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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00580450
• Date of registration: 21/12/2007
• Prospective Registration: No
• Primary sponsor: University Of Perugia
• Public title: Thymosin Alfa 1 in Recipients of Allogeneic Hematopoietic Transplantation for Hematological Malignancies
• Scientific title: Phase I/II Clinical Trial on Thymosin Alfa 1 of Allogeneic Hematopoietic Transplantation
• Date of first enrolment: December 2007
• Target sample size: 9
• Recruitment status: Not yet recruiting
• URL: http://clinicaltrials.gov/show/NCT00580450
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1/Phase 2

Countries of recruitment

Italy

Contacts

• Name: Massimo F Martelli, Prof

• Name: Andrae Velardi, MD, Prof.

• Name: Andrea Velardi, Prof
• Affiliation: Hematology Section, University of Perugia

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Hematological Malignancies

Intervention(s)

Drug: Thymosin alpha 1

Primary Outcome(s)

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

Secondary ID(s)

ST 1472 06/01/27

(ST 1472)

Source(s) of Monetary Support

Please refer to primary and secondary sponsors