LymphomaPhase 1/2NCT00809276
Allo BMT Using Matched Related/Unrelated Donors With FluBu and HiCY
A Phase 1/2 study testing Busulfan, Fludarabine, Cytoxan in people with Lymphoma and Multiple Myeloma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 3 sites in United States.
Trial summary
The purpose of this research is to find the most effective and least toxic way to prevent GVHD after BMT. Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- Lymphoma, Multiple Myeloma, Leukemia
- What is being tested?
- Busulfan, Fludarabine, Cytoxan
- How many people
- 92 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2009to Dec 2011
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients ages between 0 to and 65 years of age.
- Patient must have a genotypically HLA-identical sibling, a phenotypically matched first-degree relative or an unrelated matched donor.
- Acute lymphocytic leukemia (ALL) in CR1 with high risk features
- Acute myeloid leukemia (AML) in CR1 with high risk features defined as:
- Greater than 1 cycle of induction therapy required to achieve remission, ii. Preceding myelodysplastic syndrome (MDS) other than myelofibrosis, secondary AML iii. Presence of Flt3 mutations or internal tandem duplications, iv. FAB M6 or M7 classification or adverse cytogenetics for overall survival such as those associated with MDS, M6, M7 leukemia, or v. Complex karyotype [> 3 abnormalities]
- Acute Leukemias in 2nd or greater remission
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- Refractory or Relapsed AML
- AML transformed from MDS
- Myelodysplastic syndrome (MDS) beyond refractory anemia
- Chronic myeloid leukemia (CML)
- Chronic myelomonocytic leukemia
- Philadelphia-negative myeloproliferative disorder
- Relapsed chemotherapy-sensitive Hodgkin's or Non-Hodgkin's lymphoma
- Multiple Myeloma-Stage III
Who cannot join
- Prior autologous or allogeneic stem cell transplant.
- Performance status greater than 2
- Active infection.
- Inadequate cardiac function; arrythmias or symptomatic cardiac disease.
- Inadequate pulmonary function; FEV1, FVC, DLCO <50% of predicted
- Inadequate Serum creatinine clearance <60
Show all 9Show fewer
- InadequatebHepatic function
- Positive serology for HIV-1, 2 or HTLV-1, 2.
- Pregnancy. Female patient must have negative pregnancy test
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The Sydney Kimmel Comprehensive Cancer center
Baltimore, Maryland, 21231
Marcos deLima, MD
Houston, Texas, 77030
Paul V. O'Donnell, M.D., Ph.D.
Seattle, Washington, 98109
About this study
Official title: Trial of Allogeneic BMT for Hematologic Malignancies Using HLA-matched Related or Unrelated Donors With Fludarabine and IV Busulfan as Pre-transplant Conditioning Followed by Post-transplant Immunosuppression With High-dose Cyclophosphamide
The purpose of this research is to find the most effective and least toxic way to prevent GVHD after BMT.
Read the detailed description
A person who has cancer of the blood or lymph glands can be treated by bone marrow transplantation (BMT). BMT has developed over several decades of research on both animal and human subjects as an effective treatment of various malignant and nonmalignant hematologic diseases. Many hematologic malignancies can be successfully treated with a combination of high-dose chemotherapy or chemo-radiotherapy and transplantation of allogeneic bone marrow or peripheral blood stem cells (alloBMT)
However, a possible side effect of BMT is graft versus host disease (GVHD). GVHD occurs when cells of the donor's immune system, which are present in the bone marrow, attack the BMT recipient's normal tissue. Prevention of GVHD is important for the success of the bone marrow transplant. This research is being done to find the most effective and least toxic way to prevent GVHD after BMT
- Conditions
- Lymphoma, Multiple Myeloma, Leukemia, Myelodysplastic Syndrome
- Being tested
- Busulfan, Fludarabine, Cytoxan
- Keywords
- Acute lymphocytic leukemia (ALL), Acute myeloid leukemia (AML), Acute Leukemia, Refractory or Relapsed AML, Myelodysplastic syndrome (MDS), Chronic myeloid leukemia (CML), Chronic myelomonocytic leukemia, Hodgkin's Lymphoma, Non-Hodgkin's lymphoma, Philadelphia-negative myeloproliferative disorder, Hematologic Malignancies, Transplantation, Busulfan, Fludarabine, Cytoxan, Bone Marrow, Allogeneic, Related donor, unrelated donor
- Medical subject headings
- Lymphoma, Multiple Myeloma, Leukemia, Myelodysplastic Syndromes, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Myelomonocytic, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Busulfan, Fludarabine, CytoxanDrug
Also called BMT, Cyclophosphamide, Allogeneic, Transplantation
Busulfan once a day for 4 days
Fludarabine once a day for 4 days
Bone marrow transplant
Cytoxan two doses
What is being measured
The primary outcome is the main question the study is designed to answer.
To Determine the Optimal Regimen of Post-graft Immunosuppression With High-dose Cy Following Fludarabine, Busulfan, and Transplantation of Fully HLA-matched Bone Marrow That Leads to an Acceptable Incidence of Grades III/IV Acute GVHD
Percentage of participants with grade III-IV acute graft versus host disease (GVHD). GVHD is graded on a combination of skin symptoms (rash), gut symptoms (diarrhea), and liver symptoms (using a lab test called bilirubin). Grades range from I to IV, where I is the least severe and IV is the most severe.
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 posted17 Dec 2008 (estimated)
- Study startMay 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- M.D. Anderson Cancer Center, Fred Hutchinson Cancer Center, Otsuka Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Leo Luznik, MD, Study chair, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00809276
- Sponsor's protocol ID
- J0844
- Other IDs
- NA_00017193
- Status last verified
- Jan 2015
- First submitted
- 16 Dec 2008
- Last updated
- 16 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Kanakry CG, O'Donnell PV, Furlong T, de Lima MJ, Wei W, Medeot M, Mielcarek M, Champlin RE, Jones RJ, Thall PF, Andersson BS, Luznik L. Multi-institutional study of post-transplantation cyclophosphamide as single-agent graft-versus-host disease prophylaxis after allogeneic bone marrow transplantation using myeloablative busulfan and fludarabine conditioning. J Clin Oncol. 2014 Nov 1;32(31):3497-505. doi: 10.1200/JCO.2013.54.0625. Epub 2014 Sep 29.
PubMed 25267759
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Allogeneic BMT for Hematologic Malignancies Using HLA-matched Related or Unrelated Donors With Fludarabine and IV Busulfan as Pre-transplant Conditioning Followed by Post-transplant Immunosuppression With High-dose Cyclophosphamide
- ClinicalTrials.gov ID
- NCT00809276
- Acronym / sponsor ID
- J0844
- Conditions
- Lymphoma, Multiple Myeloma, Leukemia, Myelodysplastic Syndrome
- Keywords
- Acute lymphocytic leukemia (ALL), Acute myeloid leukemia (AML), Acute Leukemia, Refractory or Relapsed AML, Myelodysplastic syndrome (MDS), Chronic myeloid leukemia (CML), Chronic myelomonocytic leukemia, Hodgkin's Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- M.D. Anderson Cancer Center, Fred Hutchinson Cancer Center, Otsuka Pharmaceutical Co., Ltd.
- Study start
- May 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 17 Dec 2008 (estimated)
- Results
- Posted 19 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to find the most effective and least toxic way to prevent GVHD after BMT.
Detailed description
A person who has cancer of the blood or lymph glands can be treated by bone marrow transplantation (BMT). BMT has developed over several decades of research on both animal and human subjects as an effective treatment of various malignant and nonmalignant hematologic diseases. Many hematologic malignancies can be successfully treated with a combination of high-dose chemotherapy or chemo-radiotherapy and transplantation of allogeneic bone marrow or peripheral blood stem cells (alloBMT)
However, a possible side effect of BMT is graft versus host disease (GVHD). GVHD occurs when cells of the donor's immune system, which are present in the bone marrow, attack the BMT recipient's normal tissue. Prevention of GVHD is important for the success of the bone marrow transplant. This research is being done to find the most effective and least toxic way to prevent GVHD after BMT
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Patients ages between 0 to and 65 years of age.
- Patient must have a genotypically HLA-identical sibling, a phenotypically matched first-degree relative or an unrelated matched donor.
- Acute lymphocytic leukemia (ALL) in CR1 with high risk features
- Acute myeloid leukemia (AML) in CR1 with high risk features defined as:
- Acute Leukemias in 2nd or greater remission
Key exclusion criteria (9 listed)
- Prior autologous or allogeneic stem cell transplant.
- Performance status greater than 2
- Active infection.
- Inadequate cardiac function; arrythmias or symptomatic cardiac disease.
- Inadequate pulmonary function; FEV1, FVC, DLCO <50% of predicted
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 |
|---|---|---|
| Busulfan, Fludarabine, CytoxanAlso: BMT, Cyclophosphamide, Allogeneic, TransplantationBusulfan once a day for 4 days Fludarabine once a day for 4 days Bone marrow transplant Cytoxan two doses | Drug | – |
Primary outcome
To Determine the Optimal Regimen of Post-graft Immunosuppression With High-dose Cy Following Fludarabine, Busulfan, and Transplantation of Fully HLA-matched Bone Marrow That Leads to an Acceptable Incidence of Grades III/IV Acute GVHD
Time frame: 1 year
Percentage of participants with grade III-IV acute graft versus host disease (GVHD). GVHD is graded on a combination of skin symptoms (rash), gut symptoms (diarrhea), and liver symptoms (using a lab test called bilirubin). Grades range from I to IV, where I is the least severe and IV is the most severe.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25267759Kanakry CG, O'Donnell PV, Furlong T, de Lima MJ, Wei W, Medeot M, Mielcarek M, Champlin RE, Jones RJ, Thall PF, Andersson BS, Luznik L. Multi-institutional study of post-transplantation cyclophosphamide as single-agent graft-versus-host disease prophylaxis after allogeneic bone marrow transplantation using myeloablative busulfan and fludarabine conditioning. J Clin Oncol. 2014 Nov 1;32(31):3497-505. doi: 10.1200/JCO.2013.54.0625. Epub 2014 Sep 29.
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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.
Leo Luznik, MD study chair
Johns Hopkins University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Busulfan, Fludarabine, Cytoxan in people with Lymphoma and Multiple Myeloma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 3 sites in United States.
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 14 inclusion and 9 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: finished, as of the sponsor's last update on 16 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 19 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
To Determine the Optimal Regimen of Post-graft Immunosuppression With High-dose Cy Following Fludarabine, Busulfan, and Transplantation of Fully HLA-matched Bone Marrow That Leads to an Acceptable Incidence of Grades III/IV Acute GVHD (time frame: 1 year). 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 NCT00809276, which also lists 1 linked publication.
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 16 Feb 2015.