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

Recruiting in Palo Alto (17 mi)

Overseen byMiguel Angel Perales, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this study is to help determine if palifermin and leuprolide acetate can help the immune system recover faster following a stem cell transplant. Blood stem cells are very young blood cells that grow in the body to become red or white blood cells or platelets. The transplant uses stem cells in the blood from another person. The donor can be a family member or a volunteer donor. This is called an allogeneic stem cell transplant. The investigators want to see if palifermin and leuprolide acetate can help the immune system recover faster after an allogenic transplant because experiments have shown they may be able to do this.

Research Team

Miguel Angel Perales, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

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

My AML is in its second or later remission.

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

See 10 more

Exclusion Criteria

I am HIV positive.

Pregnant or breast feeding

Patient is felt to not be a candidate for TBI by the BMT service

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Treatment Details

Interventions

Lupron (Hormone Therapy)
Palifermin (Growth Factor)

Trial OverviewThe 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.

Participant Groups

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.