Recruitment

Recruitment Status
Recruiting

Inclusion Criterias

No previous cytostatic treatment (splenectomy or interferon treatment are allowed)
Current histology, not older than 6 months
Age at least 18 years old
...
No previous cytostatic treatment (splenectomy or interferon treatment are allowed)
Current histology, not older than 6 months
Age at least 18 years old
Need for treatment
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)
Written consent by patient
Patients with histologically verified hairy cell leukemia
General state of health according to WHO 0-2

Exclusion Criterias

Patients not fulfilling inclusion criteria above
Pretreatment with purine analogues or other chemotherapeutics
Other florid infections
...
Patients not fulfilling inclusion criteria above
Pretreatment with purine analogues or other chemotherapeutics
Other florid infections
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
Concomitant corticosteroid therapy
Active Hepatitis
Anamnesis / diagnosis of other malignant disease (other than non-melanoma associated skin tumours or stage 0 in situ carcinoma of the cervix)
Proven HIV infection
Pregnant or lactating women
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.

Summary

Conditions
Hairy Cell Leukemia
Type
Interventional
Phase
Phase 2 & Phase 3
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 90 years
Gender
Both males and females

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 remissi...

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.

Inclusion Criterias

No previous cytostatic treatment (splenectomy or interferon treatment are allowed)
Current histology, not older than 6 months
Age at least 18 years old
...
No previous cytostatic treatment (splenectomy or interferon treatment are allowed)
Current histology, not older than 6 months
Age at least 18 years old
Need for treatment
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)
Written consent by patient
Patients with histologically verified hairy cell leukemia
General state of health according to WHO 0-2

Exclusion Criterias

Patients not fulfilling inclusion criteria above
Pretreatment with purine analogues or other chemotherapeutics
Other florid infections
...
Patients not fulfilling inclusion criteria above
Pretreatment with purine analogues or other chemotherapeutics
Other florid infections
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
Concomitant corticosteroid therapy
Active Hepatitis
Anamnesis / diagnosis of other malignant disease (other than non-melanoma associated skin tumours or stage 0 in situ carcinoma of the cervix)
Proven HIV infection
Pregnant or lactating women
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.

Locations

Olpe, 57462
Aschaffenburg, 63739
Ansbach, 91522
Mönchengladbach, 41239
Ludwigshafen, 67067
...
Olpe, 57462
Aschaffenburg, 63739
Ansbach, 91522
Mönchengladbach, 41239
Ludwigshafen, 67067
Bremen, 28209
Weilheim, 82362
Wiesbaden, 65199
Rehling, 86508
Duisburg, 47166
Neumarkt, 92318
Berlin, 12203
Herne, 44623
Kronach, 96317
Fürth, 90766
Berlin, 10407
Schweinfurt, 97421
Ehingen, 89584
Wilhelmshaven, 26389
Stuttgart, 70176
Heidelberg, 69115
Duisburg, 47228
Tübingen, 72072
Karlsruhe, 76137
Cottbus, 03046
Bad Neustadt An Der Saale, 97616
Freiburg, 79106
Landshut, 84034
Frankfurt, 60488
Düsseldorf, 40255
Friedrichshafen, 88045
Rüsselsheim, 65428
Wiesbaden, 65191
Celle, 29221
Hagen, 58095
Nürnberg, 90403
Nürnberg, 90449
Schotten, 63679
Potsdam, 14471
Kaiserslautern, 67655
Landau, 76829
Mainz, 55131
Koblenz, 56068
Marburg, 35037
Germering, 82110
Landshut, 84028
Osnabrück, 49074
Halle, 06110
Siegen, 57072
Hanau, 63450
Herne, 44625
Villingen-Schwenningen, 78050
Gießen, 35592
Frankfurt, 60389
Krefeld, 47798
Hamm, 59063
Siegen, 57072
Kempten, 87439
Schkeuditz, 04435
Leverkusen, 51375
Westerland, 25980
München, 80335
Darmstadt, 64295
Homberg, 34576
Gießen, 35392
Ulm, 89081
Weimar, 99425
Dresden, 01127
Erlangen, 91052
Lüdenscheid, 58507
Wolfsburg, 38440
Saarbrücken, 66113
Oberhausen, 46145
Trier, 54290
Kassel, 34117
München, 81377

Tracking Information

NCT #
NCT02131753
Collaborators
Not Provided
Investigators
  • Principal Investigator: Mathias J Rummel, Prof. Dr. Justus-Liebig-University | University Hospital | Medicinal Clinic IV
  • Mathias J Rummel, Prof. Dr. Justus-Liebig-University | University Hospital | Medicinal Clinic IV