A Novel "Pediatric-Inspired" Regimen With Reduced Myelosuppressive Drugs for Adults (Aged 18-60) With Newly Diagnosed Ph Negative Acute Lymphoblastic Leukemia



Status:Recruiting
Conditions:Blood Cancer, Leukemia
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 60
Updated:9/7/2018
Start Date:August 2013
End Date:August 2019
Contact:Jae Park, MD
Phone:212-639-4048

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The purpose of the study is to find out whether the combination of chemotherapy drugs that
are routinely used in children with ALL, will be safe and effective in treating adult
patients with ALL. The standard treatment for adults with ALL consists of many chemotherapy
drugs that are given in different combinations and in several steps. In adult ALL there is no
standard which drugs to give and how to combine them. Some leukemias have a chromosome
abnormality called Philadelphia chromosome (also called Ph Positive) and some leukemias do
not (called Ph Negative). In this study we want to see whether this combination of
chemotherapy drugs will be safe and effective in treating adult patients with Ph Negative
ALL.


Inclusion Criteria:

- Previously untreated Ph negative precursor B-cell or T-cell ALL confirmed by
conventional flow cytometry or immunohistochemical stain Patients who have untreated
B-cell or T-cell ALL confirmed by conventional flow cytometry or immunohistochemical
stain, but Ph status is unknown, may also enroll.

- Patients with T-cell or B cell lymphoblastic lymphoma confirmed by conventional
immature T- or pre B cell markers even if the bone marrow is not involved are also
eligible

- Age 18 - 60 years

- ECOG performance status of 0-2

- Adequate renal function as demonstrated by a serum creatinine ≤ 2.0 mg/dl or a
creatinine clearance of > 60 ml/min.

- Adequate hepatic function as demonstrated by a total bilirubin < 2.0 mg/dl (unless
attributable to Gilbert's disease) and an alkaline phosphatase, AST, and ALT ≤ 4 times
the upper limit of normal (unless clinically considered to be related to liver
involvement with leukemia

- Normal cardiac function as demonstrated by a left ventricular ejection fraction ≥ 50%
on echocardiogram or MUGA scan

- Negative serum pregnancy test in women of childbearing potential

- Men and women of childbearing potential must be willing to practice an effective
method of birth control during treatment and at least 4 months after treatment is
finished.

- Patients with central nervous system involvement by ALL are eligible and may receive
concomitant treatment with radiation therapy and/or intrathecal chemotherapy in
accordance with standard medical practice. For patients with CNS disease,
dexamethasone may be temporarily administered instead of prednisone to reduce CNS
pressure, at the discretion of the treating physician and after discussion with the
MSK PI. Once dexamethasone is no longer needed, prednisone should be given as per
protocol for 28 days.

Exclusion Criteria:

- Previous treatment for ALL, except for prior steroids and/or hydroxyurea

- Patients known to have Philadelphia (Ph)+ ALL are not eligible. Leukemia cell samples
will be obtained from all patients enrolled before starting protocol treatment and
submitted for Philadelphia chromosome testing by either karyotyping, or for bcr/abl1
translocation by FISH or by PCR for bcr/abl1. Patients who are later found to have Ph+
ALL should have treatment on this trial discontinued and will not be considered in the
evaluation

- Lymphoid blastic crisis of chronic myelogenous leukemia

- Mature B-cell (Burkitt's) ALL

- Active serious infections not controlled by antibiotics

- Pregnant women or women who are breast-feeding

- Concurrent active malignancy requiring immediate therapy

- Clinically significant cardiac disease (NY Heart Association Class III or IV),
including chronic arrhythmias, or pulmonary disease

- Known HIV positive status

- Other serious or life-threatening conditions deemed unacceptable by the principal
investigator
We found this trial at
4
sites
Allentown, Pennsylvania 18105
Phone: 610-402-7880
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Jae Park, MD
Phone: 212-639-4048
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, New York 10065
Principal Investigator: Ellen Ritchie, MD
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