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Alkylating agents

Cyclophosphamide + Tacrolimus + Mycophenolate for Preventing Graft Versus Host Disease in Blood Cancers

Phase 2
Waitlist Available
Led By Monzr Al Malki, MD
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Suitable donor
Patients with myelodysplastic syndrome (MDS) with intermediate-2 or high risk per International Prognostic Scoring System (IPSS) or myeloproliferative neoplasm; primary or secondary if high-risk features or refractory disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from stem cell infusion to grade 3-4 acute graft versus host disease (gvhd), moderate-severe chronic gvhd, relapse, progression or death (from any cause), whichever occurs first, assessed for up to 1 year.
Awards & highlights

Study Summary

This trial tests how well high doses of cyclophosphamide, tacrolimus, and mycophenolate mofetil prevent graft versus host disease in patients with blood cancer undergoing stem cell transplant.

Who is the study for?
This trial is for patients with various blood cancers needing a stem cell transplant and have no suitable related donor. They must not be pregnant, breastfeeding, or have uncontrolled infections or other serious illnesses. Participants need to agree to contraception use and sign informed consent. Donors must match certain genetic criteria and agree to donate stem cells.Check my eligibility
What is being tested?
The study tests if high doses of cyclophosphamide, tacrolimus, and mycophenolate mofetil can prevent graft versus host disease after a donor stem cell transplant in patients with hematological malignancies undergoing either myeloablative or reduced intensity transplantation.See study design
What are the potential side effects?
Potential side effects may include immune system suppression leading to increased infection risk, liver function changes, gastrointestinal symptoms like nausea or diarrhea, potential fertility impacts due to high-dose medications used in the treatment regimen.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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The participant has a donor who is a good match for the transplant.
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You have myelodysplastic syndrome (MDS) with a high risk of getting worse, or myeloproliferative neoplasm with high-risk features or a disease that does not respond to treatment.
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You have certain types of blood cancers that respond well to chemotherapy.
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You have a donor who is not related to you but is a good match for a transplant.
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You do not have a lot of leukemia cells in your blood or bone marrow.
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You have a high risk of, or your multiple myeloma has not responded well to previous treatments.
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You do not have a close family member who is a suitable match for a stem cell or bone marrow transplant.
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You are able to perform daily activities and take care of yourself without much difficulty.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from stem cell infusion to grade 3-4 acute graft versus host disease (gvhd), moderate-severe chronic gvhd, relapse, progression or death (from any cause), whichever occurs first, assessed for up to 1 year.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from stem cell infusion to grade 3-4 acute graft versus host disease (gvhd), moderate-severe chronic gvhd, relapse, progression or death (from any cause), whichever occurs first, assessed for up to 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
Graft-Versus-Host Disease-Free, Relapse-Free Survival (GRFS) at 1 Year
Secondary outcome measures
Acute Graft Versus Host Disease (aGVHD) of Grades 2-4 According to the Consensus Grading
Overall Survival (OS) at 1 Year

Trial Design

3Treatment groups
Experimental Treatment
Group I: Regimen C (fludarabine, TBI, PBSC HCT, GVHD prophylaxis)Experimental Treatment9 Interventions
Patients receive fludarabine phosphate IV over 60 minutes on days -7 to -5 and TBI BID on days -4 to -1. Patients undergo PBSC HCT on day 0. Patients receive cyclophosphamide IV over 1-2 hours on days 3-4, mycophenolate mofetil IV or PO TID beginning on days 5 and stopping on day 35 if no severe GVHD is present-35, and tacrolimus IV continuously on days 5-180 with a taper beginning on day 90 in the absence of disease progression or unacceptable toxicity.
Group II: Regimen B (fludarabine, busulfan, PBSC HCT, GVHD prophylaxis)Experimental Treatment9 Interventions
Patients receive fludarabine phosphate IV over 1-3 hours and busulfan IV over 3 hour on days -5 to -2. Patients undergo PBSC HCT on day 0. Patients receive cyclophosphamide IV over 1-2 hours on days 3-4, mycophenolate mofetil IV or PO TID beginning on days 5 and stopping on day 35 if no severe GVHD is present-35, and tacrolimus IV continuously on days 5-180 with a taper beginning on day 90 in the absence of disease progression or unacceptable toxicity.
Group III: Regimen A (fludarabine, melphalan, PBSC HCT, GVHD prophylaxis)Experimental Treatment9 Interventions
Patients receive fludarabine phosphate IV over 60 minutes on days -7 to -3 and melphalan hydrochloride IV over 20 minutes on day -2. Patients undergo PBSC HCT on day 0. Patients receive cyclophosphamide IV over 1-2 hours on days 3-4, mycophenolate mofetil IV or PO TID beginning on days 5 and stopping on day 35 if no severe GVHD is present-35, and tacrolimus IV continuously on days 5-180 with a taper beginning on day 90 in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Melphalan Hydrochloride
2016
Completed Phase 2
~70
Busulfan
2008
Completed Phase 3
~1120
Peripheral Blood Stem Cell Transplantation
1997
Completed Phase 3
~1330
Hematopoietic Cell Transplantation
2006
Completed Phase 2
~360
Mycophenolate Mofetil
1997
Completed Phase 4
~2380
Cyclophosphamide
1995
Completed Phase 3
~3780
Tacrolimus
2011
Completed Phase 4
~4740
Total-Body Irradiation
1997
Completed Phase 3
~1180
Fludarabine Phosphate
1997
Completed Phase 3
~2390

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
558 Previous Clinical Trials
1,917,414 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,608 Total Patients Enrolled
1 Trials studying Graft-versus-Host Disease
236 Patients Enrolled for Graft-versus-Host Disease
Monzr Al Malki, MDPrincipal InvestigatorCity of Hope Medical Center

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT03128359 — Phase 2
Graft-versus-Host Disease Research Study Groups: Regimen B (fludarabine, busulfan, PBSC HCT, GVHD prophylaxis), Regimen C (fludarabine, TBI, PBSC HCT, GVHD prophylaxis), Regimen A (fludarabine, melphalan, PBSC HCT, GVHD prophylaxis)
Graft-versus-Host Disease Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT03128359 — Phase 2
Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03128359 — Phase 2

Frequently Asked Questions

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

How many participants have been accepted into this research project?

"Unfortunately, no more enrolments for this particular study are being accepted. Originally posted on May 30th 2017 and last edited on November 18th 2022, the trial is now closed. If you're seeking alternate opportunities to contribute data as a research participant, there are currently 6033 studies with hematologic neoplasms that have open recruitment periods, in addition to 1072 trials with Regimen B (fludarabine, busulfan, PBSC HCT, GVHD prophylaxis)."

Answered by AI

What health issues is the Regimen B (fludarabine, busulfan, PBSC HCT, GVHD prophylaxis) combination typically employed to address?

"Regimen B (fludarabine, busulfan, PBSC HCT, GVHD prophylaxis) can be administered to patients with hematopoietic stem cells deficiencies, leukemia or lung cancer."

Answered by AI

Is the age threshold for participant eligibility in this investigation over 25?

"According to the stated parameters, individuals must be of between 5 and 75 years old in order to qualify for enrolment."

Answered by AI

Are researchers seeking additional participants for this analysis?

"Currently, no new patients are being recruited for this trial. It was posted on May 30th 2017 and last modified on November 18th 2022. Those interested in other clinical trials focusing on hematologic neoplasms may find 6033 active studies while 1072 Regimen B (fludarabine, busulfan, PBSC HCT, GVHD prophylaxis) related medical experiments require volunteers."

Answered by AI

Does my medical profile meet the qualifications to partake in this experiment?

"38 individuals with hematologic neoplasms spanning from 5 to 75 years of age are admitted for this research. In order to be eligible, a set criteria must be followed: the lack of an HLA-matched related donor; availability of matched unrelated donors; and ejection fraction at rest that is greater than or equal to 50%. Moreover, patients afflicted with high risk or refractory/relapsed multiple myeloma in addition to chronic lymphocytic leukemia/small lymphocytic lymphoma, follicular marginal zone diffuse large B-cell Hodgkin's Lymphoma, and mantle cell lymphomas can all qualify provided they"

Answered by AI

What evidence is available to assess the security of Regimen B (fludarabine, busulfan, PBSC HCT, GVHD prophylaxis) for patients?

"Our risk assessment team at Power scored Regimen B (fludarabine, busulfan, PBSC HCT and GVHD prophylaxis) with a 2 due to the evidence collected from Phase 2 trials demonstrating safety but no efficacy."

Answered by AI

What other scientific assessments have assessed the efficacy of Regimen B (fludarabine, busulfan, PBSC HCT, GVHD prophylaxis)?

"Presently, 1072 clinical trials are investigating Regimen B (fludarabine, busulfan, PBSC HCT, GVHD prophylaxis). Of these active studies in progress, 192 of them have reached Phase 3. Philadelphia holds the majority of trials for this treatment with regards to location; however 30493 medical sites across the nation are conducting research on this prescription regimen."

Answered by AI
~5 spots leftby Mar 2025