Recruitment

Recruitment Status
Completed

Inclusion Criteria

Patients with histologically verified hairy cell leukaemia (HCL) Hairy cell leukaemia variant (HCLv) or
Need for treatment is indicated (see 4.3 below)
General state of health according to WHO 0-2
...
Patients with histologically verified hairy cell leukaemia (HCL) Hairy cell leukaemia variant (HCLv) or
Need for treatment is indicated (see 4.3 below)
General state of health according to WHO 0-2
Written declaration of consent by the patient
Age at least 18 years
Relapse of hairy cell leukaemia after therapy with cladribine or pentostatin
Current histology, which should not be older than 6 months, is necessary

Exclusion Criteria

Patients with proven HIV 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)
...
Patients with proven HIV 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)
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
Pregnant or lactating women
Patients, who do not fulfil the above-mentioned inclusion criteria.

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

Patients with histologically verified hairy cell leukaemia (HCL) Hairy cell leukaemia variant (HCLv) or
Need for treatment is indicated (see 4.3 below)
General state of health according to WHO 0-2
...
Patients with histologically verified hairy cell leukaemia (HCL) Hairy cell leukaemia variant (HCLv) or
Need for treatment is indicated (see 4.3 below)
General state of health according to WHO 0-2
Written declaration of consent by the patient
Age at least 18 years
Relapse of hairy cell leukaemia after therapy with cladribine or pentostatin
Current histology, which should not be older than 6 months, is necessary

Exclusion Criteria

Patients with proven HIV 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)
...
Patients with proven HIV 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)
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
Pregnant or lactating women
Patients, who do not fulfil the above-mentioned inclusion criteria.

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