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Treatment of Older Adults With Acute Lymphoblastic Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Enzon Pharmaceuticals, Inc.
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Karen Ballen, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00973752
First received: September 8, 2009
Last updated: January 13, 2014
Last verified: January 2014
  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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Massachusetts General Hospital:

Primary Outcome Measures:
  • To determine the feasibility, toxicity and efficacy of this aggressive treatment regimen in adult patients 51-75. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: August 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    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

Ages Eligible for Study:   51 Years to 75 Years
Genders Eligible for Study:   Both
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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00973752

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
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: Karen Ballen, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Karen Ballen, Director, Leukemia Program, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00973752     History of Changes
Other Study ID Numbers: 08-356
Study First Received: September 8, 2009
Last Updated: January 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
ALL

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
6-Mercaptopurine
Asparaginase
Methotrexate
Pegaspargase
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014