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Phase I/II Clinical Trial on Thymosin Alfa 1 of Allogeneic Hematopoietic Transplantation

Phase 1/Phase 2
18 Years
65 Years
Not Enrolling
Hematological Malignancies

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Trial Information

Phase I/II Clinical Trial on Thymosin Alfa 1 of Allogeneic Hematopoietic Transplantation

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

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


- 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

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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Andrea Velardi, Prof

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hematology Section, University of Perugia


Italy: Hematology Section, University of Perugia, Italy.

Study ID:

(ST 1472)



Start Date:

December 2007

Completion Date:

December 2010

Related Keywords:

  • Hematological Malignancies
  • Neoplasms
  • Hematologic Neoplasms