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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

Phase 2
18 Years
Open (Enrolling)
Leukemia, Lymphoid, Precursor B-Cell Lymphoblastic Leukemia-Lymphoma

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Trial Information

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

The study consists of two periods, an initial treatment period and an extended treatment
period. Patients who meet all eligibility criteria will receive: Lenalidomide 25 mg p.o.
once daily on days 1-21 plus Dexamethasone 40 mg p.o. once daily on days 1, 8, 15, and 22 of
each 28-day cycle (4-weeks cycles) until CR achievement, progression of disease or
intolerable toxicity. The daily dose of Lenalidomide and that of Dexamethasone will remain
fixed. No dose adaptations are allowed according to the hematologic toxicity. However, in
case of non-hematologic grade > 2 toxicity, the next cycle may be delayed up to 21 days
after the onset of the event until the adverse event has returned to baseline or ≤ grade 1.
Patients may be allowed to receive a pre-treatment with high doses of dexamethasone for
initial hyperleukocytosis at the discretion of the investigator. The use of hematopoietic
growth factor (HGF) during the initial or extended treatment period is also let at the
discretion of the investigator. At the end of the initial treatment period, all responding
patients (without HLA compatible donor) or patients showing sufficient clinical activity
will be allowed to receive extended treatment with cycles identical to the first cycle.
Patients may continue to receive treatment as long as the patient is tolerating the
treatment well and the patient's physician believes the patient is receiving some benefit.
The severity of adverse events will be graded according to the World Health Organization
(WHO) criteria. Any life-threatening adverse effects that are observed during the initial or
extended treatment period, which are possibly or probably related to study drug, will
require the subject to discontinue study treatment.

Inclusion Criteria:

- Documented B-cell lineage acute lymphoblastic leukemia (non-Philadelphia positive
chromosome), which under WHO guidelines is now referred to as precursor
B-lymphoblastic leukemia/lymphoma.

- 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

- Implant

- 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
effective contraception.

- 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
starts treatment

- 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.

Exclusion Criteria:

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease-Free survival (DFS)

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Emmanuelle Tavernier, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut de Cancérologie de la Loire


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

January 2010

Completion Date:

July 2013

Related Keywords:

  • Leukemia, Lymphoid
  • Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
  • antileukemic therapy
  • lymphoblastic leukemia
  • lenalidomide
  • dexamethasone
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
  • Lymphoma