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Clofarabine for Acute Myeloid Leukemia

Phase 2
Waitlist Available
Led By Seema Naik, MD
Research Sponsored by Milton S. Hershey Medical 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 a new way to give chemotherapy and a stem cell transplant to people with leukemia who have not gone into remission with other treatments.

Eligible Conditions
  • Acute Myeloid 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
Complete Remission (CR) Rate at Day 30 Post HSCT
Secondary outcome measures
Neutrophil Engraftment
Non-relapse Related Mortality
Rate of Acute Graft-versus-host Disease (GVHD)
+3 more

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

1Treatment groups
Experimental Treatment
Group I: Clofarabine 30 mg/m^2Experimental Treatment8 Interventions
Day -14 through Day -10 Clofarabine 30 mg/m^2, Day - 9 Day of rest, Day - 8 Day of rest, Day - 7 Day of rest, Day - 6 Fludarabine 40 mg/m^2 IV and Busulfan 3.2 mg/kg IV (Regimen A, Fludarabine 24 mg/m^2 IV and Cyclophosphamide 14.5 mg/kg IV for Regimen B), Day - 5 Fludarabine 40 mg/m^2 IV and Busulfan 3.2 mg/kg IV (Regimen A, Fludarabine 24 mg/m^2 IV and Cyclophosphamide 14.5 mg/kg IV for Regimen B), Day - 4 Fludarabine 40 mg/m^2 IV(Regimen A, Fludarabine 24 mg/m^2 IV for Regimen B), Day - 3 Fludarabine 40 mg/m^2 IV(Regimen A, Fludarabine 24 mg/m^2 IV for Regimen B), Day - 2 Day of Rest, Day -1 Total Body Irradiation 200 cGys, Day 0 stem cell transplant infusion, Day +1 Day of rest, Day +2 Day of rest, Day +3 Cyclophosphamide 50 mg/kg IV, Day +4 Cyclophosphamide 50 mg/kg IV, Day +5 Start G-CSF, Tacrolimus, and MMF.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mycophenolate mofetil
FDA approved
Clofarabine
FDA approved
Fludarabine
FDA approved
Busulfan
FDA approved
Total Body Irradiation (TBI)
2016
Completed Phase 3
~1220
Filgrastim
FDA approved
Cyclophosphamide
FDA approved
Tacrolimus
FDA approved

Find a Location

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor
492 Previous Clinical Trials
2,798,820 Total Patients Enrolled
Seema Naik, MDPrincipal Investigator - Penn State Cancer Institute
Penn State Geisinger Rehabilitation Center, Penn State Milton S. Hershey Medical Center, The Milton S Hershey Medical Center Physicians Group
1 Previous Clinical Trials
1 Total Patients Enrolled

Frequently Asked Questions

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

Is the recruitment phase of this study targeting individuals aged 65 or older?

"This research project is seeking out adults aged 18 or older, up to a maximum age of 55."

Answered by AI

How many participants have signed up to take part in this research?

"Affirmative. According to the details on clinicaltrials.gov, this medical trial which was created on June 3rd 2020 is actively searching for 20 patients across 1 site. The study has been updated recently as of September 16th 2022."

Answered by AI

What ailments can Clofarabine be used to address?

"Clofarabine is widely known as a lung cancer treatment, yet can also be used to battle dermatitis, atopic disorders, multiple sclerosis and both myelocytic and acute types of leukemia."

Answered by AI

Are there any open opportunities for enrollment in this trial?

"According to the clinicaltrials.gov's records, this trial is currently seeking volunteers since its initial posting on June 3rd 2020 and latest update dated September 16th 2022."

Answered by AI

Have any other experiments explored the use of Clofarabine?

"Currently, there are 1094 Clofarabine studies in operation. 200 of these experiments have advanced to Phase 3 trials. These medical investigations primarily take place near Philadelphia, Pennsylvania but span a total 31514 sites globally."

Answered by AI

Has Clofarabine obtained governmental authorization for usage?

"Clofarabine is rated 2 on a safety scale of 1 to 3, as it has been through Phase 2 trials with some evidence supporting its safety but lack thereof for efficacy."

Answered by AI

To which demographic is this research endeavor applicable?

"This experiment requires 20 participants, aged between 18 and 55 with leukemia. Other important guidelines include: prepared to receive a haplotically-matched or mismatched allogeneic HSCT from related donors, men and women must use contraceptive methods due to unknown risks to the fetus., ages ranging from 18 till 75 years old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Clofarabine Pre-conditioning Followed by Stem Cell Transplant for Non-remission AML
Seema Naik, MD 2020. "Clofarabine Pre-conditioning Followed by Stem Cell Transplant for Non-remission AML". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04002115.
~0 spots leftby Apr 2025
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