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Stem Cell Transplant for Blood Cancers

Phase 2

Recruiting

Led By Usama Gergis, MD

Research Sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University

Eligibility Criteria Checklist

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

Must have

Patients must have adequate organ function including cardiac, pulmonary, liver, renal, and performance status criteria

Patients with untreated hematologic malignancies where allogeneic HSCT is the sole or best option for cure

Must not have

Human Immunodeficiency Virus (HIV) positive

Inability to tolerate specified doses of cyclophosphamide or total body irradiation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Approved for 20 Other Conditions

All Individual Drugs Already Approved

Summary

This trial is testing how well a donor's stem cells can treat patients with high-risk blood cancers.

Who is the study for?

This trial is for adults with high-risk blood cancers who have a partially matched related donor. They must be in good health with proper heart, lung, liver function, and kidney clearance. A performance status showing they're mostly independent in daily activities is required. HIV-positive individuals, those with central nervous system cancer involvement or significant psychiatric disorders are excluded.

What is being tested?

The study tests if a stem cell transplant from a donor after receiving full-body radiation and chemotherapy can treat patients with aggressive blood cancers effectively without causing severe side effects. The goal is to stop cancer growth and prevent the immune system from rejecting the new cells.

What are the potential side effects?

Potential side effects include reactions to the infusion of stem cells, damage to organs due to radiation and chemotherapy (like heart or lung problems), increased risk of infections because of weakened immunity, and possible graft-versus-host disease where donated cells attack the body.

Eligibility Criteria

Inclusion Criteria

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

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My heart, lungs, liver, kidneys, and overall health are in good condition.

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I have a blood cancer and a stem cell transplant is my best chance for a cure.

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I have a donor who is partially matched to me for a transplant.

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I am 18 years old or older.

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I am undergoing a stem cell transplant for my blood cancer, hoping for a cure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am HIV positive.

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I cannot tolerate certain doses of cyclophosphamide or total body irradiation.

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My cancer has spread to my brain or spinal cord.

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I am not pregnant and willing to use contraception.

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I need assistance with my daily activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at two years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at two years

This trial's timeline: 3 weeks for screening, Varies for treatment, and at two 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

Overall Survival (OS)

Secondary study objectives

Incidence of graft failure

Perinatal death

Awards & Highlights

No Placebo-Only Group

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

Approved for 20 Other Conditions

This treatment demonstrated efficacy for 20 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (TBI, DLI, chemotherapy, HSCT)Experimental Treatment6 Interventions

Patients undergo Total-Body Irradiation (TBI) twice daily on days -10 to -8 and and donor lymphocyte infusion (DLI) on day -6. Patients receive cyclophosphamide IV on days -3 and -2, tacrolimus IV beginning on day -1 and then orally at least 2 or 3 days prior to discharge with taper starting on day 42, and mycophenolate mofetil IV twice daily on days -1 to 28. Patients undergo Allogeneic Hematopoietic Stem Cell Transplantation on day 0.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mycophenolate mofetil

FDA approved

Cyclophosphamide

FDA approved

Donor Lymphocyte Infusion

1995

Completed Phase 2

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