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cyclophosphamide for Blood Cancers

Phase 2
Waitlist Available
Led By Dianna S. Howard
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Available familial haploidentical (4 to 6 out of 8 HLA loci-matched) donor
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial gives chemo to stop bone marrow growth before transplanting donor stem cells. The goal is to see if the donor stem cells help the patient's bone marrow make blood cells, and if the chemo helps prevent graft-versus-host disease.

Eligible Conditions
  • Blood Cancer
  • Graft-versus-Host Disease

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have a family member who is a partially matched donor for the transplant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
12 Month Disease Free Survival Probability
Secondary outcome measures
Overall Survival
Progression Free Survival
Rate of Acute GvHD
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (stem cell transplant with GVHD prophylaxis)Experimental Treatment6 Interventions
PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV QD on days -6 to -2. Patients receiving myeloablative conditioning receive busulfan IV every 6 hours for 16 doses on days -7 to -4 and patients receiving reduced intensity conditioning receive busulfan IV every 6 hours for 8 doses on days -5 to -4. Patients also receive cyclophosphamide IV QD on days -3 and -2 TRANSPLANT: Patients undergo stem cell transplant on day 0. GVHD PROPHYLAXIS: Patients receive cyclophosphamide QD on days 3 and 4, tacrolimus on days 5-180, and mycophenolate mofetil on days 5-35. Allogeneic hematopoietic stem cell transplantation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
fludarabine phosphate
2000
Completed Phase 3
~2660
busulfan
1999
Completed Phase 3
~3630
cyclophosphamide
1994
Completed Phase 3
~8140
allogeneic hematopoietic stem cell transplantation
2005
Completed Phase 3
~890
tacrolimus
2004
Completed Phase 4
~3750
mycophenolate mofetil
2000
Completed Phase 3
~1730

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,236 Previous Clinical Trials
1,002,895 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,638 Previous Clinical Trials
40,929,792 Total Patients Enrolled
1 Trials studying Blood Cancers
70 Patients Enrolled for Blood Cancers
Dianna S. HowardPrincipal InvestigatorWake Forest University Health Sciences

Frequently Asked Questions

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

Has the cyclophosphamide drug been sanctioned by the FDA?

"Cyclophosphamide's safety is rated 2 as this Phase 2 trial provides some evidence of its security but has yet to demonstrate any efficacy."

Answered by AI

Am I eligible to join the research project?

"Admission to this medical trial necessitates that participants meet the following conditions: Remission of any acute hematologic malignancy or satisfactory management of chronic cancers, Ages 18-69 years old. A total of 27 enrollees are accepted in to the study."

Answered by AI

What is the current enrolment size for this trial?

"This medical trial is no longer open for enrollment. The first post was published on February 25th 2015 and the last update was made on August 5th 2022. As a substitute, 173 trials are available in which patients with an illness can participate, along with 1025 studies involving cyclophosphamide that have active participants."

Answered by AI

Are there any records of prior experiments utilizing cyclophosphamide?

"Presently, 1025 clinical trials are being conducted in regard to cyclophosphamide. Out of this number, 183 have progressed to the third stage. Most studies on cyclophosphamide are based out of Philadelphia; however, there are currently 29603 research sites running relevant tests for this medication."

Answered by AI

What illnesses is cyclophosphamide most regularly used to ameliorate?

"Cyclophosphamide is commonly implemented to treat lung cancer, but it also has found success with dermatitis, atopic disorders, multiple sclerosis, leukemia and myelocytic acute diseases."

Answered by AI

Are there any available positions in this trial for prospective participants?

"This trial is no longer seeking volunteers. It was initially posted on February 25th 2015, and last edited August 5th 2022. For anyone looking for other studies to join, 173 medical trials are actively recruiting patients with their condition while 1025 research projects require cyclophosphamide participants."

Answered by AI

Is enrollment available for individuals aged 40 or above in this research?

"The age requirements to qualify for this study are 18 years old or above, and 69 years of age or under."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Donor Stem Cell Transplant Followed by Cyclophosphamide in Treating Patients With Hematological Diseases
2015. "Donor Stem Cell Transplant Followed by Cyclophosphamide in Treating Patients With Hematological Diseases". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02248597.
~3 spots leftby Apr 2025
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