Palbociclib and Dexamethasone in Treating Participants With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia

NCT ID: NCT03472573

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-09
• Study Completion Date: 2022-06-09

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.

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.

Conditions

Recurrent B Acute Lymphoblastic Leukemia; Refractory B Acute Lymphoblastic Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Palbociclib

Intervention Type: DRUG

Given PO

Dexamethasone

Intervention Type: DRUG

Given PO

Interventions

Palbociclib

Given PO

Intervention Type: DRUG

Dexamethasone

Given PO

Intervention Type: DRUG

Other Intervention 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; Baycuten; Cortidexason; Decacort; Desamethasone; Gammacorten; Loverine; Millicorten; Visumetazone

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Sidney Kimmel Cancer Center at Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Margaret Kasner, MD

Role: PRINCIPAL_INVESTIGATOR

Sidney Kimmel Cancer Center at Thomas Jefferson University

Locations

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://hospitals.jefferson.edu/

Thomas Jefferson University Hospital

Other Identifiers

JT 11586

Identifier Type: OTHER

Identifier Source: secondary_id

17P.676

Identifier Type: -

Identifier Source: org_study_id