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Stem Cell Transplant + Chemotherapy for Leukemia and Lymphoma

Phase 1 & 2

Waitlist Available

Led By Christine Ho

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

Have a Karnofsky performance status score of > 50%

Left ventricular ejection fraction > 40%

Must not have

Known human immunodeficiency virus (HIV) positive

Pregnant or nursing female participants

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying how well chemotherapy, total body irradiation, and post-transplant cyclophosphamide work in reducing rates of graft versus host disease in patients with hematologic malignancies undergoing a donor stem cell transplant.

Who is the study for?

This trial is for patients with various blood cancers or bone marrow disorders who have a compatible donor for stem cell transplant. They should be in certain disease states, like remission or very good partial response, and have adequate organ function. Participants must not be HIV positive, pregnant, nursing, or have severe myelofibrosis; they need to understand the study and agree to use birth control.

What is being tested?

The trial tests if chemotherapy combined with total body irradiation and post-transplant cyclophosphamide can reduce graft versus host disease after a donor stem cell transplant. It includes drugs like fludarabine phosphate and melphalan hydrochloride that stop cancer cells from growing.

What are the potential side effects?

Potential side effects include damage to organs due to chemotherapy and radiation, increased risk of infections from immune suppression, possible infertility due to treatment regimens, fatigue from anemia caused by bone marrow suppression, nausea/vomiting from chemo drugs.

Eligibility Criteria

Inclusion Criteria

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

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I am able to care for myself but cannot do normal activities or work.

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My heart pumps well, with an ejection fraction over 40%.

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I am approved to undergo a specific radiation dose before a transplant.

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My lymphoma is currently in complete remission.

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My bone marrow has less than 5% myeloblasts.

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I have a donor match for my transplant.

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I have severe aplastic anemia and if I have a mismatched donor, I've been treated with ATG.

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I have been diagnosed with a specific type of blood cancer or severe aplastic anemia.

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 am currently pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 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

Extensive chronic graft versus host disease (GVHD)

Secondary study objectives

Clinical response assessed as per bone marrow transplant (BMT) standard of care

Cumulative incidence of grade III-IV acute graft versus host disease (GVHD)

Cumulative incidence of relapse

+4 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: Prevention (chemotherapy, TBI, cyclophosphamide)Experimental Treatment8 Interventions

CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan hydrochloride IV over 30 minutes on day -2. Patients undergo TBI on day -1. STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sirolimus

2013

Completed Phase 4

~2750

Allogeneic Hematopoietic Stem Cell Transplantation

2012

Completed Phase 2

~1240