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Treatment of Older Adults With Acute Lymphoblastic Leukemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00973752
First Posted: September 9, 2009
Last Update Posted: March 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Enzon Pharmaceuticals, Inc.
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Amir Fathi, Massachusetts General Hospital
  Purpose
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.

Condition Intervention Phase
Acute Lymphoblastic Leukemia Drug: Prednisone Drug: Vincristine Drug: Doxorubicin Drug: PEG-asparaginase Drug: Cytarabine Drug: Methotrexate Drug: Imatinib Drug: Clofarabine Drug: 6 Mercaptopurine Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Older Adults With Acute Lymphoblastic Leukemia

Resource links provided by NLM:


Further study details as provided by Amir Fathi, Massachusetts General Hospital:

Primary Outcome Measures:
  • Overall Survival at One Year [ Time Frame: 1 years ]
    The number of participants alive one year after baseline.


Enrollment: 30
Study Start Date: August 2009
Study Completion Date: April 2016
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   51 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00973752


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Massachusetts General Hospital
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Enzon Pharmaceuticals, Inc.
Genzyme, a Sanofi Company
Investigators
Principal Investigator: Amir Fathi, MD Massachusetts General Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amir Fathi, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00973752     History of Changes
Other Study ID Numbers: 08-356
First Submitted: September 8, 2009
First Posted: September 9, 2009
Results First Submitted: December 16, 2016
Results First Posted: March 30, 2017
Last Update Posted: March 30, 2017
Last Verified: February 2017

Keywords provided by Amir Fathi, Massachusetts General Hospital:
ALL

Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Doxorubicin
Clofarabine
Pegaspargase
Methotrexate
Prednisone
Cytarabine
Vincristine
Asparaginase
6-Mercaptopurine
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites