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Alkylating agents

Reduced-Dose Cyclophosphamide for Blood Cancer

Phase 1 & 2

Recruiting

Led By Christopher G Kanakry, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects must have a histologically or cytologically confirmed hematologic malignancy with standard indication for allogeneic hematopoietic cell transplantation

Age criteria: 60-85 years, or age 18-60 years and unfit for myeloablative conditioning

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial is for people with blood cancer who are getting a blood or marrow transplant, using a lower dose of cyclophosphamide to see if it's effective and has fewer side effects.

Who is the study for?

Adults aged 18-85 with blood cancers not responding well to standard treatments or at high relapse risk, and their donors. Participants must have a suitable donor, agree to contraception use, and meet specific health criteria like adequate organ function. Excluded are those on other investigational drugs, with poorly controlled cancer or significant unrelated illnesses.Check my eligibility

What is being tested?

The trial is testing if a lower dose of cyclophosphamide can reduce side effects while still preventing graft-versus-host disease in bone marrow transplant patients. It includes chemotherapy, radiation, and post-transplant medications over several weeks with follow-up visits up to five years.See study design

What are the potential side effects?

Potential side effects include reactions from the chemotherapy drug cyclophosphamide such as nausea, hair loss, mouth sores; Mesna may cause allergic reactions; Filgrastim can lead to bone pain; TBI might result in fatigue; Mycophenolate Mofetil could cause stomach issues; Sirolimus may increase infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a blood cancer confirmed by lab tests, needing a stem cell transplant.

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I am between 60-85 years old, or 18-60 and not suitable for intensive treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

determine if optimal dose of PTCy to prevent grade III-IV acute GVHD (aGVHD) at day +60

Secondary outcome measures

Chronic GVHD at one year

Estimation of platelet engraftment, neutrophil engraftment.

Grade II-IV acute GVHD at day 100 and 200

+5 more

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Group I: Younger, HLA-mismatchedExperimental Treatment8 Interventions

Subjects age 18-60 unfit for MAC with hematologic malignancies and an HLA-haploidentical or HLA-mismatched unrelated donor

Group II: Younger, HLA-matchedExperimental Treatment8 Interventions

Subjects age 18-60 unfit for MAC with hematologic malignancies and an HLA-matched related or unrelated donor

Group III: Older, HLA-mismatchedExperimental Treatment8 Interventions

Subjects age 60-85 with hematologic malignancies and an HLA-haploidentical or HLA-mismatched unrelated donor

Group IV: Older, HLA-matchedExperimental Treatment8 Interventions

Subjects age 60-85 with hematologic malignancies and an HLA-matched related or unrelated donor

Group V: DonorsActive Control1 Intervention

Collection of research samples on bone marrow donors

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mesna

2003

Completed Phase 2

~1380

Total Body Irradiation (TBI)

2016

Completed Phase 3

~1220

Filgrastim

2000

Completed Phase 3

~3670

Cyclophosphamide

1995

Completed Phase 3

~3770

Mycophenolate Mofetil

1997

Completed Phase 4

~2380

Allogeneic HSCT

2015

Completed Phase 2

~60

Fludarabine

2012

Completed Phase 3

~1100

Sirolimus

2013

Completed Phase 4

~2750

0 / 2Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,665 Previous Clinical Trials

40,925,534 Total Patients Enrolled

1 Trials studying Blood Cancers

70 Patients Enrolled for Blood Cancers

Christopher G Kanakry, M.D.Principal InvestigatorNational Cancer Institute (NCI)

4 Previous Clinical Trials

1,146 Total Patients Enrolled

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04959175 — Phase 1 & 2

Blood Cancers Research Study Groups: Donors, Older, HLA-matched, Younger, HLA-matched, Older, HLA-mismatched, Younger, HLA-mismatched

Blood Cancers Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT04959175 — Phase 1 & 2

Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04959175 — Phase 1 & 2

Frequently Asked Questions

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

How many people can still enroll in this research project?

"At this time, the trial detailed on clinicaltrials.gov is actively looking for participants. This particular study was initially posted on September 23rd 2021 and was most recently updated on November 17th 2022."

Answered by AI

Does this research require participants to be a certain age?

"As long as they are between 12 and 85 years old, patients of any age are welcome to participate in this trial."

Answered by AI

For what types of disorders or diseases is Allogeneic HSCT most often used?

"Allogeneic HSCT is the transplant of healthy cells from a donor to a patient. This procedure is most often used in cases of bone marrow transplants, but can also be effective for leukemia, certain infections, and some types of lung cancer."

Answered by AI

To whom does this research opportunity extend?

"320 people are needed for this study, that have hematologic neoplasms and are between the ages of 12-85. They also must meet these additional criteria: -INCLUSION CRITERIA - Recipient, Myelodysplastic syndrome of intermediate or higher score by the Revised International Prognostic Scoring System (IPSS-R), B-cell lymphoma including Hodgkin lymphoma that has relapsed within 1 year of completion of primary treatment, after autologous transplantation or has progressed through at least 2 lines of therapy."

Answered by AI

How many people are in this clinical trial?

"The listing on clinicaltrials.gov verifies that this trial is recruiting patients. This experiment was originally advertised on September 23rd 2021 and has since been updated on November 17th 2022. The study requires 320 individuals at 2 separate locations."

Answered by AI

Are there other cases in which Allogeneic HSCT has been used before?

"2035 total clinical trials studying allogeneic HSCT have been completed since the original 1997 study at City of Hope Comprehensive Cancer Center. Currently, 1145 studies are ongoing; a large number of these taking place in Philadelphia, Pennsylvania."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase I/II Study to Reduce Post-transplantation Cyclophosphamide Dosing for Older or Unfit Patients Undergoing Bone Marrow Transplantation for Hematologic Malignancies

2021. "Phase I/II Study to Reduce Post-transplantation Cyclophosphamide Dosing for Older or Unfit Patients Undergoing Bone Marrow Transplantation for Hematologic Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04959175.

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