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Growth Factor

Palifermin for Stem Cell Transplant Outcomes

Phase 1 & 2

Waitlist Available

Led By Steven Z Pavletic, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Patients must have no suitable HLA matched sibling donor available and must have one or more potentially suitable HLA matched unrelated donor(s) in the National Marrow Donor Registry or other available registry

Patients must have a diagnosis of hematologic malignancy meeting specific disease status criteria

Must not have

Active infection that is not responding to antimicrobial therapy

Active CNS involvement by malignancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether the drug palifermin can help improve the results of stem cell transplants from HLA-matched unrelated donors.

Who is the study for?

Adults over 18 with blood or bone marrow cancer, no HLA-matched sibling donor but a potential unrelated match, must understand and consent to the study. They should have good physical function, agree to use contraception if applicable, and live in the US. Excluded are HIV patients, pregnant women, those with certain psychiatric conditions or active infections not responding to treatment.

What is being tested?

The trial is testing high doses of palifermin given before chemotherapy for safety and effectiveness in preventing chronic GVHD and improving immune function after an allogeneic stem cell transplant from HLA-matched unrelated donors.

What are the potential side effects?

Palifermin may cause skin reactions like rash or itching, mouth sores, swelling in limbs or face, elevated amylase levels which could indicate pancreas issues. Other side effects can include taste changes and allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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I don't have a family donor but may have a match in a donor registry.

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I have been diagnosed with a blood cancer that meets certain criteria.

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My acute lymphoblastic leukemia is in its first complete remission.

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My donor's HLA type matches mine at the A, B, and C genes.

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I am 18 years old or older.

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I can care for myself but may need occasional help.

Exclusion Criteria

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

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I have an infection that isn't getting better with treatment.

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My cancer has spread to my brain or spinal cord.

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I am HIV positive.

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I have had a condition where my lymphocytes grow abnormally.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

For Phase I:To assess the safety and tolerability

For Phase II portion: to determine the incidence of severe chronic GVHD

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: 2/ Phase II armExperimental Treatment7 Interventions

Induction chemotherapy, then palifermin at the MTDdetermined in Phase 1, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression

Group II: 1/Phase 1: Dose escalation armExperimental Treatment7 Interventions

Induction chemotherapy, then palifermin at escalating doses, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

FLAG

2007

Completed Phase 2

~100

EPOCH-F

2007

Completed Phase 2

~100