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Leukemia, LymphoidPhase 2RV-405 LALNCT01116193

Repeat-dose Study of Lenalidomide (Revlimid ®) Plus Dexamethasone in Patients With Lymphoblastic Leukemia

A Phase 2 study testing Lenalidomide plus dexamethasone in people with Leukemia, Lymphoid and Precursor B-Cell Lymphoblastic Leukemia-Lymphoma, run by Institut de Cancérologie de la Loire at 4 sites in France.

Completed

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

Official record
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Trial summary

The study objectives are to evaluate the safety and efficacy of the oral administration of lenalidomide in combination with dexamethasone in the treatment of adult patients with refractory or relapsed non-Ph+ B-cell lineage acute lymphoblastic leukemia (ALL). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Lenalidomide plus dexamethasone
How many people
10 participants
Where
4 sitesFrance
Study dates
Jan 2010to Aug 2013
Phase
Phase 2
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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 sterilization.
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

4 sites in 1 country.

France4 sites

  • CHU de Clermont-Ferrand

    Clermont-Ferrand, 63003

  • Hôpital Michallon

    Grenoble, 38000

  • Hôpital Edouard Herriot

    Lyon, 69003

  • Institut de Cancerologie de la Loire

    Saint-Priest-en-Jarez, 42271

Other trials in France

About this study

Official title: 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 objectives are to evaluate the safety and efficacy of the oral administration of lenalidomide in combination with dexamethasone in the treatment of adult patients with refractory or relapsed non-Ph+ B-cell lineage acute lymphoblastic leukemia (ALL).

Read the detailed description

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.

Being tested
Lenalidomide plus dexamethasone
Keywords
antileukemic therapy, lymphoblastic leukemia, lenalidomide, dexamethasone
Medical subject headings
Leukemia, Lymphoid, Precursor B-Cell Lymphoblastic Leukemia-Lymphoma, Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

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

  • Lenalidomide plus dexamethasoneDrug

    Also called Revlimid ®, 25mg

    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

What is being measured

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

  1. Disease-Free survival (DFS)

    Measured: 2 years

Secondary outcomes (8)

  1. Time to response

    Measured: 28 days

  2. Duration of response

    Measured: 2 years

  3. To determine quality of life (QOL): European Organization for Research and Treatment of Cancer QOL questionnaire for patients with cancer (EORTC QLQ-C30)

    Measured: All 28 days

  4. Progression-free survival

    Measured: 2 years

  5. Feasibility of stem cell transplantation (SCT), in case of response, after one or more cycles of lenalidomide plus dexamethasone therapy

    Measured: all 28 days

  6. Safety of lenalidomide plus dexamethasone: adverse events (type, frequency, severity of adverse events, and relationship of adverse events to study drug).

    Measured: All 28 days

  7. To assess the efficacy of lenalidomide plus low-dose dexamethasone: complete response (CR), complete response without platelets (CRp), partial response (PR), and overall response (CR + CRp + PR).

    Measured: 1, 8, 15, and 22 of each 28-day cycle (4-weeks cycles) and after treatment, patients will be seen at least twice weekly until they attain a CR

  8. Overall survival

    Measured: 2 years

Timeline

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

  1. First posted4 May 2010 (estimated)
  2. Study startJan 2010
  3. Primary completionJul 2012
  4. Study completionAug 2013

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01116193
Sponsor's protocol ID
2009-01b
Other IDs
2009-009372-13, 2009
Acronym
RV-405 LAL
Status last verified
Jan 2011
First submitted
26 Apr 2010
Last updated
14 Sep 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lenalidomide plus dexamethasone in people with Leukemia, Lymphoid and Precursor B-Cell Lymphoblastic Leukemia-Lymphoma, run by Institut de Cancérologie de la Loire at 4 sites in France.

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 35 inclusion and 8 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 14 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Disease-Free survival (DFS) (time frame: 2 years). 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 NCT01116193.

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 14 Sep 2017.

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