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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
All Individual Drugs Already Approved
Approved for 60 Other Conditions
No Placebo-Only Group
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Dose-limiting Toxicity (DLT)
Secondary study objectives
Overall response rate (ORR)
Side effects data
From 2021 Phase 3 trial • 693 Patients • NCT0202850763%
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%
Flu like symptoms
10%
Obesity
9%
Pain in extremity
9%
Constipation
8%
Fever
7%
Pruritus
7%
Bone pain
7%
Dizziness
7%
Dyspepsia
7%
Hot flashes
5%
Dysgeusia
5%
Pain
3%
Nail disorder
3%
Respiratory infection
3%
Abdominal pain
1%
Spinal cord compression
1%
Heart failure
1%
Bronchial infection
1%
Pleural effusion
1%
Ascites
1%
Urinary tract infection
1%
Breast infection
1%
Dyspnea
1%
Gallbladder infection
1%
Renal failure
1%
Thromboembolic event
1%
Dislocation of hip
1%
Palmar-plantar erythrodysesthesia syndrome
1%
Osteonecrosis of jaw
1%
Cholecystitis acute
1%
Gastrointestinal infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 2: Palbociclib Plus Fulvestrant
Cohort 1 and 2: Capecitabine
Cohort 1: Palbociclib Plus Exemestane
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 60 Other Conditions
This treatment demonstrated efficacy for 60 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Palbociclib
FDA approved
Bortezomib
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
2,469 Previous Clinical Trials
17,501,725 Total Patients Enrolled
Tanja A Gruber, MDPrincipal InvestigatorStanford Universiy
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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 1 -(without Ph+ / Ph like mutation)
- Group 2: Cohort 2-(Ph+ / Ph like ALL subtypes):
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.
- Approved for 60 Other Conditions - This treatment demonstrated efficacy for 60 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
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