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Depletion of CD45RA Positive Naive T Cells for the Prevention of Graft Versus Host Disease in Older Patients Undergoing Allogeneic Hematopoietic Cell Transplantation for Acute Leukemia or Myelodysplastic Syndrome

ConditionsAcute Biphenotypic LeukemiaAcute LeukemiaAcute Leukemia of Ambiguous LineageAcute Lymphoblastic LeukemiaAcute Myeloid LeukemiaAcute Undifferentiated LeukemiaBlastic Plasmacytoid Dendritic Cell NeoplasmBurkitt LeukemiaBurkitt LymphomaChronic Myeloid Leukemia, BCR-ABL1 PositiveLymphoblastic LymphomaMast Cell LeukemiaMixed Phenotype Acute LeukemiaMyelodysplastic Syndrome
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorFred Hutchinson Cancer Center

About this trial

This phase II trial tests how well removing CD45RA positive naive T cells works to prevent graft versus host disease in older patients undergoing standard of care allogeneic hematopoietic stem cell transplantation for the treatment of acute leukemia or myelodysplastic syndrome (MDS). Allogeneic hematopoietic stem cell transplantation is when healthy cells are collected from a donor and infused into a patient to help the patient's bone marrow make more healthy cells and platelets and help destroy any remaining cancer cells. Giving chemotherapy and total-body irradiation before a stem cell transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. Sometimes the transplanted cells from a donor can attack the body's normal cells (called graft-versus-host disease). Removing the T cells from the donor cells before the transplant may stop this from happening. Giving CD45RA positive naive T cell depleted allogenic hematopoietic stem cell transplant may prevent graft versus host disease while treating acute leukemia or myelodysplastic syndrome in older adults.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

PARTICIPANT: Age > 60 years

Acute lymphocytic leukemia (ALL) in first or subsequent morphological remission (< 5% marrow blasts by morphology).

Acute myeloid leukemia (AML) in first or subsequent morphological remission (< 5% marrow blasts by morphology).

Other acute leukemia or related neoplasm (including but not limited to 'mixed phenotype' 'biphenotypic', 'acute undifferentiated' or 'ambiguous lineage' acute leukemia, blastic plasmacytoid dendritic cell neoplasm, lymphoblastic lymphoma, Burkitt leukemia/lymphoma, mast cell leukemia, chronic myeloid leukemia [CML] with blast crisis or other chronic myeloproliferative neoplasm) in first or subsequent morphological remission (< 5% marrow blasts by morphology).

Disqualifiers

Acute leukemia: circulating abnormal blasts detectable by standard pathology.

MDS: > 5% circulating abnormal blasts by standard pathology

PARTICIPANT: Patients with promyelocytic leukemia (APL)

PARTICIPANT: Patients with active extramedullary disease are excluded. History of extramedullary disease is allowed if only minimal residual disease is present prior to HCT

Trial design

Design model

Single group

Treatments tested in this trial

  • Allogeneic CD34+-enriched and CD45RA-depleted PBSCs

    Biological/Vaccine

    Given IV

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Bone Marrow Aspiration

    Procedure/Surgery

    Undergo bone marrow aspiration

  • Bone Marrow Biopsy

    Procedure/Surgery

    Undergo bone marrow biopsy

  • Cyclophosphamide

    Drug

    Given IV

  • Fludarabine

    Drug

    Given IV

  • Total-Body Irradiation

    Radiation

    Undergo total-body irradiation

Treatment groups

52 Participants
are divided into 1 treatment group
Group A: Treatment (CD34-selected graft with CD45RA-depleted PBSC)Experimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

Graft versus host disease (GVHD) relapse-free survival

Defined as duration between date of transplant and documentation of the date of first occurrence of: relapse, grade III-IV acute GVHD, chronic GVHD, or death due to any cause. Will be estimated using the method of Kaplan Meier. Ninety percent confidence intervals (to be consistent with 1-sided 5% testing) around proportions at milestone time points (e.g. 1-year) will be calculated using the log-log transformation.

Time frame
At 1 year

Secondary outcomes

1

Overall survival

Defined as duration from date of transplant to date of death due to any cause. Will be estimated using the method of Kaplan Meier. Ninety percent confidence intervals (to be consistent with 1-sided 5% testing) around proportions at milestone time points (e.g. 1-year) will be calculated using the log-log transformation.

Time frame
At day 365 and 730 days post transplant
2

Time to relapse

Defined as duration date of transplant to first documentation of \>/=5% leukemic blasts by morphology in bone marrow, circulating leukemic blasts or extramedullary disease (extramedullary disease definite i.e., proven by biopsy or probably based on clinical assessment if biopsy not feasible).

Time frame
At 1 year post transplant
3

Treatment related mortality

Defined as death deemed related to transplant and not attributable to the underlying disease. Proportions and their associated 90% confidence intervals will be estimated, confidence intervals will be estimated using the Wilson Score method.

Time frame
At day 100 and 365 days post transplant
4

Graft rejection or graft failure rate

Graft failure will be operationally defined as failure to achieve an absolute neutrophil count (ANC) ≥ 0.5 × 10\^9/L before death or second transplant, or decrease to absolute neutrophil count \< 0.1 × 10\^9/L for 14 consecutive days (date of graft failure defined as the 14th day) after an established donor graft despite daily administration of granulocyte colony stimulating factor (G-CSF) and ≤ 20% bone marrow cellularity on bone marrow aspirate or biopsy any time in the first 2 years following transplant. Graft rejection will be defined by \< 5% of donor T cell (CD3+) chimerism in the absence of relapse.

Time frame
Two years post transplant

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fred Hutchinson Cancer Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: