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LeukemiaPhase 2NCT01746849

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

A Phase 2 study testing Palifermin, Lupron and peripheral blood stem cell transplantation in people with Leukemia and Multiple Myeloma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
Palifermin, Lupron and peripheral blood stem cell transplantation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
1 siteUnited States
Study dates
Dec 2012to Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Treatment Portion:
  • AML in 1st remission - for patients whose AML does not have "good risk" cytogenetic features (i.e. t (8;21), t(15;17), inv 16 without c-kit mutations).
  • Acute leukemias of ambiguous lineage in ≥ 1st remission
  • Secondary AML in remission
  • AML in ≥ 2nd remission
  • ALL in 1st remission with clinical or molecular features indicating a high risk for relapse; or ALL ≥ 2nd remission
Show all 20Show fewer
  • CML failing to respond to or not tolerating imatinib, dasatinib or nilotinib in first chronic phase of disease; CML in accelerated phase, second chronic phase, or in CR after accelerated phase or blast crisis.
  • Non-Hodgkins lymphoma with chemo responsive disease in any of the following categories:
  • intermediate or high grade lymphomas who have failed to achieve a first CR or have relapsed following a 1st remission who are not candidates for autologous transplants.
  • b.ii. any NHL in remission which is considered not curable with chemotherapy alone and not eligible/appropriate for autologous transplant.
  • Myelodysplastic syndrome (MDS): RA/RCMD with high risk cytogenetic features or transfusion dependence, RAEB-1 and RAEB-2
  • Chronic myelomonocytic leukemia: CMML-1 and CMML-2.
  • Patient's age is ≥18 or ≤60 years old
  • Patients must have a Karnofsky (adult) or Lansky (pediatric) Performance Status ≥ 70%
  • Patients must have adequate organ function measured by:
  • Cardiac: asymptomatic or if symptomatic then LVEF at rest must be > 50% and must improve with exercise.
  • Pulmonary: asymptomatic or if symptomatic, DLCO > 60% of predicted (corrected for hemoglobin)
  • Hepatic: < 3xULN ALT and < 1.5 total serum bilirubin, unless there is congenital benign hyperbilirubinemia
  • Renal: serum creatinine < 1.2 mg/dL or if serum creatinine is outside the normal range, the CrCl > 50 ml/min (measured or calculated/estimated)
  • Patients have a plan to receive a CD34-selected peripheral blood stem cell transplant with TBI-based conditioning.

Who cannot join

  • Active extramedullary disease
  • Active and uncontrolled infection at time of transplantation
  • Patients who have undergone a prior allogeneic or autologous stem cell transplant within the previous six months.
  • Pregnant or breast feeding
  • HIV infection
  • Patient is felt to not be a candidate for TBI by the BMT service
  • Donor Inclusion Criteria:
  • Donor must be willing and able to undergo PBSC collection.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this study

Official title: Phase II Study of Palifermin With Leuprolide Acetate or Degarelix For the Promotion of Immune Recovery Following Total Body Irradiation Based T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation

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.

Read the detailed description

Patients will be randomized to one of two arms: palifermin with Lupron, and control. The control arm consists of a standard TCD allo-HSCT without the addition of palifermin or Lupron.

Patients randomized to receive Lupron will receive a three month depot dose 3-6 weeks prior to the start date of the pre-transplant conditioning regimen. Patients assigned to receive palifermin will receive this drug 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. The preparative regimen to be used for transplants will consist of: hyperfractionated TBI administered in 11 doses over 4 days for a total of 1375 cGy, thiotepa 5 mg/kg/day IV x 2 days and cyclophosphamide with mesna prophylaxis 60 mg/kg/day IV x 2 days. All patients will receive ATG for two doses prior to transplant, except recipients of mismatched grafts (in the GVHD vector) will receive three doses. G-CSF mobilized CD34 PBSCs obtained from the HLA compatible donor will be infused on day 0. Patients assigned to receive palifermin will receive three additional daily doses of the drug, 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 and d+2. Patients assigned to receive Lupron will receive a further 3-month depot injection approximately 3 months (+/- one week) post the first dose. Supportive care will be administered as per the BMT Service guidelines. The conditioning regimen may be modified to allow an extra day during conditioning or prior to the graft infusion if required by donor and/or patient scheduling restrictions.

Being tested
Palifermin, Lupron, peripheral blood stem cell transplantation, Total-Body Irradiation (TBI), Thiotepa
Keywords
LUPRON DEPOT, PALIFERMIN, 12-077
Medical subject headings
Leukemia, Multiple Myeloma, Myelodysplastic Syndromes, Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01746849
Study groupRoleWhat they receive
palifermin with LupronExperimentalAll 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.
Receives: Biological: Palifermin; Biological: Lupron; Procedure: peripheral blood stem cell transplantation; Radiation: Total-Body Irradiation (TBI); Drug: Thiotepa; Drug: Cyclophosphamide
palifermin with DegarelixExperimentalParticipants 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.
Receives: Biological: Palifermin; Procedure: peripheral blood stem cell transplantation; Radiation: Total-Body Irradiation (TBI); Drug: Thiotepa; Drug: Cyclophosphamide; Drug: Degarelix

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. a CD4+ T cell count of greater than 200

    Will be documented by flow cytometry performed in the clinical lab on peripheral blood.

    Measured: 6 months

Secondary outcomes (4)

  1. Overall Survival

    Overall survival is defined as the time from transplant to death of last follow-up.

    Measured: 2 years

  2. Transplant Related Mortality

    TRM is defined as death at any time from the commencement of pre-transplant conditioning due to any cause other than disease relapse with the exception of automobile or other accidents.

    Measured: 6 months

  3. Incidence of infections

    Any bacterial, viral, fungal or parasitic infection that necessitates therapy will be noted.

    Measured: 2 years

  4. Relapse

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2012 (estimated)
  2. Study startDec 2012
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01746849
Sponsor's protocol ID
12-077
Status last verified
Jan 2026
First submitted
7 Dec 2012
Last updated
7 Jan 2026
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Palifermin, Lupron and peripheral blood stem cell transplantation in people with Leukemia and Multiple Myeloma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

a CD4+ T cell count of greater than 200 (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01746849.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.

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