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An Open Label Randomized Phase II Study of Palifermin With or Without Leuprolide Acetate Versus Control for the Promotion of Immune Recovery Following Total Body Irradiation Based T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation


Phase 2
18 Years
60 Years
Open (Enrolling)
Both
Leukemia, Multiple Myeloma, Myelodysplastic Syndrome, Non-Hodgkin's Lymphoma

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Trial Information

An Open Label Randomized Phase II Study of Palifermin With or Without Leuprolide Acetate Versus Control for the Promotion of Immune Recovery Following Total Body Irradiation Based T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation


Inclusion Criteria:



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).

- 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

- 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)

- Patients have a plan to receive a peripheral blood stem cell collection.

- Patients must have no change in disease status from treatment eligibility documented
by bone marrow or appropriate imaging within 14 days (bone marrow) or 30 days
(imaging) of transplant

- 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:

1. Hepatic: < 3x ULN ALT and < 1.5 total serum bilirubin, unless there is
congenital benign hyperbilirubinemia.

2. Renal: serum creatinine <1.2 mg/dl or if serum creatinine is outside the normal
range, then CrCl > 50 ml/min (measured or calculated/estimated)

- Patients must receive a peripheral blood stem cell transplant

Exclusion Criteria:

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

a CD4+ T cell count of greater than 200

Outcome Description:

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

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Jenna Goldberg, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

12-077

NCT ID:

NCT01746849

Start Date:

December 2012

Completion Date:

December 2016

Related Keywords:

  • Leukemia
  • Multiple Myeloma
  • Myelodysplastic Syndrome
  • Non-Hodgkin's Lymphoma
  • LUPRON DEPOT
  • PALIFERMIN
  • 12-077
  • Leukemia
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021