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Hairy Cell Leukemia (HCL)Phase 2NCT02157181

Treatment of Hairy Cell Leukaemia Variant and Relapsing Hairy Cell Leukaemia With Cladribine Plus Rituximab

A Phase 2 study testing 2CdA +/- Rituximab in people with Hairy Cell Leukemia (HCL), run by Jurgen Barth at 47 sites in Germany.

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 will test the effectiveness (rate of complete remissions, total remission rate and duration of remission) and toxicity of the combined immuno/chemotherapy with subcutaneous cladribine (LITAK®) plus anti-CD20* antibody rituximab in patients requiring treatment for relapsed hairy cell leukaemia or hairy cell… Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Hairy Cell Leukemia (HCL)
What is being tested?
2CdA +/- Rituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
89 participants
Where
47 sitesGermany
Study dates
Jun 2004to Jan 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 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with histologically verified hairy cell leukaemia (HCL) Hairy cell leukaemia variant (HCLv) or
  • Relapse of hairy cell leukaemia after therapy with cladribine or pentostatin
  • Need for treatment is indicated (see 4.3 below)
  • Age at least 18 years
  • General state of health according to WHO 0-2
  • Written declaration of consent by the patient
  • Current histology, which should not be older than 6 months, is necessary

Who cannot join

  • Patients, who do not fulfil the above-mentioned inclusion criteria.
  • Patients with severe functional limitations of the heart according to New York Heart Association III / IV, of the lung according to WHO degree III / IV, the liver (bilirubin > 2mg/dl, alkaline phosphatase, raised GOT and GPT (glutamate- pyruvate transaminase) values more than twice normal), diseases of the central nervous system, including psychoses. Creatinine > 2 mg/dl, or creatinine clearance < 50 mg/min
  • Patients with proven HIV infections
  • Patients with active hepatitis
  • Patients with other florid infections
  • Patients with anamnesis / diagnosis of another malignant disease (other than nonmelanoma associated skin tumours or stage 0 in situ carcinoma of the cervix)
  • Pregnant or lactating women

Trial locations and contacts

47 sites in 1 country.

47 sites in 1 country

Germany47 sites

  • Community based hemato-oncology medical office

    Ansbach, 91522

  • Community based hemato-oncology medical office

    Aschaffenburg, 63739

  • Community based hemato-oncology medical office

    Celle, 29221

  • St.-Johannes-Hospital

    Dortmund, 44137

  • Städtische Kliniken Esslingen

    Esslingen am Neckar, 73728

  • Universitätsklinik Frankfurt

    Frankfurt am Main, 60596

  • Universitätsklinik Freiburg

    Freiburg im Breisgau, 79106

  • Community based hemato-oncology medical office

    Fürth, 90766

  • University Clinic | Med. Cinic IV Justus-Liebig-University

    Giessen, 3592

  • Wilhelm-Anton-Hospital

    Goch, 47574

  • Kath. Krankenhaus Hagen gem. GmbH

    Hagen, 58095

  • Community based hemato-oncology medical office

    Halle, 06108

  • Community based hemato-oncology medical office

    Hamburg, 21073

  • Meditinische Hochschule (MHH)

    Hanover, 30623

  • Community based hemato-oncology medical office

    Heidelberg, 69115

  • Marienhospital Herne/ Klinikum der Ruhr-Universität Bochum

    Herne, 44625

  • Community based hemato-oncology medical office

    Hilden, 40721

  • Community based hemato-oncology medical office

    Hildesheim, 31134

  • Klinikum Idar-Oberstein

    Idar-Oberstein, 55743

  • Community based hemato-oncology medical office

    Jena, 07743

  • Community based hemato-oncology medical office

    Kassel, 34125

  • Community based hemato-oncology medical office

    Kiel, 24105

  • Community based hemato-oncology medical office

    Koblenz, 56068

  • Community based hemato-oncology medical office

    Kronach, 96317

  • Community based hemato-oncology medical office

    Leer, 26789

  • Community based hemato-oncology medical office

    Leipzig, 04103

  • Städtische Kliniken

    Leverkusen, 51375

  • Community based hemato-oncology medical office

    Magdeburg, 39104

  • Community based hemato-oncology medical office

    Marburg, 35037

  • Community based hemato-oncology medical office

    München, 80335

  • Community based hemato-oncology medical office

    München, 81241

  • Klinikum Großhadern

    München, 81377

  • Klinik Schwäbisch Gmünd / Staufer Klinik

    Mutlangen, 73557

  • Community based hemato-oncology medical office

    Neunkirchen, 66538

  • Community based hemato-oncology medical office

    Neuwied, 56564

  • Community based hemato-oncology medical office

    Niddatal, 61194

  • Community based hemato-oncology medical office

    Nuremberg, 90449

  • MVZ Klinikum Osnabrück

    Osnabrück, 49076

  • Community based hemato-oncology medical office

    Pforzheim, 75179

  • Klinikum Ernst von Bergmann gGmbH

    Potsdam, 14467

  • St. Josefs-Krankenhaus

    Potsdam, 14471

  • Community based hemato-oncology medical office

    Schweinfurt, 97421

  • St. Marien-Krankenhaus

    Siegen, 57072

  • Community based hemato-oncology medical office

    Straubing, 94315

  • Diakonie-Klinikum Stuttgart

    Stuttgart, 70176

  • Community based hemato-oncology medical office

    Villingen, 78050

  • Community based hemato-oncology medical office

    Wolfsburg, 38440

Other trials in Germany

About this study

Official title: Study on the Treatment of Hairy Cell Leukaemia Variant and Relapsing Hairy Cell Leukaemia

The study will test the effectiveness (rate of complete remissions, total remission rate and duration of remission) and toxicity of the combined immuno/chemotherapy with subcutaneous cladribine (LITAK®) plus anti-CD20* antibody rituximab in patients requiring treatment for relapsed hairy cell leukaemia or hairy cell leukaemia variant independent of any previous therapy.

CD20* = cluster of differentiation antigen 20

Read the detailed description

The trial is a prospective, multi-centre, open Phase II study on patients with hairy cell leukaemia variant or with relapsed hairy cell leukaemia.

Being tested
2CdA +/- Rituximab
Keywords
HCL variant, HCL relapse, Risk stratified
Medical subject headings
Leukemia, Hairy Cell

What participants receive

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

  • 2CdA +/- RituximabDrug

    Also called Cladribine, Syn 2CdA, (LITAK®) 0.14 mg/kg, Rituximab (Mabthera®; Rituxan®) 375 mg/m²

    Cladribine 0.14 mg/kg daily subcutaneous bolus injection Rituximab 375 mg/m² infusion

Study groups in NCT02157181
Study groupRoleWhat they receive
HCL, 2CdA +/- RituximabExperimentalRisk stratification 1. HCL variant will be treated with cladribine plus rituximab, independent of previous therapy 2. Relapses of HCL will be treated with cladribine plus rituximab, duration of remission of the previous therapy is < 3 years. 3. All repeated relapses (> 1st relapse) after previous therapies with purine analogues and/or interferon will be treated with cladribine plus rituximab. Cladribine (LITAK®) 0.14 mg/kg daily Days 8-12 subcutaneous bolus injection Rituximab (Mabthera®) 375 mg/m2 daily Days 1, 8, 15, 22 infusion 4. Relapses of HCL will be treated with cladribine monotherapy, if the duration of remission of the previous therapy is > 3 years. Cladribine (LITAK®) 0.14 mg/kg daily Days 1-5 subcutaneous bolus injection
Receives: Drug: 2CdA +/- Rituximab

What is being measured

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

  1. Rate of complete remissions (CR)

    Determination of the rate of complete remission and duration of remission after one cycle of subcutaneous cladribine (LITAK®) plus four administrations of rituximab

    • in patients with hairy cell leukaemia variant
    • in patients with relapsed hairy cell leukaemia

    Measured: 4 months after treatment

Secondary outcomes (1)

  1. Overall remission rate (ORR)

    The rate of CR + PR will be determined

    Measured: 4 months after treatment

Timeline

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

  1. First posted5 Jun 2014 (estimated)
  2. Study startJun 2004
  3. Primary completionSep 2012
  4. Study completionJan 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
89 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02157181
Sponsor's protocol ID
NHL 4-2004
Status last verified
Aug 2024
First submitted
21 May 2014
Last updated
22 Aug 2024
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 2CdA +/- Rituximab in people with Hairy Cell Leukemia (HCL), run by Jurgen Barth at 47 sites in Germany.

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 7 inclusion and 7 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 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in Germany. 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?

Rate of complete remissions (CR) (time frame: 4 months after treatment). 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 NCT02157181.

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 22 Aug 2024.

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