Know Cancer

or
forgot password

A Feasibility Trial of Post Transplant Infusion of Allogeneic Regulatory T Cells Simultaneously With Allogeneic Conventional T Cells in Patients With Hematologic Malignancies Undergoing Allogeneic Myeloablative Hematopoietic Cell Transplantation From Haploidentical Related Donors


N/A
N/A
60 Years
Open (Enrolling)
Both
Leukemia, Leukemia Chronic Myelogenous Leukemia (CML), Blood and Marrow Transplant (BMT), Myelodysplastic Syndromes (MDS), Lymphomas: Non-Hodgkin

Thank you

Trial Information

A Feasibility Trial of Post Transplant Infusion of Allogeneic Regulatory T Cells Simultaneously With Allogeneic Conventional T Cells in Patients With Hematologic Malignancies Undergoing Allogeneic Myeloablative Hematopoietic Cell Transplantation From Haploidentical Related Donors


Inclusion Criteria:

Recipient Inclusion Criteria

3.1.1 Patients with the following diseases that are histopathologically confirmed are
eligible:

1. Acute leukemia (in first remission with poor risk factors and molecular prognosis;
AML with -5,-7, t(6;9), tri8, -11 and ALL with Ph+ t(9;22), t(4;22), (q34;q11)

2. Acute leukemia with refractory disease or >CR1

3. Chronic myelogenous leukemia (accelerated, blast or second chronic phase)

4. Myelodysplastic syndrome (in high and high intermediate risk categories)

5. Non-Hodgkin's lymphoma with poor risk features not suitable for autologous
transplantation

6. Refractory CLL

3.1.2 There are no limits on amount of prior therapy but there must be at least 21 days
from the end of most recent prior therapy to start of transplant conditioning regimen.

3.1.3 The recipient must be <= 60 years old at time of registration.

3.1.5 Karnofsky Performance Status > 70%

3.1.6 The recipient must have a related donor genotypically HLA-A, B,C and DRB1, DQ loci
haploidentical to the recipient (but differing for 2-3 HLA alleles on the unshared
haplotype in the GvHD direction) and no HLA matched sibling or matched unrelated donor is
identified.

3.1.7 Adequate cardiac and pulmonary function (LVEF > 45%, DLCO >50% corrected for
hemoglobin)

3.1.8 Serum creatinine <1.5 mg/dL or creatinine clearance >50 ml/min for those above serum
creatinine of 1.5; serum bilirubin <2.0 mg/dL; ALT <2x ULN (unless secondary to disease)

3.1.9 No prior myeloablative therapy or hematopoeitic cell transplantation

Donor Inclusion Criteria

3.3.1 Age < 70 years and weight > 25 kg. 3.3.2 Medical history and physical examination
confirm good health status as defined by institutional standards 3.3.3 Seronegative for
HIV Ag, hepatitis B sAg or PCR+ or hepatitis C ab or PCR+ within 30 days of apheresis
collection 3.3.4 Genotypically haploidentical as determined by HLA typing 3.3.5 Female
donors of child-bearing potential must have a negative serum or urine beta-HCG test within
three weeks of mobilization 3.3.6 Capable of undergoing leukapheresis, have adequate
venous access, and be willing to undergo insertion of a central catheter should
leukapheresis via peripheral vein be inadequate 3.3.7 Capable of agreeing to second
donation of PBPC (or a bone marrow harvest) should the patient fail to demonstrate
sustained engraftment following the transplant 3.3.8 The donor or legal guardian greater
than 18 years of age, capable of signing an IRB-approved consent form.

3.3.9 Donor Selection

The order of donor section will be as follows:

1. If available, the recipient's biological mother will be the preferential donor

2. If the biological mother is not available, then other available haploidentical donors
will be selected based upon the presence of NK alloreactivity between donor and
recipient. The donor will be selected based on the presence of NK alloreactivity as
determined by high-resolution HLA typing of the C locus of both donor and
recipient. Recipients lacking a KIR-ligand present in the donor along with the
corresponding KIR defines "NK alloreactivity". An NK alloreactive donor will be
preferentially chosen.

3. If more than 1 NK alloreactive donor is available, then preference will be to use an
NK alloreactive donor that is CMV seronegative.

Exclusion Criteria:Recipient Exclusion Criteria

3.2.1 The recipient is a suitable candidate for autologous transplantation or allogeneic
transplantation with an available matched related or unrelated donor.

3.2.2 Seropositive for any of the following: HIV ab, hepatitis B sAg or PCR+ or
hepatitis C ab or PCR+ 3.2.3 History of invasive Aspergillosis; presence of any other
active, uncontrolled bacterial, viral or fungal infection 3.2.4 Uncontrolled CNS disease
involvement 3.2.7 The recipient is a lactating female

3.4 Donor Exclusion Criteria 3.4.1 Evidence of active infection or viral hepatitis 3.4.3
Factors which place the donor at increased risk for complications from leukapheresis or
G-CSF therapy 3.4.4 Lactating female 3.4.5 HIV positive

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:

Determine safety and feasibility of infusing conventional T cells and regulatory T cell after HCT.

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

Ginna Laport

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Food and Drug Administration

Study ID:

BMT204

NCT ID:

NCT01050764

Start Date:

June 2009

Completion Date:

March 2013

Related Keywords:

  • Leukemia
  • Leukemia Chronic Myelogenous Leukemia (CML)
  • Blood and Marrow Transplant (BMT)
  • Myelodysplastic Syndromes (MDS)
  • Lymphomas: Non-Hodgkin
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Lymphoma
  • Myelodysplastic Syndromes
  • Preleukemia
  • Chronic Disease

Name

Location

Stanford University School of MedicineStanford, California  94305-5317