Palbociclib in Combo w/Chemotherapy in Peds Relapsed/Refractory Acute Lymphoblastic Leukemia (NCT04996160) | Clinical Trial Compass
CompletedPhase 1
Palbociclib in Combo w/Chemotherapy in Peds Relapsed/Refractory Acute Lymphoblastic Leukemia
United States2 participantsStarted 2021-07-09
Plain-language summary
With this research study has following goals
* To confirm the highest tolerable dose of palbociclib in combination with chemotherapy is safe and well-tolerated.
* To learn more about side effects of palbociclib in combination with chemotherapy;
* To learn more about the biological effects of palbociclib on the cells in your body
Who can participate
Age range25 Years
SexALL
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Inclusion criteria
✓. Participants must have a diagnosis of acute lymphoblastic leukemia and disease meets at least one of the following criteria:
✓. relapsed or refractory to chemotherapy as defined by ≥ 5% leukemic blasts in the bone marrow or flow cytometry confirmed leukemic blasts in the peripheral blood
✓. relapsed after hematopoietic stem cell transplantation (HSCT)
✓. Subjects must have had histologic, morphologic or flow cytometric verification of the malignancy at relapse
✓. Prior Treatment:
✓. Subjects who relapse while receiving standard ALL maintenance chemotherapy will not be required to have a waiting period before entry onto this study.
Exclusion criteria
✕. At least 14 days must have elapsed since the completion of cytotoxic therapy, with the exception of standard maintenance therapy and steroids.
✕. At least 7 days must have elapsed since completion of therapy with a biologic agent. For agents that have known adverse events occurring beyond 7 days after administration, this period prior to enrollment must be extended beyond the time during which adverse events are known to occur.
✕. At least 3 half lives must have elapsed since prior therapy that included a monoclonal antibody with the exception of blinatumomab. Subjects must have been off blinatumomab infusion for at least 7 days and all drug related toxicity must have resolved to Grade 2 or lower as outlined in the inclusion/exclusion criteria.
✕
What they're measuring
1
Dose-limiting Toxicity (DLT)
Timeframe: within 30 days from last treatment with palbociclib.
. At least 42 days must have elapsed since CAR T cell therapy.
✕. At least 90 days have elapsed since bone marrow transplant and participant is off immune suppression for \> 2 weeks, if applicable with no evidence of active GVHD.
✕. At least 2 weeks must have elapsed since local XRT (small port); ≥ 3 months must have elapsed if prior cranial or craniospinal XRT was received, if ≥ 50% of the pelvis was irradiated, or if TBI was received; ≥ 6 weeks must have elapsed if other substantial bone marrow irradiation was given.
✕. Participants must be \< 25 years of age.
✕. Karnofsky or Lansky performance score is \> 50% (corresponding to ECOG Score of \< 2). The Lansky performance score should be used for participants \< 16 years and the Karnofsky performance score for participants ≥ 16 years (see Appendix D). Subjects who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.