Recruitment

Recruitment Status
Completed

Inclusion Criterias

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

Exclusion Criterias

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

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

Exclusion Criterias

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

Locations

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

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