Graft Versus Host DiseasePhase 2NCT00740467
Stem Cell Transplant in Treating Patients With Hematological Cancer or Other Disorders
A Phase 2 study testing anti-thymocyte globulin, busulfan and cyclophosphamide in people with Graft Versus Host Disease and Leukemia, run by Institut Paoli-Calmettes at 1 site in France.
Trial summary
RATIONALE: Giving chemotherapy, such as fludarabine, busulfan, and cyclophosphamide, together with antithymocyte globulin before a donor stem cell transplant helps stop the growth of cancer and abnormal cells. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Graft Versus Host Disease, Leukemia, Lymphoma
- What is being tested?
- anti-thymocyte globulin, busulfan and cyclophosphamide
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2008to Jan 2010
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
DISEASE CHARACTERISTICS:
- Diagnosis of any of the following hematological cancers with a poor prognosis:
- Acute myeloid leukemia meeting 1 of the following criteria:
- Third complete remission (CR3) or beyond
- CR2 after an early bone marrow relapse (< 24 months)
- Refractory disease after ≥ 2 chemotherapy courses of induction therapy
- Acute lymphoblastic leukemia meeting 1 of the following criteria:
- CR3 after ≥ 1 bone marrow relapse
- CR2 after early bone marrow relapse (currently or within 6 months after stopping maintenance therapy)
- Chronic myelogenous leukemia meeting the following criteria:
- Accelerated phase
- Second chronic phase
- No other treatment options
- Multiple myeloma meeting the following criteria:
- Failed conventional therapy (including autologous hematopoietic stem cell transplantation)
- No other treatment alternatives
- Chronic lymphocytic leukemia meeting the following criteria:
- Failed conventional therapy
- No other treatment alternatives
- Hodgkin lymphoma meeting the following criteria:
- Failed conventional therapy
- No other treatment alternatives
- Non-Hodgkin lymphoma meeting the following criteria:
- Failed conventional therapy
- No other treatment alternatives
- Not eligible for standard myeloablative allograft due to increased toxicity
- Healthy related donor available and meeting the following criteria:
- Brother, sister, father, mother, cousin, uncle, or aunt
- At least an identical HLA haplotype
- Identical genotype on 1 haplotype (in terms of HLA-A, B, C, and DR)
- Different on ≤ 4 alleles on the other haplotype
- No HLA-identical intra- or extra-familial donor cord blood available within the next 3 months
PATIENT CHARACTERISTICS:
- Karnofsky performance status 70-100%
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No contraindication to allogeneic transplantation, including any of the following:
- Cardiac systolic ejection fraction < 40%
- DLCO level limiting use of fludarabine
- Creatinine clearance < 30 mL/min
- Transaminases and/or bilirubin > 3 times upper limit of normal (unless due to Gilbert disease or cancer)
- HIV seropositivity
- Human T-cell lymphotrophic virus type 1 seropositivity
- Uncontrolled bacterial, viral, or fungal infection
- No contraindication to any of the study drugs
- No prior or concurrent psychiatric illness
- No other cancer in the past 5 years except for basal cell skin cancer or carcinoma in situ of the cervix
- No concurrent serious, uncontrolled condition
- No patients deprived of liberty or subject to legal protection
PRIOR CONCURRENT THERAPY:
- No participation in a study of allografts in the past month
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, 13273
Contact Person, 33-4-91-22-37-54
About this study
Official title: Allograft of Hematopoietic Stem Cells With Reduced-intensity Conditioning From a HLA-haploidentical Family Donor: Phase II Study of Combined Immunosuppression Before and After Transplantation
RATIONALE: Giving chemotherapy, such as fludarabine, busulfan, and cyclophosphamide, together with antithymocyte globulin before a donor stem cell transplant helps stop the growth of cancer and abnormal cells. Giving chemotherapy before or after transplant also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer and abnormal cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well stem cell transplant works in treating patients with hematological cancer or other disorders.
Read the detailed description
OBJECTIVES:
Primary
- Evaluate the incidence of graft acceptance in patients with hematological disorders treated with combined immunosuppression before and after HLA-haploidentical hematopoietic stem cell transplantation.
Secondary
- Evaluate efficacy of this regimen in these patients.
- Evaluate toxicity of this regimen in these patients.
- Assess survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
- Reduced-intensity conditioning: Patients receive fludarabine phosphate IV on days -6 to -1, busulfan IV on days -6 to -5, and anti-thymocyte globulin IV on days -4 to -1.
- Transplantation: Patients undergo transplantation of donor hematopoietic stem cells on day 0. Patients also receive cyclophosphamide IV on day 3 and filgrastim (G-CSF) beginning on day 4 and continuing until blood counts recover.
- Immunosuppression: Patients receive cyclosporine IV beginning on day -2 and continuing for 6 months and mycophenolate mofetil 4 times a day on days 4-84.
- Conditions
- Graft Versus Host Disease, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Precancerous Condition
- Being tested
- anti-thymocyte globulin, busulfan, cyclophosphamide, cyclosporine, fludarabine phosphate
- Keywords
- graft versus host disease, adult acute myeloid leukemia in remission, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), recurrent adult acute myeloid leukemia, adult acute lymphoblastic leukemia in remission, recurrent adult acute lymphoblastic leukemia, accelerated phase chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia, refractory multiple myeloma, relapsing chronic myelogenous leukemia, recurrent adult Hodgkin lymphoma, adult nasal type extranodal NK/T-cell lymphoma, anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma
- Medical subject headings
- Graft vs Host Disease, Leukemia, Lymphoma, Multiple Myeloma, Neoplasms, Plasma Cell, Precancerous Conditions, Congenital Abnormalities, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-thymocyte globulinBiological
busulfanDrug
cyclophosphamideDrug
cyclosporineDrug
nonmyeloablative allogeneic hematopoietic stem cell transplantationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of graft acceptance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2008 (estimated)
- Study startJan 2008
- Primary completionJan 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft Versus Host DiseaseStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Investigators
- Didier Blaise, MD, Study chair, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00740467
- Sponsor's protocol ID
- CDR0000592923
- Other IDs
- IPC-ITT-06-01, INCA-RECF0627, EUDRACT-2006-001369-14
- Status last verified
- Jul 2009
- First submitted
- 22 Aug 2008
- Last updated
- 28 Jan 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allograft of Hematopoietic Stem Cells With Reduced-intensity Conditioning From a HLA-haploidentical Family Donor: Phase II Study of Combined Immunosuppression Before and After Transplantation
- ClinicalTrials.gov ID
- NCT00740467
- Acronym / sponsor ID
- CDR0000592923
- Conditions
- Graft Versus Host Disease, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Precancerous Condition
- Keywords
- graft versus host disease, adult acute myeloid leukemia in remission, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), recurrent adult acute myeloid leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jan 2010 (estimated)
- First posted
- 25 Aug 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.
RATIONALE: Giving chemotherapy, such as fludarabine, busulfan, and cyclophosphamide, together with antithymocyte globulin before a donor stem cell transplant helps stop the growth of cancer and abnormal cells. Giving chemotherapy before or after transplant also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer and abnormal cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well stem cell transplant works in treating patients with hematological cancer or other disorders.
Detailed description
OBJECTIVES:
Primary
- Evaluate the incidence of graft acceptance in patients with hematological disorders treated with combined immunosuppression before and after HLA-haploidentical hematopoietic stem cell transplantation.
Secondary
- Evaluate efficacy of this regimen in these patients.
- Evaluate toxicity of this regimen in these patients.
- Assess survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
- Reduced-intensity conditioning: Patients receive fludarabine phosphate IV on days -6 to -1, busulfan IV on days -6 to -5, and anti-thymocyte globulin IV on days -4 to -1.
- Transplantation: Patients undergo transplantation of donor hematopoietic stem cells on day 0. Patients also receive cyclophosphamide IV on day 3 and filgrastim (G-CSF) beginning on day 4 and continuing until blood counts recover.
- Immunosuppression: Patients receive cyclosporine IV beginning on day -2 and continuing for 6 months and mycophenolate mofetil 4 times a day on days 4-84.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| anti-thymocyte globulin | Biological | – |
| busulfan | Drug | – |
| cyclophosphamide | Drug | – |
| cyclosporine | Drug | – |
| fludarabine phosphate | Drug | – |
| mycophenolate mofetil | Drug | – |
| nonmyeloablative allogeneic hematopoietic stem cell transplantation | Procedure or surgery | – |
Primary outcome
Incidence of graft acceptance
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2010.
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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.
Didier Blaise, MD study chair
Institut Paoli-Calmettes
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 anti-thymocyte globulin, busulfan and cyclophosphamide in people with Graft Versus Host Disease and Leukemia, run by Institut Paoli-Calmettes at 1 site in France.
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: status not confirmed, as of the sponsor's last update on 28 Jan 2010. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of graft acceptance. 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 28 Jan 2010.