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Alkylating agents

Combination Therapy for Blood Cancer

Phase 2

Waitlist Available

Led By Sophia Balderman

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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Relapse Rate

Secondary study objectives

Engraftment Rate

Overall Survival

Progression Free Survival

+3 more

Other study objectives

Immune Reconstitution

Lymphoid Chimerism Expressed as a Percentage of Donor Cells

Myeloid Chimerism Expressed as a Percentage of Donor Cells

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Cyclophosphamide

2010

Completed Phase 4

~2310

Peripheral Blood Stem Cell Transplantation

1997

Completed Phase 3

~1330