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

NCT03472573 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: 17P.676JT 11586
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent B Acute Lymphoblastic Leukemia; Refractory B Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (2)

• Incidence of dose limiting toxicities (DLT) of the combination of palbociclib and dexamethasone

  Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 should be used for grading.

  Up to 28 days after discontinuation of palbociclib and dexamethasone

• 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

  CTCAE version 4.03 should be used for grading.

  Up to 28 days after discontinuation of palbociclib and dexamethasone

Secondary Outcomes (1)

• Clinically relevant responses to therapy determined by bone marrow biopsy

  Up to 1 year

Study Arms (1)

Treatment (palbociclib, dexamethasone)

EXPERIMENTAL

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; Drug: Dexamethasone

Interventions

Palbociclib DRUG

Given PO

Also known as: 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

Treatment (palbociclib, dexamethasone)

Dexamethasone DRUG

Given PO

Also known as: Baycuten, Cortidexason, Decacort, Desamethasone, Gammacorten, Loverine, Millicorten, Visumetazone

Treatment (palbociclib, dexamethasone)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University: lead
• Pfizer: collaborator

Study Sites (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

• Thomas Jefferson University Hospital

MeSH Terms

Conditions

Burkitt Lymphoma

Interventions

palbociclib; Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Margaret Kasner, MD

  Sidney Kimmel Cancer Center at Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: March 21, 2018
• Study Start: May 9, 2018
• Primary Completion: August 4, 2021
• Study Completion: June 9, 2022
• Last Updated: May 15, 2025

Record last verified: 2025-05

Locations

US (1)