Health TrialsbyHealthPanel

MT2021-08T Cell Receptor Alpha/Beta Depletion PBSC Transplantation for Heme Malignancies

ConditionsHematologic MalignancyAcute LeukemiaRemissionAcute Myeloid LeukemiaAcute Lymphoblastic LeukemiaAMLTP53Intrachromosomal Amplification of Chromosome 21Cytogenetic AbnormalityCNS LeukemiaMinimal Residual DiseaseMyelodysplasiaJuvenile Myelomonocytic LeukemiaSomatic MutationPTPN11 Gene MutationN-RAS Gene AmplificationNeurofibromatosis 1NF1 MutationCBL Gene MutationMonosomy 7Chromosome AbnormalityFetal HemoglobinLymphoblastic LymphomaHigh Grade Non-Hodgkin's Lymphoma, Adult
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeUp to 60
SponsorMasonic Cancer Center, University of Minnesota

About this trial

This is a phase II, open-label, prospective study of T cell receptor alpha/beta depletion (TCR α/β TCD) peripheral blood stem cell (PBSC) transplantation for children and adults with hematological malignancies. This is a safety/feasibility study of the investigational procedure/product.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histological confirmation of hematological malignancies

Acute leukemias

Acute Myeloid Leukemia (AML) and related precursor neoplasms

Acute lymphoblastic leukemia (ALL)/lymphoma

Disqualifiers

Pregnant or breastfeeding.

Active uncontrolled infection within 1 week of starting preparative therapy

Known seropositive for HIV or known active Hepatitis B or C infection with detectable viral load by PCR.

Any prior autologous or allogeneic transplant

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fludarabine

    Drug

    Fludarabine 25mg/m2 IV on days -8 to -6 or days -4 to -2. 40mg/m2 IV on days -5 to -2.

  • Busulfan

    Drug

    Busulfan 82.1 mg\*hr/L IV on days -5 to -2 or days -8 to -5

  • Melphalan

    Drug

    Melphalan 50 mg/m2 IV on days -4 to -2

  • Rituximab

    Drug

    200 mg/m2 intravenous given once on day-1

  • Levetiracetam

    Drug

    As seizures have occurred following high dose busulfan, all patients will be treated with Keppra beginning day -6 and continuing until day -1 per institutional guidelines.

  • Alpha/Beta T Cell-Depleted Hematopoietic Stem Cells

    Biological/Vaccine

    Patients will be treated on the most medically appropriate regimen followed by an infusion at Day 0 of Alpha/Beta T Cell-Depleted Hematopoietic Stem Cells.

  • Thymoglobulin

    Drug

    rabbit anti-thymocyte globulin (rATG). Used in conditioning regimens for in vivo depletion of T cells, and the use of fludarabine model-based dosing to optimize dosing.

  • Cyclophosphamide

    Drug

    Cyclophosphamide 60 mg/kg IV over 2 hours on days -3 and -2

Treatment groups

70 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Arm 1A: Fludarabine (flu), Total Body Irradiation (TBI), Flu/TBI Regimen, Closed to AccrualExperimental treatment 4 interventions
Group B: Arm 2A: Fludarabine (flu), Busulfan (bu), Flu/Bu Regimen, Closed to AccrualExperimental treatment 4 interventions
Group C: Arm 3A: Fludarabine (flu), Busulfan (bu), Melphalan (Mel) Regimen for Pediatric Patients OnlyExperimental treatment 5 interventions
Group D: Arm 1B: ATG, Fludarabine (flu), Total Body Irradiation (TBI), Flu/TBI RegimenExperimental treatment 4 interventions
Group E: Arm 2B: ATG, Fludarabine (flu), Busulfan (bu), Flu/Bu RegimenExperimental treatment 5 interventions
Group F: Arm 3B: ATG, Fludarabine (flu), Busulfan (bu), Melphalan (Mel) Regimen for Pediatric Patients OnlyExperimental treatment 6 interventions
Group G: Arm 4B: ATG, Busulfan (BU), Cyclophosphamide (CY)Experimental treatment 5 interventions
Group H: Arm 5B: ATG, Cyclophosphamide (CY), Total Body Irradiation (TBI)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Determine the rate of GVHD after alpha beta TCR depletion

GVHD incidence after treatment.

Time frame
100 days

Secondary outcomes

1

Transplant engraftment

Monitor median rate of engraftment by 42 days.

Time frame
42 days
2

Graft Failure

Determine the rate of graft failure by day 100 (defined as lack of achievement of an ANC \>=500/mL with associated pancytopenia)

Time frame
100 days
3

Non-relapse mortality (NRM)

Determine the incidence of non-relapse mortality (NRM) at 100 days and 1 year

Time frame
12 months
4

Overall survival (OS)

Number of participants experiencing progression free survival at one year follow up

Time frame
12 months

Other outcomes

Sponsors and contacts

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

Masonic Cancer Center, University of Minnesota

Lead sponsor

Source ClinicalTrials.gov
Apply now