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Leukemia, LymphocyticPhase 1NCT03792256

Palbociclib in Combination With Chemotherapy in Treating Children With Relapsed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL)

A Phase 1 study testing Palbociclib, Cytarabine and Methotrexate in people with Leukemia, Lymphocytic and Lymphoblastic Lymphoma, run by Children's Oncology Group at 19 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 12 months to 31 years
What is being tested?
Palbociclib, Cytarabine and Methotrexate
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
19 sitesUnited States
Study dates
11 Apr 2019to 30 Sep 2023
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 months to 31 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Patients with recurrent or refractory B- or T-lineage lymphoblastic leukemia and lymphoma.
  • Patients with leukemia must have ≥ 5% (M2 or M3) bone marrow blasts with or without an extramedullary site of relapse. Morphologic relapse for M2 should be confirmed using flow cytometry, FISH and/or cytogenetics or molecular techniques.
  • Patients with LL must have either measurable or evaluable disease.
  • Patients with first or greater relapsed T-lineage ALL or LL and second or greater relapsed B-lineage ALL or LL are eligible.
  • Patients with primary refractory disease with at least 2 prior induction attempts or first relapse refractory to at least one prior re-induction attempt are eligible.
  • Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients <= 16 years of age.
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  • Note: Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
  • Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment. If after the required timeframe, the numerical eligibility criteria are met, e.g., blood count criteria, the patient is considered to have recovered adequately.
  • Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive. See DVL homepage for commercial and Phase 1 investigational agent classifications. For agents not listed, the duration of this interval must be discussed with the study chair and the study-assigned Research Coordinator prior to enrollment.
  • A waiting period prior to enrollment is not required for patients receiving standard cytotoxic maintenance chemotherapy (i.e., corticosteroid, vincristine, 6MP, and/or methotrexate).
  • Intrathecal cytotoxic therapy: No waiting period is required for patients having received intrathecal cytarabine, methotrexate, and/or hydrocortisone. Intrathecal chemotherapy given at the time of diagnostic LP to evaluate for relapse prior to study enrollment is allowed.
  • At least 14 days must have elapsed after the completion of other cytotoxic therapy, with the exception of hydroxyurea, for patients not receiving standard maintenance therapy. Additionally, patients must have fully recovered from all acute toxic effects of prior therapy.
  • NOTE: Cytoreduction with hydroxyurea in patients can be initiated and continued for up to 24 hours prior to the start of protocol therapy.
  • Note: Intrathecal chemotherapy that is given up to 72 hours prior to initiation of systemic chemotherapy per AINV18P1 counts as protocol therapy and not prior anti-cancer therapy. Intrathecal chemotherapy given > 72 hours prior does not count as protocol therapy.
  • Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or ANC counts): >= 7 days after the last dose of agent. See DVL homepage for commercial and Phase 1 investigational agent classifications. For agents not listed, the duration of this interval must be discussed with the study chair and the study-assigned Research Coordinator prior to enrollment.
  • NOTE: Cytoreduction with prednisone or methylprednisolone for <= 120 hours (5 days) in patients can be initiated and continued for up to 24 hours prior to the start of protocol therapy.
  • Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody with the exception of blinatumomab, and toxicity related to prior antibody therapy must be recovered to Grade <= 1. Patients must have been off blinatumomab infusion for at least 14 days and all drug related toxicity must have resolved to Grade <= 1.
  • Corticosteroids: If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid and toxicity related to prior immune therapy must be recovered to Grade <= 1 off corticosteroids.
  • Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the study chair and the study-assigned Research Coordinator.
  • Interleukins, Interferons and Cytokines (other than Hematopoietic Growth Factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than Hematopoietic Growth Factors)
  • Stem cell Infusions (with or without TBI):
  • Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including DLI or boost infusion: >= 84 days after infusion and no evidence of GVHD.
  • Autologous stem cell infusion including boost infusion: >= 42 days.
  • Cellular Therapy: >= 30 days after the completion of any type of cellular therapy (e.g. modified T cells, NK cells, dendritic cells, etc.)
  • XRT/External Beam Irradiation including Protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial BM radiation.
  • Patients must not have received prior exposure to palbociclib or another CDK4/6 inhibitor.
  • Adequate Renal Function Defined as:
  • Creatinine clearance or radioisotope GFR ≥ 70ml/min/1.73 m2 or
  • A serum creatinine based on age/gender as follows:
  • Age: 1 to < 2 years; Male: 0.6 mg/dL; Female: 0.6 mg/dL
  • Age: 2 to < 6 years; Male: 0.8 mg/dL; Female: 0.8 mg/dL
  • Age: 6 to < 10 years; Male: 1 mg/dL; Female: 1 mg/dL
  • Age: 10 to < 13 years; Male: 1.2 mg/dL; Female: 1.2 mg/dL
  • Age: 13 to < 16 years; Male: 1.5 mg/dL; Female: 1.4 mg/dL
  • Age: >= 16 years; Male: 1.7 mg/dL; Female: 1.4 mg/dL
  • Adequate Liver Function Defined as:
  • bilirubin (sum of conjugated + unconjugated) <= 1.5 x upper limit of normal (ULN) for age
  • SGPT (ALT) <= 225 U/L unless disease-related. For the purpose of this study, the ULN for SGPT is 45 U/L.
  • Serum albumin >= 2 g/dL.
  • Adequate Cardiac Function Defined As:
  • Shortening fraction of >= 27% by echocardiogram, or
  • Ejection fraction of >= 50% by gated radionuclide study.
  • All patients and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.

Who cannot join

  • Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies. Based on the mechanism of action, palbociclib may be expected to cause fetal harm if used during pregnancy. Pregnancy tests must be obtained in girls who are post-menarche. Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method for the duration of study therapy. Women of reproductive potential should use effective contraception during treatment and for at least 3 weeks after the last dose of palbociclib. Males with female partners of reproductive potential should use effective contraception during treatment and for 3 months after the last dose of palbociclib. Animal data suggests that palbociclib may affect male fertility.
  • Prednisone or methylprednisolone for ≤ 120 hours (5 days) may be administered for cytoreduction up to 24 hours prior to the start of protocol therapy and as treatment for allergic reactions or for physiologic replacement/stress dosing of hydrocortisone for documented adrenal insufficiency. Corticosteroids are not allowed for other indications. If used to modify immune adverse events related to prior therapy, ≥ 14 days must have elapsed since last dose of corticosteroid.
  • Patients who are currently receiving another investigational drug.
  • Patients who are currently receiving other anti-cancer agents are not eligible [except patients receiving hydroxyurea, which may be continued until 24 hours prior to start of protocol therapy].
  • 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. Strong inducers or inhibitors of CYP3A4 are prohibited from 14 days prior to enrollment to the end of the study.
  • Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant.
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  • Patients must be able to swallow intact capsules or liquid. Patients that are unable to swallow oral medications may receive palbociclib through an NG tube. G tube administration is not allowed.
  • Patients who have an uncontrolled infection defined as below:
  • Fever above 38.2°C within 48 hours of study enrollment with clinical signs of infection. Fever that is determined to be due to tumor burden is allowed if patients have documented negative blood cultures for at least 48 hours prior to enrollment and no concurrent signs or symptoms of active infection or hemodynamic instability.
  • A positive fungal culture within 30 days of study enrollment or active therapy for presumed invasive fungal infection.
  • Patients may be receiving IV or oral antibiotics to complete a course of therapy for a prior documented infection as long as cultures have been negative for at least 48 hours and signs or symptoms of active infection have resolved. For patients with c. difficile diarrhea, at least 72 hours of antibacterial therapy must have elapsed and stools must have normalized to baseline.
  • Active viral or protozoal infection requiring IV treatment.
  • Patients known to have one of the following concomitant genetic syndromes: Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachmann syndrome or any other known bone marrow failure syndrome.
  • Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.
  • Cumulative prior anthracycline exposure must not exceed 400 mg/m2 of DOXOrubicin equivalents

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

United States19 sites

  • C S Mott Children's Hospital

    Ann Arbor, Michigan, 48109

  • Children's Healthcare of Atlanta - Egleston

    Atlanta, Georgia, 30322

  • Children's Hospital Colorado

    Aurora, Colorado, 80045

  • Children's Hospital of Alabama

    Birmingham, Alabama, 35233

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

  • Riley Hospital for Children

    Indianapolis, Indiana, 46202

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Saint Jude Children's Research Hospital

    Memphis, Tennessee, 38105

  • University of Minnesota/Masonic Cancer Center

    Minneapolis, Minnesota, 55455

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016

  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

    New York, New York, 10032

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Children's Hospital of Orange County

    Orange, California, 92868

  • Lucile Packard Children's Hospital Stanford University

    Palo Alto, California, 94304

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Children's Hospital of Pittsburgh of UPMC

    Pittsburgh, Pennsylvania, 15224

  • Primary Children's Hospital

    Salt Lake City, Utah, 84113

  • Seattle Children's Hospital

    Seattle, Washington, 98105

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

Official title: A Phase 1 Study of Palbociclib (IND#141416), A CDK 4/6 Inhibitor, in Combination With Chemotherapy in Children With Relapsed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL)

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To estimate the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of palbociclib administered in combination with re-induction chemotherapy in pediatric patients with relapsed B- or T-lineage ALL/LL.

II. To define and describe the toxicities of palbociclib administered on this schedule.

III. To characterize the pharmacokinetics of palbociclib in pediatric patients with relapsed B- or T-lineage ALL/LL.

SECONDARY OBJECTIVES:

  1. To preliminarily define the antitumor activity of palbociclib in combination with chemotherapy for children with relapsed ALL/LL within the confines of a Phase 1 study.

II. To assess the biologic activity of palbociclib in this patient population.

OUTLINE:

Patients receive Palbociclib PO (or via NG-tube) once daily on Days 1-21; Intrathecal cytarabine (IT ARAC) on Day 1, Doxorubicin IV push or infusion over 1-15 min on Day 4; Prednisone or prednisolone PO on days 4-31; Vincristine IV push or mini-bag per institutional policy on Days 4, 11, 18, and 25; and Pegaspargase IV over 1-2 hours on Days 5, and 18. If CNS3 leukemia is present, patients receive Intrathecal Triple Therapy (ITT) on days 4, 11,18, and 25. If CNS1 or 2 disease status, patients receive Methotrexate (IT MTX) on Days 18 and 32. Patients known to be CNS3 at study entry may receive ITT on Day 1 rather than IT ARAC. Treatment will be given for one cycle, 32 days, in the absence of disease progression or unacceptable toxicity.

Being tested
Palbociclib, Cytarabine, Methotrexate, Hydrocortisone, Doxorubicin
Medical subject headings
Leukemia, Lymphoid, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, T-Cell, Leukemia, T-Cell, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PalbociclibDrug

    Given PO (or via NG- tube)

  • CytarabineDrug

    Given intrathecally (IT)

  • MethotrexateDrug

    Given intrathecally (IT)

  • HydrocortisoneDrug

    Given IT

  • DoxorubicinDrug

    Given intravenously (IV)

  • PrednisoloneDrug

    Either prednisone or prednisolone is given PO

  • VincristineDrug

    Given IV

  • PegaspargaseDrug

    Given IV

  • HydrocortisoneDrug

    Given intrathecally (IT)

  • PrednisoneDrug

    Either prednisone or prednisolone is given PO

Study groups in NCT03792256
Study groupRoleWhat they receive
Treatment (Palbociclib)ExperimentalPatients 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.
Receives: Drug: Palbociclib; Drug: Cytarabine; Drug: Methotrexate; Drug: Hydrocortisone; Drug: Doxorubicin; Drug: Prednisolone; Drug: Vincristine; Drug: Pegaspargase; Drug: Prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency of Dose Limiting Toxicities of Palbociclib

    The frequency (%) of patients experiencing a cycle 1 dose limiting toxicity at least possibly attributable to Palbociclib by study part and dose level.

    Measured: Up to 32 days

  2. Frequency of Adverse Events of Palbociclib

    The frequency (%) of patients experiencing adverse events at least possibly attributable to Palbociclib by study part and dose level.

    Measured: Up to 26 months

  3. Area Under the Drug Concentration Curve of Palbociclib

    The median (min, max) of the area under the drug concentration curve for Palbociclib determined by measures at 0, 1, 2, 4, 8, and 24 hours post-dose on day 11 by study part and dose level.

    Measured: Up to 11 days

  4. Half-life of Palbociclib

    The median (min, max) of the half-life of Palbociclib determined by measures at 0, 1, 2, 4, 8, and 24 hours post-dose on day 11 by study part and dose level.

    Measured: Up to 11 days

  5. Maximum Serum Concentration of Palbociclib

    Median (min, max) of the maximum serum concentration of Palbociclib determined by measures at 0, 1, 2, 4, 8, and 24 hours post-dose on day 11 by study part and dose level

    Measured: Up to 11 days

  6. Time to Reach Maximum Serum Concentration of Palbociclib

    Median (min, max) of the maximum time to reach serum concentration of Palbociclib determined by measures at 0, 1, 2, 4, 8, and 24 hours post-dose on day 11 by study part and dose level

    Measured: Up to 11 days

  7. Clearance of Palbociclib

    Median (min, max) of the clearance of Palbociclib determined by measures at 0, 1, 2, 4, 8, and 24 hours post-dose on day 11 by study part and dose level

    Measured: Up to 11 days

Secondary outcomes (11)

  1. Number of Participants With at Least Partial Response to Palbociclib

    Frequency (%) of patients with at least partial response to Palbociclib per leukemia/lymphoma specific response criteria: Complete Response (CR), M1 marrow (<5% blasts) and absolute neutrophil count (ANC) at least 500/uL and platelet count at least 50000/uL without transfusion for 7 days; Complete response with incomplete recovery (CRi), M1 marrow (<5% blasts), ANC<500uL, platelet count <50,000uL; Partial Response (PR), Complete disappearance of circulating blasts and achievement of M2 marrow status if M3 originally, without new sites of extramedullary disease, and with ANC ≥ 500/µL. Complete response in the marrow without resolution of extramedullary sites. Overall Response (OR) = CR+CRi+PR

    Measured: up to 26 months

  2. Absolute Peripheral Blast Count of Palbociclib

    Median (min, max) of absolute peripheral blast count of palbociclib by study part and dose level

    Measured: Up to 3 days

  3. Radiographic Response of Palbociclib in Patients With LL Patients

    Number of LL patients with radiographic response by study part and dose level. Complete Response (CR): Disappearance of all disease; Partial Response (PR): 50% decrease in SPD (the sum of the products of the largest diameter and the perpendicular diameter for a tumor mass). Total responders = CR+PR

    Measured: Day 32

  4. RB1 Expression of Palbociclib

    Median (min,max) of RB1 expression of palbociclib by study part and dose level

    Measured: Up to 4 days

  5. Phospho-RB1 Expression of Palbociclib

    Median (min,max) of Phospho-RB1 expression of palbociclib by study part and dose level

    Measured: Up to 4 days

  6. Cyclin D3 Expression of Palbociclib

    Median (min,max) of Cyclin D3 expression of palbociclib by study part and dose level

    Measured: Up to 4 days

  7. CDK4 Expression of Palbociclib

    Median (min,max) of CDK4 expression of palbociclib by study part and dose level

    Measured: Up to 4 days

  8. CDK6 Expression of Palbociclib

    Median (min,max) of CDK6 expression of palbociclib by study part and dose level

    Measured: Up to 4 days

  9. p27Kip1 Expression of Palbociclib

    Median (min,max) of p27Kip1 expression of palbociclib by study part and dose level

    Measured: Up to 4 days

  10. Ki67 Biological Activity of Palbociclib

    Median (min,max) of CD1a biological activity of palbociclib

    Measured: Up to 32 days

  11. DAPI Biological Activity of Palbociclib

    Median (min,max) of DAPI biological activity of palbociclib by study part and dose level

    Measured: up to 26 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jan 2019
  2. Study start11 Apr 2019
  3. Primary completion30 Jun 2021
  4. Study completion30 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03792256
Sponsor's protocol ID
AINV18P1
Other IDs
NCI-2019-02774
Status last verified
Mar 2025
First submitted
29 Nov 2018
Last updated
21 Mar 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Raetz EA, Teachey DT, Minard C, Liu X, Norris RE, Denic KZ, Reid J, Evensen NA, Gore L, Fox E, Loh ML, Weigel BJ, Carroll WL. Palbociclib in combination with chemotherapy in pediatric and young adult patients with relapsed/refractory acute lymphoblastic leukemia and lymphoma: A Children's Oncology Group study (AINV18P1). Pediatr Blood Cancer. 2023 Nov;70(11):e30609. doi: 10.1002/pbc.30609. Epub 2023 Aug 8.

    PubMed 37553297

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Palbociclib, Cytarabine and Methotrexate in people with Leukemia, Lymphocytic and Lymphoblastic Lymphoma, run by Children's Oncology Group at 19 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 43 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of Dose Limiting Toxicities of Palbociclib (time frame: Up to 32 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03792256, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.

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