Recruitment

Recruitment Status
Completed

Inclusion Criteria

Relapse of hairy cell leukaemia after therapy with cladribine or pentostatin
Age at least 18 years
General state of health according to WHO 0-2
...
Relapse of hairy cell leukaemia after therapy with cladribine or pentostatin
Age at least 18 years
General state of health according to WHO 0-2
Need for treatment is indicated (see 4.3 below)
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 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 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 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
Pregnant or lactating women
Patients with other florid infections
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

Relapse of hairy cell leukaemia after therapy with cladribine or pentostatin
Age at least 18 years
General state of health according to WHO 0-2
...
Relapse of hairy cell leukaemia after therapy with cladribine or pentostatin
Age at least 18 years
General state of health according to WHO 0-2
Need for treatment is indicated (see 4.3 below)
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 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 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 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
Pregnant or lactating women
Patients with other florid infections
Patients, who do not fulfil the above-mentioned inclusion criteria.

Locations

Ansbach, 91522
Esslingen, 73728
Siegen, 57072
Niddatal, 61194
Magdeburg, 39104
...
Ansbach, 91522
Esslingen, 73728
Siegen, 57072
Niddatal, 61194
Magdeburg, 39104
Osnabrück, 49076
Kronach, 96317
München, 81241
Hagen, 58095
Hannover, 30623
Idar-Oberstein, 55743
Frankfurt am Main, 60596
Straubing, 94315
München, 81377
Hilden, 40721
Hildesheim, 31134
Halle, 06108
Kiel, 24105
Koblenz, 56068
Leverkusen, 51375
Potsdam, 14467
Goch, 47574
Fürth, 90766
Nürnberg, 90449
Villingen, 78050
Jena, 07743
Neunkirchen, 66538
Potsdam, 14471
Hamburg, 21073
Leipzig, 04103
Marburg, 35037
Schweinfurt, 97421
Dortmund, 44137
Neuwied, 56564
Herne, 44625
Stuttgart, 70176
Freiburg, 79106
Mutlangen, 73557
Wolfsburg, 38440
Gießen, 3592
Kassel, 34125
Celle, 29221
Aschaffenburg, 63739
München, 80335
Pforzheim, 75179
Leer, 26789
Heidelberg, 69115

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