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

Phase 1

• Conditions: eukemia, Myeloid; MedDRA version: 20.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000012984; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-002146-72-Outside-EU/EEA
• Lead Sponsor: Celgene Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-03
• Last Update Posted: 10 July 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

1. Male or female is 1 to = 18 years of age at the time of signing the Informed Consent Form / Informed Assent Form (ICF/IAF).
2.Subject (when applicable, parental/legal representative) must understand and voluntarily provide permission to the ICF/IAF prior to conducting any study-related assessments/procedures.
3.Subject has Relapsed or Refractory Acute Myeloid Leukemia (rrAML) after at least 2 prior induction attempts
4.Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
5.Subject has a Karnofsky score of = 50% (subjects = 16 years of age) or a Lansky score = 50% (subjects < 16 years of age).
6.Subject has a resting left ventricular ejection fraction (LVEF) of = 40% obtained by echocardiography.
7.Subject has 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.
8.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.
9.Graft-versus-host disease criteria:
- Subject must be at least 2 months (from first dose of lenalidomide) from stem cell infusion.
- Subject must have no evidence of active acute or chronic GVHD (Grade 0) for 4 weeks prior to the first dose of lenalidomide.
?Physiologic dosing of hydrocortisone is permitted.
10.At least 4 weeks (from first dose) elapsed from donor lymphocyte infusion (DLI) without conditioning.
11.Subject has adequate renal function
12.Subject has adequate liver function
13.Female Children of Childbearing Potential (FCCBP), Female of Childbearing Potential (FCBP) and male subjects that have reached puberty must agree to undergo physician-approved reproductive education and discuss the side effects of the study therapy on reproduction with parent(s) and/or guardian(s).
14.All subjects and/or parents/guardians must have an understanding that lenalidomide could have a potential teratogenic risk. Female Children of Childbearing Potential, defined as females who have achieved menarche and/or breast development in Tanner Stage 2 or greater and have not undergone a hysterectomy or bilateral oophorectomy and FCBP defined as a sexually mature woman who has not undergone a hysterectomy or bilateral oophorectomy and has not been naturally postmenopausal for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months) must meet the following conditions below:
- Medically supervised serum pregnancy tests with a sensitivity of at least 25 mIU/mL must be conducted in FCCBP/FCBP, including those who commit to complete abstinence*. FCCBP/FCBP must have two pregnancy tests (with a minimum sensitivity of 25 mIU/mL) prior to starting treatment with lenalidomide. The first pregnancy test must be performed within 10 - 14 days prior to the start of lenalidomide treatment and the second pregnancy test must be performed within 24 hours prior to starting treatment with lenalidomide.
•Female subjects must, as appropriate to age and at the discretion of the study Investigator, either commit to true abstinence* from heterosexual contact (which must be reviewed on a monthly basis) and/or agree to the use of two reliable forms of app

Exclusion Criteria

1. Subject has Down syndrome.
2.Subject has French-American-British classification (FAB) type M3 leukemia (acute promyelocytic leukemia) or identification of t(15;17).
3.Subject has isolated Central Nervous System (CNS) involvement or extramedullary relapse. (Subjects with combined CNS/marrow relapse may be Subject has 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.
5. Subject has 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.
6. Subject has had prior treatment with lenalidomide. 7. Subject is pregnant or lactating. 8. Subject has 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).
9. Subject has known Human Immunodeficiency Virus (HIV) positivity (subjects who are receiving antiretroviral therapy for HIV disease).
10. Subject has 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.
11. The presence of any of the following will exclude a subject from enrollment:
•Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
•Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
•Subject has any condition that confounds the ability to interpret data from the study.
12. Subject has cardiac disorders (Common Terminology Criteria for Adverse Events [CTCAE] version 4.03 Grade 3 or 4).
13. Subject has a history of well-documented prior veno-occlusive disease (VOD).
14. Subject has any other organ dysfunction (CTCAE version 4.03 Grade 4) that will interfere with the administration of the therapy according to this protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified