Hairy Cell LeukemiaPhase 2/3NCT02131753
Therapy Optimisation for the Treatment of Hairy Cell Leukemia
A Phase 2/3 study testing Cladribine s.c. injection, HCL treatment in people with Hairy Cell Leukemia, run by University of Giessen at 76 sites in Germany.
Trial summary
The trial will test the effectiveness and toxicity of subcutaneous treatment with one cycle of cladribine in patients with hairy cell leukemia requiring treatment. They have to be untreated so far or may be pretreated with alpha-interferon. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hairy Cell Leukemia
- What is being tested?
- Cladribine s.c. injection, HCL treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 76 sitesGermany
- Study dates
- May 2004to Dec 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 leukemia
- Presence of hairy cells in the bone marrow and peripheral blood detected by positive TRAP staining and / or co expression if cell surface antigens cluster of differentiation (CD) 19/CD25 or CD19/CD103 (b-ly7)
- No previous cytostatic treatment (splenectomy or interferon treatment are allowed)
- Need for treatment
- Age at least 18 years old
- General state of health according to WHO 0-2
- Current histology, not older than 6 months
- Written consent by patient
Who cannot join
- Patients not fulfilling inclusion criteria above
- Hairy cell leukemia variants (HCL-V): presence of lymphoid cells in bone marrow and / or peripheral blood, which have an intermediate morphology between hairy cells and prolymphocytes (negative TRAP staining and co- expression of CD19/CD103 without CD25
- Pretreatment with purine analogues or other chemotherapeutics
- Concomitant corticosteroid therapy
- Severe dysfunction of the heart (NYHA III or IV), the lung (WHO-Grade III or IV), the liver, except due to lymphoma (bilirubin > 2 mg/dl, alkaline phosphatase, glutamate-oxalacetate transaminase and glutamate-pyruvate transaminase > 2 x upper limit of normal), the kidneys (creatinin > 2 mg/dl or creatinine clearance < 50 ml/min), central nervous system diseases including psychoses.
- Proven HIV infection
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- Active Hepatitis
- Other florid infections
- Anamnesis / diagnosis of other malignant disease (other than non-melanoma associated skin tumours or stage 0 in situ carcinoma of the cervix)
- Pregnant or lactating women
Trial locations and contacts
76 sites in 1 country. Contact the study team or a site near you to ask about taking part.
76 sites in 1 country
Germany76 sites, 76 recruiting
- Recruiting
Community based hemato-oncology medical office
Ansbach, 91522
Sebastian Müller, PhD
Sebastian Müller, PhD
- Recruiting
Community based hemato-oncology medical office
Aschaffenburg, 63739
Manfred Welslau, PhD
Manfred Welslau, PhD
- Recruiting
Rhön-Saale-Klinik gGmbH
Bad Neustadt an der Saale, 97616
Klaus Wutke, PhD
Klaus Wutke, PhD
- Recruiting
Community based hemato-oncology medical office
Berlin, 10407
Herbert Lebahn, PhD
Herbert Lebahn, PhD
- Recruiting
Charité - Universitätsmedizin Berlin
Berlin, 12203
Eckhard Thiel, Prof PhD
Eckhard Thiel, Prof PhD
- Recruiting
Community based hemato-oncology medical office
Bremen, 28209
Karl Wietholt, PhD
Karl Wietholt, PhD
- Recruiting
Community based hemato-oncology medical office
Celle, 29221
Felix Marquard, PhD
Felix Marquard, PhD
- Recruiting
Community based hemato-oncology medical office
Cottbus, 03046
Ulrich von Grünhagen, PhD
Ulrich von Grünhagen, PhD
- Recruiting
Community based hemato-oncology medical office
Darmstadt, 64295
Georgi Kojouharoff, PhD
Georgi Kojouharoff, PhD
- Recruiting
Community based hemato-oncology medical office
Dresden, 01127
Steffen Dörfel, PhD
Steffen Dörfel, PhD
- Recruiting
Community based hemato-oncology medical office
Duisburg, 47166
Johannes Selbach, PhD
Johannes Selbach, PhD
- Recruiting
Klinik Duisburg-West
Duisburg, 47228
Rüdiger Lang, PhD
Rüdiger Lang, PhD
- Recruiting
Universitätsklinik Düsseldorf
Düsseldorf, 40255
Guido Kobbe, PhD
Guido Kobbe, PhD
- Recruiting
Community based hemato-oncology medical office
Ehingen, 89584
Martin Simon, PhD
Martin Simon, PhD
- Recruiting
Community based hemato-oncology medical office
Erlangen, 91052
Michael J Eckart, PhD
Michael J Eckart, PhD
- Recruiting
Community based hemato-oncology medical office
Frankfurt, 60389
Wolfgang U Knauf, Prof PhD
Wolfgang U Knauf, Prof PhD
- Recruiting
Krankenhaus Nordwest
Frankfurt, 60488
Eckhart Weidmann, Prof PhD
Eckhart Weidmann, Prof PhD
- Recruiting
Community based hemato-oncology medical office
Freiburg im Breisgau, 79106
Matthias Zaiss, PhD
Matthias Zaiss, PhD
- Recruiting
Community based hemato-oncology medical office
Friedrichshafen, 88045
Helmut Oettle, PhD
Helmut Oettle, PhD
- Recruiting
Community based hemato-oncology medical office
Fürth, 90766
Harald Wagner, PhD
Harald Wagner, PhD
- Recruiting
Community based hemato-oncology medical office
Germering, 82110
Johann Mittermüller, PhD
Johann Mittermüller, PhD
- Recruiting
Community based hemato-oncology medical office
Giessen, 35392
Georg Ch Schließer, PhD
Georg Ch Schließer, PhD
- Recruiting
University Clinic | Medicinal Clinic IV
Giessen, 35592
Mathias J Rummel, Prof. Dr., +4964198542 ext. 650, mathias.rummel@innere.med.uni-giessen.de
Juergen Barth, +4964198542 ext. 603, juergen.barth@innere.med.uni-giessen.de
- Recruiting
St.-Marien-Hospital
Hagen, 58095
H W Lindemann, PhD
H W Lindemann, PhD
- Recruiting
Community based hemato-oncology medical office
Halle, 06110
Robert Rohrberg, PhD
Robert Rohrberg, PhD
- Recruiting
Evangelisches Krankenhaus
Hamm, 59063
Jörg Schubert, Prof PhD
Jörg Schubert, Prof PhD
- Recruiting
Community based hemato-oncology medical office
Hanau, 63450
Gerd Lautenschläger, PhD
Gerd Lautenschläger, PhD
- Recruiting
Community based hemato-oncology medical office
Heidelberg, 69115
Stefan Fuxius, PhD
Stefan Fuxius, Phd
- Recruiting
Community based hemato-oncology medical office
Herne, 44623
Lars Hahn, PhD
Lars Hahn, PhD
- Recruiting
Marienkrankenhaus
Herne, 44625
Dirk Strumberg, Prof PhD
Dirk Strumberg, Prof PhD
- Recruiting
Community based hemato-oncology medical office
Homberg (Ohm), 34576
Wolfgang Weber, PhD
Wolfgang Weber, PhD
- Recruiting
Community based hemato-oncology medical office
Kaiserslautern, 67655
Manfred Reeb, PhD
Manfred Reeb, PhD
- Recruiting
Städtisches Klinikum
Karlsruhe, 76137
Martin Bentz, Prof. PhD
Martin Bentz, Prof. PhD
- Recruiting
Community based hemato-oncology medical office
Kassel, 34117
Ulrike Söling, PhD
Ulrike Söling, PhD
- Recruiting
Klinikum Kempten-Oberallgäu
Kempten, 87439
Otto Prümmer, PhD
Otto Prümmer, PhD
- Not yet recruiting
Community based hemato-oncology medical office
Koblenz, 56068
Rudolf Weide, Prof PhD
Rudolf Weide, Prof PhD
- Recruiting
Community based hemato-oncology medical office
Krefeld, 47798
Michael Neise, PhD
Michael Neise, PhD
- Recruiting
Community based hemato-oncology medical office
Kronach, 96317
Martina Stauch, PhD
Stauch Martina, PhD
- Recruiting
Community based hemato-oncology medical office
Landau, 76829
Eva Huntenburg, PhD
Eva Huntenburg, PhD
- Recruiting
Community based hemato-oncology medical office
Landshut, 84028
Ursula Vehling-Kaiser, PhD
Ursula Vehling-Kaiser, PhD
- Recruiting
Community based hemato-oncology medical office
Landshut, 84034
Barbara Kempf, PhD
Barbara Kempf, PhD
- Recruiting
Klinikum Leverkusen GmbH
Leverkusen, 51375
Norbert Niederle, Prof PhD
Norbert Niederle, Prof PhD
- Recruiting
Community based hemato-oncology medical office
Lüdenscheid, 58507
Dietrich Kämpfe, PhD
Dietrich Kämpfe, PhD
- Recruiting
St. Marienkrankenhaus
Ludwigshafen, 67067
H Weiss, Prof PhD
H Weiss, Prof PhD
- Recruiting
Universitätsklinik Mainz
Mainz, 55131
Georg Heß, PhD
Georg Heß, PhD
- Recruiting
Community based hemato-oncology medical office
Marburg, 35037
Christina Balser, PhD
Christina Balser, PhD
- Recruiting
Community based hemato-oncology medical office
Mönchengladbach, 41239
Ulrich Grabenhorst, PhD
Ulrich Grabenhorst, PhD
- Recruiting
Community based hemato-oncology medical office
München, 80335
Peter Bojko, PhD
Peter Bojko, PhD
- Recruiting
University Clinic Großhadern
München, 81377
Martin Dreyling, Prof PhD
Martin Dreyling, Prof PhD
- Recruiting
Community based hemato-oncology medical office
Neumarkt, 92318
Ekkehart Ladda, PhD
Ekkehart Ladda, PhD
- Recruiting
Community based hemato-oncology medical office
Nuremberg, 90403
Michael Schauer, PhD
Michael Schauer, PhD
- Recruiting
Community based hemato-oncology medical office
Nuremberg, 90449
Joachim Zimber, PhD
Joachim Zimber, PhD
- Recruiting
St. Clemens Hospital
Oberhausen, 46145
Jutta Schneider, PhD
Jutta Schneider, PhD
- Recruiting
St. Martinus-Hospital
Olpe, 57462
Clemens Müller-Naendrup, PhD
Clemens Müller-Naendrup, PhD
- Recruiting
Community based hemato-oncology medical office
Osnabrück, 49074
Gertrud Lenzen, PhD
Gertrud Lenzen, PhD
- Recruiting
St. Josefs-Krankenhaus
Potsdam, 14471
Michael Göner, PhD
Michael Göner, PhD
- Recruiting
Community based hemato-oncology medical office
Rehling, 86508
Stephan Hochdörfer, PhD
Stephan Hochdörfer, PhD
- Recruiting
Community based hemato-oncology medical office
Rüsselsheim am Main, 65428
Michael Baldus, Phd
Michael Baldus, Phd
- Recruiting
Caritas Klinik St. Theresia
Saarbrücken, 66113
Axel Matzdorff, Prof PhD
Axel Matzdorff, Prof PhD
- Recruiting
Community based hemato-oncology medical office
Schkeuditz, 04435
Thomas Edelmann, PhD
Thomas Edelmann, PhD
- Recruiting
Kreiskrankenhaus Schotten
Schotten, 63679
M Graubner, PhD
M Graubner, PhD
- Recruiting
Community based hemato-oncology medical office
Schweinfurt, 97421
Reginhard von Hirschhausen, PhD
Reginhard von Hirschhausen, PhD
- Recruiting
Community based hemato-oncology medical office
Siegen, 57072
F A Trux, PhD
F A Trux, PhD
- Recruiting
St.-Marien-Krankenhaus
Siegen, 57072
Winfried Gassmann, PhD
Winfried Gassmann, PhD
- Recruiting
Diakonie - Klinikum Stuttgart
Stuttgart, 70176
Else Heidemann, Prof PhD
Else Heidemann, Prof. PhD
- Recruiting
Community based hemato-oncology medical office
Trier, 54290
Hans P Laubenstein, PhD
Hans P Laubenstein, PhD
- Recruiting
Community based hemato-oncology medical office
Tübingen, 72072
Swen H Jacki, PhD
Swen H Jacki, PhD
- Recruiting
University Clinic Ulm
Ulm, 89081
Christian Buske, Prof PhD
Christian Buske, Prof PhD
- Recruiting
Städtisches Krankenhaus Villingen
Villingen-Schwenningen, 78050
Wolfram Brugger, Prof PhD
Wolfram Brugger, Prof. PhD
- Recruiting
Community based hemato-oncology medical office
Weilheim, 82362
Michael Sandherr, PhD
Michael Sandherr, PhD
- Recruiting
Sophien- und Hufeland Klinikum
Weimar, 99425
Thomas Hoffmann, Phd
Thomas Hoffmann, PhD
- Recruiting
Asklepios Nordseeklinik
Westerland, 25980
Willy Nettekoven, PhD
Willy Nettekoven, PhD
- Recruiting
Community based hemato-oncology medical office
Wiesbaden, 65191
Klaus M Josten, PhD
Klaus M Josten, PhD
- Recruiting
Dr. Horst-Schmidt-Kliniken
Wiesbaden, 65199
Norbert Frickhofen, Prof PhD
Norbert Frickhofen, Prof PhD
- Recruiting
Community based hemato-oncology medical office
Wilhelmshaven, 26389
Yolanda Rodemer, PhD
Yolanda Rodemer, PhD
- Recruiting
Community based hemato-oncology medical office
Wolfsburg, 38440
Joachim Haessner, PhD
Joachim Haessner, PhD
About this study
The trial will test the effectiveness and toxicity of subcutaneous treatment with one cycle of cladribine in patients with hairy cell leukemia requiring treatment.
They have to be untreated so far or may be pretreated with alpha-interferon.
Read the detailed description
Evaluation of remission status will take place 4 months after treatment. In addition, it will be tested whether patients with non-optimal response will have a benefit from a second cycle of cladribine.
Non-optimal response is: patients with detectable residual disease; achievement of partial remission or detectable residual infiltration in the bone marrow.
- Conditions
- Hairy Cell Leukemia
- Being tested
- Cladribine s.c. injection, HCL treatment
- Keywords
- hairy cell leukemia, untreated, cladribine subcutaneous
- 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.
Cladribine s.c. injection, HCL treatmentDrug
Also called Litak(R), 2-CdA
Patients with hairy cell leukemia and the need for treatment are given cladribine 0.14 mg/kg for 5 consecutive days as a s. c bolus injection
| Study group | Role | What they receive |
|---|---|---|
| Cladribine s.c. injection, HCL treatment | Other | Cladribine 0.14 mg/kg body weight for 5 consecutive days (d 1 - 5) as subcutaneous bolus injection for patients with hairy cell leukemia needing treatment Receives: Drug: Cladribine s.c. injection, HCL treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the rate of complete remissions after one cycle with subcutaneous cladribine
Measured: 4 months after treatment
Secondary outcomes (1)
Rate of complete remissions in patient who still have detectable residual disease
A second cycle of cladribine after an interval of 4 months following the first cycle.
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.
- First posted6 May 2014 (estimated)
- Study startMay 2004
- Primary completionDec 2025 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hairy Cell LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jurgen Barth, University of Giessen
- Investigators
- Mathias J Rummel, Prof. Dr., Principal investigator, Justus-Liebig-University | University Hospital | Medicinal Clinic IV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02131753
- Sponsor's protocol ID
- NHL 3-2004
- Status last verified
- Aug 2024
- First submitted
- 30 Apr 2014
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapy Optimisation for the Treatment of Hairy Cell Leukemia
- ClinicalTrials.gov ID
- NCT02131753
- Acronym / sponsor ID
- NHL 3-2004
- Conditions
- Hairy Cell Leukemia
- Keywords
- hairy cell leukemia, untreated, cladribine subcutaneous
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Study start
- May 2004
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 6 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The trial will test the effectiveness and toxicity of subcutaneous treatment with one cycle of cladribine in patients with hairy cell leukemia requiring treatment.
They have to be untreated so far or may be pretreated with alpha-interferon.
Detailed description
Evaluation of remission status will take place 4 months after treatment. In addition, it will be tested whether patients with non-optimal response will have a benefit from a second cycle of cladribine.
Non-optimal response is: patients with detectable residual disease; achievement of partial remission or detectable residual infiltration in the bone marrow.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cladribine s.c. injection, HCL treatment | Other | Drug: Cladribine s.c. injection, HCL treatmentCladribine 0.14 mg/kg body weight for 5 consecutive days (d 1 - 5) as subcutaneous bolus injection for patients with hairy cell leukemia needing treatment |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with histologically verified hairy cell leukemia
- Presence of hairy cells in the bone marrow and peripheral blood detected by positive TRAP staining and / or co expression if cell surface antigens cluster of differentiation (CD) 19/CD25 or CD19/CD103 (b-ly7)
- No previous cytostatic treatment (splenectomy or interferon treatment are allowed)
- Need for treatment
- Age at least 18 years old
Key exclusion criteria (10 listed)
- Patients not fulfilling inclusion criteria above
- Hairy cell leukemia variants (HCL-V): presence of lymphoid cells in bone marrow and / or peripheral blood, which have an intermediate morphology between hairy cells and prolymphocytes (negative TRAP staining and co- expression of CD19/CD103 without CD25
- Pretreatment with purine analogues or other chemotherapeutics
- Concomitant corticosteroid therapy
- Severe dysfunction of the heart (NYHA III or IV), the lung (WHO-Grade III or IV), the liver, except due to lymphoma (bilirubin > 2 mg/dl, alkaline phosphatase, glutamate-oxalacetate transaminase and glutamate-pyruvate transaminase > 2 x upper limit of normal), the kidneys (creatinin > 2 mg/dl or creatinine clearance < 50 ml/min), central nervous system diseases including psychoses.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cladribine s.c. injection, HCL treatmentAlso: Litak(R), 2-CdAPatients with hairy cell leukemia and the need for treatment are given cladribine 0.14 mg/kg for 5 consecutive days as a s. c bolus injection | Drug | Cladribine s.c. injection, HCL treatment |
Primary outcome
Determination of the rate of complete remissions after one cycle with subcutaneous cladribine
Time frame: 4 months after treatment
1 secondary outcome
Rate of complete remissions in patient who still have detectable residual disease
Time frame: 4 months after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mathias J Rummel, Prof. Dr. principal investigator
Justus-Liebig-University | University Hospital | Medicinal Clinic IV
76 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cladribine s.c. injection, HCL treatment in people with Hairy Cell Leukemia, run by University of Giessen at 76 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 8 inclusion and 10 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: looking for participants now, 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 76 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mathias J Rummel, Prof PhD (+4964198542 ext. 650, mathias.rummel@innere.med.uni-giessen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of the rate of complete remissions after one cycle with subcutaneous cladribine (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?
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.