Children's National Medical Center(5.4 mi away)Contact
+18 other location
stem cell transplantation
graft versus host disease
stem cell infusion
bone marrow procedure
blood cell count
left ventricular fractional shortening
AINV18P1 is a Phase 1 study where palbociclib will be administrated in combination with a
standard re-induction platform in pediatric relapsed Acute Lymphoblastic Leukemia (ALL) and
lymphoblastic lymphoma (LL). LL patients are included because the patient population is rare
and these patients are most commonly treated with ALL regimens. The proposed palbociclib
starting dose for this study will be 50 mg/m^2/day for 21 days.
I. To estimate the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of
palbociclib administered in combination with re-induction chemotherapy in pediatric patients
with relapsed B- or T-lineage ALL/LL.
II. To define and describe the toxicities of palbociclib administered on this schedule.
III. To characterize the pharmacokinetics of palbociclib in pediatric patients with relapsed
B- or T-lineage ALL/LL.
I. To preliminarily define the antitumor activity of palbociclib in combination with
chemotherapy for children with relapsed ALL/LL within the confines of a Phase 1 study.
II. To assess the biologic activity of palbociclib in this patient population.
Patients receive Palbociclib PO (or via NG-tube) once daily on Days 1-21; Intrathecal
cytarabine (IT ARAC) on Day 1, Doxorubicin IV push or infusion over 1-15 min on Day 4;
Prednisone or prednisolone PO on days 4-31; Vincristine IV push or mini-bag per institutional
policy on Days 4, 11, 18, and 25; and Pegaspargase IV over 1-2 hours on Days 5, and 18. If
CNS3 leukemia is present, patients receive Intrathecal Triple Therapy (ITT) on days 4, 11,18,
and 25. If CNS1 or 2 disease status, patients receive Methotrexate (IT MTX) on Days 18 and
32. Patients known to be CNS3 at study entry may receive ITT on Day 1 rather than IT ARAC.
Treatment will be given for one cycle, 32 days, in the absence of disease progression or
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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