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DNA Methyltransferase Inhibitor

Palbociclib Combination Therapy for Refractory Leukemia

Phase 1

Recruiting

Led By Tapan M Kadia

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with a diagnosis of histologically confirmed relapsed or refractory (R/R) acute myeloid leukemia or R/R acute lymphoblastic leukemia for which no available standard therapies are indicated or anticipated to result in a durable response

Eastern Cooperative Oncology Group (ECOG) performance status of =< 2

Must not have

Patients with active, uncontrolled central nervous system (CNS) leukemia will not be eligible

Uncontrolled intercurrent illness including, but not limited to active uncontrolled infection, symptomatic congestive heart failure (New York Heart Association [NYHA] class III or IV), unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the side effects and best dose of the drug palbociclib, given alone and with other drugs, to treat patients with leukemia that has returned or does not respond to previous treatment.

Who is the study for?

This trial is for adults with relapsed or refractory acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL), who have no standard treatment options left. They should not have received leukemia therapy in the last 14 days, must be physically stable with certain organ function levels maintained, and women of childbearing age need a negative pregnancy test and agree to use contraception.

What is being tested?

The study is testing palbociclib alone and combined with sorafenib, decitabine, or dexamethasone to see which works best for stopping tumor growth in recurrent or resistant leukemia. It's looking at side effects and the best doses for these drugs.

What are the potential side effects?

Possible side effects include damage to organs from blocking enzymes needed by cells, chemotherapy-related issues like cell death or division prevention that can lead to fatigue, infection risk increase, potential heart problems due to drug interactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My leukemia has returned or didn't respond to treatment, and no standard treatments are expected to work.

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I can take care of myself but might not be able to do heavy physical work.

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I have relapsed or refractory acute lymphoblastic leukemia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have active, uncontrolled leukemia in my brain or spinal cord.

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I do not have any severe illnesses that could interfere with the study.

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I do not have a history of serous retinopathy.

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I have been treated with palbociclib before.

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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum tolerated dose (MTD) as determined by dose limiting toxicity (DLT)

Secondary study objectives

Assessment of biomarkers of response and resistance

Efficacy as determined by complete response (CR]), complete remission without platelet recovery (CRp), complete remission without blood count recovery (CRi), partial response (PR), or clinical benefit (CB)

Pharmacodynamic (PD) effects of palbociclib

Side effects data

From 2021 Phase 3 trial • 693 Patients • NCT02028507

63%

Neutrophil count decreased

51%

Fatigue

37%

Hypertension

25%

Nausea

23%

Weight loss

19%

Back pain

17%

Diarrhea

17%

Headache

17%

Mucositis

16%

Weight gain

15%

Vomiting

13%

Hypothermia

13%

Arthralgia

12%

Anorexia

12%

Alopecia

11%

Anemia

11%

Cough

11%

Upper respiratory infection

10%

Obesity

10%

Flu like symptoms

Pain in extremity

Constipation

Fever

Bone pain

Dizziness

Dyspepsia

Hot flashes

Pruritus

Pain

Dysgeusia

Abdominal pain

Respiratory infection

Nail disorder

Spinal cord compression

Heart failure

Pleural effusion

Ascites

Breast infection

Dyspnea

Gallbladder infection

Renal failure

Dislocation of hip

Bronchial infection

Urinary tract infection

Thromboembolic event

Osteonecrosis of jaw

Palmar-plantar erythrodysesthesia syndrome

Cholecystitis acute

Gastrointestinal infection

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 2: Palbociclib Plus Fulvestrant

Cohort 1 and 2: Capecitabine

Cohort 1: Palbociclib Plus Exemestane

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Arm III (palbociclib, dexamethasone)Experimental Treatment2 Interventions

Patients receive palbociclib as in Arm I. Patients also receive dexamethasone PO QD or IV over 15-30 minutes on days 1-4 and 15-18 beginning on cycle 2. Treatment repeats every 28 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.

Group II: Arm II (palbociclib, decitabine)Experimental Treatment2 Interventions

Patients receive palbociclib as in Arm I. Beginning cycle 2, patients receive palbociclib PO QC on days 1-7 and decitabine IV QD over 1 hour on days 8-17 of cycle 2 and days 8-12 of cycles 3-8. Treatment repeats every 28 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.

Group III: Arm I (palbociclib, sorafenib)Experimental Treatment2 Interventions

Patients receive palbociclib PO QD on days 1-28. Patients also receive sorafenib PO QD on days 1-28 beginning on cycle 2. Treatment repeats every 28 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

2007

Completed Phase 4

~2650

Decitabine

2004

Completed Phase 3

~1720