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Chronic Lymphocytic LeukemiaPhase 2HYDRICNCT01625741

Phase II Study of High-Dose Rituximab in High-Risk Chronic Lymphocytic Leukemia Patients in Suboptimal Response After Induction Immunochemotherapy

A Phase 2 study testing Rituximab in people with Chronic Lymphocytic Leukemia, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 15 sites in Belgium.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study explores the potential to improve the quality of response obtained after induction treatment in Chronic Lymphocytic Leukemia (CLL), by giving a short and intense consolidation schema using high-dose rituximab. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Chronic Lymphocytic Leukemia
What is being tested?
Rituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
15 sitesBelgium
Study dates
Jul 2012to May 2015
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • B-cell Chronic Lymphocytic Leukemia defined by standard NCI criteria in first line or in relapse
  • > 18 years-old
  • Presence of Minimal Residual Disease (MRD positivity) by Flow Cytometry criteria in these two clinical situations :
  • Patients in Complete Remission (defined by standard criteria including Bone Marrow examination) after rituximab-containing immunochemotherapy (ICT), who show persisting MRD either in the Peripheral Blood at least 6 months after the last dose of rituximab-containing immunochemotherapy or in the Bone Marrow at least 3 months after the last dose of rituximab-containing ICT
  • Patients in continuous CR who show MRD relapse in PB or BM without clinical progression (as defined by NCI) at any time after ICT
  • ICT should have comprised:
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  • Rituximab combined with fludarabine, with or without an alkylating drug, with or without an anthracycline (ex: Fludarabine-Rituximab, Fluda-Cyclophsphamide-Rituximab, FCR-Mitoxantrone, R-bendamustine…)
  • At least 4 cycles
  • Patients should have recovered from the toxicities of ICT
  • POOR PROGNOSTIC FEATURES (before induction ICT) defined by at least one of the following markers: stage C Binet, unmutated IgVH genes, 17p deletion, 11q deletion, Zap-70 positivity, high CD38, mutated IgVH genes if VH3-21 usage
  • In addition, in patients with 11q deletion and/or presence of bulky lymph nodes prior to induction therapy, absence of profound lymph nodes at response evaluation should have been confirmed by CT scan
  • CIRS ≤6
  • Absence of significant geriatric syndromes and/or significant limitations in instrumental activities of daily living (IADL)
  • Performance status (ECOG) < 2
  • Neutrophils > 1000/microL, platelets > 100,000/microL
  • Creatinine clearance > 50 ml/min (clearance can be reevaluated after adequate hydration of the patient)
  • Patient's written informed consent

Who cannot join

  • Less than CR defined by standard criteria response after ICT
  • Ongoing active infections (bacterial, viral or fungal)
  • Known infection with HIV
  • Subjects with any serological evidence of current or past hepatitis B or hepatitis C exposure are excluded unless the serological findings are clearly due to vaccination.
  • Concomitant treatment with steroids, or any immunosuppressive drug
  • Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
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  • Transformation into an aggressive B-cell malignancy (eg. diffuse large B-cell lymphoma, Hodgkin lymphoma)
  • Pregnancy, breast feeding, female patients with childbearing potential or male patients who are unwilling to use adequate contraception
  • Intolerance to rituximab
  • Concomitant severe disease (uncompensated cardiac insufficiency, severe respiratory insufficiency…)
  • Severe hypogammaglobulinemia with recurrent infections, unless the patient is receiving substitutive IV immunoglobulins
  • Transaminases (AST, ALT) > 3 xULN
  • Conjugated bilirubin > 2 xULN
  • Prior autologous stem cell transplantation less than 12 months
  • Prior allogeneic stem cell transplantation
  • Central Nervous System involvement
  • Any coexisting medical or psychological condition that would preclude participation to the required study procedures
  • Prior history of malignancies, other than CLL, unless subject has been free of the disease for > 4 years. Exceptions include the following: basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, incidental histologic finding prostate cancer (TNM stage of T1a or T1b)
  • Participation in any clinical study or having taken any investigational therapy which would interfere with the study drug for a disease other than CLL, within 28 days prior to initiating the maintenance therapy.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

Belgium15 sites

  • ZNA Middelheim

    Antwerp, 2020

  • Clinique Sud Luxembourg

    Arlon, 6700

  • AZ Sint-Jan

    Bruges, 8000

  • Clinique Saint Jean

    Brussels, 1000

  • ULB Erasme

    Brussels, 1070

  • Cliniques universitaires Saint Luc

    Brussels, 1200

  • Grand Hôpital de Charleroi

    Charleroi, 6000

  • UZ Gent

    Ghent, 9000

  • Hôpital de Jolimont

    Haine-Saint-Paul, 7100

  • KUL Gasthuisberg

    Leuven, 3000

  • CHU ULg Sart Tilman

    Liège, 4000

  • CHR Clinique Saint Joseph

    Mons, 7000

  • Clinique Saint Pierre

    Ottignies, 1340

  • Heilig-Hartziekenhuis

    Roeselaere, 8800

  • Clinique universitaire de Mont Godinne

    Yvoir, 5530

Other trials in Belgium

About this study

This study explores the potential to improve the quality of response obtained after induction treatment in Chronic Lymphocytic Leukemia (CLL), by giving a short and intense consolidation schema using high-dose rituximab. Patients in suboptimal response (Minimal Residual Disease persistence) after induction will be selected, as well as those who have a Minimal Residual Disease (MRD) relapse after having achieved MRD negativity.

Read the detailed description

This study is reserved for patients with residual disease at the end of therapy at the level of Minimal Residual Disease (MRD-positive either in the peripheral blood at least 6 months after the last dose of rituximab-containing immunochemotherapy or in the bone marrow at least 3 months after the last dose of rituximab-containing immunochemotherapy). Patients who have achieved MRD eradication and who have MRD relapse (reappearance of residual leukemic cells using 7/8-color flow cytometry in peripheral blood or bone marrow) are also eligible for the study.

Rituximab will be given intravenously at a monthly dose of 2000 mg four months (in total 4 doses of 2000 mg each), starting within one month after informed consent signature.

The patients will be followed during the treatment period with rituximab. A final evaluation will be done 3 months after the last dose of rituximab.

Being tested
Rituximab
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.

  • RituximabDrug

    Also called Mabthera

    2000 mg, IV, monthly, for 4 months (= 4 doses)

Study groups in NCT01625741
Study groupRoleWhat they receive
rituximabExperimental4 monthly administrations of rituximab
Receives: Drug: Rituximab

What is being measured

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

  1. rate of conversion into Minimal Residual Disease negativity

    Evaluate the rate of conversion into MRD negativity 3 months after the administration of 4 monthly courses of high-dose (2000 mg) rituximab in high-risk CLL patients with suboptimal response after immunochemotherapy (ICT), or MRD relapse after ICT.

    Measured: Month 7 (= 3 months after the last dose of rituximab)

Secondary outcomes (3)

  1. toxicity of the consolidation treatment by rituximab

    Measured: from first administration of rituximab until end of follow-up period (= 12 months after the last rituximab administration)

  2. Pharmacokinetic/Pharmacodynamic correlation

    correlation between the level of MRD conversion at month 7 and pharmacokinetic dosage of rituximab performed after each rituximab perfusions, 1 month and 3 months after last rituximab.

    Measured: month 7

  3. quality of life study

    from selection visit until last follow-up visit planned 1 years after the last rituximab perfusion

    Measured: during 17 months

Timeline

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

  1. First posted21 Jun 2012 (estimated)
  2. Study startJul 2012
  3. Primary completionMay 2015
  4. Study completionMay 2015

Why it stopped: Stopped by Principal Investigator decision

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
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01625741
Sponsor's protocol ID
HYDRIC
Acronym
HYDRIC
Status last verified
Sep 2015
First submitted
6 Jun 2012
Last updated
29 Sep 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rituximab in people with Chronic Lymphocytic Leukemia, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 15 sites in Belgium.

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 17 inclusion and 19 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: stopped early, as of the sponsor's last update on 29 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Belgium. 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 was stopped early (reason given: Stopped by Principal Investigator decision). Results are not available in the source record.

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?

rate of conversion into Minimal Residual Disease negativity (time frame: Month 7 (= 3 months after the last dose of rituximab)). 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 NCT01625741.

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 29 Sep 2015.

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