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Haploidentical Stem Cell Transplantation Utilizing Purified CD34+ Hematopoietic Cells for Patients With Hematologic Malignancies


Phase 3
2 Years
21 Years
Not Enrolling
Both
Leukemia, Acute Lymphocytic (ALL), Leukemia, Myeloid, Acute(AML), Leukemia, Myeloid, Chronic(CML), Juvenile Myelomonocytic Leukemia(JMML), Hemoglobinuria, Paroxysmal Nocturnal (PNH), Lymphoma, Non-Hodgkin (NHL), Myelodysplastic Syndrome (MDS)

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Trial Information

Haploidentical Stem Cell Transplantation Utilizing Purified CD34+ Hematopoietic Cells for Patients With Hematologic Malignancies


Secondary outcome evaluations for this clinical study include the following:

- To estimate overall survival, disease free survival and event free survival for these
patients

- To estimate the incidence of grade 2 to 4 acute GvHD in these patients

- To estimate the incidence of chronic GvHD and graft failure in these patients

- To estimate the incidence of non-hematologic peri-transplant regimen-related toxicity
and regimen-related mortality in the first 100 days after transplantation in these
patients

- To estimate the number of patients who require donor lymphocyte infusions and/or stem
cell boosts after transplantation in this group of patients and evaluate its impact on
immune reconstitution and engraftment

- To estimate the number of patients who develop evidence of EBV reactivation or post
transplant lymphoproliferative disease (PTLPD) post transplant in this group of
patients

- Describe the pharmacokinetics of rabbit anti-thymocyte globulin (rATG) in patients
receiving allogeneic transplantation and determine the frequency of rATG antibody
development

- Explore dose and patient characteristics as determinants of active rATG pharmacokinetic
parameters

Originally this study began as a randomized comparison of two methods of stem cell selection
utilizing the CliniMACS device. Both arms provided a purified product of CD34+
hematopoietic cells that was depleted of T-lymphocytes. One arm utilized a positive
selection methodology using an anti-CD34 antibody and the other arm utilized negative
selection with the anti-CD3 antibody OKT-3. There were no toxicities noted that would have
required the study to be interrupted early, however, due to low accrual, it was decided to
redesign the study. The new design focused on the standard arm utilizing negative
selection, and all subsequent participants were treated in that manner. The patients who
were treated on the positive selection arm are continuing to be monitored as specified in
the original protocol, but will be reported in a descriptive manner only. The primary and
secondary objectives of the current version of this study will be answered only by those
patients receiving a haploidentical stem cell transplant utilizing a negative selection
methodology.


Inclusion Criteria:



- Lacking a HLA-identical sibling or unrelated donor matched at 6 HLA loci formally
requested within an approximate 90 day period from search initiation and who has a
mismatched family member donor available

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

- Must have one of the following diagnosis:

- Acute lymphoid leukemia (ALL) in second, third, or subsequent remission.

- ALL in first remission but high risk for relapse.

- Acute myeloid leukemia (AML) in relapse or remission.

- Secondary AML / MDS

- Chronic myeloid leukemia (CML)

- Juvenile myelomonocytic leukemia (JMML).

- Myelodysplastic syndrome (MDS).

- Paroxysmal nocturnal hemoglobinuria (PNH)

- Non-Hodgkin lymphoma in second or subsequent CR

- Patients with a shortening fraction ≥ 25%

- Patients with a creatinine clearance ≥ 40cc/min/1.73m^2

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

- Patients with direct bilirubin ≤ 3 mg/dL or SGPT ≤ 500 U/L

- Patients with a Karnofsky or Lansky (age dependent) performance score of ≥ 70

- Mismatched family member donor is available, HIV negative and ≥ 18 years of age

Exclusion Criteria:

- Patients who have received a previous hematopoietic stem cell allograft

- Patients with a known allergy to rabbit or murine products

- Patients with isolated CNS, testicular or other isolated extramedullary site of
relapse

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To describe rate of hematopoietic and immune reconstitution in first 100 days posttransplant for pediatric patients with high-risk hematologic malignancies receiving haploidentical transplant processed with investigational CliniMACS cell sorting device.

Outcome Time Frame:

September 2005

Safety Issue:

Yes

Principal Investigator

Gregory A. Hale, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Food and Drug Administration

Study ID:

HAPSCT

NCT ID:

NCT00186823

Start Date:

March 2002

Completion Date:

January 2009

Related Keywords:

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

Name

Location

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