Treatment of Hairy Cell Leukaemia Variant and Relapsing Hairy Cell Leukaemia With Cladribine Plus Rituximab
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
Inclusion Criteria
- Current histology, which should not be older than 6 months, is necessary
- Age at least 18 years
- Patients with histologically verified hairy cell leukaemia (HCL) Hairy cell leukaemia variant (HCLv) or
- ...
- Current histology, which should not be older than 6 months, is necessary
- Age at least 18 years
- Patients with histologically verified hairy cell leukaemia (HCL) Hairy cell leukaemia variant (HCLv) or
- Written declaration of consent by the patient
- Relapse of hairy cell leukaemia after therapy with cladribine or pentostatin
- General state of health according to WHO 0-2
- Need for treatment is indicated (see 4.3 below)
Exclusion Criteria
- Patients, who do not fulfil the above-mentioned inclusion criteria.
- Patients with proven HIV infections
- 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, who do not fulfil the above-mentioned inclusion criteria.
- Patients with proven HIV infections
- 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 other florid infections
- Patients with active hepatitis
- 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
Summary
- Conditions
- Hairy Cell Leukemia (HCL)
- Type
- Interventional
- Phase
- Phase 2
- 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
The trial is a prospective, multi-centre, open Phase II study on patients with hairy cell leukaemia variant or with relapsed hairy cell leukaemia.
The trial is a prospective, multi-centre, open Phase II study on patients with hairy cell leukaemia variant or with relapsed hairy cell leukaemia.
Inclusion Criteria
- Current histology, which should not be older than 6 months, is necessary
- Age at least 18 years
- Patients with histologically verified hairy cell leukaemia (HCL) Hairy cell leukaemia variant (HCLv) or
- ...
- Current histology, which should not be older than 6 months, is necessary
- Age at least 18 years
- Patients with histologically verified hairy cell leukaemia (HCL) Hairy cell leukaemia variant (HCLv) or
- Written declaration of consent by the patient
- Relapse of hairy cell leukaemia after therapy with cladribine or pentostatin
- General state of health according to WHO 0-2
- Need for treatment is indicated (see 4.3 below)
Exclusion Criteria
- Patients, who do not fulfil the above-mentioned inclusion criteria.
- Patients with proven HIV infections
- 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, who do not fulfil the above-mentioned inclusion criteria.
- Patients with proven HIV infections
- 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 other florid infections
- Patients with active hepatitis
- 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
Tracking Information
- NCT #
- NCT02157181
- 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
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