Palbociclib + Chemotherapy for Childhood Leukemia and Lymphoma

Recruiting in Palo Alto (17 mi)

+18 other locations

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Children's Oncology Group

No Placebo Group

Breakthrough Therapy

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

AINV18P1 is a Phase 1 study where palbociclib will be administrated in combination with a standard re-induction platform in pediatric relapsed Acute Lymphoblastic Leukemia (ALL) and lymphoblastic lymphoma (LL). LL patients are included because the patient population is rare and these patients are most commonly treated with ALL regimens. The proposed palbociclib starting dose for this study will be 50 mg/m\^2/day for 21 days.

Eligibility Criteria

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.

Inclusion Criteria

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

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

I have never taken palbociclib or similar medications.

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Exclusion Criteria

You are currently taking part in another study that involves testing an experimental drug.

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

I do not have any infections that are currently uncontrolled.

See 6 more

Treatment Details

Interventions

Palbociclib (CDK4/6 Inhibitor)

Trial OverviewThe 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.

Participant Groups

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.