Know Cancer

or
forgot password

Haploidentical Stem Cell Transplantation Utilizing T-Cell Depletion as Therapy for Patients With Refractory Hematological Malignancies


Phase 2
2 Years
21 Years
Not Enrolling
Both
Acute Lymphoblastic Leukemia (ALL), Acute Myeloid Leukemia (AML), Secondary AML, Myelodysplastic Syndrome (MDS), Secondary MDS, Chronic Myeloid Leukemia, Juvenile Myelomonocytic Leukemia (JMML), Paroxysmal Nocturnal Hemoglobinuria (PNH), Lymphoma, Non-Hodgkin, Hodgkin Disease

Thank you

Trial Information

Haploidentical Stem Cell Transplantation Utilizing T-Cell Depletion as Therapy for Patients With Refractory Hematological Malignancies


Secondary objectives for this protocol are to 1) assess the kinetics of lymphohematopoietic
reconstitution and 2) describe the short and long-term (up to 5 years post- transplant)
toxicity of haploidentical stem cell transplantation, including GVHD, in children with
refractory hematological malignancies.


Inclusion Criteria:

Refractory hematological malignancies (chemoresistant relapse or
primary induction failure) including:

- Acute lymphoblastic leukemia (ALL), must have isolated or combined bone marrow
relapse or primary induction failure. Patients with extramedullary relapse are not
eligible unless they have previously received a stem cell transplant

- Acute myeloid leukemia (AML) >25% blasts in bone marrow

- Secondary AML

- Myelodysplastic syndrome (MDS)

- Secondary MDS

- Chronic myeloid leukemia (CML)

- Juvenile myelomonocytic leukemia (JMML)

- Paroxysmal nocturnal hemoglobinuria (PNH)

- Non-Hodgkin's lymphoma (NHL)*

- Hodgkin's Disease (HD)*

*Patients with lymphomas must have failed standard non-cross reactive combination
salvage chemotherapy with or without radiation therapy followed by autologous stem
cell transplant or patients with chemo resistant disease

- If patient has had previous stem cell transplant, must not be no earlier than 3
months from previous date of transplant

- Patients with shortening fraction greater than or equal to 25%

- Patients with creatinine clearance greater than or equal to 40cc/min/1.73m^2

- Patients with FVC greater than or equal to 40% of predicted, or pulse oximetry
greater than or equal to 92% on room air

- Patients with a performance score (Lansky/Karnofsky) of greater than or equal to 50

- Must have a suitable family member donor that is HIV negative, greater than or equal
to 18 years of age available for stem cell donation

Exclusion Criteria:

- Patients with a known allergy to murine products

- (Female Patients) Patient is pregnant

- Female Patients) Patient is lactating

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To ask in terms of one-year survival the efficacy of haploidentical stem cell transplantation in children with refractory hematological malignancies.

Outcome Time Frame:

July 2006

Safety Issue:

Yes

Principal Investigator

Gregory Hale, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Food and Drug Administration

Study ID:

REFSCT

NCT ID:

NCT00145613

Start Date:

June 2003

Completion Date:

February 2009

Related Keywords:

  • Acute Lymphoblastic Leukemia (ALL)
  • Acute Myeloid Leukemia (AML)
  • Secondary AML
  • Myelodysplastic Syndrome (MDS)
  • Secondary MDS
  • Chronic Myeloid Leukemia
  • Juvenile Myelomonocytic Leukemia (JMML)
  • Paroxysmal Nocturnal Hemoglobinuria (PNH)
  • Lymphoma, Non-Hodgkin
  • Hodgkin Disease
  • Haploidentical stem cell transplant
  • High risk hematologic malignancies
  • Allogeneic stem cell transplant
  • Mismatched family member stem cell donor
  • Neoplasms
  • Hemoglobinuria
  • Hodgkin Disease
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Hemoglobinuria, Paroxysmal
  • Myelodysplastic Syndromes
  • Preleukemia
  • Leukemia, Myelomonocytic, Acute
  • Leukemia, Myelomonocytic, Chronic
  • Leukemia, Myelomonocytic, Juvenile
  • Hematologic Neoplasms

Name

Location

St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794