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CDK4/6 Inhibitor
Palbociclib + Chemotherapy for Acute Lymphoblastic Leukemia
Phase 1
Recruiting
Led By Tanja A Gruber, MD
Research Sponsored by Tanja Andrea Gruber
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trial is testing the safety and effectiveness of a new cancer drug.
Who is the study for?
This trial is for children and young adults under 25 with acute lymphoblastic leukemia that's come back or didn't respond to treatment. They should be off certain medications, have no severe infections, and not be pregnant. Participants need functioning major organs and a minimum performance score indicating they can do daily activities.Check my eligibility
What is being tested?
The study tests the highest dose of palbociclib (a cancer drug) that's safe when given with chemotherapy in young patients with leukemia. It aims to understand the side effects and how this drug affects cancer cells in the body.See study design
What are the potential side effects?
Possible side effects include those common to chemotherapy like nausea, hair loss, low blood cell counts leading to increased infection risk, fatigue, as well as potential liver issues. Palbociclib may also cause low white blood cell counts which can lead to infections.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose-limiting Toxicity (DLT)
Secondary outcome measures
Overall response rate (ORR)
Side effects data
From 2023 Phase 2 trial • 55 Patients • NCT0300797996%
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%
Arthralgia
35%
Anorexia
35%
Hyponatremia
35%
Cough
35%
Aspartate aminotransferase increased
33%
Edema limbs
33%
Alanine aminotransferase increased
33%
Creatinine increased
31%
Hyperkalemia
31%
Hypercalcemia
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%
Hyperglycemia
20%
Dysgeusia
20%
Depression
20%
Myalgia
20%
Fall
19%
Pain in extremity
19%
Rash maculopapular
17%
Peripheral sensory neuropathy
17%
Upper respiratory infection
17%
Sinusitis
17%
Fever
17%
Anxiety
17%
Sore throat
15%
Hypoalbuminemia
13%
Urinary tract infection
13%
Hyperhidrosis
13%
Bone pain
13%
Nasal congestion
13%
Dry skin
11%
Hypernatremia
11%
Allergic rhinitis
11%
Weight loss
9%
Hypophosphatemia
9%
Epistaxis
9%
COVID-19
9%
Dysphagia
7%
Blurred vision
7%
Skin infection
7%
Non-cardiac chest pain
7%
Tooth infection
7%
Vertigo
7%
Breast pain
7%
Bronchitis
7%
Postnasal drip
7%
Common cold
7%
Neck pain
7%
Lymphedema
6%
Cellulitis
6%
Knee pain
6%
Death
6%
Cataract
6%
Dehydration
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%
Back spasms
4%
Burn
4%
Vaginal dryness
4%
Flu-like symptoms
4%
Watering eyes
4%
Edema trunk
4%
Dry eye
4%
Head injury
4%
Skin bump
4%
Sinus pain
4%
Right arm numbness
4%
Nodule
4%
Hip pain
4%
Peripheral motor neuropathy
4%
Memory impairment
4%
Hypothyroidism
4%
Broken tooth
4%
Abdominal 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%
Intrascapular pain
2%
Paronychia
2%
Puncture wound
2%
Urine discoloration
2%
Pharyngitis
2%
Sinus tachycardia
2%
Vaginal discharge
2%
Hemorrhoids
2%
Leg pain
2%
Wrist fracture
2%
Activated partial thromboplastin time prolonged
2%
Hypermagnesemia
2%
Erythema multiforme
2%
Erythema right breast
2%
Vaginal infection
2%
Sinus congestion
2%
Localized edema
2%
Yeast infection
2%
Diverticulitis
2%
Sepsis
2%
Photophobia
2%
Blood bilirubin increased
2%
Facial nerve disorder
2%
Paresthesia
2%
Urinary retention
2%
Agitation
2%
Oral fissure
2%
Eye lid pain
2%
Flank pain
2%
Cognitive disturbance
2%
Generalized weakness
2%
Rhinovirus
2%
Wound infection
2%
COPD
2%
Nail loss
2%
Fracture
2%
Fever blister
2%
Wrist pain
2%
Hoarseness
2%
Laryngeal inflammation
2%
Bladder infection
2%
Fungal toe infection
2%
Respiratory syncytial virus (RSV)
2%
Shoulder nodule
2%
Vaginal itching
2%
Lung cancer
2%
Hyperuricemia
2%
Bilateral nares sores
2%
Peeling lips
2%
Vaginal itch
2%
Head injury - upper left occipital swelling
2%
Acoustic neuroma
2%
Eye lid pain/soreness
2%
Open cutaneous area left breast
2%
Peeling skin palms of hands
2%
Mole pain
2%
Itchy scalp
2%
Spinal fracture
2%
Cold sweats
2%
Radiation recall reaction (dermatologic)
2%
Asthma
2%
Hand cramps
2%
Left hand puncture wound
2%
C. difficile
2%
Gait disturbance
2%
Myocardial infarction
2%
Red eye
2%
Groin pain
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
2Treatment groups
Experimental Treatment
Group I: Cohort 2-(Ph+ / Ph like ALL subtypes):Experimental Treatment4 Interventions
Dose escalation phase- 12 subjects in Cohort 2, Palbociclib dose escalation will begin at 75 mg/m2/day, on Days 1 to 5; 11 to 15; and 21 to 30, and escalate or de escalate. All subjects will receive palbociclib with dexamethasone, bortezomib, and doxorubicin. dexamethasone of each 30 day cycle for up to 3 cycles for responders which include complete remission, complete remission morphologic, and partial response as defined in section 10.2.1. Bortezomib will be given on Days 7, 10, 17 and 20. Doxorubicin will be given on Days 7 and 17. Subjects with Ph+ / Ph-like mutation will receive a tyrosine kinase inhibitor (TKI or KI, either dasatinib or ruxolitinib).3 on 3 dose escalation with 2 dose levels.
Group II: Cohort 1 -(without Ph+ / Ph like mutation)Experimental Treatment4 Interventions
Dose expansion phase-10 subjects in Cohort 1, 100 mg/m2/daily palbociclib on Days 1 to 5; 11 to 15; and 21 to 30, in combination with chemotherapy. All subjects will receive palbociclib with dexamethasone, bortezomib, and doxorubicin. dexamethasone of each 30 day cycle for up to 3 cycles for responders which include complete remission, complete remission morphologic, and partial response as defined in section 10.2.1. Bortezomib will be given on Days 7, 10, 17 and 20. Doxorubicin will be given on Days 7 and 17.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Palbociclib
FDA approved
Bortezomib
FDA approved
Doxorubicin
FDA approved
Dexamethasone
FDA approved
Find a Location
Who is running the clinical trial?
Tanja Andrea GruberLead Sponsor
1 Previous Clinical Trials
90 Total Patients Enrolled
Stanford UniversityLead Sponsor
2,400 Previous Clinical Trials
17,341,807 Total Patients Enrolled
Tanja A Gruber, MDPrincipal InvestigatorStanford Universiy
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You can breathe comfortably and have no trouble exercising, and your oxygen levels are above 94%.If you have taken bortezomib or other similar drugs in the past and they didn't work for you, you cannot participate. But if you had a good response initially and then the condition came back, you can still participate.You need to wait for at least 42 days after receiving CAR T cell therapy.You have taken a medication called palbociclib or other drugs that work similarly to it in the past.You have had a bone marrow transplant and your disease has come back.You are currently receiving chemotherapy or targeted anti-cancer medications, except for medications that are directly delivered into the spinal canal (intrathecal therapy).
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 2-(Ph+ / Ph like ALL subtypes):
- Group 2: Cohort 1 -(without Ph+ / Ph like mutation)
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 60 Other Conditions - This treatment demonstrated efficacy for 60 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What conditions does Palbociclib commonly address?
"Palbociclib is typically prescribed to address synovitis, however it may also offer relief from ophthalmia, sympathetic conditions, branch retinal vein occlusion and macular edema."
Answered by AI
What adverse effects have been observed with Palbociclib usage?
"Due to its status as a Phase 1 trial, which has limited data on safety and efficacy, Palbociclib's risk is estimated at 1 by the Power team."
Answered by AI
Are there any open slots in this experiment for participants?
"This medical study is actively searching for new participants, as confirmed by data hosted on clinicaltrials.gov. It was first posted in July 2021 and the most recent update occurred two months later in September 2021."
Answered by AI
Has Palbociclib been tested in any other scientific investigations?
"Currently, 1027 clinical trials for Palbociclib are in progress. Of these, 258 have moved past Phase 3 of the process and Joliet, Illinois is home base to many studies related to this treatment. However, it can be found at a total of 46926 research locations worldwide."
Answered by AI
Is this research the initial examination of its type?
"Palbociclib has had a long history of observed research, with the inaugural trial sponsored by Alfacell in 1997. After this first study involving 300 participants, Palbociclib was given Phase 3 drug approval. Currently, 1027 studies regarding this medication are ongoing across 2763 cities and 80 countries."
Answered by AI
What is the scope of participants for this research experiment?
"Affirmative. One can find that the clinical trial is currently open to recruit participants on clinicaltrials.gov, which was first published in July 9th 2021 and recently edited on September 20th 2021; this research project aims to enroll 22 individuals across one facility."
Answered by AI
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