Recruitment

Recruitment Status
Recruiting

Inclusion Criteria

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

Exclusion Criteria

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

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 Criteria

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

Exclusion Criteria

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

Locations

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

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