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Chronic Lymphocytic LeukemiaPhase 2RICACNCT01849939

Eradication of Residual Disease by Preemptive Immunointervention After Allogeneic Hematopoietic Stem Cells Transplantation in Chronic Lymphocytic Leukemia

A Phase 2 study testing Fludarabin (post-allograft immunosuppressive therapy modulation and DLI Mononuclear cells from allogenic blood) in people with Chronic Lymphocytic Leukemia and Lymphocytic Lymphoma, run by University Hospital, Clermont-Ferrand at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Usually Chronic lymphocytic leukemia (CLL) is a disease of the elderly patients. However, the diagnosis in young patients become more frequently with poor prognosis. The identification of new prognostic factors permits early determination of the high risk population and provide them the therapeutic intensification. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Fludarabin (post-allograft immunosuppressive therapy modulation and DLI Mononuclear cells from allogenic blood)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
1 siteFrance
Study dates
Sep 2012to Sep 2017
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with CLL (Matutes score 4 or 5) stages A, B, C with evolution criteria according IWCLL 2008 or lymphocytic lymphoma with severity criteria (EBMT criteria) which indicated allograft (deletion 17p) and requiring treatment
  • Age: 18-70 years
  • At least one of the following criteria of poor prognosis (EBMT recommendations - Dreger 2007)
  • No response or relapse within 12 months of treatment with purine analogues (including "fludarabine refractory" i.e patients in response <PR and / or relapse within 6 months after at least 2 courses of Fludurabine)
  • relapse within 24 months after combination therapy including purine analogs or autograft, with indication of new start of treatment
  • Mutation/deletion 17p13 (p53) with indication for treatment
Show all 12Show fewer
  • Partial response (PR) or complete response (CR) at the last treatment (IWCLL 2008)
  • Residual mass <5 cm (clinical and CT scan)
  • Identical intrafamilial donor HLA (or with a mismatch) or in the absence of family donor, an unrelated donor 10/10 for HLA A, B, C, DR, DQ and is committed to giving DLI (see consent form donor)
  • Sorror score comorbidity: ≤ 2
  • Written informed consent
  • Member or beneficiary of a social security system

Who cannot join

  • Richter Syndrome
  • Usual contraindications for realisation of allogeneic transplantation including
  • Uncontrolled bacterial, viral or fungal infection
  • Pregnancy or lactating women
  • Cardiac contraindication : Cardiac ejection fraction <50%
  • Pulmonary contraindication : DLCO <50%
Show all 11Show fewer
  • Renal contraindication : Creatininine clearance <30 ml / min
  • Hepatic contraindication : AST and / or ALT and / or total bilirubine> 2 N except Gilbert disease or localisation specific LLC
  • HIV positivity
  • Cancer evolution or de novo occurred in the previous 5 years except basal cell cancer skin or carcinoma in situ of the cervix of uterus
  • Affection psychiatric disease

Trial locations and contacts

1 site in 1 country.

Patrick LACARIN contact

04 73 75 11 95

placarin@chu-clermontferrand.fr

France1 site, 1 recruiting

  • CHU Clermont-Ferrand

    Clermont-Ferrand, 63003

    Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr

    Recruiting

Other trials in France

About this study

Official title: Reduced Intensity Conditioning Allogeneic Transplantation for CLL With Preemptive MDR Management (ICLL 03 RICAC-PMM)

Usually Chronic lymphocytic leukemia (CLL) is a disease of the elderly patients. However, the diagnosis in young patients become more frequently with poor prognosis. The identification of new prognostic factors permits early determination of the high risk population and provide them the therapeutic intensification. Allogeneic transplantation of hematopoietic stem cells transplantation (AHSCT) allows to long-term remission and in some cases complete and definitive eradication of the disease. After chemotherapy or antibodies, the Minimal Residual Disease (MRD) negativity is associated with better disease-free survival. MRD negativity occurs in some patients with the appearance of GVHD, stopping the immunosuppression or after donor lymphocyte injection (DLI). The negativity of MRD in the first year post-transplant is correlated with better progression-free survival or overall survival (Dreger 2010, Farina 2009, Caballero 2005, Algrin, 2011). So, MRD negativity may be an objective after AHSCT. The aim of this prospective study is to evaluate a standardized preemptive immunointervention of post-allograft immunosuppressive therapy modulation and DLI administration according to MRD level. The objective is to obtain MRD negativity at 12 months after AHSCT.

Read the detailed description

Patients will receive AHSCT with Fludarabine-Busulfan based conditioning :

  • Fludarabine : 30 mg/m2/day - from Day-6 to Day-2
  • Busulfan IV : 3.2 mg/kg/day - on Day-5 and Day-4
  • ATG (Anti-thymocyte Globulin) : 2.5 mg/kg/day on Day-2 and Day-1

Preemptive immunointervention post AHSCT consists in reduce immunosuppressive treatment more or less associated with DLI according to :

  • the presence or absence of severe Graft versus host disease (GVHD) (acute grade 2 and / or chronic)
  • the presence or absence of a response on criteria of response IWCLL
  • Getting or not a blood MRD negative (<-10 ^ -4) evaluated by flow cytometry
Being tested
Fludarabin (post-allograft immunosuppressive therapy modulation and DLI Mononuclear cells from allogenic blood)
Keywords
Allogeneic transplantation of hematopoietic stem cells transplantation, Chronic Lymphocytic Leukemia, Donor Lymphocyte Injection, Preemptive immunointervention
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

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

  • Fludarabin (post-allograft immunosuppressive therapy modulation and DLI Mononuclear cells from allogenic blood)Drug

Study groups in NCT01849939
Study groupRoleWhat they receive
FludarabinExperimentalNot described
Receives: Drug: Fludarabin (post-allograft immunosuppressive therapy modulation and DLI Mononuclear cells from allogenic blood)

What is being measured

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

  1. MRD(Minimal Residual Disease) negativity level

    Measured: 12 months after AHSCT(Allogenic Transplantation of Hematopoietic Stem Cells Transplantation)

Secondary outcomes (6)

  1. Incidence of relapses progression

    Measured: at 12 months

  2. Incidence of toxic deaths

    Measured: at 12 months

  3. Incidence of GVHD (acute and chronic)

    Measured: at 12 months

  4. Survival (progression free survival, overall survival, survival without treatment)

    Measured: at 12 months

  5. Post-transplant chimerism (total blood and lymphoid T lymphocyte populations)

    Measured: baseline; 1, 2, 3, 6 and 12 months

  6. Incidence of infectious complications and severity

    The aim of this prospective study is to evaluate a standardized preemptive immunointervention of post-allograft immunosuppressive therapy modulation and DLI administration according to MRD level. The objective is to obtain MRD negativity at 12 months after AHSCT

    Measured: at 12 months

Timeline

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

  1. First posted9 May 2013 (estimated)
  2. Study startSep 2012
  3. Primary completionSep 2017 (estimated)
  4. Study completionSep 2017 (estimated)

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
43 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01849939
Sponsor's protocol ID
CHU-0150
Other IDs
2011-A00906-35
Acronym
RICAC
Status last verified
May 2013
First submitted
12 Mar 2013
Last updated
9 May 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fludarabin (post-allograft immunosuppressive therapy modulation and DLI Mononuclear cells from allogenic blood) in people with Chronic Lymphocytic Leukemia and Lymphocytic Lymphoma, run by University Hospital, Clermont-Ferrand at 1 site 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 12 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 9 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MRD(Minimal Residual Disease) negativity level (time frame: 12 months after AHSCT(Allogenic Transplantation of Hematopoietic Stem Cells Transplantation)). 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 NCT01849939.

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 9 May 2013.

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