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Treatment of Hairy Cell Leukaemia Variant and Relapsing Hairy Cell Leukaemia With Cladribine Plus Rituximab

Primary Purpose

Hairy Cell Leukemia (HCL)

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
2CdA +/- Rituximab
Sponsored by
Jurgen Barth
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hairy Cell Leukemia (HCL) focused on measuring HCL variant, HCL relapse, Risk stratified

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with histologically verified hairy cell leukaemia (HCL) Hairy cell leukaemia variant (HCLv) or
  • Relapse of hairy cell leukaemia after therapy with cladribine or pentostatin
  • Need for treatment is indicated (see 4.3 below)
  • Age at least 18 years
  • General state of health according to WHO 0-2
  • Written declaration of consent by the patient
  • 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 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 proven HIV infections
  • Patients with active hepatitis
  • Patients with other florid infections
  • 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

Sites / Locations

  • Community based hemato-oncology medical office
  • Community based hemato-oncology medical office
  • Community based hemato-oncology medical office
  • St.-Johannes-Hospital
  • Städtische Kliniken Esslingen
  • Universitätsklinik Frankfurt
  • Universitätsklinik Freiburg
  • Community based hemato-oncology medical office
  • University Clinic | Med. Cinic IV Justus-Liebig-University
  • Wilhelm-Anton-Hospital
  • Kath. Krankenhaus Hagen gem. GmbH
  • Community based hemato-oncology medical office
  • Community based hemato-oncology medical office
  • Meditinische Hochschule (MHH)
  • Community based hemato-oncology medical office
  • Marienhospital Herne/ Klinikum der Ruhr-Universität Bochum
  • Community based hemato-oncology medical office
  • Community based hemato-oncology medical office
  • Klinikum Idar-Oberstein
  • Community based hemato-oncology medical office
  • Community based hemato-oncology medical office
  • Community based hemato-oncology medical office
  • Community based hemato-oncology medical office
  • Community based hemato-oncology medical office
  • Community based hemato-oncology medical office
  • Community based hemato-oncology medical office
  • Städtische Kliniken
  • Community based hemato-oncology medical office
  • Community based hemato-oncology medical office
  • Klinik Schwäbisch Gmünd / Staufer Klinik
  • Community based hemato-oncology medical office
  • Community based hemato-oncology medical office
  • Klinikum Großhadern
  • Community based hemato-oncology medical office
  • Community based hemato-oncology medical office
  • Community based hemato-oncology medical office
  • Community based hemato-oncology medical office
  • MVZ Klinikum Osnabrück
  • Community based hemato-oncology medical office
  • Klinikum Ernst von Bergmann gGmbH
  • St. Josefs-Krankenhaus
  • Community based hemato-oncology medical office
  • St. Marien-Krankenhaus
  • Community based hemato-oncology medical office
  • Diakonie-Klinikum Stuttgart
  • Community based hemato-oncology medical office
  • Community based hemato-oncology medical office

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HCL, 2CdA +/- Rituximab

Arm Description

Risk stratification HCL variant will be treated with cladribine plus rituximab, independent of previous therapy Relapses of HCL will be treated with cladribine plus rituximab, duration of remission of the previous therapy is < 3 years. All repeated relapses (> 1st relapse) after previous therapies with purine analogues and/or interferon will be treated with cladribine plus rituximab. Cladribine (LITAK®) 0.14 mg/kg daily Days 8-12 subcutaneous bolus injection Rituximab (Mabthera®) 375 mg/m2 daily Days 1, 8, 15, 22 infusion Relapses of HCL will be treated with cladribine monotherapy, if the duration of remission of the previous therapy is > 3 years. Cladribine (LITAK®) 0.14 mg/kg daily Days 1-5 subcutaneous bolus injection

Outcomes

Primary Outcome Measures

Rate of complete remissions (CR)
Determination of the rate of complete remission and duration of remission after one cycle of subcutaneous cladribine (LITAK®) plus four administrations of rituximab in patients with hairy cell leukaemia variant in patients with relapsed hairy cell leukaemia

Secondary Outcome Measures

Overall remission rate (ORR)
The rate of CR + PR will be determined

Full Information

First Posted
May 21, 2014
Last Updated
June 3, 2014
Sponsor
Jurgen Barth
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1. Study Identification

Unique Protocol Identification Number
NCT02157181
Brief Title
Treatment of Hairy Cell Leukaemia Variant and Relapsing Hairy Cell Leukaemia With Cladribine Plus Rituximab
Official Title
Study on the Treatment of Hairy Cell Leukaemia Variant and Relapsing Hairy Cell Leukaemia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jurgen Barth

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study will test the effectiveness (rate of complete remissions, total remission rate and duration of remission) and toxicity of the combined immuno/chemotherapy with subcutaneous cladribine (LITAK®) plus anti-CD20* antibody rituximab in patients requiring treatment for relapsed hairy cell leukaemia or hairy cell leukaemia variant independent of any previous therapy. CD20* = cluster of differentiation antigen 20
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hairy Cell Leukemia (HCL)
Keywords
HCL variant, HCL relapse, Risk stratified

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HCL, 2CdA +/- Rituximab
Arm Type
Experimental
Arm Description
Risk stratification HCL variant will be treated with cladribine plus rituximab, independent of previous therapy Relapses of HCL will be treated with cladribine plus rituximab, duration of remission of the previous therapy is < 3 years. All repeated relapses (> 1st relapse) after previous therapies with purine analogues and/or interferon will be treated with cladribine plus rituximab. Cladribine (LITAK®) 0.14 mg/kg daily Days 8-12 subcutaneous bolus injection Rituximab (Mabthera®) 375 mg/m2 daily Days 1, 8, 15, 22 infusion Relapses of HCL will be treated with cladribine monotherapy, if the duration of remission of the previous therapy is > 3 years. Cladribine (LITAK®) 0.14 mg/kg daily Days 1-5 subcutaneous bolus injection
Intervention Type
Drug
Intervention Name(s)
2CdA +/- Rituximab
Other Intervention Name(s)
Cladribine, Syn 2CdA, (LITAK®) 0.14 mg/kg, Rituximab (Mabthera®; Rituxan®) 375 mg/m²
Intervention Description
Cladribine 0.14 mg/kg daily subcutaneous bolus injection Rituximab 375 mg/m² infusion
Primary Outcome Measure Information:
Title
Rate of complete remissions (CR)
Description
Determination of the rate of complete remission and duration of remission after one cycle of subcutaneous cladribine (LITAK®) plus four administrations of rituximab in patients with hairy cell leukaemia variant in patients with relapsed hairy cell leukaemia
Time Frame
4 months after treatment
Secondary Outcome Measure Information:
Title
Overall remission rate (ORR)
Description
The rate of CR + PR will be determined
Time Frame
4 months after treatment
Other Pre-specified Outcome Measures:
Title
Acute and late toxicity
Description
All kind of adverse events, laboratory abnormalities, infections, unplanned hospitalisations will be measured
Time Frame
From day 1 of treatment period up to 120 months
Title
Degree of induced immunodeficiency
Description
Degree of immunosupression with CD4/CD8 quotient as indicating biomarker will be measured. Duration of immunosupression as well as infectious and other complications which result from therapy will be reported
Time Frame
From day 1 of treatment period up to 120 months
Title
Frequency of secondary neoplasia during the life-long follow-up period
Description
Rate of secondary neoplasia as safety issue will be determined
Time Frame
From day 1 of treatment period up to 120 months
Title
Overall survival (OS)
Description
Determination of the overall survival times of all patients
Time Frame
From achieving a remission until death

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with histologically verified hairy cell leukaemia (HCL) Hairy cell leukaemia variant (HCLv) or Relapse of hairy cell leukaemia after therapy with cladribine or pentostatin Need for treatment is indicated (see 4.3 below) Age at least 18 years General state of health according to WHO 0-2 Written declaration of consent by the patient 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 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 proven HIV infections Patients with active hepatitis Patients with other florid infections 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathias J Rummel, Prof. Dr.
Organizational Affiliation
Justus-Liebig-University | University Hospital | Medicinal Clinic IV
Official's Role
Principal Investigator
Facility Information:
Facility Name
Community based hemato-oncology medical office
City
Ansbach
ZIP/Postal Code
91522
Country
Germany
Facility Name
Community based hemato-oncology medical office
City
Aschaffenburg
ZIP/Postal Code
63739
Country
Germany
Facility Name
Community based hemato-oncology medical office
City
Celle
ZIP/Postal Code
29221
Country
Germany
Facility Name
St.-Johannes-Hospital
City
Dortmund
ZIP/Postal Code
44137
Country
Germany
Facility Name
Städtische Kliniken Esslingen
City
Esslingen
ZIP/Postal Code
73728
Country
Germany
Facility Name
Universitätsklinik Frankfurt
City
Frankfurt am Main
ZIP/Postal Code
60596
Country
Germany
Facility Name
Universitätsklinik Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Community based hemato-oncology medical office
City
Fürth
ZIP/Postal Code
90766
Country
Germany
Facility Name
University Clinic | Med. Cinic IV Justus-Liebig-University
City
Gießen
ZIP/Postal Code
3592
Country
Germany
Facility Name
Wilhelm-Anton-Hospital
City
Goch
ZIP/Postal Code
47574
Country
Germany
Facility Name
Kath. Krankenhaus Hagen gem. GmbH
City
Hagen
ZIP/Postal Code
58095
Country
Germany
Facility Name
Community based hemato-oncology medical office
City
Halle
ZIP/Postal Code
06108
Country
Germany
Facility Name
Community based hemato-oncology medical office
City
Hamburg
ZIP/Postal Code
21073
Country
Germany
Facility Name
Meditinische Hochschule (MHH)
City
Hannover
ZIP/Postal Code
30623
Country
Germany
Facility Name
Community based hemato-oncology medical office
City
Heidelberg
ZIP/Postal Code
69115
Country
Germany
Facility Name
Marienhospital Herne/ Klinikum der Ruhr-Universität Bochum
City
Herne
ZIP/Postal Code
44625
Country
Germany
Facility Name
Community based hemato-oncology medical office
City
Hilden
ZIP/Postal Code
40721
Country
Germany
Facility Name
Community based hemato-oncology medical office
City
Hildesheim
ZIP/Postal Code
31134
Country
Germany
Facility Name
Klinikum Idar-Oberstein
City
Idar-Oberstein
ZIP/Postal Code
55743
Country
Germany
Facility Name
Community based hemato-oncology medical office
City
Jena
ZIP/Postal Code
07743
Country
Germany
Facility Name
Community based hemato-oncology medical office
City
Kassel
ZIP/Postal Code
34125
Country
Germany
Facility Name
Community based hemato-oncology medical office
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Community based hemato-oncology medical office
City
Koblenz
ZIP/Postal Code
56068
Country
Germany
Facility Name
Community based hemato-oncology medical office
City
Kronach
ZIP/Postal Code
96317
Country
Germany
Facility Name
Community based hemato-oncology medical office
City
Leer
ZIP/Postal Code
26789
Country
Germany
Facility Name
Community based hemato-oncology medical office
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Städtische Kliniken
City
Leverkusen
ZIP/Postal Code
51375
Country
Germany
Facility Name
Community based hemato-oncology medical office
City
Magdeburg
ZIP/Postal Code
39104
Country
Germany
Facility Name
Community based hemato-oncology medical office
City
Marburg
ZIP/Postal Code
35037
Country
Germany
Facility Name
Klinik Schwäbisch Gmünd / Staufer Klinik
City
Mutlangen
ZIP/Postal Code
73557
Country
Germany
Facility Name
Community based hemato-oncology medical office
City
München
ZIP/Postal Code
80335
Country
Germany
Facility Name
Community based hemato-oncology medical office
City
München
ZIP/Postal Code
81241
Country
Germany
Facility Name
Klinikum Großhadern
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
Community based hemato-oncology medical office
City
Neunkirchen
ZIP/Postal Code
66538
Country
Germany
Facility Name
Community based hemato-oncology medical office
City
Neuwied
ZIP/Postal Code
56564
Country
Germany
Facility Name
Community based hemato-oncology medical office
City
Niddatal
ZIP/Postal Code
61194
Country
Germany
Facility Name
Community based hemato-oncology medical office
City
Nürnberg
ZIP/Postal Code
90449
Country
Germany
Facility Name
MVZ Klinikum Osnabrück
City
Osnabrück
ZIP/Postal Code
49076
Country
Germany
Facility Name
Community based hemato-oncology medical office
City
Pforzheim
ZIP/Postal Code
75179
Country
Germany
Facility Name
Klinikum Ernst von Bergmann gGmbH
City
Potsdam
ZIP/Postal Code
14467
Country
Germany
Facility Name
St. Josefs-Krankenhaus
City
Potsdam
ZIP/Postal Code
14471
Country
Germany
Facility Name
Community based hemato-oncology medical office
City
Schweinfurt
ZIP/Postal Code
97421
Country
Germany
Facility Name
St. Marien-Krankenhaus
City
Siegen
ZIP/Postal Code
57072
Country
Germany
Facility Name
Community based hemato-oncology medical office
City
Straubing
ZIP/Postal Code
94315
Country
Germany
Facility Name
Diakonie-Klinikum Stuttgart
City
Stuttgart
ZIP/Postal Code
70176
Country
Germany
Facility Name
Community based hemato-oncology medical office
City
Villingen
ZIP/Postal Code
78050
Country
Germany
Facility Name
Community based hemato-oncology medical office
City
Wolfsburg
ZIP/Postal Code
38440
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Treatment of Hairy Cell Leukaemia Variant and Relapsing Hairy Cell Leukaemia With Cladribine Plus Rituximab

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