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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

Must not have

HIV infection

Active extramedullary disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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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My cancer has spread outside the bone marrow.

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I had a stem cell transplant less than 6 months ago.

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I do not have an active, uncontrolled infection at the time of transplantation.

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

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

Primary study objectives

a CD4+ T cell count of greater than 200

Secondary study objectives

Incidence of infections

Overall Survival

Transplant Related Mortality

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: 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

2010

Completed Phase 4

~2310

Degarelix

2002

Completed Phase 3

~3730