A Phase II, Multi-center, Open-label, Repeat-dose Study of Lenalidomide (Revlimid ®) Plus Low-dose Dexamethasone in Patients With Refractory B Cell Lineage Acute Lymphoblastic Leukemia or in Relapse After 2 Lines of Treatment
- Documented B-cell lineage acute lymphoblastic leukemia (non-Philadelphia positive
chromosome), which under WHO guidelines is now referred to as precursor
- Must have failed to at least two treatment regimens for B lineage ALL or must be
refractory to chemotherapy. The inclusion of a patient with Ph+ ALL can be possible
after contacting the principal investigator in presence of a T315I mutation and
absence of investigational trial targeting this abnormality.
- Performance status of ≤ 2 by Eastern Cooperative Oncology Group (ECOG) criteria.
- Any age ≥ 18 years is allowed.
- Life expectancy of at least 3 months.
- Adequate liver function (aspartate transaminase [AST] and/or alanine transaminase
[ALT] not > 3 times upper limits of normal).
- Adequate kidney function (calculated creatinine clearance > 50 ml/min).
- Signed informed consent prior to start of any study-specific procedures.
- The patients refusing the preservation of their biological samples can however
participate in the study.
- All subjects must
- Agree to abstain from donating blood while taking study drug therapy and for one
week following discontinuation of study drug therapy.
- Agree not to share study medication with another person and to return all unused
study drug to the investigator
Female subjects of childbearing potential must :
- Understand that the study medication is expected to have a teratogenic risk
- Agree to use, and be able to comply with, effective contraception without
interruption, 4 weeks before starting study drug, throughout the entire duration of
study drug therapy (including dose interruptions) and for 4 weeks after the end of
study drug therapy, even if she has amenorrhoea. This applies unless the subject
commits to absolute and continued abstinence confirmed on a monthly basis. The
following are effective methods of contraception
- Levonorgestrel-releasing intrauterine system (IUS)
- Medroxyprogesterone acetate depot
- Tubal sterilization
- Sexual intercourse with a vasectomised male partner only; vasectomy must be
confirmed by two negative semen analyses
- Ovulation inhibitory progesterone-only pills (i.e., desogestrel)
- If not established on effective contraception, the female subject must be
referred to an appropriately trained health care professional for contraceptive
advice in order that contraception can be initiated
- Understand that even if she has amenorrhea, she must follow all the advice on
- Understand the potential consequences of pregnancy and the need to rapidly consult if
there is a risk of pregnancy
- Agree to have a medically supervised pregnancy test with a minimum sensitivity of 25
mIU/mL on the day of the study visit or in the 3 days prior to the study visit once
the subject has been on effective contraception for at least 4 weeks. This
requirement also applies to women of childbearing potential who practice complete and
continued abstinence. The test should ensure the subject is not pregnant when she
- Agree to have a medically supervised pregnancy test every 4 weeks including 4 weeks
after the end of study treatment, except in the case of confirmed tubal
Criteria for women of non-childbearing potential
A female subject or a female partner of a male subject is considered to have childbearing
potential unless she meets at least one of the following criteria:
- Age ≥ 50 years and naturally amenorrhoeic for ≥ 1 year (Amenorrhoea following cancer
therapy does not rule out childbearing potential.)
- Premature ovarian failure confirmed by a specialist gynaecologist
- Previous bilateral salpingo-oophorectomy, or hysterectomy
- XY genotype, Turner syndrome, uterine agenesis.
Male subjects must
- Agree to use condoms throughout study drug therapy, during any dose interruption and
for one week after cessation of study therapy if their partner is of childbearing
potential and has no contraception.
- Agree not to donate semen during study drug therapy and for one week after end of
study drug therapy.
- Active serious infection not controlled by oral or intravenous antibiotics.
- Treatment with any investigational antileukemic agent or chemotherapy agent in at
least 7 days prior to study entry and lack of full recovery from side effects due to
prior therapy independent of when that therapy was given.
- Rapidly progressive disease with compromised organ function judged to be
life-threatening by the Investigator.
- Patients with clinical evidence of active central nervous system (CNS) disease.
- Pregnant and/or lactating female.
- Patients with known human immunodeficiency virus (HIV) infection.
- Patients with known active hepatitis B and/or hepatitis C infection.
- Hypersensitive or intolerant to any component of the study drug formulation.