Hematologic MalignanciesPhase 2NCT00693927
Nonmyeloablative Stem Cell Transplantation With CD8-depleted or Unmanipulated Peripheral Blood Stem Cells (PBSC)
A Phase 2 study testing Unmanipulated PBSC after nonmyeloablative conditioning and CD8-depleted PBSC after nonmyeloablative conditioning in people with Hematologic Malignancies, run by University of Liege at 1 site in Belgium.
Trial summary
Prospective randomized study of allogeneic minitransplantation from HLA-identical family or unrelated donors comparing unmanipulated or CD8-depleted PBSC. The conditioning regimen will be 2 Gy TBI alone (related donor with low-risk of transplant rejection) or 2 Gy TBI and 3 x 30 mg/m2 fludarabine (unrelated donor or… Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Hematologic Malignancies
- What is being tested?
- Unmanipulated PBSC after nonmyeloablative conditioning and CD8-depleted PBSC after nonmyeloablative conditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2002to May 2008
- Phase
- Phase 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 Up to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
- Patients 1.1. Diseases Malignant diseases confirmed histologically and not rapidly progressing:
- Hematologic malignancies
- AML;
- ALL;
- CML and other myeloproliferative disorders;
- MDS;
- Multiple myeloma;
- CLL;
- Non-Hodgkin's lymphoma;
- Hodgkin's disease.
- Non-hematologic malignancies
- Renal cell carcinoma (metastatic). 1.2. Inclusion criteria
- Male or female; female patients must use a reliable contraception method;
- Age lower than 70 yrs (family donor) or lower than 65 yrs (unrelated donor);
- HIV negative;
- No terminal organ failure;
- No uncontrolled infection, arrhythmia or hypertension;
- Family donor (HLA-identical) or unrelated donor (matched for A-B by low resolution typing and for DRB1-DQB1 by high resolution typing);
- No previous radiation therapy precluding the use of 2 Gy TBI
- Informed consent given by patient or his/her guardian if of minor age. 1.3. Clinical situations
- Theoretical disease indication for a standard allo-transplant, but not feasible because:
- Age > 55 yrs;
- Unacceptable end organ performance;
- Patient's refusal.
- Indication for a standard auto-transplant:
- perform mini-allotransplantation 2-6 months after standard autotransplant.
- Not an indication for intensification but a potential candidate for cellular immunotherapy.
- Donors
2.1. Inclusion criteria
- Related to the recipient (sibling, parent or child) or unrelated;
- Male or female;
- Weight > 15 Kg (because of leukapheresis);
- HIV negative;
- No major contraindication for allogeneic PBSC donation by generally accepted criteria;
- Informed consent given by donor or his/her guardian if of minor age.
2.2. Exclusion criteria
- Any condition not fulfilling inclusion criteria;
- Unable to undergo leukapheresis because of poor vein access or other reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nonmyeloablative Stem Cell Transplantation With CD8-depleted or Unmanipulated Peripheral Blood Stem Cells: A Prospective Randomized Phase II Trial
Prospective randomized study of allogeneic minitransplantation from HLA-identical family or unrelated donors comparing unmanipulated or CD8-depleted PBSC. The conditioning regimen will be 2 Gy TBI alone (related donor with low-risk of transplant rejection) or 2 Gy TBI and 3 x 30 mg/m2 fludarabine (unrelated donor or high risk of transplant rejection). Patients will receive a short but intensive immunosuppressive treatment (cyclosporine and mycophenolate mofetil) to ensure both graft-versus-host and host-versus-graft tolerance. The rationale for using PBSC instead of marrow transplant is to avoid general anesthesia of the donor and to minimize the risk of rejection. The rationale for CD8+ depletion is to diminish the risk of GVHD after PBSC transplantation or DLI.
- Conditions
- Hematologic Malignancies
- Being tested
- Unmanipulated PBSC after nonmyeloablative conditioning, CD8-depleted PBSC after nonmyeloablative conditioning
- Keywords
- Hematopoietic cell transplantation, Allogeneic, Nonmyeloablative, CD8-depletion, PBSC, GVHD, Hematological malignancies and renal cell carcinoma
- Medical subject headings
- Hematologic Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unmanipulated PBSC after nonmyeloablative conditioningProcedure or surgery
Conditioning regimen with 2 Gy TBI with or without added fludarabine (90 mg/m2).
Unmanipulated PBSC from HLA-identical sibling or HLA-matched related or unrelated donor
CD8-depleted PBSC after nonmyeloablative conditioningProcedure or surgery
Also called Conditioning regimen with 2 Gy TBI with or without added fludarabine (90 mg/m2)., CD8-depleted PBSC from HLA-identical sibling or HLA-matched related or unrelated donor
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Unmanipulated PBSC Receives: Procedure: Unmanipulated PBSC after nonmyeloablative conditioning |
| 2 | Experimental | CD8-Depleted PBSC Receives: Procedure: CD8-depleted PBSC after nonmyeloablative conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute GVHD in CD8-depleted versus unmanipulated groups
Measured: 180 days
Incidence of chronic GVHD (overall and extensive) in CD8-depleted versus unmanipulated groups.
Measured: 1-year
Secondary outcomes (3)
Incidence of graft rejection [according to the risk of transplant rejection (see table 1 above)] in CD8-depleted versus unmanipulated groups.
Measured: 1-year
T cell (CD3) and myeloid (CD13) chimerism in CD8-depleted versus unmanipulated groups.
Measured: 1-year and then long term
Quality and timing of immune reconstitution in CD8-depleted versus unmanipulated groups.
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2008 (estimated)
- Study startMar 2002
- Primary completionMay 2005
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yves Beguin, University of Liege
- Investigators
- Yves Beguin, MD, PhD, Study chair, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00693927
- Sponsor's protocol ID
- Minitransplant - random
- Status last verified
- Sep 2011
- First submitted
- 29 May 2008
- Last updated
- 2 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nonmyeloablative Stem Cell Transplantation With CD8-depleted or Unmanipulated Peripheral Blood Stem Cells: A Prospective Randomized Phase II Trial
- ClinicalTrials.gov ID
- NCT00693927
- Acronym / sponsor ID
- Minitransplant - random
- Conditions
- Hematologic Malignancies
- Keywords
- Hematopoietic cell transplantation, Allogeneic, Nonmyeloablative, CD8-depletion, PBSC, GVHD, Hematological malignancies and renal cell carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- Mar 2002
- Primary completion
- May 2005 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 9 Jun 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.
Prospective randomized study of allogeneic minitransplantation from HLA-identical family or unrelated donors comparing unmanipulated or CD8-depleted PBSC. The conditioning regimen will be 2 Gy TBI alone (related donor with low-risk of transplant rejection) or 2 Gy TBI and 3 x 30 mg/m2 fludarabine (unrelated donor or high risk of transplant rejection). Patients will receive a short but intensive immunosuppressive treatment (cyclosporine and mycophenolate mofetil) to ensure both graft-versus-host and host-versus-graft tolerance. The rationale for using PBSC instead of marrow transplant is to avoid general anesthesia of the donor and to minimize the risk of rejection. The rationale for CD8+ depletion is to diminish the risk of GVHD after PBSC transplantation or DLI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Unmanipulated PBSC after nonmyeloablative conditioningUnmanipulated PBSC |
| 2 | Experimental | Procedure: CD8-depleted PBSC after nonmyeloablative conditioningCD8-Depleted PBSC |
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Unmanipulated PBSC after nonmyeloablative conditioningConditioning regimen with 2 Gy TBI with or without added fludarabine (90 mg/m2). Unmanipulated PBSC from HLA-identical sibling or HLA-matched related or unrelated donor | Procedure or surgery | 1 |
| CD8-depleted PBSC after nonmyeloablative conditioningAlso: Conditioning regimen with 2 Gy TBI with or without added fludarabine (90 mg/m2)., CD8-depleted PBSC from HLA-identical sibling or HLA-matched related or unrelated donor | Procedure or surgery | 2 |
Primary outcome
Incidence of acute GVHD in CD8-depleted versus unmanipulated groups
Time frame: 180 days
Incidence of chronic GVHD (overall and extensive) in CD8-depleted versus unmanipulated groups.
Time frame: 1-year
3 secondary outcomes
Incidence of graft rejection [according to the risk of transplant rejection (see table 1 above)] in CD8-depleted versus unmanipulated groups.
Time frame: 1-year
T cell (CD3) and myeloid (CD13) chimerism in CD8-depleted versus unmanipulated groups.
Time frame: 1-year and then long term
Quality and timing of immune reconstitution in CD8-depleted versus unmanipulated groups.
Time frame: 1-year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2011.
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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.
Yves Beguin, MD, PhD study chair
University of Liege
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Unmanipulated PBSC after nonmyeloablative conditioning and CD8-depleted PBSC after nonmyeloablative conditioning in people with Hematologic Malignancies, run by University of Liege at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 2 Sep 2011. 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 Belgium. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of acute GVHD in CD8-depleted versus unmanipulated groups (time frame: 180 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 2 Sep 2011.