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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
relapsed after hematopoietic stem cell transplantation (HSCT)
At least 42 days must have elapsed since CAR T cell therapy
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have had a bone marrow transplant and your disease has come back.
Select...
You need to wait for at least 42 days after receiving CAR T cell therapy.
Select...
You can breathe comfortably and have no trouble exercising, and your oxygen levels are above 94%.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

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 • NCT03007979
91%
White blood cell count decreased
87%
Neutrophil count decreased
87%
Hypertension
83%
Fatigue
76%
Anemia
72%
Lymphocyte count decreased
57%
Nausea
54%
Back pain
52%
Diarrhea
52%
Hot flashes
44%
Headache
44%
Arthralgia
43%
Cough
43%
Alopecia
41%
Anorexia
41%
Dizziness
39%
Insomnia
35%
Hypercalcemia
35%
Pain
33%
Creatinine increased
33%
Platelet count decreased
31%
Dyspnea
31%
Edema limbs
31%
Hyponatremia
31%
Constipation
30%
Hyperkalemia
30%
Aspartate aminotransferase increased
28%
Peripheral sensory neuropathy
28%
Alkaline phosphatase increased
28%
Vomiting
28%
Alanine aminotransferase increased
28%
Hypocalcemia
28%
Depression
26%
Mucositis oral
26%
Anxiety
24%
Dyspepsia
22%
Chills
22%
Rash maculopapular
20%
Dysgeusia
20%
Hyperglycemia
19%
Sinusitis
19%
Dry skin
17%
Allergic rhinitis
17%
Hypokalemia
17%
Sore throat
17%
Myalgia
17%
Fall
15%
Hypoalbuminemia
15%
Upper respiratory infection
13%
Fever
13%
Hyperhidrosis
11%
Epistaxis
11%
Urinary tract infection
11%
Breast pain
11%
Bone pain
11%
Arthritis
11%
Lymphedema
9%
Skin infection
9%
Knee pain
9%
Hypernatremia
9%
Pain in extremity
9%
Pleural effusion
9%
Nasal congestion
9%
Dysphagia
9%
Gastroesophageal reflux disease
7%
Hypophosphatemia
7%
Itchy skin
7%
Postnasal drip
7%
Common cold
7%
Neck pain
7%
Thromboembolic event
6%
Blurred vision
6%
Respiratory syncytial virus (RSV)
6%
Vertigo
6%
Red eye
6%
Non-cardiac chest pain
6%
Psoriasis
6%
Body aches
6%
Buttock pain
6%
Bronchitis
6%
Lung infection
6%
Sacroliac joint pain
6%
Shoulder pain
6%
Osteopenia
6%
Rash acneiform
6%
Leg stiffness
6%
Gout
6%
Weight loss
6%
Blister
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%
Hypothyroidism
4%
Broken tooth
4%
Sinus pain
4%
Hemoglobin increased
4%
Dry mouth
4%
Tick bite
4%
Allergic reaction
4%
Extremity infection
4%
Hypoglycemia
4%
Generalized muscle weakness
4%
Sleep apnea
4%
Right thumb bump
4%
Urinary frequency
4%
Chest pain - cardiac
4%
Muscle cramp
4%
Muscle spasm
4%
Bruising
4%
Bug bite
4%
Burn - left hand
4%
Brittle nail
2%
Gait disturbance
2%
Peeling lips
2%
Cataract
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%
Erythema multiforme
2%
Peeling skin palms of hands
2%
Urinary retention
2%
Mole pain
2%
Itchy scalp
2%
Spinal fracture
2%
Tooth infection
2%
Laryngeal inflammation
2%
Activated partial thromboplastin time prolonged
2%
Abdominal pain
2%
Fracture
2%
Urine discoloration
2%
Asthma
2%
Hoarseness
2%
Wrist fracture
2%
Hand cramps
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%
Dry lips
2%
Paronychia - infection right middle
2%
Snake bite
2%
Muscle weakness lower limb
2%
Right arm pain
2%
Mitral valve disease
2%
Tinnitus
2%
Vestibular schwannoma
2%
Oral dysesthesia
2%
Oral pain
2%
Stomach pain
2%
Toothache
2%
Ulcerative colitis
2%
Acute bronchitis
2%
COVID-19
2%
Otitis media
2%
INR increased
2%
Lymphocyte count increased
2%
Hypomagnesemia
2%
Bilateral leg pain
2%
Chest wall pain
2%
Flank pain
2%
Left sided flank pain
2%
Sternum pain
2%
ADHD
2%
Confusion
2%
Hallucinations
2%
Mood swings
2%
Nasal dryness
2%
Productive cough
2%
Rhinovirus
2%
Voice alteration
2%
Cellulitis
2%
Hypotension
2%
Cold sensitivity
2%
Sciatic pain
2%
Osteonecrosis of jaw
2%
Nasal drainage
2%
Heart failure
2%
Skin bumps
2%
Skin hypopigmentation
2%
Acute kidney injury
2%
Asystole
2%
Generalized weakness
2%
Sepsis
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%
Eye lid pain
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
Dexamethasone
FDA approved
Bortezomib
FDA approved
Palbociclib
FDA approved
Doxorubicin
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
2,374 Previous Clinical Trials
17,332,905 Total Patients Enrolled
Tanja A Gruber, MDPrincipal InvestigatorStanford Universiy

Media Library

Palbociclib (CDK4/6 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04996160 — Phase 1
Acute Lymphoblastic Leukemia Research Study Groups: Cohort 1 -(without Ph+ / Ph like mutation), Cohort 2-(Ph+ / Ph like ALL subtypes):
Acute Lymphoblastic Leukemia Clinical Trial 2023: Palbociclib Highlights & Side Effects. Trial Name: NCT04996160 — Phase 1
Palbociclib (CDK4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04996160 — Phase 1

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
~6 spots leftby Mar 2025