Trials Sponsors Conditions Drugs Pricing

Conditions

Hairy Cell Leukemia (HCL)

Keywords

HCL variantHCL relapseRisk stratified

Outcome Measures

Primary Outcomes (1)

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
4 months after treatment

Secondary Outcomes (1)

Overall remission rate (ORR)
4 months after treatment

Other Outcomes (4)

Acute and late toxicity
From day 1 of treatment period up to 120 months
Degree of induced immunodeficiency
From day 1 of treatment period up to 120 months
Frequency of secondary neoplasia during the life-long follow-up period
From day 1 of treatment period up to 120 months
+1 more other outcomes

Study Arms (1)

HCL, 2CdA +/- Rituximab

EXPERIMENTAL

Risk stratification 1. HCL variant will be treated with cladribine plus rituximab, independent of previous therapy 2. Relapses of HCL will be treated with cladribine plus rituximab, duration of remission of the previous therapy is \< 3 years. 3. 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 4. 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

Drug: 2CdA +/- Rituximab

Interventions

2CdA +/- RituximabDrug

Cladribine 0.14 mg/kg daily subcutaneous bolus injection Rituximab 375 mg/m² infusion

Also known as: Cladribine, Syn 2CdA, (LITAK®) 0.14 mg/kg, Rituximab (Mabthera®; Rituxan®) 375 mg/m²

HCL, 2CdA +/- Rituximab

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 90 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

Jurgen Barth
Otherlead

Study Sites (47)

Community based hemato-oncology medical office

Ansbach, 91522, Germany

Community based hemato-oncology medical office

Aschaffenburg, 63739, Germany

Community based hemato-oncology medical office

Celle, 29221, Germany

St.-Johannes-Hospital

Dortmund, 44137, Germany

Städtische Kliniken Esslingen

Esslingen am Neckar, 73728, Germany

Universitätsklinik Frankfurt

Frankfurt am Main, 60596, Germany

Universitätsklinik Freiburg

Freiburg im Breisgau, 79106, Germany

MeSH Terms

Conditions

Leukemia, Hairy Cell

Interventions

CladribineRituximab

Condition Hierarchy (Ancestors)

LeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

2-Chloroadenosine

Study Officials

Mathias J Rummel, Prof. Dr.
Justus-Liebig-University | University Hospital | Medicinal Clinic IV
PRINCIPAL INVESTIGATOR

Enrollment

89 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: Professor Dr. med Mathias Rummel

Study Record Dates

First Submitted

May 21, 2014

First Posted

June 5, 2014

Study Start

June 2004

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (4)

Study Arms (1)

HCL, 2CdA +/- Rituximab

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (47)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (4)

Study Arms (1)

HCL, 2CdA +/- Rituximab

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (47)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations