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Haploidentical Hematopoietic Stem Cell Transplantation Utilizing Partial T-Cell Depletion as Immunotherapy for Hematologic Malignancies


Phase 2
2 Years
21 Years
Not Enrolling
Both
Leukemia, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Chronic Myeloid Leukemia, Juvenile Myelomonocytic Leukemia, Myelodysplastic Syndrome, Paroxysmal Nocturnal Hemoglobinuria, Hodgkin's Lymphoma, Non-Hodgkin Lymphoma

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Trial Information

Haploidentical Hematopoietic Stem Cell Transplantation Utilizing Partial T-Cell Depletion as Immunotherapy for Hematologic Malignancies


Secondary outcome evaluations for this clinical study included the following:

- To estimate one-year overall survival for research participants with high risk
malignancies who receive a haploidentical HSCT

- To compare overall survival and cumulative incidence of relapse for the two groups of
patients with their corresponding historical controls

- To estimate disease-free survival and event-free survival in participants with
hematologic malignancies who receive a haploidentical HSCT

- To estimate the incidence of overall grade 3-4 acute GvHD in research participants with
hematologic malignancies who receive a haploidentical HSCT

- To estimate the incidence of chronic GvHD and graft failure in research participants
with hematologic malignancies who receive a haploidentical HSCT

- To estimate the incidence of non-hematologic regimen-related toxicity and
regimen-related mortality in the first 100 days post-transplant in research
participants with hematologic malignancies who receive a haploidentical HSCT

- To estimate the number of research participants who develop evidence of EBV
reactivation or post-transplant lymphoproliferative disease (PTLPD)

- To describe disease-free survival, GvHD and engraftment in research participants
receiving grafts from Killer immunoglobulin-like receptor (KIR) mismatched and KIR
matched haploidentical donors


Inclusion Criteria:



Eligible participants were assigned to one of two different strata dependent on diagnosis,
disease status and/or past transplant experience. Both strata received the same
intervention but will be followed and analyzed separately.

- Group A must have one of the following diagnosis

- Acute lymphoid leukemia (ALL) in second or subsequent remission or high risk in
first remission

- Acute myeloid leukemia (AML) in remission or with ≤ 25% blasts in bone marrow

- Chronic myeloid leukemia (CML)

- Juvenile myelomonocytic leukemia (JMML)

- Myelodysplastic syndrome (MDS)

- Paroxysmal nocturnal hemoglobinuria (PNH)

- Hodgkin's (HD) or non-Hodgkin's lymphoma (NHL) in second or subsequent remission
after autologous HSCT, or unable to have hematopoietic stem cells collected for
autologous HSCT

- Group B must have one of the following refractory diagnosis (chemoresistant relapse
or primary induction failure)

- Acute lymphoid leukemia (ALL)

- Acute myeloid leukemia (AML) ≥ 25% blast in bone marrow

- Secondary AML / MDS

- Chronic myeloid leukemia (CML) in accelerated phase or blast crisis

- Juvenile myelomonocytic leukemia (JMML)

- Myelodysplastic syndrome (MDS)

- Hodgkin's (HD) or non-Hodgkin's lymphoma (NHL) with residual disease followed by
autologous HSCT or who have chemo-resistant disease

- Or patients who have undergone prior allogeneic HSCT or who have a co-morbid
condition that in the medical opinion of the Transplant Faculty makes standard
myeloablation prohibited

- At least 2 and less than or equal to 21 years of age

- Lacks suitable HLA-identical sibling or matched available unrelated donor and has a
mismatched family member donor that is available, HIV negative and at least 18 years
old

- Cardiac shortening fraction ≥ 25%

- Creatinine clearance ≥ 40 cc/min/1.73m^2

- FVC ≥ 40% of predicted or pulse oximetry ≥ 92% on room air

- Direct bilirubin ≤ 3 mg/dL or SGPT ≤ 500 U/L

- Karnofsky or Lansky (age dependent) performance score of ≥ 50

Exclusion Criteria:

- Known allergy to murine products

- Lactating (female patient)

- Pregnancy (female patient)

- Active central nervous system (CNS) leukemia

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To measure the rate of disease relapse by six months posttransplant in children and young adults with refractory hematologic malignancies who receive a haploidentical stem cell graft processed using the investigational CliniMACS cell sorting device.

Outcome Time Frame:

September 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:

HAPREF

NCT ID:

NCT00143559

Start Date:

August 2005

Completion Date:

January 2009

Related Keywords:

  • Leukemia
  • Acute Lymphoblastic Leukemia
  • Acute Myeloid Leukemia
  • Chronic Myeloid Leukemia
  • Juvenile Myelomonocytic Leukemia
  • Myelodysplastic Syndrome
  • Paroxysmal Nocturnal Hemoglobinuria
  • Hodgkin's Lymphoma
  • Non-Hodgkin Lymphoma
  • Allogeneic stem cell transplantation
  • Haploidentical stem cell transplant
  • Mismatched family member stem cell donor transplant
  • Bone marrow transplant
  • High risk hematological malignancies
  • T-cell depletion methodology
  • Miltenyi Biotec CliniMACS stem cell selection device
  • 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 Hospital Memphis, Tennessee  38105-2794