A Phase 2 interventional study of Fludarabine and Busulfan in Acute Myelogenous Leukemia, sponsored by University of Michigan Rogel Cancer Center. Completed at 1 site in United States. Open to participants aged 55 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-04-08.
Sponsored by University of Michigan Rogel Cancer Center · Phase 2, Interventional, and Treatment
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.
5,442 studies on the registry are indexed under Leukemia; 637 are open to participants now.
This study's enrollment of 56 is above the median of 38 across 4,248 interventional studies indexed under Leukemia.
Browse Leukemia studies →University of Michigan Rogel Cancer Center is the lead sponsor of 316 studies on the registry; 46 are open to participants now.
Of its 46 completed or terminated interventional studies of FDA-regulated products, 30 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
For Study Registration:
For Proceeding to Transplant:
Organ function requirements for a reduced intensity (FluBu2) regimen (must be met within 21 days of admission):
Organ function requirements for a full intensity (FluBu4) regimen (must be met within 21 days of admission):
Exclusion Criteria:
For Study Registration:
For Proceeding to Transplant:
Patients in CR will receive a reduced intensity transplant regimen consisting of Fludarabine plus Busulfan (FluBu2).
Drug: Fludarabine · Drug: Busulfan · Radiation: Total Body Irradiation · Procedure: Stem Cell Transplant
Patients in PR will receive a full intensity transplant regimen consisting of Fludarabine plus Busulfan (FluBu4).
Drug: Fludarabine · Drug: Busulfan · Procedure: Stem Cell Transplant
Fludarabine (40 mg/m2/day x 4 days)
Busulfan (3.2 mg/m2/day x 2 days or x 4 days).
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.
Allogeneic stem cell transplant from related or unrelated donor
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.
Time frame: 1 year
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.
Time frame: 1 year
| Milestone | Fludarabine Plus Busulfan |
|---|---|
| Started | 56 |
| Completed | 54 |
| Not completed | 2 |
| Withdrew: Death | 1 |
| Withdrew: Patient declined transplant | 1 |
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.
| percentage of participants | Fludarabine Plus Busulfan |
|---|---|
| Percentage of Participants With Relapse Free Survival at 1 Year | 56 (43 to 69) |
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.
| percentage of participants | Fludarabine Plus Busulfan |
|---|---|
| Percentage of Participants Alive at 1 Year | 58 (46 to 74) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fludarabine Plus Busulfan | — | 21/56 (37.5%) | 16/56 (28.6%) |
| Event | Fludarabine Plus Busulfan |
|---|---|
| FeverGeneral disorders | 3/56 |
| AnorexiaGastrointestinal disorders | 3/56 |
| NauseaGastrointestinal disorders | 3/56 |
| DiarrheaGastrointestinal disorders | 2/56 |
| VomitingGastrointestinal disorders | 2/56 |
| Syncope (fainting)Nervous system disorders | 2/56 |
| Thrombosis/embolism (vascular access-related)Vascular disorders | 2/56 |
| Cardiac ischemia/infarctionCardiac disorders | 1/56 |
| HypotensionCardiac disorders | 1/56 |
| Death not associated with CTCAE termGeneral disorders | 1/56 |
| Event | Fludarabine Plus Busulfan |
|---|---|
| AnorexiaGastrointestinal disorders | 5/56 |
| Mucositis/stomatitisGastrointestinal disorders | 5/56 |
| InfectionInfections and infestations | 4/56 |
| Blood InfectionInfections and infestations | 4/56 |
| HypoxiaRespiratory, thoracic and mediastinal disorders | 4/56 |
| Thrombosis (vascular access related)Vascular disorders | 4/56 |
| Age, Continuous(years) | Fludarabine Plus Busulfan |
|---|---|
| Median | 61 (55 to 70) |
| Sex: Female, Male(Participants) | Fludarabine Plus Busulfan |
|---|---|
| Female | 27 |
| Male | 29 |
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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University of Michigan Rogel Cancer Center