Must have platelet count ? 100 x 10^9/L within 14 days prior to randomization. Must not have required transfusion of platelets within 1 week of baseline platelet assessment.
Evidence of mucosal or internal bleeding or platelet transfusion refractory
Platelet count > 100,000/mm^3 (100 x 10^9/L). Must not have required transfusion of platelets within 1 week of baseline platelet count assessment.
Platelet count ? 50 × 109/L (without transfusion or thrombopoietin or thrombopoietin analogues within 2 weeks of study entry)
Platelet count ? 100 x 10?/L (?100,000/cubic millimeters)
Disease-related platelet transfusion within 8 weeks of registration
Evidence of mucosal or internal bleeding and/or are platelet transfusion refractory (i.e. platelet count fails to increase by > 10,000 cells/mm3 after transfusion of an appropriate dose of platelets)
Platelet count ? 50,000/uL, with or without transfusion support
Platelet count ? 100,000/mm3 without transfusion.
Platelet count >= 100 x 10^9/L (in absence of blood transfusion).
STRATUM A: Platelet count >= 50,000/mm^3 without support of a platelet transfusion within 7 days of the test
STRATUM B: Platelet count >= 50,000/mm^3 without support of a platelet transfusion within 7 days of the test
STRATUM C: Platelet count >= 50,000/mm^3 without support of a platelet transfusion within 7 days of the test
Research participant platelet count must be > 100,000; however, if platelet level is between 75,000-99,000, then CAR T-cell infusion may proceed after platelet transfusion is given and the post transfusion platelet count is > 100,000
Platelet count >= 100,000/uL (no platelet transfusion within 7 days prior to obtaining laboratory result)
Platelet count > 100,000/uL without platelet transfusion within the past 7 days
Within 7 days prior to administration of study treatment: Platelet count >= 100 x 10^9/L (unless due to bone marrow infiltration by tumor, in which case platelet >=50,000/ mm^3 is allowed).
Platelet counts >=100,000/uL (without transfusion support) results within 7 days before study drug administration
Platelet count of greater than 20,000/ul, with no platelet transfusion in prior 2 weeks
FOR ALL PHASES (Ib AND II): Blood or platelet transfusion within 7 days prior to treatment start
Platelet count < 75,000 mm3 without transfusion support within 7 days prior to testing
PHASE I: Subjects must have absolute neutrophil count (ANC) > 1,000 for 3 days and platelet transfusion independence as defined as a platelet count > 20,000 for 7 days
PHASE II: Subjects must have ANC > 1,000 for 3 days and platelet transfusion independence as defined as a platelet count > 20,000 for 7 days
FULL STUDY INCLUSION CRITERIA: Platelet count >= 75,000/mm^3, without platelet transfusion within 3 weeks before the start of study treatment
Performed within 14 days (+ 3 working days) prior to registration: Platelet count of > 100,000/mm^3 (may be reached by transfusion).
Platelet count of >= 100,000/mm^3 (Note: Transfusion or growth factor may be used for eligibility outside of 7 days)
Platelet count < 50 × 10^9/L in the 4 weeks before screening or platelet transfusion(s) within 8 weeks before screening
To be performed within 10 business days prior to day 1: Platelets >= 50,000/mm^3; NOTE: platelet transfusion and packet red blood cell transfusion can be given prior to enrollment to achieve a target platelet (Plt) >= 50,000/uL and hemoglobin of >= 8.5 g/dL
Platelet > 20 x 10^9/L without platelet transfusion within 1 week
Platelet count >= 50,000 (platelet [plt]/mm^3), with or without transfusion support; NOTE: If the patient’s bone marrow biopsy shows greater than or equal to 50% plasma cells, the platelet count should be > 3 0,000 plt/mm^3 (transfusion support or growth factor support is acceptable)
Platelet count of greater than 20,000/mul, with no platelet transfusion in 2 weeks prior to registration; this criteria is waived if the thrombocytopenia is due to bone marrow involvement with the disease
Adequate engraftment within 7 days prior to starting study therapy: ANC ? 1.0 x 109/L without daily use of myeloid growth factor; and platelet ? 25 x 109/L without platelet transfusion within 1 week
Platelet count >= 100,000/mm^3 (no transfusion within 7 days of enrollment)
Platelet count >= 40 x 10^3/mm^3 (may be post-transfusion)
Research participant platelet count must be >= 100,000; however, if platelet level is between 75,000-99,000, then T-cell infusion may proceed after platelet transfusion is given and the post transfusion platelet count is >= 100,000
Platelet count >= 20 x 10^9/L and able to achieve a platelet count of >= 50 x 10^9/L with transfusion support
Platelet count >= 100,000/uL (may be a post transfusion value)
Platelet ?100 x 10^9/L, without transfusion within 7 days preceding the lab assessment
Platelet count (>=) 10*10^9 per liter (L) (prior platelet transfusion is permitted)
Platelet count ? 100,000/mm3 (IU: ? 100 × 109/L) (excluding measurements obtained within 7 days after a transfusion of platelets).
Platelet count ?10,000 ?L with or without transfusion support
Platelet count ? 100 x 109/L (100,000/µL) without transfusion
Platelet count >= 100,000/mm^3 and no transfusion in prior 4 weeks, within 28 days of day 0.
Platelet count >= 50,000/uL; platelet transfusion is not permitted within 7 days of screening
Obtained within 14 days (or as stipulated) prior to study drug (treatment) administration: platelet count ? 50,000/ul (without platelet transfusion in the previous 5 days)
Platelet count >= 100,000/ul (no platelet transfusion for more than 3 days)
Platelet count >= 100 x 10^9/L (no transfusion allowed within 2 weeks)
Patients on Part C with acute lymphoblastic leukemia: platelet count >= 20,000/mm^3 (may receive platelet transfusions); these patients must not be known to be refractory to red cell or platelet transfusion
Platelet count must be >= 50,000/mm^3 (not achieved by transfusion)
Platelet count must be >= 75,000/mm^3 (not achieved by transfusion) unless due to underlying disease in which case there is no grade restriction
Platelet count ? 30,000 cells/?L without transfusion support 7 days before assessment. Subjects with transfusion-dependent thrombocytopenia are excluded.
Within 56 days prior to randomization: Platelet count >= 50,000/mcL (50 x 10^9/L) without platelet transfusion
Patient has evidence of mucosal or internal bleeding and/or is platelet transfusion refractory
Platelet count >= 100 x 10^9/L without transfusion, obtained within 14 days prior to initiation of study treatment
Patients with significant pulmonary dysfunction, large intracranial metastases, or significant thrombocytopenia (platelet count refractory to transfusion)
Subjects with evidence of mucosal or internal bleeding and/or platelet refractory (i.e., unable to maintain a platelet count >= 50,000 cells/mm^3)
Platelet count < 75,000 cells/mm^3 at time of screening evaluation; transfusion may not be used to meet platelet eligibility criteria within 7 days of obtaining screening evaluation
Platelet count >= 100 x 10^9/L without platelet transfusion within 7 days
Platelet count >= 40 x 10^3/mm^3 (may be post-transfusion)
Hematologic function, as follows (no platelet transfusion within 2 weeks and no RBC transfusion within 4 days before the first dose of study drug)
Platelet transfusion within 2 weeks and RBC transfusion within 4 days before the first dose of study drug
At least 4 weeks (28 days) prior to registration: Platelet count >= 100 x 10^9/L (no transfusion allowed within 2 weeks)
Platelet count > 100,000/uL without platelet transfusion within the past 7 days
Platelet count ? 10,000 ?L with or without transfusion support
Platelet count < 75,000 cells/mm^3 at time of screening evaluation; transfusion may not be used to meet platelet eligibility criteria within 7 days of obtaining screening evaluation
Platelet count >= 75,000/m^3 (no transfusion within 7 days of enrollment)
Platelet count >= 20,000/ul without transfusion for 7 days
Platelet count ? 75 × 109/L without previous transfusion within 10 days of first study drug administration
Platelet count >= 50,000/uL (platelet count must be assessed at least 7 days after a prior transfusion, if any)
Received platelet transfusion within 14 days prior to Screening evaluations.
The mean of the two platelet counts taken within 1 month prior to dosing must be =< 50 x 10^9/L; platelets counts must reflect pre-transfusion trough results or be obtained no sooner than 1 week after platelet transfusion to assure stable baseline platelet count; the platelet count obtained should be outside the expected nadir of prior therapies
Platelet count >= 20,000/mm^3 without transfusion support and no abnormal bleeding
Patients >= 35 days post HCT with platelet count =< 20 x 10^9/l sustained for 7 days or patients are platelet transfusion dependent
Platelet count >= 75,000/mm^3 (without platelet transfusion or myeloid growth factor support within two weeks of screening)
Patients must have platelet count >= 10,000/mm^3 within 72 hours of initiating the induction cycle (for patients with platelets < 10,000/mm^3 at baseline, platelet transfusion support is allowed which is institutional standard of care for AML)
Platelet count must be >= 75,000/mm^3 (not achieved by transfusion)
Patients with evidence of mucosal or internal bleeding and/or platelet transfusion refractory (i.e., unable to maintain a platelet count ? 50,000 cells/dL).
Platelet count >= 100,000 cells/mm3 without transfusion or growth factor requirement
Platelet count ? 100,000/mm3 (without platelet transfusion or growth factor support in the preceding 7 days);
Platelet count >= 100,000/uL (without transfusion within 2 weeks prior to cycle 1, day 1)
Platelet >= 50 x 10^9/L (without transfusion)
Platelet count ? 100 x 10^9/L within 14 days prior to randomization. Must not have required transfusion within 1 week of baseline platelet assessment.
Platelet count < 75,000 mm3 without transfusion support within 7 days prior to testing
Platelet count 75 x 109/L without platelet transfusion within one week. Adequate organ function:
Platelet count ? 50,000/µL, with or without transfusion support; platelet count < 50,000/µL but ? 20,000/µL, with or without transfusion support, is permissible if the subject has not had Grade ? 2 bleeding in the prior 6 months (where grading of the bleeding is determined per the National Cancer Institute's Common Terminology Criteria for Adverse Events [CTCAE], version 5.0)
Platelet count >= 20 x 10^9/L (without transfusion support within 2 weeks of registration)
Platelet count >= 20,000/mm^3 (may receive platelet transfusions); these patients must not be known to be refractory to red cell or platelet transfusion
Patient requiring platelet transfusion threshold of > 20 x 10^9/L
Failure to achieve platelet engraftment (defined as platelet count >= 20 x 10^9/L on 3 consecutive measurements without transfusion for 7 days) by day +28 post UCBT
Patients requiring more than one platelet transfusion per day
Anticipated platelet count =< 50 x 10^9/L for >= 5 days within 72 hours of enrollment
Platelet count >= 75,000/uL (> 72 hours since prior platelet transfusion)
Subjects must have a platelet count of >= 30,000 to receive immunizations; patients requiring platelet transfusions are eligible to enroll and must have a platelet count >= 30,000 within 72 hours prior to their immunization, or platelet count >= 75,000 without transfusion documented within 30 days for subjects < 12 months post-transplant and within 90 days for subjects 12-35 months post-transplant
FOR THE 31 SUBJECTS ENROLLED IN YEAR 1: Subjects must have a platelet count of >= 30,000 to receive the immunizations; patients requiring platelet transfusions are eligible to enroll and must have a platelet count >= 30,000 within 72 hours prior to their immunization, or platelet count >= 75,000 without transfusion documented within 30 days for subjects < 12 months post-transplant and within 90 days for subjects 12-35 months post-transplant
Subjects must have a platelet count of >= 30,000 to receive the immunizations; patients requiring platelet transfusions are eligible to enroll and must have a platelet count >= 30,000 within 72 hours prior to their immunization; for subjects < 12 months post-transplant, if a platelet count of >= 75,000 is documented without transfusion support within 14 days of the immunization, then an additional platelet count does not need to be repeated prior to immunization; for subjects 12-23 months post-transplant, if a platelet count of >= 75,000 is documented without transfusion support within 90 days of the immunization, then an additional platelet count does not need to be repeated prior to immunization
Platelet count of < 50,000 that cannot be corrected with transfusion
Platelet count >= 75,000/mm^3 without transfusion support > 7 days prior to registration
Platelet count >= 100,000/mm^3 (without transfusion within 2 weeks prior to cycle 1, day 1)
Evidence of mucosal or internal bleeding and/or is platelet transfusion refractory
Mucosal or internal bleeding, or platelet transfusion refractory