Multicenter Phase II study of haploidentical hematopoietic cell transplantation with CD3/CD19 depleted grafts after a reduced intensity conditioning regimen for adult patients with acute leukemia - Haplo CD3CD19-RIC

Phase 1

• Conditions: Patients with acute leukemia with an indication for allogeneic HCT but without a suitable HLA-identical donor

• Registration Number: EUCTR2007-006016-33-DE
• Lead Sponsor: niklinikum Tuebingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-03-12
• Last Update Posted: 21 July 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

•Patients with either ALL or AML being in CR with an indication for allogeneic HCT* but without a suitable HLA-identical donor** within an acceptable time period or with relapse after a preceding allogeneic HCT from an HLA-identical donor
•Age <65, >18 years
•Karnofsky Index >60%

**AML:high risk patients with one or more of the following risk factors:

FLT-3 mutation
Complex cytogenetics
abn(3q), -5/5q-, -7/7q-, abn(12p), abn(17p)
Late CR > induction I
Age >60
Patients in 2.CR
Secondary AML

ALL: high risk patients with one or more of the following risk factors:
Pro-B-ALL
Inital WBC >30.000/µL
CR after day 46 after Induction II
Complex cytogenetics, t(9,22), t(4,11)
Early or mature T-ALL
Initially refractory patients with late CR
Rising MRD level
Patients in 2. CR

* As acceptable HLA-identical donor not more than 1 antigen mismatch (9/10-Match) or more than 2 allelic mismatches by high-resolution typing are allowed. Critical cases should be discussed with the PI

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Patients with >5% blasts in BM at the time of transplantation
•Less than 3 months after preceding HCT
•CNS involvement with disease
•History of neurologic impairment such as: seizures, severe peripheral neuropathy, signs of leukencephalopathy, CNS infection, multiple intrathecal chemotherapies, CNS irradiation. In case of heavy preatreatment with irradiation or intrathecal chemotherapy pretransplant CNS MRI and neurological consultation are mandatory
•Fungal infections with radiological progression after receipt of amphotericin B or active triazole for greater than 1 month.
•Liver function abnormalities with bilirubin >2 mg/dL and elevation of transaminases higher 2x upper limit of normal.
•Chronic active viral hepatitis
•Ejection fraction <40 % on echocardiography
•Patients with > grade II hypertension by CTC criteria
•Creatinine clearance <50 ml/min
•Respiratory failure necessitating supplemental oxygen or DLCO <30%
•Allergy against murine antibodies
•HIV-Infection
•Female patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control during study treatment and for at least 12 months thereafter. (Women of childbearing potential must have a negative serum pregnancy test at study entry)
•Concurrent severe and/or uncontrolled medical disease (e.g. uncontrolled diabetes, congestive heart failure, myocardial infarction within 6 months prior to the study, unstable and uncontrolled hypertension, chronic renal disease, or active uncontrolled infection) which could compromise participation in the study
•Patients with a history of psychiatric illness or condition which could interfere with their ability to understand the requirements of the study (this includes alcoholism/drug addiction)
•Patients unwilling or unable to comply with the protocol
•Unable to give informed consent
•Enrollment in an other trial interfering with the endpoints of this study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified