Clinical trial in patients undergoing allo-transplant of hematopoietic stem cell (allo-HSCT) who have developed one or more post-transplant cytopenias

• Conditions: Allogeneic post-transplant cytopenias.; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2013-000534-35-ES
• Lead Sponsor: Fundación Castellano Leonesa de Hematología y Hemoterapia (FUCALHH)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-09
• Last Update Posted: 5 August 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients with hematologic malignancies who have undergone allo-HSCT and are diagnosed with one or more cytopenias peripheral with full chimerism in bone marrow. They may be included:
a. Patients who have received BM or PS as cell source
b. Patients who have received cells from a family donor or HLA-matched unrelated
c. Patients transplanted with myeloablative or nonmyeloablative conditioning.
2. Patients must have adequate cardiac function without evidence of uncontrolled hypertension, congestive heart failure, angina pectoris or myocardial infarction within 6 months prior to the process.
3. Adequate pulmonary function with no evidence of obstructive or restrictive pulmonary disease severe.
4. Patients between 18 and 70 years
5. Signature of informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

Exclusion Criteria

1. Patients whose blood disease has not been controlled by the transplantation or is in progress at the time of treatment.
2. Patients who do not have full chimerism in bone marrow
3. Patients with bacterial, viral or fungal infection that is not being controlled with proper treatment.
4. Patients with poor cardiac function and / or pulmonary
5. Patients that on investigator judgment are not in a good position to tolerate treatment
6. Patients who do not have the required donor.
7. Pregnant women or with risk of pregnancy due to inadequate contraceptive measures.
8. Patients <18 or> 70 years.
9. Patients who do not sign the consent form.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified