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CINJALL: Treatment for Children With Acute Lymphocytic Leukemia


Phase 2
1 Year
30 Years
Not Enrolling
Both
Acute Lymphocytic Leukemia

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Trial Information

CINJALL: Treatment for Children With Acute Lymphocytic Leukemia


Outline of Therapy:

Combinations of chemotherapy drugs will be given orally, intravenously and intrathecally
(directly into the cerebrospinal fluid by spinal tap) over a period of roughly two and a
half years.

Therapy will be divided into five phases:

Induction (4 weeks): chemotherapy given to produce a clinical remission (defined by normal
blood counts, with the absence of leukemia cells in the blood and fewer than 5% leukemia
cells in the bone marrow).

Consolidation (11 weeks): chemotherapy given to consolidate the remission. Delayed
Intensification (7 weeks) Intensive chemotherapy aimed at killing any resistant leukemia
cells will be given only for patients at high risk of relapse.

Intensive Continuation (approximately 1 year): Eight week cycles of chemotherapy, given
eight times.

Continuation (final year of therapy): Eight week cycles of largely oral chemotherapy, with
one clinic visit for a lumbar puncture every eight weeks.

Irradiation: radiation will be given in the middle of intensive continuation to the head and
spine of those patients who have leukemia cells found in the cerebrospinal fluid at the time
of diagnosis.

Follow-up: After the conclusion of therapy, there will be periodic office visits, initially
monthly, then gradually spaced out to annual visits. The purpose of these visits is to
evaluate for late side-effects of therapy.

Inclusion Criteria


Inclusion/Exclusion Criteria:

Newly Diagnosed ALL, excluding mature B-cell ALL (surface Ig positive) Patients with overt
CNS or testicular disease are eligible Informed consent according to institutional and FDA
guidelines. Adequate organ function is required. All patients with evidence of
significant organ dysfunction not thought to be attributable to ALL (patients with
clinically significant congestive heart failure, cardiac ejection fraction <40%, total
bilirubin >2, serum creatinine >2) will be ineligible. Note: echocardiogram or MUGA are
required prior to therapy ONLY for those patients with history or physical findings
suggestive of cardiac dysfunction not directly attributable to anemia or ALL. Note:
Patients with total bilirubin >2 but direct (conjugated) bilirubin less than the upper
limit of normal will still be eligible. These patients should be evaluated for deficiency
of the enzyme glucuronyl transferase.

HIV seropositive patients will not be excluded from this study. Patients with medical,
psychological, or psychiatric problems that are likely to compromise their ability to
tolerate intensive therapy will be ineligible. Any questions about the appropriateness of
patient for this study should be directed to the Principal Investigator.

Patients greater than 1 year of age and less than 29.99 years of age are eligible.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The purpose of this research study is to identify better ways to treat children and young adults with acute lymphocytic leukemia (ALL).

Outcome Time Frame:

3 years

Safety Issue:

Yes

Principal Investigator

Peter Cole, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Medicine and Dentistry New Jersey

Authority:

United States: Food and Drug Administration

Study ID:

020101-0220003389

NCT ID:

NCT00176462

Start Date:

February 2001

Completion Date:

September 2008

Related Keywords:

  • Acute Lymphocytic Leukemia
  • Acute Lymphocytic Leukemia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

Name

Location
Cancer Institute of New Jersey New Brunswick, New Jersey  08901