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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 : Recruiting
First Posted : March 21, 2018
Last Update Posted : December 8, 2020
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

Study Description
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Brief Summary:
This phase I trial studies the side effects and best dose of palbociclib when given together with dexamethasone in treating participants with B-cell acute lymphoblastic leukemia that has come back after a period of improvement or does not respond to treatment. Palbociclib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Dexamethasone is a steroid medication that is used in combination with other medications to treat B-cell acute lymphoblastic leukemia. Giving palbociclib together with dexamethasone may work better in treating patients with B-cell acute lymphoblastic leukemia.

Condition or disease Intervention/treatment Phase
Recurrent B Acute Lymphoblastic Leukemia Refractory B Acute Lymphoblastic Leukemia Drug: Palbociclib Drug: Dexamethasone Phase 1

Detailed Description:

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 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
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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:
  • 571190-30-2
  • 6-Acetyl-8-cyclopentyl-5-methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-8h-pyrido(2,3-d)pyrimidin-7-one
  • Ibrance
  • PD-0332991

Drug: Dexamethasone
Given PO
Other Names:
  • Baycuten
  • Cortidexason
  • Decacort
  • Desamethasone
  • Gammacorten
  • Loverine
  • Millicorten
  • Visumetazone


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Margaret Kasner, MD 215-955-8874 margaret.kasner@jefferson.edu

Locations
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United States, Pennsylvania
Sidney Kimmel Cancer Center at Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Margaret Kasner, MD    215-955-8874    margaret.kasner@jefferson.edu   
Principal Investigator: Margaret Kasner, MD         
Sponsors and Collaborators
Sidney Kimmel Cancer Center at Thomas Jefferson University
Pfizer
Investigators
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Principal Investigator: Margaret Kasner, MD Sidney Kimmel Cancer Center at Thomas Jefferson University
More Information
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Additional Information:

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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: December 8, 2020
Last Verified: December 2020

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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
Additional relevant MeSH terms:
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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