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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 must not have had leukemia therapy for 14 days prior to starting palbociclib. However, patients with rapidly proliferative disease may receive hydroxyurea as needed until 24 hours prior to starting therapy on this protocol and during the first cycle of study
Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient or his legally authorized representative is required prior to their enrollment on the protocol
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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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I haven't received leukemia treatment in the last 14 days, except possibly hydroxyurea.
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I understand the study's requirements and have signed the consent form.
Select...
My leukemia has returned or didn't respond to treatment, and no standard treatments are expected to work.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
I have relapsed or refractory acute lymphoblastic leukemia.
Select...
My leukemia has returned or didn't respond to treatment, and no standard treatments are expected to work.
Select...
I have relapsed or refractory acute lymphoblastic leukemia.
Select...
I can take care of myself but might not be able to do heavy physical work.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose (MTD) as determined by dose limiting toxicity (DLT)
Secondary outcome measures
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)
Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
+1 more

Side effects data

From 2023 Phase 2 trial • 55 Patients • NCT03007979
96%
White blood cell count decreased
87%
Neutrophil count decreased
80%
Anemia
74%
Lymphocyte count decreased
67%
Hypertension
61%
Fatigue
56%
Diarrhea
54%
Nausea
43%
Platelet count decreased
41%
Alopecia
39%
Headache
39%
Hot flashes
37%
Dizziness
37%
Insomnia
37%
Dyspepsia
35%
Anorexia
35%
Cough
35%
Hyponatremia
35%
Arthralgia
35%
Aspartate aminotransferase increased
33%
Edema limbs
33%
Alanine aminotransferase increased
33%
Creatinine increased
31%
Hypercalcemia
31%
Hyperkalemia
31%
Mucositis oral
31%
Vomiting
31%
Hypocalcemia
30%
Dyspnea
30%
Alkaline phosphatase increased
30%
Back pain
28%
Constipation
26%
Pain
26%
Hypokalemia
24%
Chills
20%
Dysgeusia
20%
Hyperglycemia
20%
Depression
20%
Myalgia
20%
Fall
19%
Pain in extremity
19%
Rash maculopapular
17%
Upper respiratory infection
17%
Sinusitis
17%
Fever
17%
Peripheral sensory neuropathy
17%
Anxiety
17%
Sore throat
15%
Hypoalbuminemia
13%
Urinary tract infection
13%
Hyperhidrosis
13%
Bone pain
13%
Nasal congestion
13%
Dry skin
11%
Allergic rhinitis
11%
Hypernatremia
11%
Weight loss
9%
Epistaxis
9%
Hypophosphatemia
9%
COVID-19
9%
Dysphagia
7%
Blurred vision
7%
Skin infection
7%
Tooth infection
7%
Vertigo
7%
Non-cardiac chest pain
7%
Breast pain
7%
Bronchitis
7%
Postnasal drip
7%
Common cold
7%
Neck pain
7%
Lymphedema
6%
Cataract
6%
Knee pain
6%
Cellulitis
6%
Dehydration
6%
Death
6%
Itchy skin
6%
Psoriasis
6%
Body aches
6%
Buttock pain
6%
Lung infection
6%
Allergic reaction
6%
Hypoglycemia
6%
Urinary frequency
6%
Osteopenia
6%
Rash acneiform
6%
Gout
6%
Bug bite
6%
Arthritis
6%
Thromboembolic event
4%
Dry eye
4%
Right arm numbness
4%
Nodule
4%
Watering eyes
4%
Edema trunk
4%
Flu-like symptoms
4%
Vaginal dryness
4%
Hip pain
4%
Peripheral motor neuropathy
4%
Skin bump
4%
Head injury
4%
Memory impairment
4%
Back spasms
4%
Burn
4%
Abdominal pain
4%
Hypothyroidism
4%
Broken tooth
4%
Sinus pain
4%
Dry lips
4%
Toothache
4%
Tick bite
4%
Extremity infection
4%
Hypomagnesemia
4%
Generalized muscle weakness
4%
Pleural effusion
4%
Sleep apnea
4%
Right thumb bump
4%
Osteonecrosis of jaw
4%
Chest pain - cardiac
4%
Acute kidney injury
4%
Muscle cramp
4%
Muscle spasm
4%
Gastroesophageal reflux disease
4%
Bruising
4%
Burn - left hand
4%
Brittle nail
2%
Gait disturbance
2%
Peeling lips
2%
Paresthesia
2%
Vaginal itch
2%
Photophobia
2%
Facial nerve disorder
2%
Erythema right breast
2%
Head injury - upper left occipital swelling
2%
Acoustic neuroma
2%
Radiation recall reaction (dermatologic)
2%
Eye lid pain/soreness
2%
Open cutaneous area left breast
2%
Respiratory syncytial virus (RSV)
2%
Erythema multiforme
2%
Peeling skin palms of hands
2%
Urinary retention
2%
Mole pain
2%
Itchy scalp
2%
Spinal fracture
2%
Laryngeal inflammation
2%
Groin pain
2%
Bilateral nares sores
2%
Sepsis
2%
Yeast infection
2%
Sinus congestion
2%
Wrist pain
2%
Hyperuricemia
2%
Vaginal infection
2%
Rhinovirus
2%
Myocardial infarction
2%
Flank pain
2%
Cognitive disturbance
2%
Generalized weakness
2%
Bladder infection
2%
Vaginal itching
2%
Wound infection
2%
Shoulder nodule
2%
Puncture wound
2%
Lung cancer
2%
Sinus tachycardia
2%
Intrascapular pain
2%
Leg pain
2%
Localized edema
2%
Hypermagnesemia
2%
Agitation
2%
Eye lid pain
2%
Blood bilirubin increased
2%
Fever blister
2%
Cold sweats
2%
Fungal toe infection
2%
COPD
2%
Diverticulitis
2%
Paronychia
2%
Activated partial thromboplastin time prolonged
2%
Fracture
2%
Urine discoloration
2%
Asthma
2%
Hoarseness
2%
Wrist fracture
2%
Hand cramps
2%
Red eye
2%
C. difficile
2%
Hemorrhoids
2%
Pharyngitis
2%
Left hand puncture wound
2%
Vaginal discharge
2%
Nail loss
2%
Oral fissure
2%
Superficial thrombophlebitis
2%
Paronychia - infection right middle
2%
Snake bite
2%
Hemoglobin increased
2%
Muscle weakness lower limb
2%
Right arm pain
2%
Mitral valve disease
2%
Tinnitus
2%
Vestibular schwannoma
2%
Dry mouth
2%
Oral dysesthesia
2%
Oral pain
2%
Stomach pain
2%
Ulcerative colitis
2%
Acute bronchitis
2%
Otitis media
2%
INR increased
2%
Lymphocyte count increased
2%
Bilateral leg pain
2%
Chest wall pain
2%
Left sided flank pain
2%
Sternum pain
2%
ADHD
2%
Confusion
2%
Sacroliac joint pain
2%
Shoulder pain
2%
Hallucinations
2%
Mood swings
2%
Nasal dryness
2%
Productive cough
2%
Voice alteration
2%
Hypotension
2%
Cold sensitivity
2%
Sciatic pain
2%
Nasal drainage
2%
Heart failure
2%
Skin bumps
2%
Skin hypopigmentation
2%
Leg stiffness
2%
Asystole
2%
Failure to thrive
2%
Intracranial hemorrhage
2%
Gastric ulcer
2%
Gingival pain
2%
Hematochezia
2%
Hemorrhoidal hemorrhage
2%
Dilation of appendix with periappendiceal fat stranding seen on CT
2%
Edema face
2%
Yeast infection under right breast
2%
Weight gain
2%
Spasticity
2%
Syncope
2%
Blister
2%
Sores bilateral nares
2%
Stomach rash
2%
Tender nail bed
100%
80%
60%
40%
20%
0%
Study treatment Arm
Palbociclib + Letrozole or + Fulvestrant

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
Decitabine
2004
Completed Phase 3
~1680
Dexamethasone
2007
Completed Phase 4
~2590
Palbociclib
2017
Completed Phase 3
~3710
Sorafenib
2014
Completed Phase 3
~1670

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,962 Previous Clinical Trials
1,803,311 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,293 Total Patients Enrolled
Tapan M KadiaPrincipal InvestigatorM.D. Anderson Cancer Center
13 Previous Clinical Trials
1,119 Total Patients Enrolled

Media Library

Decitabine (DNA Methyltransferase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03132454 — Phase 1
Acute Myelogenous Leukemia Research Study Groups: Arm III (palbociclib, dexamethasone), Arm I (palbociclib, sorafenib), Arm II (palbociclib, decitabine)
Acute Myelogenous Leukemia Clinical Trial 2023: Decitabine Highlights & Side Effects. Trial Name: NCT03132454 — Phase 1
Decitabine (DNA Methyltransferase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03132454 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available slots for participation in this research study?

"The clinical trial's progress can be tracked on clinicaltrials.gov; the study was initially advertised on July 25th 2017 and most recently updated June 29th 2022, indicating that it is actively searching for participants."

Answered by AI

What related investigations have been done concerning Palbociclib?

"Currently, 838 Palbociclib trials are underway with 196 of them in the advanced Phase 3. Joliet, Illinois is a hub for research on this medication yet there are 29250 locations conducting clinical experiments involving Palbociclib across the globe."

Answered by AI

What potential hazards does Palbociclib present to individuals?

"Due to its Phase 1 status, Palbociclib has only been granted a score of 1 in terms of safety by the Power team since there is relatively limited clinical data available on efficacy and safety."

Answered by AI

How many participants have been enlisted for this medical research?

"Correct. The clinicaltrials.gov webpage confirms that the trial, which was first published on July 25th 2017, is still actively recruiting patients across one medical centre with a sample size of 54 individuals."

Answered by AI

What medical conditions can Palbociclib be used to address?

"Palbociclib is effective at treating ophthalmia, sympathetic eye conditions, branch retinal vein occlusions and macular edema."

Answered by AI
~5 spots leftby Dec 2024