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Stem Cell Infusion for Leukemia

Phase 2
Waitlist Available
Led By Stefan Ciurea, 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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial is testing whether a stem cell transplant is a safe and effective treatment for people with leukemia who have failed other treatments.

Eligible Conditions
  • Leukemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Response (OR) Post Transplant
Treatment-Related Mortality (TRM)
Secondary outcome measures
Overall Survival (OS)

Side effects data

From 2020 Phase 3 trial • 256 Patients • NCT01471444
95%
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

3Treatment groups
Experimental Treatment
Group I: Matched Unrelated Donor GroupExperimental Treatment8 Interventions
Salvage Chemotherapy Before Transplant: Decitabine 20 mg/m2 by vein on Days 1 - 5. Cytarabine 1 g/m2 by vein on Days 6 - 10. Idarubicin 10 mg/m2 by vein on Days 6 - 8. Clofarabine 15 mg/m2 by vein on Days 6 - 9. Stem Cell Transplant: Test dose Busulfan 32 mg/m2 given by vein on Day -8. Busulfan AUC 5,000 by vein on Days -6 to -3. Fludarabine 10 mg/m2 by vein on Days -6 to -3. Clofarabine 40 mg/m2 by vein on Days -6 to -3. Thymoglobulin 2.0 mg/Kg by vein on Days -3 and -2. Stem cell infusion performed on Day 0.
Group II: Matched Sibling Donor GroupExperimental Treatment7 Interventions
Salvage Chemotherapy Before Transplant: Decitabine 20 mg/m2 by vein on Days 1 - 5. Cytarabine 1 g/m2 by vein on Days 6 - 10. Idarubicin 10 mg/m2 by vein on Days 6 - 8. Clofarabine 15 mg/m2 by vein on Days 6 - 9. Stem Cell Transplant: Test dose Busulfan 32 mg/m2 by vein on Day -8. Busulfan AUC 5,000 by vein on Days -6 to -3. Fludarabine 10 mg/m2 by vein on Days -6 to -3. Clofarabine 40 mg/m2 by vein on Days -6 to -3. Stem cell infusion performed on Day 0.
Group III: Haploidentical Donor GroupExperimental Treatment11 Interventions
Salvage Chemotherapy Before Transplant: Decitabine 20 mg/m2 by vein on Days 1 - 5. Cytarabine 1 g/m2 by vein on Days 6 - 10. Idarubicin 10 mg/m2 by vein on Days 6 - 8. Clofarabine 15 mg/m2 by vein on Days 6 - 9. Stem Cell Transplant: Test dose Busulfan 32 mg/m2 given by vein on Day -8. Busulfan AUC 5,000 by vein on Days -6 to -3. Fludarabine 10 mg/m2 by vein on Days -6 to -3. Clofarabine 40 mg/m2 by vein on Days -6 to -3. Total body irradiation (TBI) delivered at 2Gy on Day -2. Stem cell infusion performed on Day 0. Cyclophosphamide 50 mg/kg by vein on Days +3 and +4. Tacrolimus 0.015 mg/kg/day by vein or mouth on Day +5. Mycophenolate mofetil 15 mg/kg/dose by vein or by mouth three times a day from Day +5 to Day+100.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytarabine
FDA approved
Busulfan
FDA approved
Clofarabine
FDA approved
Total Body Irradiation (TBI)
2016
Completed Phase 3
~1220
Antithymocyte immunoglobulin (rabbit)
FDA approved
Fludarabine
FDA approved
Idarubicin
FDA approved
Mycophenolate mofetil
FDA approved
Stem Cell Infusion
2006
Completed Phase 3
~1080
Tacrolimus
FDA approved
Decitabine
FDA approved
Cyclophosphamide
FDA approved

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,971 Previous Clinical Trials
1,787,226 Total Patients Enrolled
451 Trials studying Leukemia
31,456 Patients Enrolled for Leukemia
Stefan Ciurea, MDPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
1,929 Total Patients Enrolled
2 Trials studying Leukemia
1,929 Patients Enrolled for Leukemia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the general efficacy of Stem Cell Infusion in medical trials?

"There are a total of 1,314 Stem Cell Infusion trials currently underway. Out of those, 225 have reached Phase 3 and are still active. The majority of these studies originate from Philadelphia, Pennsylvania; however, there are 34812 locations running trials for this treatment worldwide."

Answered by AI

Which patients would be the best candidates for this clinical trial?

"Eligible participants for this research must have a diagnosis of leukemia, be between 18-60 years old, and there are currently around 11 spots open."

Answered by AI

Are octogenarians able to join this research project?

"This study only enrolls participants that fall between 18 and 60 years old."

Answered by AI

Are there risks associated with Stem Cell Infusion therapy?

"While there is some evidence backing the safety of stem cell infusion, as this is only a phase 2 trial, more research needs to be done to support its efficacy."

Answered by AI

What are some of the primary indications for Stem Cell Infusion?

"Most often, stem cell infusions are used as a cancer treatment for lung cancer patients. However, this medical intervention can also be used to ameliorate dermatitis, atopic conditions, multiple sclerosis, and acute myelocytic leukemia."

Answered by AI

Are we currently able to enroll patients in this clinical trial?

"This study is not currently enrolling patients. The listing was created on September 14th, 2015 and last updated on May 22nd, 2019. If you are looking for other trials, there are 1521 active leukemia studies and 1314 Stem Cell Infusion studies that are still recruiting patients."

Answered by AI

How many people are you enrolling in this clinical trial?

"At the moment, this particular trial is not looking for new patients. The listing was first created on September 14th, 2015 and edited most recently on May 22nd, 2019. However, there are currently 1521 trials actively recruiting leukemia patients and 1314 stem cell infusion trials with open enrollment periods."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Allogeneic Hematopoietic Stem Cell Transplantation (AlloSCT) Initial Salvage Therapy for Induction Failure Acute Myeloid Leukemia (AML)
2015. "Allogeneic Hematopoietic Stem Cell Transplantation (AlloSCT) Initial Salvage Therapy for Induction Failure Acute Myeloid Leukemia (AML)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02441803.
~1 spots leftby Apr 2025
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