Phase 2
N=30
Treatment of Older Adults With Acute Lymphoblastic Leukemia
Acute Lymphoblastic Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT00973752 ↗Enrolled (actual)
30
Serious AEs
33.3%
Results posted
Mar 2017
Primary outcome: Primary: Overall Survival at One Year — 19 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Prednisone (Drug); Vincristine (Drug); Doxorubicin (Drug); PEG-asparaginase (Drug); Cytarabine (Drug); Methotrexate (Drug); Imatinib (Drug); Clofarabine (Drug); 6 Mercaptopurine (Drug)
- Age
- Adult, Older Adult · 51+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival at One Year |
19 | — |
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.
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT00973752). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.