Leukemia Clinical Trial
Official title:
DFCI ALL Adult Consortium Protocol: Adult ALL Trial
Verified date | October 2009 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | Unspecified |
Study type | Interventional |
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer
cells, either by killing the cells or by stopping them from dividing. Giving more than one
drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This phase II trial is studying the side effects of combination chemotherapy and to
see how well it works in treating adult patients with newly diagnosed acute lymphoblastic
leukemia.
Status | Not yet recruiting |
Enrollment | 180 |
Est. completion date | |
Est. primary completion date | January 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 50 Years |
Eligibility |
DISEASE CHARACTERISTICS: - Diagnosis of acute lymphoblastic leukemia (ALL) - No known mature B-cell ALL*, defined by the presence of surface immunoglobulin, L3 morphology, t(8;14)(q24;q32), t(8;22), or t(2;8) - Patients with T-cell surface markers and t(8;14)(q24;q11) are eligible NOTE: *Patients with mature B-cell ALL will be removed from the study as soon as that diagnosis is made. - No secondary ALL (i.e., ALL arising after another malignancy) PATIENT CHARACTERISTICS: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No known HIV positivity (HIV testing is not required) - No comorbid medical condition that would, in the investigator's opinion, make participation in this study and adherence to the study guidelines a compromise to the study objectives - No active psychiatric or mental illness that would make giving informed consent or careful clinical follow-up unlikely PRIOR CONCURRENT THERAPY: - No prior anti-leukemic therapy except = 1 week of steroids, emergent radiotherapy to the mediastinum, hydroxyurea, or emergent leukapheresis - Patients who have received steroids within the past 7 days are eligible but will not receive steroid prophase therapy on study - No concurrent chronic steroids or anti-metabolite therapy |
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Ohio State University Comprehensive Cancer Center | National Cancer Institute (NCI) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of intensification therapy, measured as the percentage of patients who, having achieved a complete remission after induction therapy, receive > 25 weeks of pegaspargase IV as part of intensification therapy | No | ||
Primary | Toxicity | Yes | ||
Secondary | Complete remission rate | No | ||
Secondary | Disease-free and overall survival | No | ||
Secondary | Prognostic significance of prednisone prophase response, minimal residual disease at various time points, tyrosine kinase mutations, and gene expression profiles at diagnosis | No |
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