Hematological MalignanciesPhase 1/2NCT00580450
Thymosin Alfa 1 in Recipients of Allogeneic Hematopoietic Transplantation for Hematological Malignancies
A Phase 1/2 study testing Thymosin alpha 1 in people with Hematological Malignancies, run by University Of Perugia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hematological Malignancies
- What is being tested?
- Thymosin alpha 1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2007to Dec 2010
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- 11q23 translocation
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- 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
- Recipient CMV positive as measured by pp65 antigenemia and PCR
- Adequate cardiac function: Asymptomatic of if symptomatic then left ventricular ejection fraction at rest be >45% and must improve with exercise,
- Adequate hepatic function: <2 x GOT and GPT and <2.0 mg total serum bilirubin unless liver is involved in disease,
- Adequate renal function: Serum creatinine within normal range or if serum creatinine outside normal range then creatinine clearance >50 ml/min,
- Adequate Pulmonary function: Diffusion capacity >50% of predicted (corrected for hemoglobin)
- Normal TSH or evidence of proper thyroid hormone replacement.
- 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.
- Negative pregnancy test prior to first study medication dose.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Hematology Section, University of Perugia
Perugia, Perugia, 06122
Massimo F Martelli, Prof, +39 075 578 4170, ematol@unipg.it
Franco Aversa, Prof, +39 075 578 4179, aversa@unipg.it
About this study
Official title: Phase I/II Clinical Trial on Thymosin Alfa 1 of Allogeneic Hematopoietic Transplantation
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.
Read the 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.
- Conditions
- Hematological Malignancies
- Being tested
- Thymosin alpha 1
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thymosin alpha 1Drug
1.6 mg sc once a day for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| 2 | No intervention | Not described |
| 1 | Experimental | Not described Receives: Drug: Thymosin alpha 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy in terms of improvement of immunological reconstitution, infectious mortality; safety as prevention of GvHD.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionDec 2007
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematological MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Of Perugia
- Sponsor type
- University, hospital or other
- Investigators
- Andrea Velardi, Prof, Principal investigator, Hematology Section, University of Perugia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00580450
- Sponsor's protocol ID
- (ST 1472)
- Other IDs
- ST 1472 06/01/27
- Status last verified
- Nov 2007
- First submitted
- 21 Dec 2007
- Last updated
- 24 Dec 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Clinical Trial on Thymosin Alfa 1 of Allogeneic Hematopoietic Transplantation
- ClinicalTrials.gov ID
- NCT00580450
- Acronym / sponsor ID
- (ST 1472)
- Conditions
- Hematological Malignancies
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- University Of PerugiaUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2010 (estimated)
- First posted
- 24 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | No intervention | – |
| 1 | Experimental | Drug: Thymosin alpha 1 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- 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:
- Recipient CMV positive as measured by pp65 antigenemia and PCR
- Adequate cardiac function: Asymptomatic of if symptomatic then left ventricular ejection fraction at rest be >45% and must improve with exercise,
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thymosin alpha 11.6 mg sc once a day for 16 weeks | Drug | 1 |
Primary outcome
Efficacy in terms of improvement of immunological reconstitution, infectious mortality; safety as prevention of GvHD.
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Velardi, Prof principal investigator
Hematology Section, University of Perugia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Thymosin alpha 1 in people with Hematological Malignancies, run by University Of Perugia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrae Velardi, MD, Prof. (+39 075 578 3151, velardi@unipg.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy in terms of improvement of immunological reconstitution, infectious mortality; safety as prevention of GvHD. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2007; AzTrials last refreshed its copy on 8 Nov 2026.