Hematologic MalignanciesPhase 3NCT01217723
Thymoglobulin in Unrelated Hematopoietic Progenitor Cell Transplantation
A Phase 3 study testing Anti-Thymocyte Globulin (Rabbit) and Patients will receive a standard preparative regimen (i.e. one that does not contain Thymoglobulin) in people with Hematologic Malignancies, run by McMaster University at 10 sites in Canada.
Trial summary
This is a randomized trial for patients undergoing hematopoietic progenitor cell transplantation (HPCT) from an unrelated donor. Approximately 50% of the patients enrolled will receive Thymoglobulin® as part of the preparative regimen prior to HPCT. Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Hematologic Malignancies
- What is being tested?
- Anti-Thymocyte Globulin (Rabbit) and Patients will receive a standard preparative regimen (i.e. one that does not contain Thymoglobulin)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 10 sitesCanada
- Study dates
- Apr 2010to Jan 2014
- 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 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The recipient has a hematologic malignancy
- The recipient will receive one of the specified preparative regimens
- The recipient will receive either a bone marrow ("HPC, Marrow") or blood progenitor cell ("HPC, Apheresis") graft
- The recipient has an unrelated donor who with high resolution typing is either fully MHC matched at HLA-A, B, C and DRB1 with the recipient or is 1-antigen or 1-allele mismatched at A, B, C or DRB1 loci The recipient meets the transplant centre's criteria for unrelated donor allogeneic transplantation , either myeloablative or non-myeloablative (syn. RIC).
- The recipient has good performance status (Karnofsky ≥60%)
- Recipient has given signed informed consent For the questionnaire component only, be able to complete the questionnaires in English or with a validated translation (as posted on the project website)
Who cannot join
- The recipient is HIV antibody positive
- The recipient has a hypersensitivity to rabbit proteins or Thymoglobulin pharmaceutical excipients, glycine or mannitol
- The recipient has active or chronic infection (i.e. infection requiring oral or IV therapy)
- The recipient (if female and of childbearing potential) is pregnant or breast-feeding at the time of enrollment
- The recipient (if female and of childbearing potential) does not agree to use an adequate contraceptive method from the time of enrollment until a minimum of one year following transplant
- The recipient (if male and fertile) does not agree to use an adequate contraceptive method from the time of enrollment until a minimum of one year following transplant
- For the questionnaire component only, the recipient is unable to participate due to cognitive, linguistic or emotional difficulties (i.e. the recipient can participate in the main study but will be excluded from the questionnaire component
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Canada10 sites, 10 recruiting
- Recruiting
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 2YA
Stephen Couban, MD, 902-473-7006, stephen.couban@cdha.nshealth.ca
- Recruiting
Juravinski Hospital & Cancer Centre
Hamilton, Ontario, L8V 1C3
Irwin Walker, MD, 905-521-2100 ext. 76384, walkeri@mcmaster.ca
- Not yet recruiting
Hopital de l'Enfant Jesus
Montreal, Quebec, G1J 1Z4
Genevieve Gallagher, MD, 418-649-5727, genevieve.gallagher.cha@ssss.gouv.qc.ca
- Recruiting
Hopital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4
Jean Roy, MD, 514-252-3400 ext. 3404, jroy.hmr@ssss.gouv.qc.ca
- Not yet recruiting
Royal Victoria Hospital
Montreal, Quebec, H3A 1A1
Gizelle Popradi, MD, 514-934-1934 ext. 31558, gizelle.propardi@muhc.mcgill.ca
- Not yet recruiting
Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Jason Tay, MD, 613-737-8899 ext. 73034, jtay@toh.on.ca
- Not yet recruiting
L'Hotel Dieu de Quebec
Québec, Quebec, G1R 2J6
Felix Couture, MD, felixcou@videotron.ca
- Not yet recruiting
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
John Kuruvilla, MD, 416-946-4466, john.kuruvilla@uhn.on.ca
- Recruiting
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
Holly M Kerr, BA, BSN, 604-875-4111 ext. 63196, hkerr@bccancer.bc.ca
Catherine L Singh, 604-875-4111 ext. 69013, csingh@bccancer.bc.ca
- Recruiting
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
David Szwajcer, MD, 204-787-4179, david.szwajcer@cancercare.mb.ca
About this study
Official title: A Randomized Trial of Thymoglobulin to Prevent Chronic Graft Versus Host Disease in Patients Undergoing Hematopoietic Progenitor Cell Transplantation (HPCT) From Unrelated Donors
This is a randomized trial for patients undergoing hematopoietic progenitor cell transplantation (HPCT) from an unrelated donor. Approximately 50% of the patients enrolled will receive Thymoglobulin® as part of the preparative regimen prior to HPCT. The other 50% of the patients enrolled will receive a standard preparative regimen. Thymoglobulin is known to suppress the types of cells that can cause a transplant complication known as "chronic graft versus host disease (cGVHD)". The goal of this trial is to find out if adding Thymoglobulin to the preparative regimen will result in a decrease in cGVHD.
Read the detailed description
This study is a non-blinded, randomized, multicentre trial testing the effect of Thymoglobulin® vs. placebo on the primary outcome of cGVHD. Subjects will be children and adults having unrelated donor transplants.
Intervention: Infusion of Thymoglobulin® on three days prior to the transplant.
Hypothesis: The hypothesis is that the use of Thymoglobulin® in the experimental group will result in an absolute 20% increase in the number of patients free of cGVHD at 12 months, the time of peak incidence, from 20% in the control group to 40% in the experimental group.
Outcome Measures: The Primary Outcome Measure is freedom from cGVHD at 12 months from transplantation, defined as withdrawal of all systemic immunosuppressive agents and without resumption up to 12 months (a binary end-point, yes/no). Secondary outcome measures: Quality of Life, overall incidence of cGVHD (including untreated cases and resolved cases), the incidence of "extensive" cGVHD, time to non-relapse mortality, time to all-cause mortality, time to relapse of leukemia, graft rejection or failure (Yes vs. No), serious infection (Yes vs. No), CMV activation (Yes vs. No), organ-specific grading of chronic graft versus host disease, resumption of immunosuppressive agents after 12 months (Yes vs. No), doses of immunosuppressive drugs still required at 12 months, and incidence of acute graft versus host disease.
- Conditions
- Hematologic Malignancies
- Being tested
- Anti-Thymocyte Globulin (Rabbit), Patients will receive a standard preparative regimen (i.e. one that does not contain Thymoglobulin)
- Keywords
- Acute leukemia (myeloid,lymphoid,or biphenotypic), Chronic myeloid leukemia, Chronic lymphocytic leukemia, Lymphoma, Myelodysplastic syndrome, Myeloproliferative disorder
- Medical subject headings
- Hematologic Neoplasms, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Myelodysplastic Syndromes, Myeloproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-Thymocyte Globulin (Rabbit)Biological
Also called Thymoglobulin, ATGr, rabbit
Thymoglobulin 0.5 mg/kg on Day -2 prior to the Transplant, 2.5 mg/kg on Day -1, and 2.5 mg/kg on the day of transplant.
Patients will receive a standard preparative regimen (i.e. one that does not contain Thymoglobulin)Other
The standard preparative regimen can be myeloablative or reduced intensity.
| Study group | Role | What they receive |
|---|---|---|
| Thymoglobulin | Experimental | Thymoglobulin will be administered on Days -2, -1 prior to the transplant and on the day of transplant. Receives: Biological: Anti-Thymocyte Globulin (Rabbit) |
| No Thymoglobulin | Other | Patients will receive a standard preparative regimen. (i.e. one that does not normally contain Thymoglobulin.) Receives: Other: Patients will receive a standard preparative regimen (i.e. one that does not contain Thymoglobulin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from Chronic GVHD
"Freedom from Chronic GVHD" is defined as withdrawal of all systemic immunosuppressive agents and without resumption up to 12 months (a binary endpoint, yes/no)
Measured: 12 months post transplant
Secondary outcomes (1)
Quality of Life
A series of questionnaires measured at the screening interval (up to 3 months prior to transplant), 6, 12 and 24 months post transplant.
Measured: Measured at Screening, Month 6, 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2010 (estimated)
- Study startApr 2010
- Primary completionJan 2014 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hematologic MalignanciesStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Genzyme, a Sanofi Company, The Canadian Blood and Marrow Transplant Group
- Investigators
- Irwin Walker, MD, Study chair, McMaster University, Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01217723
- Sponsor's protocol ID
- CBMTG 0801
- Status last verified
- Sep 2010
- First submitted
- 29 Sep 2010
- Last updated
- 8 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chakupurakal G, Freudenberger P, Skoetz N, Ahr H, Theurich S. Polyclonal anti-thymocyte globulins for the prophylaxis of graft-versus-host disease after allogeneic stem cell or bone marrow transplantation in adults. Cochrane Database Syst Rev. 2023 Jun 21;6(6):CD009159. doi: 10.1002/14651858.CD009159.pub3.
PubMed 37341189Walker I, Panzarella T, Couban S, Couture F, Devins G, Elemary M, Gallagher G, Kerr H, Kuruvilla J, Lee SJ, Moore J, Nevill T, Popradi G, Roy J, Schultz KR, Szwajcer D, Toze C, Foley R; Cell Therapy Transplant Canada. Addition of anti-thymocyte globulin to standard graft-versus-host disease prophylaxis versus standard treatment alone in patients with haematological malignancies undergoing transplantation from unrelated donors: final analysis of a randomised, open-label, multicentre, phase 3 trial. Lancet Haematol. 2020 Feb;7(2):e100-e111. doi: 10.1016/S2352-3026(19)30220-0. Epub 2020 Jan 17.
PubMed 31958417Naeije L, Kariminia A, Abdossamadi S, Azadpour S, Subrt P, Kuzeljevic B, Irvine MA, Walker I, Schultz KR. Anti-Thymocyte Globulin Prophylaxis Induces a Decrease in Naive Th Cells to Inhibit the Onset of Chronic Graft-versus-Host Disease: Results from the Canadian Bone Marrow Transplant Group (CBMTG) 0801 Study. Biol Blood Marrow Transplant. 2020 Mar;26(3):438-444. doi: 10.1016/j.bbmt.2019.11.015. Epub 2019 Nov 19.
PubMed 31756535
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Thymoglobulin to Prevent Chronic Graft Versus Host Disease in Patients Undergoing Hematopoietic Progenitor Cell Transplantation (HPCT) From Unrelated Donors
- ClinicalTrials.gov ID
- NCT01217723
- Acronym / sponsor ID
- CBMTG 0801
- Conditions
- Hematologic Malignancies
- Keywords
- Acute leukemia (myeloid,lymphoid,or biphenotypic), Chronic myeloid leukemia, Chronic lymphocytic leukemia, Lymphoma, Myelodysplastic syndrome, Myeloproliferative disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Genzyme, a Sanofi Company, The Canadian Blood and Marrow Transplant Group
- Study start
- Apr 2010
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 8 Oct 2010 (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 is a randomized trial for patients undergoing hematopoietic progenitor cell transplantation (HPCT) from an unrelated donor. Approximately 50% of the patients enrolled will receive Thymoglobulin® as part of the preparative regimen prior to HPCT. The other 50% of the patients enrolled will receive a standard preparative regimen. Thymoglobulin is known to suppress the types of cells that can cause a transplant complication known as "chronic graft versus host disease (cGVHD)". The goal of this trial is to find out if adding Thymoglobulin to the preparative regimen will result in a decrease in cGVHD.
Detailed description
This study is a non-blinded, randomized, multicentre trial testing the effect of Thymoglobulin® vs. placebo on the primary outcome of cGVHD. Subjects will be children and adults having unrelated donor transplants.
Intervention: Infusion of Thymoglobulin® on three days prior to the transplant.
Hypothesis: The hypothesis is that the use of Thymoglobulin® in the experimental group will result in an absolute 20% increase in the number of patients free of cGVHD at 12 months, the time of peak incidence, from 20% in the control group to 40% in the experimental group.
Outcome Measures: The Primary Outcome Measure is freedom from cGVHD at 12 months from transplantation, defined as withdrawal of all systemic immunosuppressive agents and without resumption up to 12 months (a binary end-point, yes/no). Secondary outcome measures: Quality of Life, overall incidence of cGVHD (including untreated cases and resolved cases), the incidence of "extensive" cGVHD, time to non-relapse mortality, time to all-cause mortality, time to relapse of leukemia, graft rejection or failure (Yes vs. No), serious infection (Yes vs. No), CMV activation (Yes vs. No), organ-specific grading of chronic graft versus host disease, resumption of immunosuppressive agents after 12 months (Yes vs. No), doses of immunosuppressive drugs still required at 12 months, and incidence of acute graft versus host disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thymoglobulin | Experimental | Biological: Anti-Thymocyte Globulin (Rabbit)Thymoglobulin will be administered on Days -2, -1 prior to the transplant and on the day of transplant. |
| No Thymoglobulin | Other | Other: Patients will receive a standard preparative regimen (i.e. one that does not contain Thymoglobulin)Patients will receive a standard preparative regimen. (i.e. one that does not normally contain Thymoglobulin.) |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- The recipient has a hematologic malignancy
- The recipient will receive one of the specified preparative regimens
- The recipient will receive either a bone marrow ("HPC, Marrow") or blood progenitor cell ("HPC, Apheresis") graft
- The recipient has an unrelated donor who with high resolution typing is either fully MHC matched at HLA-A, B, C and DRB1 with the recipient or is 1-antigen or 1-allele mismatched at A, B, C or DRB1 loci The recipient meets the transplant centre's criteria for unrelated donor allogeneic transplantation , either myeloablative or non-myeloablative (syn. RIC).
- The recipient has good performance status (Karnofsky ≥60%)
Key exclusion criteria (7 listed)
- The recipient is HIV antibody positive
- The recipient has a hypersensitivity to rabbit proteins or Thymoglobulin pharmaceutical excipients, glycine or mannitol
- The recipient has active or chronic infection (i.e. infection requiring oral or IV therapy)
- The recipient (if female and of childbearing potential) is pregnant or breast-feeding at the time of enrollment
- The recipient (if female and of childbearing potential) does not agree to use an adequate contraceptive method from the time of enrollment until a minimum of one year following transplant
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 |
|---|---|---|
| Anti-Thymocyte Globulin (Rabbit)Also: Thymoglobulin, ATGr, rabbitThymoglobulin 0.5 mg/kg on Day -2 prior to the Transplant, 2.5 mg/kg on Day -1, and 2.5 mg/kg on the day of transplant. | Biological | Thymoglobulin |
| Patients will receive a standard preparative regimen (i.e. one that does not contain Thymoglobulin)The standard preparative regimen can be myeloablative or reduced intensity. | Other | No Thymoglobulin |
Primary outcome
Freedom from Chronic GVHD
Time frame: 12 months post transplant
"Freedom from Chronic GVHD" is defined as withdrawal of all systemic immunosuppressive agents and without resumption up to 12 months (a binary endpoint, yes/no)
1 secondary outcome
Quality of Life
Time frame: Measured at Screening, Month 6, 12 and 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2010.
- Derived from this study: PubMed 37341189Chakupurakal G, Freudenberger P, Skoetz N, Ahr H, Theurich S. Polyclonal anti-thymocyte globulins for the prophylaxis of graft-versus-host disease after allogeneic stem cell or bone marrow transplantation in adults. Cochrane Database Syst Rev. 2023 Jun 21;6(6):CD009159. doi: 10.1002/14651858.CD009159.pub3.
- Derived from this study: PubMed 31958417Walker I, Panzarella T, Couban S, Couture F, Devins G, Elemary M, Gallagher G, Kerr H, Kuruvilla J, Lee SJ, Moore J, Nevill T, Popradi G, Roy J, Schultz KR, Szwajcer D, Toze C, Foley R; Cell Therapy Transplant Canada. Addition of anti-thymocyte globulin to standard graft-versus-host disease prophylaxis versus standard treatment alone in patients with haematological malignancies undergoing transplantation from unrelated donors: final analysis of a randomised, open-label, multicentre, phase 3 trial. Lancet Haematol. 2020 Feb;7(2):e100-e111. doi: 10.1016/S2352-3026(19)30220-0. Epub 2020 Jan 17.
- Derived from this study: PubMed 31756535Naeije L, Kariminia A, Abdossamadi S, Azadpour S, Subrt P, Kuzeljevic B, Irvine MA, Walker I, Schultz KR. Anti-Thymocyte Globulin Prophylaxis Induces a Decrease in Naive Th Cells to Inhibit the Onset of Chronic Graft-versus-Host Disease: Results from the Canadian Bone Marrow Transplant Group (CBMTG) 0801 Study. Biol Blood Marrow Transplant. 2020 Mar;26(3):438-444. doi: 10.1016/j.bbmt.2019.11.015. Epub 2019 Nov 19.
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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.
Irwin Walker, MD study chair
McMaster University, Faculty of Health Sciences
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Anti-Thymocyte Globulin (Rabbit) and Patients will receive a standard preparative regimen (i.e. one that does not contain Thymoglobulin) in people with Hematologic Malignancies, run by McMaster University at 10 sites in Canada.
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 6 inclusion and 7 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 8 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Holly M Kerr, BA, BSN (604-875-4111 ext. 63196, hkerr@bccancer.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from Chronic GVHD (time frame: 12 months post transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01217723, which also lists 3 linked publications.
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 8 Oct 2010.