A Study of Lenalidomide in Pediatric Subjects With Relapsed or Refractory Acute Myeloid Leukemia

Completed · Phase 2

Conditions studied: Leukemia, Myeloid

In brief

To determine the activity of lenalidomide in the treatment of pediatric subjects with relapsed/refractory acute myeloid leukemia (AML) (with second or greater relapse or refractory to at least 2 prior induction attempts) measured by morphological complete response defined as either a CR or CRi within the first 4 cycles of treatment.

Key facts

Study ID: NCT02538965
Run by: Celgene
People needed: 17
Starts: 2015-11-19
Expected to finish: 2019-01-11
Last updated by the study team: 2020-01-07

Who can join

Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Participants must satisfy the following criteria to be enrolled in the study:
Male or female is 1 to ≤ 18 years of age at the time of signing the Informed Consent Form / Informed Assent Form (ICF/IAF).
Participants (when applicable, parental/legal representative) must understand and voluntarily provide permission to the ICF/IAF prior to conducting any study-related assessments/procedures.
Participants have relapsed or refractory acute myeloid leukemia after at least 2 prior induction attempts:
Bone marrow aspirate or biopsy must have ≥ 5% blasts by morphology and/or flow cytometry.
Each block of chemotherapy is a separate reinduction attempt.
Donor lymphocyte infusion (DLI) is considered a reinduction attempt.
Participants are willing and able to adhere to the study visit schedule and other protocol requirements.
Participants have a Karnofsky score of ≥ 50% (participants ≥ 16 years of age) or a Lansky score ≥ 50% (participants < 16 years of age).
Participants have a resting left ventricular ejection fraction (LVEF) of ≥ 40% obtained by echocardiography.
Participants have recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to first dose. All prior treatment-related toxicities must have resolved to ≤ Grade 2 prior to enrollment.
Regarding radiation therapy, time elapsed prior to first dose of lenalidomide:
2 weeks for local palliative radiation therapy (XRT).
8 weeks if prior craniospinal chemoradiation therapy (CRT) or if ≥ 50% radiation of pelvis.
6 weeks if other bone marrow radiation has been administered.
Graft-versus-host disease criteria:
Participants must be at least 2 months (from first dose of lenalidomide) from stem cell infusion.
Participants must have no evidence of active acute or chronic GVHD (Grade 0) for 4 weeks prior to the first dose of lenalidomide.
If the participants have a history of maximum Grade 1 or 2 GVHD that was treated with systemic steroid (≥ 0.5 mg/kg/day prednisone equivalents) or other non-steroid systemic IST, the participant must be off all IST for at least 2 weeks, and must have ceased treatment doses of steroids for GVHD (≥ 0.5 mg/kg/day prednisone equivalents) for at least 4 weeks.
If the participants have a history of Grade 3 or greater GVHD, the participants must be off all systemic IST for 4 weeks
Topical therapy is permitted and does not imply the participants have active acute or chronic GVHD.
Physiologic dosing of hydrocortisone is permitted.
At least 4 weeks (from first dose) elapsed from donor lymphocyte infusion (DLI) without conditioning.
Participants have adequate renal function, which is defined as:
Creatinine clearance calculated using the Schwartz formula, or radioisotope glomerular filtration rate (GFR) > 70 mL/min/1.73 m2.

You may not qualify if…

Participants have Down syndrome.
Participants have French-American-British classification (FAB) type M3 leukemia (acute promyelocytic leukemia) or identification of t(15;17).
Participants have isolated central nervous system (CNS) involvement or extramedullary relapse. (Participants with combined CNS/marrow relapse may be enrolled).
Participants had prior treatment with cytotoxic chemotherapy within 2 weeks of the first dose of lenalidomide with the exception of hydroxyurea (allowed prior to the first dose of lenalidomide and through Day 14 of Cycle 1) and intrathecal (IT) cytarabine will be administered within 2 weeks prior to administration of lenalidomide.
Participants have had prior treatment with biologic antineoplastic agents less than 7 days before the first dose of lenalidomide. For agents that have known adverse events (AEs) occurring beyond 7 days after administration (ie, monoclonal antibodies), this period must be extended beyond the time during which acute AEs are known to occur.
Participants have had prior treatment with lenalidomide.
Participant is pregnant or lactating.
Participants have an uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment).
Participants has known Human Immunodeficiency Virus (HIV) positivity (participants who are receiving antiretroviral therapy for HIV disease).
Participants have a prior history of malignancies other than AML unless the subject has been free of the disease for ≥ 5 years from first dose of lenalidomide.
The presence of any of the following will exclude a participant from enrollment:
Participants have any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.
Participants have any condition including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she were to participate in the study.
Participants have any condition that confounds the ability to interpret data from the study.
Participants have cardiac disorders (Common Terminology Criteria for Adverse Events [CTCAE] version 4.03 Grade 3 or 4).
Participants have a history of well-documented prior veno-occlusive disease (VOD).
Participants have any other organ dysfunction (CTCAE version 4.03 Grade 4) that will interfere with the administration of the therapy according to this protocol.

Where it is running

Phoenix Childrens Hospital — Phoenix, Arizona, United States
Arkansas Children's Hospital — Little Rock, Arkansas, United States
Miller Children's Hospital — Long Beach, California, United States
Children's Hospital of Los Angeles — Los Angeles, California, United States
Southern California Permanente Medical Group — Los Angeles, California, United States
Valley Children's Hospital — Madera, California, United States
Children's Hospital of Orange County — Orange, California, United States
Lucile Salter Packard Children's Hospital at Stanford — Palo Alto, California, United States
Loma Linda University — San Bernardino, California, United States
UCSF Children's Hospital — San Francisco, California, United States
Colorado Children's Hospital — Aurora, Colorado, United States
Connecticut Children's Medical Center — Hartford, Connecticut, United States
Alfred I Dupont Hospital For Children — Wilmington, Delaware, United States
Children's Hospital National Medical Center — Washington D.C., District of Columbia, United States
Golisano Children's Hospital of Southwest Florida — Fort Myers, Florida, United States
Nemours Children's Clinic — Jacksonville, Florida, United States
All Children's Hospital — St. Petersburg, Florida, United States
Children's Healthcare of Atlanta — Atlanta, Georgia, United States
Ann and Robert H Lurie Childrens Hospital of Chicago — Chicago, Illinois, United States
Advocate Chilldren's Hospital — Oak Lawn, Illinois, United States
Riley Hospital For Children at IU Health — Indianapolis, Indiana, United States
Kosair Children's Hospital — Louisville, Kentucky, United States
Children's Hospital New Orleans — New Orleans, Louisiana, United States
Johns Hopkins University — Baltimore, Maryland, United States
Children's Hospital — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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