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Cladribine Plus Pegylated Interpheron Alfa-2a in Systemic Mastocytosis

This study is currently recruiting participants.
Verified August 2016 by LUIS ESCRIBANO, Hospital Virgen de la Salud
Sponsor:
ClinicalTrials.gov Identifier:
NCT01602939
First Posted: May 21, 2012
Last Update Posted: August 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
LUIS ESCRIBANO, Hospital Virgen de la Salud
May 16, 2012
May 21, 2012
August 29, 2016
May 2012
February 2017   (Final data collection date for primary outcome measure)
To evaluate the effect of therapy on bone marrow mast cell infiltration. [ Time Frame: 6 months ]
Evaluation of bone marrow response will be assessed by immunohistochemestry, citology, flow cytometry and molecular analyses of bone marrow samples.
To evaluate the effect of therapy on the grade of bone marrow and cutaneous mast cell infiltration, as well as on organomegalies or bone alterations. [ Time Frame: 6 months ]
Evaluation of bone marrow response will be assessed by immunohistochemestry, citology, flow cytometry and molecular analyses of bone marrow samples. Evaluation of cutaneous response will be assessed by macroscopic inspection including photographs and by skin immunohistochemestry. Evaluation of organomegalies response will be assessed by abdominal ultrasound and/or computerized tomography. Evaluation of bone response will be assessed by dual X-ray absorptiometry and/or X-ray survey and/or computerized tomography.
Complete list of historical versions of study NCT01602939 on ClinicalTrials.gov Archive Site
  • To determine the effect of therapy on serum tryptase levels and other altered peripheral blood parameters due to mastocytosis. [ Time Frame: 6 months ]
    Serum tryptase and any other mastocytosis-related altered biochemical parameter at diagnosis will be measured monthly until the end of therapy.
  • To evaluate the effect of therapy on mast cell-mediator release symptoms: pruritus, flushing, gastrointestinal symptoms or anaphylaxis). [ Time Frame: 6 months ]
    Specific questionnaires regarding mast cell-mediator release symptoms will be filled monthly by each patient until the end of therapy.
  • To determine de safety of combined therapy with low doses of cladribine plus pegylated interpheron alpha-2a. [ Time Frame: 6 months ]
    Potentially drugs-related adverse events will be recorded in each case following accepted criteria (NIH CTCAE).
  • To evaluate the effect of therapy on mastocytosis skin lesions. [ Time Frame: 6 moths ]
    Evaluation of cutaneous response will be assessed by macroscopic inspection including photographs and by skin immunohistochemestry.
  • To evaluate the effect of therapy on mastocytosis-related organomegalies. [ Time Frame: 6 months ]
    Evaluation of organomegalies response will be assessed by abdominal ultrasound and/or computerized tomography.
  • To evaluate the effect of therapy on mastocytosis-related bone alterations. [ Time Frame: 6 months ]
    Evaluation of bone response will be assessed by X-ray survey and/or computerized tomography.
  • To determine the effect of therapy on serum tryptase levels and other altered peripheral blood parameters due to mastocytosis. [ Time Frame: 6 months ]
    Serum tryptase and any other mastocytosis-related altered biochemical parameter at diagnosis will be measured monthly until the end of therapy.
  • To evaluate the effect of therapy on mast cell-mediator release symptoms: pruritus, flushing, gastrointestinal symptoms or anaphylaxis). [ Time Frame: 6 months ]
    Specific questionnaires regarding mast cell-mediator release symptoms will be filled monthly by each patient until the end of therapy.
  • To determine de safety of combined therapy with low doses of cladribine plus pegylated interpheron alpha-2a. [ Time Frame: 6 months ]
    Potentially drugs-related adverse events will be recorded in each case following accepted criteria (NIH CTCAE).
Not Provided
Not Provided
 
Cladribine Plus Pegylated Interpheron Alfa-2a in Systemic Mastocytosis
Subcutaneous Cladribine Plus Pegylated Interpheron Alfa-2a in Advanced Systemic Mastocytosis With D816V and Other Exon 17 KIT Mutations.
The aim of this study is to evaluate the efficacy in terms of clinical and biological response rates of Cladribine plus Pegylated Interpheron alpha-2a therapy in patients with advanced systemic mastocytosis carrying D816V or other exon 17 KIT mutations.
Not Provided
Interventional
Phase 2
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Systemic Mastocytosis
Drug: Cladribine and pegylated interpheron alpha-2a

Cladribine (0.07 mg/Kg/day) s.c for 5 consecutive days each month for a total of 6 months.Cladribine daily doses could be increased up to 0.14 mg/Kg in the fourth, fifth and sixth cycles of therapy if no objetive response is achieved after the third cycle.

Pegylated Interpheron alpha-2a (1 mcgr/Kg) s.c weekly for a total of 6 months.

Experimental: 2CDA+IFN
Intervention: Drug: Cladribine and pegylated interpheron alpha-2a
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
June 2017
February 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age older than 18 years.
  • Diagnosis of advanced systemic mastocytosis (aggressive systemic mastocytosis or proggressing systemic mastocytosis) with D816V or other exon 17 KIT mutations.
  • ECOG ≤ 3.
  • Signed informed consent.

Exclusion Criteria:

  • Impaired liver function (total bilirubin ≥ 2.0 mg/dl, AST or ALT > 3 x upper limit of normal)not related to mastocytosis.
  • Impaired renal function (≥ 2.0 mg/dL)not related to mastocytosis.
  • Grade III-IV cytopenias not related to mastocytosis. Severe cardiopathy (grade III/IV of NYHA, or left ventricular ejection fraction < 50%).
  • Pregnancy or breastfeeding.
  • Female patients who do not use contraceptive methods.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Luis Escribano, MD, PhD +34925269335 lescribanom@sescam.jccm.es
Contact: Iván Alvarez-Twose, MD +34925269336 ivana@sescam.jccm.es
Spain
 
 
NCT01602939
EC11-187
No
Not Provided
Plan to Share IPD: Undecided
LUIS ESCRIBANO, Hospital Virgen de la Salud
Hospital Virgen de la Salud
Not Provided
Principal Investigator: Luis Escribano, MD, PhD Instituto de Estudios de Mastocitosis de Castilla La Mancha
Hospital Virgen de la Salud
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP