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Growth Factor

Palifermin + Leuprolide Acetate for Hematopoietic Stem Cell Transplantation in Blood Cancers

Phase 2

Waitlist Available

Led By Christina Cho, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Chronic myelomonocytic leukemia: CMML-1 and CMML-2

AML in ≥ 2nd remission

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing if palifermin and leuprolide acetate can help the immune system recover faster following an allogeneic stem cell transplant.

Who is the study for?

Adults aged 18-60 with certain blood cancers like leukemia, lymphoma, or myelodysplastic syndrome who are in remission but at high risk for relapse. They must be fit enough for a stem cell transplant (with performance status ≥70%) and have good organ function. Pregnant women, recent transplant recipients, those with active infections or HIV are excluded.Check my eligibility

What is being tested?

The trial is testing if palifermin combined with leuprolide acetate can speed up immune recovery after an allogeneic stem cell transplant following total body irradiation. Participants will receive these drugs along with standard treatments including chemotherapy and radiation.See study design

What are the potential side effects?

Possible side effects include reactions to the infusion of medications, hormonal changes due to leuprolide acetate, mouth sores from palifermin, and typical risks associated with chemotherapy and radiation such as fatigue, nausea, infection risk increase.

Eligibility Criteria

Inclusion Criteria

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

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My condition is chronic myelomonocytic leukemia, either CMML-1 or CMML-2.

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My AML is in its second or later remission.

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My leukemia is in its first remission but at high risk of returning, or it's in a second or later remission.

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My organs are functioning well.

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My acute leukemia is in its first or later remission.

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I am scheduled for a stem cell transplant with specific preparation.

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My chronic myeloid leukemia did not respond well to initial treatments, or I am in an advanced stage.

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I have a specific type of bone marrow disorder.

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My Non-Hodgkin's lymphoma responds to chemotherapy.

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I am between 18 and 60 years old.

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I am mostly able to care for myself and carry out daily activities.

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My secondary AML is currently in remission.

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My AML is in its first remission and does not have 'good risk' features.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

a CD4+ T cell count of greater than 200

Secondary outcome measures

Incidence of infections

Overall Survival

Relapse

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: palifermin with LupronExperimental Treatment6 Interventions

All patients undergo total body irradiation (TBI) on days -9 to -6 & receive thiotepa intravenously (IV) over 2-4 hours on days -5 to -4, cyclophosphamide IV over 30-60 minutes on days -3 to -2, & anti-thymocyte globulin infused over 12 hours on days -3 to -2 Pts undergo T-cell depleted allogeneic hematopoietic stem cell transplant on day 0. Pts will receive a three month depot dose of Lupron 3-6 weeks prior to the start date of the pre-transplant conditioning regimen. Pts will receive palifermin at 60mcg/kg/day IV on three consecutive days, 24 hours apart with the last dose administered no less than 24 & no more than 48 hours prior to the start of cytoreduction. Pts will receive three additional daily doses of palifermin the first approximately 6 hours after the stem cell infusion on day 0, followed by two daily doses given at 24 hour intervals on d+1 & d+2. Pts will receive a further 3-month depot injection of Lupron approximately 3 months (+/- one week) post the first dose.

Group II: palifermin with DegarelixExperimental Treatment6 Interventions

Participants on the degarelix arm will receive a loading dose of degarelix 240 mcg subcutaneous 4-14 days before the start of pre-transplant conditioning. All participants will receive palifermin at 60mcg/kg/day IV on three consecutive days, 24 hours apart with the last dose administered no less than 24 and no more than 48 hours prior to the start of cytoreduction.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

1995

Completed Phase 3

~3780

Degarelix

2002

Completed Phase 3

~3600

Palifermin

2006

Completed Phase 3

~1200

Lupron

2018

Completed Phase 3

~2050

peripheral blood stem cell transplantation

1997

Completed Phase 3

~4330

Total-Body Irradiation (TBI)

2013

Completed Phase 2

~50

Thiotepa

2008

Completed Phase 3

~2150

0 / 13Eligibility criteria met

Find a Location

Who is running the clinical trial?

Swedish Orphan BiovitrumIndustry Sponsor

92 Previous Clinical Trials

12,432 Total Patients Enrolled

4 Trials studying Leukemia

111 Patients Enrolled for Leukemia

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,538 Total Patients Enrolled

116 Trials studying Leukemia

9,260 Patients Enrolled for Leukemia

Christina Cho, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

1 Previous Clinical Trials

25 Total Patients Enrolled

Media Library

Palifermin (Growth Factor) Clinical Trial Eligibility Overview. Trial Name: NCT01746849 — Phase 2

Leukemia Research Study Groups: palifermin with Lupron, palifermin with Degarelix

Leukemia Clinical Trial 2023: Palifermin Highlights & Side Effects. Trial Name: NCT01746849 — Phase 2

Palifermin (Growth Factor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01746849 — Phase 2

Frequently Asked Questions

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

To what types of illnesses is Palifermin commonly administered?

"Palifermin has been deemed the most effective form of treatment for multiple sclerosis, yet it is also able to ameliorate symptoms associated with leukemia, myelocytic, acute retinoblastoma and histiocytic lymphoma."

Answered by AI

Does this research experiment accept participants over the age of 20?

"Based on the inclusion criteria, this clinical trial is applicable for patients aged 18 to 60. For those younger than 18 or older than 65, there are 787 and 2837 studies respectively available."

Answered by AI

What is the participant quota for this clinical inquiry?

"This medical trial is not currently open to new participants. Posted on December 1st 2012, it was last updated January 21st 2022. For those looking for alternative trials, 2439 studies are actively recruiting patients with leukemia and 914 studies have opened recruitment for Palifermin treatments."

Answered by AI

Has Palifermin been explored in any other research projects?

"Currently, there are 914 active Palifermin studies with 181 of them being Phase 3 trials. While Philadelphia Pennsylvania is the hub for these researches, a total of 33450 sites globally offer treatment options and data collection opportunities as part of this clinical trial."

Answered by AI

Has Palifermin received regulatory approval from the Food and Drug Administration?

"Our experts at Power assigned Palifermin a rating of 2, as this phase 2 trial has only produced evidence regarding its safety but not efficacy."

Answered by AI

Do I meet the qualifications to take part in this medical study?

"This medical trial is seeking 82 volunteers between the ages of 18 and 60 with leukemia. Furthermore, these participants must meet a set of additional criteria that are listed: remissionary acute myeloid leukaemia (AML), ambiguous lineage leukemias in first or later remissions, intermediate/high-grade lymphomas not amenable to autologous transplants, AMLs without "good risk" cytogenetic features such as t(8;21) or inv 16 lacking c-kit mutations in either first or subsequent remissions, ALLs with molecular indicators for relapse after 1st remission or any non-Hod"

Answered by AI

Are there any remaining openings for participants in this experiment?

"The records found on clinicaltrials.gov indicate that this study, which was posted in December 2012 and last updated in January 2022, is not accepting any further enrollees. However, there are 3353 other studies actively recruiting participants at the moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Palifermin With Leuprolide Acetate for the Promotion of Immune Recovery Following Total Body Irradiation Based T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation

2012. "Palifermin With Leuprolide Acetate for the Promotion of Immune Recovery Following Total Body Irradiation Based T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01746849.

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