Recruitment

Recruitment Status
Completed

Inclusion Criteria

Need for treatment is indicated (see 4.3 below)
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)
Relapse of hairy cell leukaemia after therapy with cladribine or pentostatin
General state of health according to WHO 0-2
Age at least 18 years
Written declaration of consent by the patient
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

Exclusion Criteria

Patients, who do not fulfil the above-mentioned inclusion criteria.
Patients with anamnesis / diagnosis of another malignant disease (other than nonmelanoma associated skin tumours or stage 0 in situ carcinoma of the cervix)
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 anamnesis / diagnosis of another malignant disease (other than nonmelanoma associated skin tumours or stage 0 in situ carcinoma of the cervix)
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 active hepatitis
Patients with other florid infections
Pregnant or lactating women
Patients with proven HIV infections

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

Need for treatment is indicated (see 4.3 below)
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)
Relapse of hairy cell leukaemia after therapy with cladribine or pentostatin
General state of health according to WHO 0-2
Age at least 18 years
Written declaration of consent by the patient
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

Exclusion Criteria

Patients, who do not fulfil the above-mentioned inclusion criteria.
Patients with anamnesis / diagnosis of another malignant disease (other than nonmelanoma associated skin tumours or stage 0 in situ carcinoma of the cervix)
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 anamnesis / diagnosis of another malignant disease (other than nonmelanoma associated skin tumours or stage 0 in situ carcinoma of the cervix)
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 active hepatitis
Patients with other florid infections
Pregnant or lactating women
Patients with proven HIV infections

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