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Alkylating agents

Peripheral Blood Stem Cell Transplantation for Chronic Myelogenous Leukemia

Phase 2
Waitlist Available
Led By Philip McCarthy, MD
Research Sponsored by Roswell Park Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 years
Awards & highlights

Study Summary

This trial is studying how well fludarabine phosphate, cyclophosphamide, total body irradiation, and donor stem cell transplant work in treating patients with blood cancer.

Who is the study for?
This trial is for patients with various blood cancers or related conditions who have a suitable related half-matched (haploidentical) donor. They must be able to tolerate radiation, have decent organ function, and not be pregnant. Those with uncontrolled diseases, recent other treatments, or prior allogeneic transplants are excluded.Check my eligibility
What is being tested?
The study tests if fludarabine phosphate and cyclophosphamide chemotherapy combined with total body irradiation followed by stem cell transplant from a half-matched donor can treat blood cancer effectively. It aims to see if this approach helps the bone marrow recover and fight cancer better.See study design
What are the potential side effects?
Potential side effects include damage to organs from radiation, immune system reactions against the donor cells, infection risks due to weakened immunity post-transplant, chemotherapy-related nausea and hair loss, as well as possible heart or lung complications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Relapse Rate
Secondary outcome measures
Engraftment Rate
Overall Survival
Progression Free Survival
+3 more
Other outcome measures
Immune Reconstitution
Lymphoid Chimerism Expressed as a Percentage of Donor Cells
Myeloid Chimerism Expressed as a Percentage of Donor Cells

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (fludarabine, cyclophosphamide, TBI, PBSCT)Experimental Treatment5 Interventions
Patients receive fludarabine phosphate IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 2 hours on days -6 and -5. Patients undergo TBI on days -1 and PBSCT on day 0.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Peripheral Blood Stem Cell Transplantation
1997
Completed Phase 3
~1330
Cyclophosphamide
1995
Completed Phase 3
~3770
Fludarabine Phosphate
1997
Completed Phase 3
~2390
Total-Body Irradiation
1997
Completed Phase 3
~1180

Find a Location

Who is running the clinical trial?

Roswell Park Cancer InstituteLead Sponsor
402 Previous Clinical Trials
30,827 Total Patients Enrolled
Philip McCarthy, MDPrincipal InvestigatorRoswell Park Cancer Institute
1 Previous Clinical Trials
15 Total Patients Enrolled
Sophia BaldermanPrincipal InvestigatorRoswell Park Cancer Institute

Frequently Asked Questions

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

Will this research be conducted with adult patients only?

"Children as young as one year old and adults up to 75 years of age may be eligible for this clinical trial, based on the inclusion criteria. There are 1702 other studies being conducted for patients under 18 and 6172 trials available for seniors."

Answered by AI

How many people have been recruited for this clinical trial?

"This study is not admitting new patients at the moment. However, if you are seeking other studies, there are 6568 trials actively recruiting participants with thalassemia and 928 trials for Peripheral Blood Stem Cell Transplantation that may have open enrollment."

Answered by AI

Are patients being recruited for this research project at present?

"This trial is not presently seeking participants anymore. The study was originally posted on 12/7/2017 and was most recently updated on 9/14/2022. If you are exploring for other studies, there are currently 6568 trials actively enrolling participants with thalassemia and 928 studies for Peripheral Blood Stem Cell Transplantation actively admitting participants."

Answered by AI

Could you please elaborate on the risks associated with Peripheral Blood Stem Cell Transplantation?

"This treatment, while still in Phase 2 trials, has shown some promise in terms of safety. However, as it is still in the early stages of testing, there is no data yet supporting its efficacy."

Answered by AI

What is the history of involving Peripheral Blood Stem Cell Transplantation in clinical trials?

"There are 928 clinical studies related to Peripheral Blood Stem Cell Transplantation currently underway. Of those, 165 are in Phase 3. The majority of trials for this treatment are based in Philadelphia, Pennsylvania; however, there are 28613 locations running trials for this treatment worldwide."

Answered by AI

What disorders does Peripheral Blood Stem Cell Transplantation commonly alleviate?

"While Peripheral Blood Stem Cell Transplantation is most often used to treat multiple sclerosis, it can also be an effective intervention for mixed-cell type lymphoma, leukemia, myelocytic, acute, and retinoblastoma."

Answered by AI

Could I join the ranks of this clinical trial's participants?

"Up to 31 individuals aged 1 year or older who currently have thalassemia are eligible for this trial. Along with meeting the age criteria, patients must also have a left ventricular ejection fraction > 40%, a Karnofsky (adult) or Lansky (for =< 16 years) performance status >= 60%. Additionally, the recipient should not have any HLA antibodies to potential donors. If the patient does have HLA antibodies, an alternative donor is preferred; though if there are no suitable alternative donors, the anti-HLAt antibodies can be depleted per transplant service guidelines. Any disease that is considered transplant eligible per TCT"

Answered by AI
~4 spots leftby Apr 2025