Treatment of Older Adults With Acute Lymphoblastic Leukemia
1 other identifier
interventional
30
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2009
Longer than P75 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 8, 2009
CompletedFirst Posted
Study publicly available on registry
September 9, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedResults Posted
Study results publicly available
March 30, 2017
CompletedMarch 30, 2017
February 1, 2017
5.3 years
September 8, 2009
December 16, 2016
February 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival at One Year
The number of participants alive one year after baseline.
1 years
Study Arms (1)
Experimental
EXPERIMENTALAll patients treated on same arm
Interventions
Orally during Induction, Consolidation 1, CNS, Consolidation 2, and Continuation therapy.
Intravenously during Induction, CNS, Consolidation 2 and Continuation Therapy
Intravenously during Induction, Consolidation 1, CNS, and Consolidation 2 therapy
Orally during Induction, Consolidation 1, CNS, Consolidation 2 and Continuation Therapy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- Dana-Farber Cancer Institutecollaborator
- Beth Israel Deaconess Medical Centercollaborator
- Enzon Pharmaceuticals, Inc.collaborator
- Genzyme, a Sanofi Companycollaborator
Study Sites (3)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Related Publications (1)
Fathi AT, DeAngelo DJ, Stevenson KE, Kolitz JE, Asch JD, Amrein PC, Attar EC, Steensma DP, Wadleigh M, Foster J, Connolly C, Galinsky I, Devoe CE, Stone RM, Neuberg DS, Ballen KK. Phase 2 study of intensified chemotherapy and allogeneic hematopoietic stem cell transplantation for older patients with acute lymphoblastic leukemia. Cancer. 2016 Aug 1;122(15):2379-88. doi: 10.1002/cncr.30037. Epub 2016 May 12.
PMID: 27171984DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Amir Fathi
- Organization
- Massachusetts General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Amir Fathi, MD
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 8, 2009
First Posted
September 9, 2009
Study Start
August 1, 2009
Primary Completion
December 1, 2014
Study Completion
April 1, 2016
Last Updated
March 30, 2017
Results First Posted
March 30, 2017
Record last verified: 2017-02