Trial record 8 of 61 for:
"Systemic mastocytosis"
Cladribine Plus Pegylated Interpheron Alfa-2a in Systemic Mastocytosis
This study is currently recruiting participants.
Verified May 2012 by Hospital Virgen de la Salud
Sponsor:
Hospital Virgen de la Salud
Information provided by (Responsible Party):
LUIS ESCRIBANO, Hospital Virgen de la Salud
ClinicalTrials.gov Identifier:
NCT01602939
First received: May 16, 2012
Last updated: May 19, 2012
Last verified: May 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Systemic Mastocytosis |
Drug: Cladribine and pegylated interpheron alpha-2a |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Subcutaneous Cladribine Plus Pegylated Interpheron Alfa-2a in Advanced Systemic Mastocytosis With D816V and Other Exon 17 KIT Mutations. |
Resource links provided by NLM:
Further study details as provided by Hospital Virgen de la Salud:
Primary Outcome Measures:
- To evaluate the effect of therapy on bone marrow mast cell infiltration. [ Time Frame: 6 months ] [ Designated as safety issue: No ]Evaluation of bone marrow response will be assessed by immunohistochemestry, citology, flow cytometry and molecular analyses of bone marrow samples.
Secondary Outcome Measures:
- To determine the effect of therapy on serum tryptase levels and other altered peripheral blood parameters due to mastocytosis. [ Time Frame: 6 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Evaluation of bone response will be assessed by X-ray survey and/or computerized tomography.
| Estimated Enrollment: | 10 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
Intervention Details:
-
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01602939
Contacts
| Contact: Luis Escribano, MD, PhD | +34925269335 | lescribanom@sescam.jccm.es |
| Contact: Iván Alvarez-Twose, MD | +34925269336 | ivana@sescam.jccm.es |
Locations
| Spain | |
| Instituto de Estudios de Mastocitosis de Castilla La Mancha; Hospital Virgen del Valle | Recruiting |
| Toledo, Spain, 45071 | |
| Contact: Luis Escribano, MD, PhD +34925269335 lescribanom@sescam.jccm.es | |
| Contact: Iván Alvarez-Twose, MD +34925269336 ivana@sescam.jccm.es | |
| Principal Investigator: Luis Escribano, MD, PhD | |
| Sub-Investigator: Iván Alvarez-Twose, MD | |
Sponsors and Collaborators
Hospital Virgen de la Salud
Investigators
| Principal Investigator: | Luis Escribano, MD, PhD | Instituto de Estudios de Mastocitosis de Castilla La Mancha |
More Information
No publications provided
| Responsible Party: | LUIS ESCRIBANO, Director of the Instituto de Estudios de Mastocitosis de Castilla La Mancha, Hospital Virgen de la Salud |
| ClinicalTrials.gov Identifier: | NCT01602939 History of Changes |
| Other Study ID Numbers: | EC11-187 |
| Study First Received: | May 16, 2012 |
| Last Updated: | May 19, 2012 |
| Health Authority: | Spain: Ministry of Health |
Keywords provided by Hospital Virgen de la Salud:
|
Mast cell Mastocytosis Mast cell disease |
Additional relevant MeSH terms:
|
Mastocytosis Urticaria Pigmentosa Mastocytoma Mastocytosis, Systemic Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Skin Diseases |
Mastocytosis, Cutaneous Pigmentation Disorders Cladribine Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013