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Palbociclib + Chemotherapy for Childhood Leukemia and Lymphoma

Phase 1

Waitlist Available

Research Sponsored by Children's Oncology Group

Eligibility Criteria Checklist

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

Must have

Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients <= 16 years of age

Patients with first or greater relapsed T-lineage ALL or LL and second or greater relapsed B-lineage ALL or LL are eligible.

Must not have

Patients who are currently receiving drugs that are strong inhibitors and/or inducers of CYP3A4 or sensitive CYP3A4 substrates and CYP3A4 substrates with a narrow therapeutic range are not eligible

Patients who have an uncontrolled infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 26 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer drug in children with leukemia or lymphoma who have relapsed after previous treatment.

Who is the study for?

This trial is for children with relapsed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL). They should have a certain level of bone marrow blasts, measurable disease, and be in good enough health to participate. Patients must not have been treated with palbociclib before and should meet specific heart, kidney, and liver function requirements.

What is being tested?

The study tests the drug palbociclib combined with standard chemotherapy in pediatric patients who've had ALL or LL return after treatment. Palbociclib will be given at a starting dose of 50 mg/m^2/day for 21 days alongside re-induction chemotherapy.

What are the potential side effects?

Possible side effects include low blood cell counts leading to increased infection risk, bleeding or bruising; fatigue; nausea; hair loss from chemotherapy; and potential heart or liver issues due to medication toxicity.

Eligibility Criteria

Inclusion Criteria

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

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I am mostly able to care for myself, regardless of my age.

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My leukemia has relapsed at least once for T-lineage and twice for B-lineage.

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I have never taken palbociclib or similar medications.

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My heart is strong, with a good pumping efficiency.

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My leukemia involves more than 5% of immature blood cells in my bone marrow.

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My condition did not improve after at least 2 initial treatments or it came back and did not improve with another treatment.

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My leukemia has relapsed with more than 5% bone marrow blasts.

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My kidney function is good based on tests.

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My liver is functioning well according to my recent tests.

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My leukemia or lymphoma has come back or didn't respond to treatment.

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My leukemia or lymphoma has come back or didn't respond to treatment.

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My lymphoma can be measured or observed.

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I am mostly able to care for myself and carry out daily activities.

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My leukemia has relapsed at least once for T-lineage and twice for B-lineage.

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My disease didn't respond to at least 2 initial treatments or didn't respond to treatment after the first relapse.

Exclusion Criteria

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

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I am not taking medication that strongly affects certain liver enzymes.

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I do not have any infections that are currently uncontrolled.

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I am taking medication to prevent graft-versus-host disease after a bone marrow transplant.

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I have a genetic condition like Down syndrome or Fanconi anemia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 26 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 26 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 26 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Area Under the Drug Concentration Curve of Palbociclib

Clearance of Palbociclib

Frequency of Adverse Events of Palbociclib

+4 more

Secondary study objectives

Absolute Peripheral Blast Count of Palbociclib

CDK4 Expression of Palbociclib

CDK6 Expression of Palbociclib

+8 more

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%

Headache

17%

Mucositis

17%

Diarrhea

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

Dizziness

Dyspepsia

Hot flashes

Bone pain

Pruritus

Pain

Dysgeusia

Abdominal pain

Respiratory infection

Nail disorder

Spinal cord compression

Heart failure

Pleural effusion

Ascites

Breast infection

Dyspnea

Gallbladder infection

Dislocation of hip

Renal failure

Bronchial infection

Urinary tract infection

Thromboembolic event

Palmar-plantar erythrodysesthesia syndrome

Osteonecrosis of jaw

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

1Treatment groups

Experimental Treatment

Group I: Treatment (Palbociclib)Experimental Treatment9 Interventions

Patients receive Palbociclib 50 mg/m\^2 (starting dose with maximum dose of 100 mg) PO (or via NG-tube) once daily on Days 1-21; Intrathecal cytarabine (IT ARAC) age-based dosing on Day 1, Doxorubicin 60 mg/m\^2 IV push or infusion over 1-15 min on Day 4; Prednisone or prednisolone 40 mg/m\^2 PO divided BID or TID on days 4-31; Vincristine 1.5 mg/m\^2 (maximum dose 2 mg) IV push or mini-bag per institutional policy on days 4, 11, 18, and 25; and Pegaspargase 2500 IU/m\^2 IV over 1-2 hours on Days 5, and 18. If CNS3 leukemia is present, patients receive Intrathecal Triple Therapy (ITT) age-based dosing on days 4, 11, 18, and 25. Patients known to be CNS3 at study entry may receive ITT on Day 1 rather than IT ARAC. If CNS1 and 2 leukemia present, patient receive Methotrexate (IT MTX) age-based dosing on Days 18 and 32. Treatment will be given for one cycle, 32 days, in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hydrocortisone

2005

Completed Phase 4

~1280

Vincristine

2003

Completed Phase 4

~2970