Palbociclib and Dexamethasone in Treating Participants With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia
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ClinicalTrials.gov Identifier: NCT03472573 |
Recruitment Status :
Completed
First Posted : March 21, 2018
Last Update Posted : June 3, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Recurrent B Acute Lymphoblastic Leukemia Refractory B Acute Lymphoblastic Leukemia | Drug: Palbociclib Drug: Dexamethasone | Phase 1 |
PRIMARY OBJECTIVES:
I. To determine the dose and schedule of the combination of palbociclib and dexamethasone in patients with relapsed or refractory adult B-cell acute lymphoblastic leukemia (ALL).
ii. To determine the safety and tolerability of the combination of palbociclib and dexamethasone in patients with relapsed or refractory adult B-cell ALL.
SECONDARY OBJECTIVES:
I. To evaluate the activity of palbociclib in combination with dexamethasone in patients with relapsed or refractory B-cell ALL.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 7 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I Trial of Palbociclib in Combination With Dexamethasone in Relapsed or Refractory Adult B-Cell Acute Lymphoblastic Leukemia (ALL) |
Actual Study Start Date : | May 9, 2018 |
Actual Primary Completion Date : | August 4, 2021 |
Actual Study Completion Date : | August 4, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Treatment (palbociclib, dexamethasone)
INDUCTION: Participants receive palbociclib PO daily and dexamethasone PO daily for 28 days in the absence of disease progression or unacceptable toxicity. Participants with disease response (M0, M1, or M2) continue to Maintenance. Patients without a disease response discontinue treatment. MAINTENANCE: Participants receive dexamethasone with a taper PO daily on days 1-7. Participants also receive palbociclib daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
Drug: Palbociclib
Given PO
Other Names:
Drug: Dexamethasone Given PO
Other Names:
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- Incidence of dose limiting toxicities (DLT) of the combination of palbociclib and dexamethasone [ Time Frame: Up to 28 days after discontinuation of palbociclib and dexamethasone ]Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 should be used for grading.
- Maximum tolerated dose (MTD) of the combination of palbociclib and dexamethasone defined as the highest dose level where a DLT occurs in at most one out of six patients treated [ Time Frame: Up to 28 days after discontinuation of palbociclib and dexamethasone ]CTCAE version 4.03 should be used for grading.
- Clinically relevant responses to therapy determined by bone marrow biopsy [ Time Frame: Up to 1 year ]Response rate defined as the proportion of patients who achieve an M, M1, or M2 response will be estimated along with a 95% confidence interval.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients must have histologic evidence of relapsed or refractory B-cell ALL
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Philadelphia chromosome positive (Ph+) patients must be refractory to or intolerant of standard tyrosine kinase inhibitor therapy
- Patients must be able to consume oral medication
- Patients must have recovered to =< grade 1 or stabilized from the toxic effects of any prior chemotherapy (except alopecia)
- Creatinine clearance (CrCL) >= 60 mL/min/1.73 m^2 calculated by Cockcroft-Gault
- Total bilirubin < 1.5 x upper limit of normal (ULN)
- Negative serum or urine pregnancy test for women with child-bearing potential
- Patients must be able to sign consent and be willing and able to comply with scheduled visits, treatment plan, procedures, and laboratory testing
Exclusion Criteria:
- Patients must not have evidence of active central nervous system (CNS) disease
- Patients must not be receiving any chemotherapy agents (except hydroxyurea); intrathecal methotrexate and intrathecal cytarabine are permissible
- Patients must not be receiving growth factors (granulocyte colony-stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor [GM-CSF]), except for erythropoietin
- Patient must not have a concurrent active malignancy for which they are receiving treatment.
- Patients with other severe concurrent disease which in the judgment of the investigator would make the patient inappropriate for entry into this study are ineligible
- Patients must not have received any investigational agents within 30 days of study entry unless they have exceeded 5 terminal half-lives of the previous study drug used for treatment
- Patients must not be pregnant or breastfeeding; pregnancy tests must be obtained for all females of child-bearing potential within 10 days prior to enrollment; males or women of childbearing potential may not participate unless they have agreed to use an effective contraceptive method (defined as hormonal contraceptives, intrauterine devices, surgical contraceptives, or condoms)
- Patients who have uncontrolled infection are not eligible; patients must have any active infections under control; fungal disease must have been adequately treated for at least 2 weeks before study entry; subjects with bacteremia must have documented negative blood cultures prior to study entry
- Patients who are candidates for allogeneic transplantation, have a suitable donor, and are willing to undergo transplantation
- Patients who are eligible for and willing to receive treatment with tisagenlecleucel.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03472573
United States, Pennsylvania | |
Sidney Kimmel Cancer Center at Thomas Jefferson University | |
Philadelphia, Pennsylvania, United States, 19107 |
Principal Investigator: | Margaret Kasner, MD | Sidney Kimmel Cancer Center at Thomas Jefferson University |
Responsible Party: | Sidney Kimmel Cancer Center at Thomas Jefferson University |
ClinicalTrials.gov Identifier: | NCT03472573 |
Other Study ID Numbers: |
17P.676 |
First Posted: | March 21, 2018 Key Record Dates |
Last Update Posted: | June 3, 2022 |
Last Verified: | June 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Dexamethasone Palbociclib Anti-Inflammatory Agents Antiemetics |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |