Acute Myelogenous LeukemiaPhase 2NCT00623935
Blood Stem Cell Transplantation for the Treatment of Older Patients With Acute Myelogenous Leukemia
A Phase 2 study testing Fludarabine, Busulfan and Total Body Irradiation in people with Acute Myelogenous Leukemia, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
The prognosis for older individuals with acute myelogenous leukemia (AML) has been historically poor, with 2 year disease-free survival rates < 20% reported. Younger patients with AML in first complete remission are routinely treated using a full intensity (myelo-ablative) chemotherapy followed by a blood stem cell… Read more about this study
- Who is it for?
- Ages 55 to 70 years
- Conditions the study is for
- Acute Myelogenous Leukemia
- What is being tested?
- Fludarabine, Busulfan and Total Body Irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Nov 2015
- Phase
- Phase 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 55 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For Study Registration:
- Age 55 - 70 years.
- Subjects diagnosed with AML (> 20% myeloblasts).
- For Proceeding to Transplant:
- Subjects must be in either complete remission (CR) or partial remission (PR) within 14 days prior to admission.
- Subjects must be > 21 days since completion of prior systemic chemotherapy or radiation therapy (including craniospinal XRT), prior to admission .
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- Organ function requirements for a reduced intensity (FluBu2) regimen (must be met within 21 days of admission):
- Cardiac: LV Ejection Fraction > 40% on MUGA or Echocardiogram.
- Pulmonary: FEV1 and FVC > 40% predicted, DLCO > 40% of predicted.
- Renal: Serum creatinine < 2.0 mg/dl. Not on hemodialysis or continuous veno-venous filtration (CVVH).
- Hepatic: serum total bilirubin < 3.0 mg/dl and AST / ALT < 4x ULN
- Karnofsky > 60%.
- Organ function requirements for a full intensity (FluBu4) regimen (must be met within 21 days of admission):
- Cardiac: LV Ejection Fraction > 40% on MUGA or Echocardiogram.
- Pulmonary: FEV1 and FVC > 50% predicted, DLCO (corrected for hemoglobin) > 50% of predicted.
- Renal: serum creatinine < 2.0 mg/dl. Not on hemodialysis or continuous veno-venous filtration (CVVH)
- Hepatic: serum total bilirubin < 3.0 mg/dl and AST / ALT < 4x ULN.
- Karnofsky > 60%.
Who cannot join
- For Study Registration:
- Subjects with M3 AML (FAB classification)
- For Proceeding to Transplant:
- Subjects who exhibit signs of progressive disease (> 20% blasts) within 14 days prior to admission for transplant
- Patients with an uncontrolled viral or fungal infection within the prior 28 days.
- Patients who are HIV1 or HIV2 positive.
- Uncontrollable medical or psychiatric disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Cancer Center
Ann Arbor, Michigan, 48109
About this study
Official title: Hematopoietic Stem Cell Transplantation for the Treatment of Older Patients With Acute Myelogenous Leukemia
The prognosis for older individuals with acute myelogenous leukemia (AML) has been historically poor, with 2 year disease-free survival rates < 20% reported. Younger patients with AML in first complete remission are routinely treated using a full intensity (myelo-ablative) chemotherapy followed by a blood stem cell transplant. For the older patient with AML, full intensity therapy transplants have been greatly limited by increased rates of toxic effects related to this type of conditioning regimen. Reduced intensity (non-myeloablative) conditioning regimens have been used in a number of clinical settings, including AML therapy, to lessen the regimen related toxicity in the older patient. Recent data from the University of Michigan Blood and Marrow Transplant Program suggests improved survival for individuals > 55 years in age undergoing reduced intensity, transplants from unrelated donors. This study will investigate the safety and efficacy of this treatment option for older patients with AML, with the primary goal being to improve the survival and lifespan for older patients with AML.
- Conditions
- Acute Myelogenous Leukemia
- Being tested
- Fludarabine, Busulfan, Total Body Irradiation, Stem Cell Transplant
- Keywords
- AML
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FludarabineDrug
Fludarabine (40 mg/m2/day x 4 days)
BusulfanDrug
Busulfan (3.2 mg/m2/day x 2 days or x 4 days).
Total Body IrradiationRadiation
Patients who receive Busulfan 3.2 mg/m2/day x 2 days and a mismatched allograft (7/8 HLA match) will also receive 200 cGy of total body irradiation (TBI) pre-transplant.
Stem Cell TransplantProcedure or surgery
Allogeneic stem cell transplant from related or unrelated donor
| Study group | Role | What they receive |
|---|---|---|
| Fludarabine plus Busulfan (CR) | Experimental | Patients in CR will receive a reduced intensity transplant regimen consisting of Fludarabine plus Busulfan (FluBu2). Receives: Drug: Fludarabine; Drug: Busulfan; Radiation: Total Body Irradiation; Procedure: Stem Cell Transplant |
| Fludarabine plus Busulfan (PR) | Experimental | Patients in PR will receive a full intensity transplant regimen consisting of Fludarabine plus Busulfan (FluBu4). Receives: Drug: Fludarabine; Drug: Busulfan; Procedure: Stem Cell Transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Relapse Free Survival at 1 Year
The primary objective was to determine the 1 year relapse free survival rate (RFS) for individuals > 55 years in age with Acute myeloid leukemia (AML) in Complete Remission (CR) or Partial Remission (PR) who undergo a 7-8/8 HLA- matched unrelated donor transplant using a reduced intensity regimen.
Measured: 1 year
Secondary outcomes (1)
Percentage of Participants Alive at 1 Year
One of the secondary objectives was to determine overall survival for patients > 55 years in age with AML undergoing full or reduced transplant with the best available donor.
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 posted26 Feb 2008 (estimated)
- Study startMar 2007
- Primary completionJun 2013
- Study completionNov 2015
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.
- Other trials for Acute Myelogenous LeukemiaStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe 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
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregory Yanik, MD, Principal investigator, University of Michigan Comprehesive Cancer Ctr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00623935
- Sponsor's protocol ID
- UMCC 2006.065
- Other IDs
- HUM00006772
- Status last verified
- Mar 2016
- First submitted
- 14 Feb 2008
- Last updated
- 8 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hematopoietic Stem Cell Transplantation for the Treatment of Older Patients With Acute Myelogenous Leukemia
- ClinicalTrials.gov ID
- NCT00623935
- Acronym / sponsor ID
- UMCC 2006.065
- Conditions
- Acute Myelogenous Leukemia
- Keywords
- AML
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Jun 2013 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 26 Feb 2008 (estimated)
- Results
- Posted 17 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The prognosis for older individuals with acute myelogenous leukemia (AML) has been historically poor, with 2 year disease-free survival rates < 20% reported. Younger patients with AML in first complete remission are routinely treated using a full intensity (myelo-ablative) chemotherapy followed by a blood stem cell transplant. For the older patient with AML, full intensity therapy transplants have been greatly limited by increased rates of toxic effects related to this type of conditioning regimen. Reduced intensity (non-myeloablative) conditioning regimens have been used in a number of clinical settings, including AML therapy, to lessen the regimen related toxicity in the older patient. Recent data from the University of Michigan Blood and Marrow Transplant Program suggests improved survival for individuals > 55 years in age undergoing reduced intensity, transplants from unrelated donors. This study will investigate the safety and efficacy of this treatment option for older patients with AML, with the primary goal being to improve the survival and lifespan for older patients with AML.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fludarabine plus Busulfan (CR) | Experimental | Drug: Fludarabine, Drug: Busulfan, Radiation: Total Body Irradiation, Procedure: Stem Cell TransplantPatients in CR will receive a reduced intensity transplant regimen consisting of Fludarabine plus Busulfan (FluBu2). |
| Fludarabine plus Busulfan (PR) | Experimental | Drug: Fludarabine, Drug: Busulfan, Procedure: Stem Cell TransplantPatients in PR will receive a full intensity transplant regimen consisting of Fludarabine plus Busulfan (FluBu4). |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age 55 - 70 years.
- Subjects diagnosed with AML (> 20% myeloblasts).
- Subjects must be in either complete remission (CR) or partial remission (PR) within 14 days prior to admission.
- Subjects must be > 21 days since completion of prior systemic chemotherapy or radiation therapy (including craniospinal XRT), prior to admission .
- Organ function requirements for a reduced intensity (FluBu2) regimen (must be met within 21 days of admission):
Key exclusion criteria (7 listed)
- Subjects with M3 AML (FAB classification)
- Subjects who exhibit signs of progressive disease (> 20% blasts) within 14 days prior to admission for transplant
- Patients with an uncontrolled viral or fungal infection within the prior 28 days.
- Patients who are HIV1 or HIV2 positive.
- Uncontrollable medical or psychiatric disorder
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 |
|---|---|---|
| FludarabineFludarabine (40 mg/m2/day x 4 days) | Drug | Fludarabine plus Busulfan (CR), Fludarabine plus Busulfan (PR) |
| BusulfanBusulfan (3.2 mg/m2/day x 2 days or x 4 days). | Drug | Fludarabine plus Busulfan (CR), Fludarabine plus Busulfan (PR) |
| Total Body IrradiationPatients who receive Busulfan 3.2 mg/m2/day x 2 days and a mismatched allograft (7/8 HLA match) will also receive 200 cGy of total body irradiation (TBI) pre-transplant. | Radiation | Fludarabine plus Busulfan (CR) |
| Stem Cell TransplantAllogeneic stem cell transplant from related or unrelated donor | Procedure or surgery | Fludarabine plus Busulfan (CR), Fludarabine plus Busulfan (PR) |
Primary outcome
Percentage of Participants With Relapse Free Survival at 1 Year
Time frame: 1 year
The primary objective was to determine the 1 year relapse free survival rate (RFS) for individuals > 55 years in age with Acute myeloid leukemia (AML) in Complete Remission (CR) or Partial Remission (PR) who undergo a 7-8/8 HLA- matched unrelated donor transplant using a reduced intensity regimen.
1 secondary outcome
Percentage of Participants Alive at 1 Year
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Gregory Yanik, MD principal investigator
University of Michigan Comprehesive Cancer Ctr
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 Fludarabine, Busulfan and Total Body Irradiation in people with Acute Myelogenous Leukemia, run by University of Michigan Rogel Cancer Center at 1 site 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 18 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: finished, as of the sponsor's last update on 8 Apr 2016. 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 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 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?
Yes. Results are posted in the registry (first posted 17 Jul 2014). 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?
Percentage of Participants With Relapse Free Survival at 1 Year (time frame: 1 year). 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 8 Apr 2016.