This trial is active, not recruiting.

Conditions leukemia, leukemia chronic myelogenous leukemia (cml), blood and marrow transplant (bmt), myelodysplastic syndromes (mds), lymphomas: non-hodgkin
Treatments clinmacs, stem cells
Sponsor Ginna Laport
Collaborator Doris Duke Charitable Foundation
Start date June 2009
End date December 2012
Trial size 24 participants
Trial identifier NCT01050764, 15919, BMT204, SU-03312009-2059


When a match related or matched unrelated donor is not available a Haploidentical donor (parent, sibling or child)is immediately available. The challenges associated with haploidentical HCT include increased risk of GVHD, graft rejection and impaired immune reconstitution. This trial will evaluate the safety and feasibility of simultaneous administration of conventional T cells and regulatory T cells after haploidentical allogeneic hematopoietic cell transplantation to overcome these challenges.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
stem cells

Primary Outcomes

Determine safety and feasibility of infusing conventional T cells and regulatory T cell after HCT.
time frame: 1 year
Determine maximum tolerated dose of infused regulatory and conventional T cells
time frame: 1 year

Secondary Outcomes

Determine 1 year OS and EFS, incidence and severity of GVHD; incidence of serious infections, immune reconstitution
time frame: 1 year

Eligibility Criteria

Male or female participants up to 60 years old.

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

Additional Information

Official title 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
Principal investigator Ginna Laport
Trial information was received from ClinicalTrials.gov and was last updated in September 2012.
Information provided to ClinicalTrials.gov by Stanford University.