philadelphia Chromosome.
  • After the participants blood counts return to normal, their bone marrow will be tested. If the bone marrow shows remission, participants will proceed to the next stage of the study. If the bone marrow does not show remission, the participants will no longer continue on this study.
  • STEM CELL or BONE MARROW TRANSPLANTATION: The next stage is stem cell or bone marrow transplantation if the participant is eligible. If the participant receives a stem cell transplant, they will receive additional chemotherapy (separate from the study drugs) followed by an infusion of stem cells. If the participant receives a bone marrow transplant, they will have a bone marrow aspirate and biopsy 3 months after the transplant and 12 months from the start fo the induction to monitor the status of the ALL. If the participant receives a bone marrow or stem cell transplant, they will continue to be a part of the study, but will not proceed with CNS Therapy, Consolidation 2 Therapy, and Continuation Therapy.
  • CENTRAL NERVOUS SYSTEM (CNS) THERAPY: CNS therapy will begin between 2 and 6 weeks following the end of Consolidation 1. This stage will last about one month. The study drugs and the way they are administered are as follows: vincristine intravenously on day 1; doxorubicin intravenously on day 1; 6 mercaptopurine orally on days 1-14; prednisone orally on days 1-5; PEG-asparaginase intravenously on days 1 and 15; methotrexate/cytarabine/prednisone intrathecally weekly for 3 weeks; imatinib orally continues daily if the participant has the Philadelphia Chromosome.
  • Radiation therapy will also be given during this stage of the participant is under 60 years old. The purpose of radiation therapy is to prevent ALL from coming back in the brain. Radiation will be given in 8 treatments, given once a day, and will be scheduled with other study treatment.
  • CONSOLIDATION 2 THERAPY: This stage begins as soon as CNS Therapy ends and lasts about 8 months. Participants will receive repeated cycles of the study drug treatment about every 4 weeks. The study drugs and the way they are administered are as follows: vincristine intravenously on day 1; doxorubicin intravenously on day 1; 6 mercaptopurine orally on days 1-14; prednisone orally days 1-5; PEG-asparaginase orally on days 1 and 15 (first cycle only); imatinib orally continues daily if the participant has Philadelphia chromosome.
  • CONTINUATION THERAPY: This stage begins at the end of Consolidation 2 Therapy. The goal of this stage is to get rid of all of the ALL in the body. Participants will receive repeated cycles of the study drug treatment every 4 weeks. It will last until the participant has been in remission for 2 years. The study drugs and the way they are administered are as follows: vincristine intravenously on day 1; mercaptopurine orally on days 1-14; prednisone orally on days 1-5; methotrexate intravenously on day 15; imatinib orally continues daily if the participant has Philadelphia chromosome.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02115
        • Beth Israel Deaconess Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

51 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Acute lymphoblastic leukemia, excluding known mature B-cell ALL by the presence of any of the following: surface immunoglobulin, L3 morphology, t(8;14)(q24;q32), t(8;22), or t(2;8).
  • Patients with mature B-cell ALL will be removed from the protocol as soon as the diagnosis is made and should be treated on a B-cell leukemia protocol.
  • Patients with lymphoblastic lymphoma are also eligible
  • No prior anti-leukemic therapy except <1 week of steroids, and/or emergent radiation therapy to the mediastinum, or hydroxyurea or emergent leukopheresis. Longer steroid use for diseases other than leukemia is permitted.
  • Age 51-75 years
  • Ejection fraction > 45%
  • Creatinine < 2.0 mg/dl
  • Total bilirubin < 3.0 mg/dl
  • ECOG (Eastern Cooperative Oncology Group) Performance Status of 0, 1, 2
  • Non-pregnant and non lactating

Exclusion Criteria:

  • Known HIV positive
  • Comorbid medical condition, in the investigator's opinion, would make participation in this trial and adherence to the protocol guidelines difficult
  • Active psychiatric or mental illness making informed consent or careful clinical follow-up unlikely

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental
All patients treated on same arm
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall Survival at One Year
Time Frame: 1 years
The number of participants alive one year after baseline.
1 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Genzyme, a Sanofi Company
Enzon Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 8, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 9, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 08-356

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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