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Alkylating agents
Stem Cell Infusion for Leukemia
Phase 2
Waitlist Available
Led By Uday Popat, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years post-transplant
Awards & highlights
Study Summary
This study is evaluating whether a new combination of drugs can help control the disease better than the standard method in patients with leukemia, lymphoma, multiple myeloma, MDS, or MPD.
Eligible Conditions
- Leukemia
- Acute Myeloid Leukemia
- Non-Hodgkin's Lymphoma
- Myelodysplastic Syndrome
- Acute Lymphoblastic Leukemia
- Chronic Lymphocytic Leukemia
- Myeloproliferative Disorder
- Hodgkin's Lymphoma
- Multiple Myeloma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years post-transplant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years post-transplant
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Non-Relapse Mortality Rate (NRM)
Secondary outcome measures
Overall Survival
Side effects data
From 2020 Phase 3 trial • 256 Patients • NCT0147144495%
Nausea
95%
Mucositis
82%
Elevated transminitis
79%
Infections
55%
Skin GvHD
50%
ATG induced fevers
45%
Fluid overload
32%
Diarrhea
32%
Neutropenic fevers
29%
Hypertension
27%
Upper GI GvHD
22%
Renal insufficiency
19%
Liver GvHD
18%
Chronic ocular GvHD
15%
ATG induced skin rash
15%
BK virus associated hemorrhagic cystitis
15%
Chronic oral GvHD
14%
GI GvHD
12%
Pneumonitis
11%
Rash
8%
Headaches
8%
Palmar-plantar erythrodysesthesia
7%
Chronic lung GvGHD
3%
ABO incompatibility
3%
Dysrhythmia
3%
Viral Infections
2%
Cardiomyopathy
2%
Poor graft function
2%
Allergic reaction to ATG
2%
Fungal Infections
2%
Ascites
2%
Hemorrhagic cystits
2%
Diffused alveolar hemorrhage
2%
Thrombocytopenia
2%
Skin GVHD
2%
Bacterial Infections
1%
PRES
1%
Hemochromatosis
1%
Transcient secondary graft failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A (Flu+Bu)
Arm B (Flu+Clo+Bu)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Fludarabine + BusulfanExperimental Treatment6 Interventions
Fludarabine administered by vein at dose of 40 mg/m2 in 100 ml of normal saline (NS) on Days -6 through -3.
First two doses of Busulfan, 80 mg/m2 administered as an outpatient or as an inpatient to facilitate for this pharmacokinetically directed therapy. Busulfan is administered at the dose calculated to achieve a total (including first two doses delivered on day -13 and -12) systemic exposure of 20,000 ± 12% µMol-min based on the pharmacokinetic studies.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Busulfan
2008
Completed Phase 3
~1120
Tacrolimus
2011
Completed Phase 4
~4740
G-CSF
2014
Completed Phase 4
~1610
Methotrexate
2013
Completed Phase 4
~3800
Stem Cell Infusion
2006
Completed Phase 3
~1080
Fludarabine monophosphate
2008
Completed Phase 3
~480
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,120 Total Patients Enrolled
451 Trials studying Leukemia
31,267 Patients Enrolled for Leukemia
Uday Popat, MDPrincipal InvestigatorM.D. Anderson Cancer Center
6 Previous Clinical Trials
186 Total Patients Enrolled
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