Recruitment

Recruitment Status
Recruiting

Inclusion Criteria

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

Exclusion Criteria

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
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.
...
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
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.
Pregnant or lactating women
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
Other florid infections
Active Hepatitis
Concomitant corticosteroid therapy
Pretreatment with purine analogues or other chemotherapeutics

Summary

Conditions
Hairy Cell Leukemia
Type
Interventional
Phase
Phase 2Phase 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

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

Exclusion Criteria

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
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.
...
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
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.
Pregnant or lactating women
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
Other florid infections
Active Hepatitis
Concomitant corticosteroid therapy
Pretreatment with purine analogues or other chemotherapeutics

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