Health TrialsbyHealthPanel

BMT-06: Study of Intensity Modulated Total Marrow Irradiation (IM-TMI)

ConditionsAcute LeukemiaMDS
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Illinois at Chicago

About this trial

This study is being done to see if the addition of a targeted form of radiation to standard conditioning regimen will increase the amount of cancer cells that are killed off in the bone marrow and reduce the chances that your disease may return. This description is called Intensity Modulated Total Marrow Irradiation (IM-TMI).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient age 18-75 years

Related donor who is, at minimum, Human Leukocyte Antigen (HLA) haploidentical or mismatched unrelated donor.

Haploidentical: The donor and recipient must be identical in at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1. A minimum match of 4/8 if using HLA-A,-B,-DRB1,-Cw, or 5/10 if using HLA-A,-B,-Cw ,-DRB1, and -DQB1, will be considered evidence that the donor and recipient share one HLA haplotype.

Unrelated donors: unrelated donors who are mismatched in one or more of the following loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1,HLA-DQB1- can be included with a maximum of 4/8 or 5/10 mismatches.

Disqualifiers

a. Left ventricular ejection fraction < 40%

b. Bilirubin > 2.0 mg/dL (unless due to Gilbert's syndrome or hemolysis), and ALT and AST > 5 x ULN

c. FEV1 and FVC < 50% of predicted or DLCO <50% of predicted once corrected for anemia

d. Karnofsky score <70

Trial design

Design model

Single group

Treatments tested in this trial

  • Conditioning regimen with half-matched (haploidentical) stem cell transplant

    Radiation

    Experimental: Total marrow irradiation 1.5 Gray (Gy) twice a daily on days -3 and -2

  • Conditioning regimen with half-matched (haploidentical) stem cell transplant

    Drug

    All patients will receive the following standard conditioning regimen: Fludarabine 30 mg/m2 IVPB daily from Day -6 (6 days before stem cell infusion) through Day -2

  • Conditioning regimen with half-matched (haploidentical) stem cell transplant

    Drug

    Cyclophosphamide 14.5 mg/kg intravenously prior to transplant on Days -6 and -5

  • Conditioning regimen with half-matched (haploidentical) stem cell transplant

    Device

    Total body irradiation 2Gy on Day -1.

  • Conditioning regimen with half-matched (haploidentical) stem cell transplant

    Other intervention

    Stem cell infusion on Day 0.

  • Conditioning regimen with half-matched (haploidentical) stem cell transplant

    Drug

    Mesna 14.5 mg/kg IV starting 30 minutes prior to cyclophosphamide on Days -6 and -5 and continuing for at least 12 hours after end of cyclophosphamide

  • Conditioning regimen with half-matched (haploidentical) stem cell transplant

    Drug

    Cyclophosphamide 50 mg/kg IV on Days 3 and 4 after transplant at a dose of 50mg/kg per day

  • Conditioning regimen with half-matched (haploidentical) stem cell transplant

    Drug

    Mesna 10 mg/kg IV every 4 hours for 10 doses starting 1 hour prior to cyclophosphamide on Days 3 and 4

  • Conditioning regimen with half-matched (haploidentical) stem cell transplant

    Drug

    Tacrolimus 0.03 mg/kg IBW Q24H starting on Day 5

  • Conditioning regimen with half-matched (haploidentical) stem cell transplant

    Drug

    Mycophenolate mofetil (MMF) 15 mg/kg PO TID (maximum daily dose of 3g/day) starting on Day 5

Treatment groups

27 Participants
are divided into 1 treatment group
Group A: Conditioning regimen with half-matched (haploidentical) stem cell transplantOther 4 interventions

Trial outcomes

Primary outcomes

1

Rate of 1 year Graft-Versus-Host Disease (GVHD) free, relapse free survival (GRFS) survival

To evaluate the number of patients with acute leukemia or MDS who are GVHD-free, relapse free (GRFS) after 1 year of undergoing undergoing a treatment regimen of haploidentical stem cell transplant with conditioning and total marrow irradiation.

Time frame
1 year

Secondary outcomes

1

The number of patients with greater than or equal to grade 4 non-hematologic toxicities

Evaluate the incidence of greater than or equal to grade 4 non-hematologic toxicities

Time frame
1 year post-stem cell transplant
2

Engraftment rates

Engraftment rates at Day 30

Time frame
30 days post-stem cell transplant
3

Rates of incidence of full donor chimerism

Rates of incidence of full donor chimerism at Day 30

Time frame
30 days post-stem cell transplant
4

The rate of overall survival (OS)

The rate of overall survival (OS)

Time frame
1 year post-stem cell transplant

Other outcomes

Sponsors and contacts

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

University of Illinois at Chicago

Lead sponsor

Source ClinicalTrials.gov
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