Thymosin Alfa 1 in Recipients of Allogeneic Hematopoietic Transplantation for Hematological Malignancies

NCT00580450 | Unknown Phase 1 DMC

• 2 other identifiers: (ST 1472)ST 1472 06/01/27
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial is to determine safety and efficacy of 16 weeks treatment with thymosin alpha 1 given at 1.6 mg dose once daily by subcutaneous injection in adult patients with hematological undergone allogenic bone marrow transplantation and CMV positive. The efficacy will be explored assessing the ability of thymosin alpha1 to prevent the infection complications.

Conditions

Hematological Malignancies

Outcome Measures

Primary Outcomes (1)

• Efficacy in terms of improvement of immunological reconstitution, infectious mortality; safety as prevention of GvHD.

  3 years

Study Arms (2)

2

NO INTERVENTION

1

EXPERIMENTAL

Drug: Thymosin alpha 1

Interventions

Thymosin alpha 1 DRUG

1.6 mg sc once a day for 16 weeks

1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent.
• Age \> 18 or \< 55.
• Patients with AML, ALL, or other haematological malignancies with an indication to transplant with or without a matched donor undergoing allogenic haploidentical hematopoietic transplantation (see Appendix 2) in any of the following categories:
• Patients in first complete remission (CR) at high risk of relapse because of unfavourable cytogenetics, such as:
• t (9;22)
• q23 translocation
• complex karyotype
• t (8;12)/ETV6-AML
• t (6;9)/DEK-CAN
• t (11;14)(q15,q11)
• Trisomy 13
• FLT-3/ITD
• Or other adverse prognostic factors, such as:
• Secondary leukemia
• CR after second line treatment

You may not qualify if:

• Evidence of active hepatitis (B and/or C) or cirrhosis
• HIV positive
• Presence of any other active, uncontrolled bacterial, viral or fungal infection
• Neurological or psychiatric dysfunctions which would impair compliance with the medical regimens and/or transplantation toleration
• Concomitant or prior history of malignancy other than surgically cured in situ carcinoma of the cervix.
• Pregnancy as documented by a urine pregnancy test or lactation.
• Any indication that the patient would not comply with the conditions of the study protocol.
• Previous treatment with thymosin alpha 1.
• Simultaneous participation in another investigational drug study or participation in any clinical trial involving investigational drugs within 3 months before study entry.

Sponsors & Collaborators

• University Of Perugia: lead

Study Sites (1)

Hematology Section, University of Perugia

Perugia, Perugia, 06122, Italy

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Thymalfasin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Thymosin; Thymus Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Proteins

Study Officials

• Andrea Velardi, Prof

  Hematology Section, University of Perugia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrae Velardi, MD, Prof.

CONTACT

+39 075 578 3151; velardi@unipg.it

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: December 24, 2007
• Study Start: December 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2010
• Last Updated: December 24, 2007

Record last verified: 2007-11

Locations

IT (1)