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Alkylating agents

Stem Cell Transplant after Chemotherapy and Radiation for Blood Cancers

Phase 2

Waitlist Available

Led By Neal Flomenberg, 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 with refractory anemia (RA) or refractory anemia with ring sideroblasts (RARS) or isolated 5q-

Patients with refractory anemia with excess blasts (RAEB)-1, refractory cytopenia with multilineage dysplasia (RCMD)+/-ringed sideroblasts (RS), or myelodysplastic syndrome (MDS) not otherwise specified (NOS) with stable disease for at least 3 months

Must not have

Patients with performance status < 90% in patients 70 years old or greater, < 80% in patients less than age 70 years

Patients with HCT-CI/age score > 5 points

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 1 year post hsct

Awards & highlights

No Placebo-Only Group

Summary

This trial uses reduced intensity chemotherapy and radiation therapy before a donor stem cell transplant to treat patients with hematologic malignancies.

Who is the study for?

This trial is for patients with various blood cancers or bone marrow disorders who have responded to initial treatments. They must have a partially matched related donor, good heart and lung function, normal liver enzymes, adequate kidney function, and agree to use contraception if needed. Excluded are those with other active cancers (except minor skin cancer), HIV positive individuals, certain performance status levels based on age, or anyone unable to consent.

What is being tested?

The study tests whether lower doses of chemotherapy drugs like cyclophosphamide and fludarabine followed by radiation therapy can prepare patients for a stem cell transplant from a donor. The goal is to reduce cancer growth while minimizing rejection of the transplanted cells and side effects.

What are the potential side effects?

Potential side effects include weakened immune system leading to increased infection risk; reactions from the body's acceptance of donor cells; possible damage to organs due to low-dose chemo/radiation; fatigue; nausea; mouth sores; hair loss.

Eligibility Criteria

Inclusion Criteria

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

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You have certain types of anemia called refractory anemia or refractory anemia with ring sideroblasts, or isolated 5q-.

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You have a specific type of myelodysplastic syndrome or related conditions and have had stable disease for at least 3 months.

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Patients with a specific type of advanced blood disorder who have responded well to chemotherapy.

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You have less than 5% of a specific type of cells in your bone marrow.

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You have a type of blood disorder called myeloproliferative disorder, except for chronic myelomonocytic leukemia (CMML).

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You have aplastic anemia.

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You have a blood or cancer disease that could be helped by a specific type of transplant, and the disease responds to chemotherapy.

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The patient must have a donor whose human leukocyte antigens (HLA) are different at 2, 3, or 4 specific locations, which may help prevent graft-versus-host disease.

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Your lung function test results show that your breathing is not severely limited.

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Your kidneys work well enough to clear at least 60 milliliters of creatinine from your body every minute.

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Patients with a health condition score or age score of 5 points or less are not eligible.

Exclusion Criteria

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

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You have a lower level of physical ability based on your age.

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Your health condition and age score is higher than 5 points.

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You have chronic myelomonocytic leukemia, unless you are in complete remission based on how the cells look under a microscope.

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You have cancer that has spread to your brain.

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You have another type of cancer, except for a skin cancer that only needs treatment in the affected area.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 1 year post hsct

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 1 year post hsct

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 year post hsct 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

Engraftment rates

Incidence and severity of GVHD

Lymphoid reconstitution

+2 more

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: RIC HSCT, GVHD prophylaxisExperimental Treatment9 Interventions

RIC: Patients receive fludarabine phosphate IV on days -10 to -8 and cyclophosphamide IV on days -3 and -2. Patients also undergo TBI followed by a DLI on day -6. TRANSPLANT: Patients undergo CD34+ peripheral blood stem cell transplant on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus PO beginning day -1 with a taper initiated on day 42 and mycophenolate mofetil IV BID on days -1 to 28 in the absence of GVHD.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mycophenolate mofetil

2014

Completed Phase 4

~3060

Tacrolimus

2019

Completed Phase 4

~5510