Chronic Myeloproliferative DisordersPhase 2NCT00806767
Fludarabine, Busulfan, and Antilymphocyte Globulin Followed by Donor Stem Cell Transplant in Treating Older Patients With Hematological Cancer
A Phase 2 study testing therapeutic immune globulin, busulfan and fludarabine phosphate in people with Chronic Myeloproliferative Disorders and Leukemia, run by Institut Paoli-Calmettes at 1 site in France.
Trial summary
RATIONALE: Giving low doses of chemotherapy before a donor stem cell transplant using stem cells that closely match the patient's stem cells, helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. Read more about this study
- Who is it for?
- Ages 56 to 74 years
- Conditions the study is for
- Chronic Myeloproliferative Disorders, Leukemia, Lymphoma
- What is being tested?
- therapeutic immune globulin, busulfan and fludarabine phosphate
- Type of treatment
- Surgery or procedure
- How many people
- 82 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2007to May 2011
- 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 56 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of a hematological malignancy
- Candidate for an allogeneic hematopoietic stem cell transplantation
- Available HLA-identical related donor
PATIENT CHARACTERISTICS:
- WHO performance status (PS) 0-1 OR Karnofsky PS 70-100%
- Life expectancy > 6 months
- LVEF ≥ 40%
- DLCO ≥ 50%
- Creatinine clearance ≥ 30 mL/min
- Transaminases and/or bilirubin ≤ 2 times upper limit of normal (ULN)
- No other cancer within the past 5 years, except for basal cell carcinoma of the skin or carcinoma in situ of the cervix
- No human T-cell leukemia virus type 1 positivity
- No HIV positivity
- No uncontrolled bacterial, viral, or fungal infection
- No contraindications to the study drugs
- No concurrent serious and uncontrolled disease
PRIOR CONCURRENT THERAPY:
- At least 1 month since prior participation in a clinical trial
Trial locations and contacts
1 site in 1 country.
France1 site
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, 13273
About this study
Official title: Phase II Study of Allogeneic Transplant of Hematopoietic Stem Cells From a Compatible Family Donor in the Treatment of Patients Over 55 Years With Hematological Malignancies
RATIONALE: Giving low doses of chemotherapy before a donor stem cell transplant using stem cells that closely match the patient's stem cells, helps stop the growth of cancer cells. It 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 cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving antilymphocyte globulin before transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well fludarabine, busulfan, and antilymphocyte globulin together with donor stem cell transplant works in treating older patients with hematological cancer.
Read the detailed description
OBJECTIVES:
Primary
- To assess non-relapse or progression-related mortality at 1 year in patients over 55 with hematological malignancies undergoing allogeneic hematopoietic stem cell transplantation from a matched related, filgrastim (G-CSF)-mobilized donor and treated with conditioning comprising fludarabine phosphate, busulfan, and anti-lymphocyte globulin.
- To assess the incidence of graft-versus-host disease in these patients.
- To assess the incidence of relapse in these patients.
- To assess cellular recovery in these patients.
- To assess myeloid and lymphocyte chimerism in these patients.
Secondary
- To study the usual clinical and biological aspects of the transplantation in these patients.
- To study the impact of the Charlson score and the suitability for allogeneic transplantation score on mortality and 1-year survival.
- To assess the quality of life (QLQ-C30) of these patients.
- To study the economic cost of transplantation from conditioning to 1 year post-transplant.
- To study the mobilization and collection of progenitor stem cells in the donors.
- To study the psychological impact of donating stem cells on the donors.
OUTLINE: This is a multicenter study.
- Conditioning: Patients receive fludarabine phosphate IV over 30 minutes on days -5 through -1, busulphan IV over 2 hours every 6 hours on days -4 and -3, and anti-lymphocyte globulin IV over 4 hours on days -2 and -1.
- Transplantation: Patients undergo allogeneic hematopoietic stem call transplantation on day 0.
Patients complete a quality of life survey (QLQ-C30). After completion of study treatment, patients are followed every month for 6 months and then every 3 months for 6 months.
- Conditions
- Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms
- Being tested
- therapeutic immune globulin, busulfan, fludarabine phosphate, allogeneic hematopoietic stem cell transplantation
- Keywords
- stage III adult Burkitt lymphoma, stage III adult diffuse large cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult diffuse small cleaved cell lymphoma, stage III adult Hodgkin lymphoma, stage III adult immunoblastic large cell lymphoma, stage III adult lymphoblastic lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage III mantle cell lymphoma, stage III marginal zone lymphoma, stage III small lymphocytic lymphoma, stage IV adult Burkitt lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult diffuse mixed cell lymphoma, stage IV adult diffuse small cleaved cell lymphoma, stage IV adult Hodgkin lymphoma, stage IV adult immunoblastic large cell lymphoma, stage IV adult lymphoblastic lymphoma
- Medical subject headings
- Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma, Neoplasms, Plasma Cell, Myelodysplastic Syndromes, Myelodysplastic-Myeloproliferative Diseases, Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic immune globulinBiological
busulfanDrug
allogeneic hematopoietic stem cell transplantationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Allogeneic hematopoietic stem cell transplant-related mortality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2008 (estimated)
- Study startMar 2007
- Primary completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloproliferative DisordersStudies 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
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Investigators
- Didier Blaise, MD, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00806767
- Sponsor's protocol ID
- CDR0000626779
- Other IDs
- IPC-2005-004, EUDRACT-2005-005051-17, IPC-T2A, INCA-RECF0452
- Status last verified
- Jul 2009
- First submitted
- 10 Dec 2008
- Last updated
- 17 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Allogeneic Transplant of Hematopoietic Stem Cells From a Compatible Family Donor in the Treatment of Patients Over 55 Years With Hematological Malignancies
- ClinicalTrials.gov ID
- NCT00806767
- Acronym / sponsor ID
- CDR0000626779
- Conditions
- Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms
- Keywords
- stage III adult Burkitt lymphoma, stage III adult diffuse large cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult diffuse small cleaved cell lymphoma, stage III adult Hodgkin lymphoma, stage III adult immunoblastic large cell lymphoma, stage III adult lymphoblastic lymphoma, stage III grade 1 follicular lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- May 2011 (actual)
- First posted
- 11 Dec 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 low doses of chemotherapy before a donor stem cell transplant using stem cells that closely match the patient's stem cells, helps stop the growth of cancer cells. It 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 cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving antilymphocyte globulin before transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well fludarabine, busulfan, and antilymphocyte globulin together with donor stem cell transplant works in treating older patients with hematological cancer.
Detailed description
OBJECTIVES:
Primary
- To assess non-relapse or progression-related mortality at 1 year in patients over 55 with hematological malignancies undergoing allogeneic hematopoietic stem cell transplantation from a matched related, filgrastim (G-CSF)-mobilized donor and treated with conditioning comprising fludarabine phosphate, busulfan, and anti-lymphocyte globulin.
- To assess the incidence of graft-versus-host disease in these patients.
- To assess the incidence of relapse in these patients.
- To assess cellular recovery in these patients.
- To assess myeloid and lymphocyte chimerism in these patients.
Secondary
- To study the usual clinical and biological aspects of the transplantation in these patients.
- To study the impact of the Charlson score and the suitability for allogeneic transplantation score on mortality and 1-year survival.
- To assess the quality of life (QLQ-C30) of these patients.
- To study the economic cost of transplantation from conditioning to 1 year post-transplant.
- To study the mobilization and collection of progenitor stem cells in the donors.
- To study the psychological impact of donating stem cells on the donors.
OUTLINE: This is a multicenter study.
- Conditioning: Patients receive fludarabine phosphate IV over 30 minutes on days -5 through -1, busulphan IV over 2 hours every 6 hours on days -4 and -3, and anti-lymphocyte globulin IV over 4 hours on days -2 and -1.
- Transplantation: Patients undergo allogeneic hematopoietic stem call transplantation on day 0.
Patients complete a quality of life survey (QLQ-C30). After completion of study treatment, patients are followed every month for 6 months and then every 3 months for 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 56 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| therapeutic immune globulin | Biological | – |
| busulfan | Drug | – |
| fludarabine phosphate | Drug | – |
| allogeneic hematopoietic stem cell transplantation | Procedure or surgery | – |
Primary outcome
Allogeneic hematopoietic stem cell transplant-related mortality
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 17 May 2011.
Related trials for Chronic Myeloproliferative Disorders
RecruitingPhase 1
Vididencel in CML-CP Patients With MRD
CML (Chronic Myelogenous Leukemia)
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingObservational study
HPC Offered for PRESERVE Expansion
Bone Marrow Transplant (BMT)
Not yet recruitingPhase 2
Ropeginterferon Alfa-2b for the Treatment of Myelodysplastic Syndrome/Myeloproliferative Neoplasm Overlap Syndromes and Chronic Myelomonocytic Leukemia
Atypical Chronic Myeloid Leukemia, Chronic Myelomonocytic Leukemia
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
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
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 therapeutic immune globulin, busulfan and fludarabine phosphate in people with Chronic Myeloproliferative Disorders 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: finished, as of the sponsor's last update on 17 May 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 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?
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?
Allogeneic hematopoietic stem cell transplant-related mortality. 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 17 May 2011.