← Back to Search

Growth Factor

Palifermin for Stem Cell Transplant Outcomes

Phase 1 & 2

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

Select...

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

Select...

My acute lymphoblastic leukemia is in its first complete remission.

Select...

I meet the specific criteria for myelofibrosis treatment.

Select...

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

Select...

My AML is in its first complete remission.

Select...

I am 18 years old or older.

Select...

I can care for myself but may need occasional help.

Select...

My lymphoma meets specific requirements.

Select...

My multiple myeloma is in complete remission.

Select...

My vital organs are functioning well.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

For Phase I:To assess the safety and tolerability

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

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

Hematopoietic stem cell transplant

2002

Completed Phase 3

~400

Rituximab

1999

Completed Phase 4

~1880

TMS

2021

Completed Phase 2

~2170

Palifermin

2006

Completed Phase 3

~1200

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,657 Previous Clinical Trials

40,933,596 Total Patients Enrolled

Steven Z Pavletic, M.D.Principal InvestigatorNational Cancer Institute (NCI)

15 Previous Clinical Trials

3,753 Total Patients Enrolled

Media Library

Palifermin (Growth Factor) Clinical Trial Eligibility Overview. Trial Name: NCT02356159 — Phase 1 & 2

Non-Hodgkin's Lymphoma Research Study Groups: 1/Phase 1: Dose escalation arm, 2/ Phase II arm

Non-Hodgkin's Lymphoma Clinical Trial 2023: Palifermin Highlights & Side Effects. Trial Name: NCT02356159 — Phase 1 & 2

Palifermin (Growth Factor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02356159 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers still looking for people to participate in this trial?

"The trial is currently ongoing, with the most recent update being on October 8th, 2022. The study was originally posted September 24th, 2015."

Answered by AI

Are there other ongoing or completed research trials that have used Hematopoietic stem cell transplantation?

"The first study investigating hematopoietic stem cell transplant was published in 1993. Since then, 849 similar studies have been completed while 425 are still ongoing. A large number of the active trials are being conducted in Minneapolis, Minnesota."

Answered by AI

How many test subjects are participating in this experiment?

"That is correct, the listing on clinicaltrials.gov currently indicates that this trial is open for recruitment. This particular study was first posted on September 24th, 2015 and most recently updated on October 8th, 2022. They are looking to enroll 50 patients at 3 different locations."

Answered by AI

How is Hematopoietic stem cell transplant most often helpful to patients?

"Diffuse large b-cell lymphoma (dlbcl) patients often respond well to hematopoietic stem cell transplants. This treatment is also effective for other conditions, like B-cell lymphomas, polyangiitis, and pemphigus vulgaris."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Palifermin (Kepivance) in Persons Undergoing Unrelated Donor Allogeneic Hematopoietic Cell Transplantation

2015. "Study of Palifermin (Kepivance) in Persons Undergoing Unrelated Donor Allogeneic Hematopoietic Cell Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02356159.

All > Minnesota > Multiple Myeloma