A PHASE 1 STUDY OF PALBOCICLIB (IND#141416) A CDK 4/6 INHIBITOR IN COMBINATION WITH CHEMOTHERAPY IN CHILDREN WITH RELAPSED ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) OR LYMPHOBLASTIC LYMPHOMA (LL)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Relapsed Acute Lymphoblastic Leukemia (all) Or Lymphoblastic Lymphoma (ll)
  • Age: Between 1 - 30 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1) Patients with recurrent or refractory B- or T-lineage lymphoblastic leukemia and lymphoma. Patients with LL must have either measurable or evaluable disease. 2) Patients with first or greater relapsed T-lineage ALL or LL and second or greater relapsed B-lineage ALL or LL are eligible. Patients with primary refractory disease with at least 2 prior induction attempts or first relapse refractory to at least one prior re-induction attempt are eligible. Patients with refractory disease, however, must not have received a standard 4-drug re-induction inclusive of a steroid, anthracycline, asparaginase and vincristine in combination (e.g., UKALLR3 or AALL01P2) as their most recent prior therapy but they may have received a re-induction regimen that contain some of these agents.

You may not be eligible for this study if the following are true:

  • 1) Patients who are currently receiving other anti-cancer agents are not eligible [except patients receiving hydroxyurea, which may be continued until 24 hours prior to start of protocol therapy]. 2) Patients who are currently receiving drugs that are strong inhibitors and/or inducers of CYP3A4 or sensitive CYP3A4 substrates and CYP3A4 substrates with a narrow therapeutic range are not eligible. Strong inducers or inhibitors of CYP3A4 are prohibited from 14 days prior to enrollment to the end of the study. See Appendix III for a list of agents.
Currently Recruiting

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