Donor Lymphocyte Infusion (DLI) of T-cells Genetically Modified With iCasp9 Suicide Gene

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

3

Participants

Timeline

Start Date

December 27, 2013

Primary Completion Date

March 7, 2017

Study Completion Date

March 7, 2017

Conditions
LeukemiaMyelomaMyeloproliferative Diseases
Interventions
DRUG

Fludarabine

40 mg/m2 by vein on Days -6 to -3.

DRUG

Melphalan

140 mg/m2 by vein on Day -2.

DRUG

Alemtuzumab

50 mg by vein on Day -1.

PROCEDURE

Stem Cell infusion

Stem cell infusion on Day 0. Goal is to administer more than 3 x 10\^6 CD34+ cells/kg of peripheral blood progenitor cells (PBPC).

DRUG

Tacrolimus

Starting dose of 0.015 mg/kg (ideal body weight) as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml (target is 10 ng/ml) between Day +1 and Day +45. Tacrolimus is changed to oral dosing when tolerated. Tacrolimus tapering should start on approximately Day +35 with the intention for the patient to be completely off the drug by approximately Day +45.

DRUG

Mini Methotrexate

5 mg/m2 by vein on Days +1, +3, +6.

DRUG

G-CSF

5 mcg/kg/day subcutaneously beginning on Day +7, and continuing until the absolute neutrophil count (ANC) is \> 500 x 10/L for 3 consecutive days.

PROCEDURE

Donor Lymphocyte Infusion (DLI)

iCasp9 (BPZ-1001)-Modified T-cells) of 3 X 10\^6/kg in 100 ml infused over approximately a one hour period between Day + 56 to Day +64.

DRUG

AP1903

0.4 mg/kg as a 2 hour infusion for patients that present with a clinical diagnosis of grade I GvHD. For patients with a clinical diagnosis of grade \> 2 GvHD, a single dose of AP1903 0.4 mg/kg as a 2 hour infusion will be administered. Patients who fail to achieve a complete response within 72 hours of an initial dose of AP1903, or within 48 hours of a second dose of AP1903, will be maintained on this dose for no less than 7 days. Patients who experience a partial response within 72 hours may receive a second dose of AP1903. Patients whose GvHD is progressing after 7 days, have no response by 14 days, or are not in a complete response at day 28 can receive secondary therapy.

DRUG

Methylprednisolone

1.6 mg/kg per day by vein divided in 2 to 3 daily doses. Patients whose GvHD resolves as defined by a complete response within 72 hours, would have steroids stopped immediately. Patients who fail to achieve a complete response within 72 hours of an initial dose of AP1903, or within 48 hours of a second dose of AP1903, will be maintained on this dose for no less than 7 days. Steroids can then be tapered as tolerated to no less than 0.6 mg/kg per day at day 28.

BEHAVIORAL

Questionnaire

Completion of a quality of life questionnaire that will take 10-15 minutes between Days + 28 and + 56, about twice a week until about 2 months after the T-cell infusion, and then 6 and 12 months after the stem cell transplant.

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bellicum Pharmaceuticals

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER

NCT01875237 - Donor Lymphocyte Infusion (DLI) of T-cells Genetically Modified With iCasp9 Suicide Gene | Biotech Hunter | Biotech Hunter