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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2007 by University Of Perugia.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00580450
First Posted: December 24, 2007
Last Update Posted: December 24, 2007
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. Read our disclaimer for details.
Information provided by:
University Of Perugia
  Purpose

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.


Condition Intervention Phase
Hematological Malignancies Drug: Thymosin alpha 1 Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Clinical Trial on Thymosin Alfa 1 of Allogeneic Hematopoietic Transplantation

Further study details as provided by University Of Perugia:

Primary Outcome Measures:
  • Efficacy in terms of improvement of immunological reconstitution, infectious mortality; safety as prevention of GvHD. [ Time Frame: 3 years ]

Estimated Enrollment: 9
Study Start Date: December 2007
Estimated Study Completion Date: December 2010
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 2
Experimental: 1 Drug: Thymosin alpha 1
1.6 mg sc once a day for 16 weeks

Detailed Description:

This is an open label, monocenter, explorative study . A total of 9 patients will be included in the study in three sequential cohort of 3 patients each. Patients will enter into the study after meeting the inclusion and exclusion criteria and signing the Informed Consent Form.

The first three patients will be treated for 16 weeks starting 40 days after transplantation; if all three patients will complete the treatment period without any serious treatment related adverse event then the recruitment of second cohort of patients will be opened and patients treated starting from 20 days after transplantation. The same procedure will be applied for the third cohort of patients starting treatment from day of transplantation.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed written informed consent.
  2. Age > 18 or < 55.
  3. 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)
      • 11q23 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
      • High blast count
      • Biphenotypic leukemia
    • Patients in 2nd or 3rd CR or in chemoresistant relapse
  4. Recipient CMV positive as measured by pp65 antigenemia and PCR
  5. Adequate cardiac function: Asymptomatic of if symptomatic then left ventricular ejection fraction at rest be >45% and must improve with exercise,
  6. Adequate hepatic function: <2 x GOT and GPT and <2.0 mg total serum bilirubin unless liver is involved in disease,
  7. Adequate renal function: Serum creatinine within normal range or if serum creatinine outside normal range then creatinine clearance >50 ml/min,
  8. Adequate Pulmonary function: Diffusion capacity >50% of predicted (corrected for hemoglobin)
  9. Normal TSH or evidence of proper thyroid hormone replacement.
  10. For women of childbearing potential participating in the study, abstinence from sexual intercourses or use of a reliable form of effective contraception during the treatment period. These may include, but are not limited to, birth control pills, IUDs, condoms, diaphragms, implants, surgical sterilization, or being in a post-menopausal state.
  11. Negative pregnancy test prior to first study medication dose.

Exclusion Criteria:

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00580450


Contacts
Contact: Andrae Velardi, MD, Prof. +39 075 578 3151 velardi@unipg.it

Locations
Italy
Hematology Section, University of Perugia Not yet recruiting
Perugia, Italy, 06122
Contact: Massimo F Martelli, Prof    +39 075 578 4170    ematol@unipg.it   
Contact: Franco Aversa, Prof    +39 075 578 4179    aversa@unipg.it   
Sub-Investigator: Katia Perruccio, MD, PhD         
Sub-Investigator: Luigina Romani, Prof         
Sponsors and Collaborators
University Of Perugia
Investigators
Principal Investigator: Andrea Velardi, Prof Hematology Section, University of Perugia
  More Information

Responsible Party: Andrea Velardi, Hematology Section, University of Perugia
ClinicalTrials.gov Identifier: NCT00580450     History of Changes
Other Study ID Numbers: (ST 1472)
ST 1472 06/01/27
First Submitted: December 21, 2007
First Posted: December 24, 2007
Last Update Posted: December 24, 2007
Last Verified: November 2007

Additional relevant MeSH terms:
Neoplasms
Thymalfasin
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents