Allogeneic Haplo-Stem Cell Transplatation (SCT)Phase 3NCT00616954
A Study to Evaluate the Effect of ATG-F on Engraftment, Graft Versus Host Disease (GVHD) and Graft Versus Leukemia (GVL) Effect in Haplo-identical SCT
A Phase 3 study testing ATG-F in people with Allogeneic Haplo-Stem Cell Transplatation (SCT) and Graft Versus Host Disease, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
This study is planned to evaluated whether ATG is needed in haploidentical stem cell transplantation Read more about this study
- Who is it for?
- Ages 3 to 70 years
- Conditions the study is for
- Allogeneic Haplo-Stem Cell Transplatation (SCT), Graft Versus Host Disease
- What is being tested?
- ATG-F
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- May 2008to Sep 2010
- Phase
- Phase 3
- 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 3 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient age 3-70 years old with a disease necessitating allogeneic SCT.
- Patients must have a mismatched donor willing and capable of donating peripheral blood stem cells and/or bone marrow progenitor cells using conventional techniques, and lymphocytes if indicated (mismatched defined as 3/6-4/6 HLA matching).
- Each patient / patient's guardian must sign written informed consent.
- Patients must have an ECOG PS ≤ 2; Creatinine <2.0 mg/dl; Ejection fraction >40%; DLCO >50% of predicted; Serum bilirubin <3 gm/dl; elevated GPT or GOT >3 x normal values.
Who cannot join
- Not fulfilling any of the inclusion criteria.
- Active life-threatening infection.
- Overt untreated infection.
- Known hypersensitivity to ATG.
- HIV seropositivity, Hepatitis B or C antigen positivity with evidence of active hepatitis.
- Pregnant or lactating women.
- Donor contraindication (HIV seropositive confirmed by Western Blot Hepatitis B antigenemia; positive HCV antibodies with positive HCV PCR; evidence of bone marrow disease; unable to donate bone marrow or peripheral blood due to concurrent medical condition).
- Inability to comply with study requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Investigator Initiated, Prospective, Randomized, Controlled Study in Order to Evaluate the Effect of Anti-thymocyte Globulin (Fresenius ATG) on Engraftment, Graft Versus Host Disease (GVHD) and Graft Versus Leukemia (GVL) Effect in Haplo-identical Allogeneic Hematopoietic Stem-cell Transplantation
This study is planned to evaluated whether ATG is needed in haploidentical stem cell transplantation
- Being tested
- ATG-F
- Keywords
- mismatched, Stem cell transplatation, Bone marrow transplantation, T cell depletion, engraftment, Patients undergoing allogeneic haplo-SCT
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATG-FDrug
ATG-f
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | with ATG-F Receives: Drug: ATG-F |
| 2 | No intervention | control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Day of day of neutrophil engraftment (ANC>0.5x10^9/L)
Measured: 30 days
Day of platelet engraftment >25x10^9/L
Measured: 30 days
Secondary outcomes (9)
AGVHD occurrence
Measured: 100 days
DFS at 100 days
Measured: 100 days
Day of platelet engraftment >50x10^9/L
Measured: 100 days
Time to AGVHD
Measured: 100 days
AGVHD grade
Measured: 100 days
OS
Measured: 100 days
Infections incidence
Measured: 100 days
TRM
Measured: 100 days
TRT
Measured: 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startMay 2008
- Primary completionJun 2010
- Study completionSep 2010
Why it stopped: low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allogeneic Haplo-Stem Cell Transplatation (SCT)Studies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Michael Y Shapira, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00616954
- Sponsor's protocol ID
- MYS-06-HMO-CTIL
- Status last verified
- Aug 2009
- First submitted
- 22 Jan 2008
- Last updated
- 21 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator Initiated, Prospective, Randomized, Controlled Study in Order to Evaluate the Effect of Anti-thymocyte Globulin (Fresenius ATG) on Engraftment, Graft Versus Host Disease (GVHD) and Graft Versus Leukemia (GVL) Effect in Haplo-identical Allogeneic Hematopoietic Stem-cell Transplantation
- ClinicalTrials.gov ID
- NCT00616954
- Acronym / sponsor ID
- MYS-06-HMO-CTIL
- Keywords
- mismatched, Stem cell transplatation, Bone marrow transplantation, T cell depletion, engraftment, Patients undergoing allogeneic haplo-SCT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low recruitment
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 15 Feb 2008 (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.
This study is planned to evaluated whether ATG is needed in haploidentical stem cell transplantation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ATG-Fwith ATG-F |
| 2 | No intervention | –control |
Who may qualify
- Ages
- 3 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patient age 3-70 years old with a disease necessitating allogeneic SCT.
- Patients must have a mismatched donor willing and capable of donating peripheral blood stem cells and/or bone marrow progenitor cells using conventional techniques, and lymphocytes if indicated (mismatched defined as 3/6-4/6 HLA matching).
- Each patient / patient's guardian must sign written informed consent.
- Patients must have an ECOG PS ≤ 2; Creatinine <2.0 mg/dl; Ejection fraction >40%; DLCO >50% of predicted; Serum bilirubin <3 gm/dl; elevated GPT or GOT >3 x normal values.
Key exclusion criteria (8 listed)
- Not fulfilling any of the inclusion criteria.
- Active life-threatening infection.
- Overt untreated infection.
- Known hypersensitivity to ATG.
- HIV seropositivity, Hepatitis B or C antigen positivity with evidence of active hepatitis.
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 |
|---|---|---|
| ATG-FATG-f | Drug | 1 |
Primary outcome
Day of day of neutrophil engraftment (ANC>0.5x10^9/L)
Time frame: 30 days
Day of platelet engraftment >25x10^9/L
Time frame: 30 days
9 secondary outcomes
AGVHD occurrence
Time frame: 100 days
DFS at 100 days
Time frame: 100 days
Day of platelet engraftment >50x10^9/L
Time frame: 100 days
Time to AGVHD
Time frame: 100 days
AGVHD grade
Time frame: 100 days
OS
Time frame: 100 days
Infections incidence
Time frame: 100 days
TRM
Time frame: 100 days
TRT
Time frame: 100 days
Results and safety
The study was stopped early (reason given: low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2015.
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.
Michael Y Shapira, MD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ATG-F in people with Allogeneic Haplo-Stem Cell Transplatation (SCT) and Graft Versus Host Disease, run by Hadassah Medical Organization at 1 site in Israel.
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 4 inclusion and 8 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: stopped early, as of the sponsor's last update on 21 Apr 2015. 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 Israel. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: low recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Day of day of neutrophil engraftment (ANC>0.5x10^9/L) (time frame: 30 days). The study lists 2 primary outcomes in all. 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 21 Apr 2015.