Treosulfan-TMI Conditioning and Rapamycin GvHD Prophylaxis Before Allo-HSCT
NCT ID: NCT03963024
Last Updated: 2020-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
9 participants
INTERVENTIONAL
2014-02-12
2019-01-31
Brief Summary
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The aim is to determine the maximum tolerated dose of TMI when combined with conditioning chemotherapy to transplant according to TrRaMM schedule.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single Arm Treatment
Conditioning treatment "Treosulfan+TMI"; SCT; GvHD prophylaxis;
Conditioning treatment "Treosulfan-TMI"
Treosulfan i.v.: 14 g/m²/d (day -6 to -4) Fludarabine i.v.: 30 mg/m²/d (day -6 to -2) Antithymocyte globulin (ATG)-Fresenius i.v.: 5/0 mg/kg (day -4 to -2) Mabthera i.v.: 200/0\* mg/m2 (day -1) TMI: (10 Gy) 2 Gy bis in die (BID) (day -2 to -1) or TMI: (12 Gy) 2 Gy BID (day -3 to -1) or TMI: (14 Gy) 2 Gy BID (day -3 to -1)
SCT
Stem Cell Transplant
GvHD prophylaxis
Rapamycin p.o.: 4 mg/d, (target 8-15 ng/ml) (starting day -7) Mycofenolate mofetile: 10 mg/kg tid, (Maximum dose 720 mg/tid) (starting from day 0)
Interventions
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Conditioning treatment "Treosulfan-TMI"
Treosulfan i.v.: 14 g/m²/d (day -6 to -4) Fludarabine i.v.: 30 mg/m²/d (day -6 to -2) Antithymocyte globulin (ATG)-Fresenius i.v.: 5/0 mg/kg (day -4 to -2) Mabthera i.v.: 200/0\* mg/m2 (day -1) TMI: (10 Gy) 2 Gy bis in die (BID) (day -2 to -1) or TMI: (12 Gy) 2 Gy BID (day -3 to -1) or TMI: (14 Gy) 2 Gy BID (day -3 to -1)
SCT
Stem Cell Transplant
GvHD prophylaxis
Rapamycin p.o.: 4 mg/d, (target 8-15 ng/ml) (starting day -7) Mycofenolate mofetile: 10 mg/kg tid, (Maximum dose 720 mg/tid) (starting from day 0)
Eligibility Criteria
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Inclusion Criteria
* any acute myeloid leukemia (AML) beyond Complete Remission (CR) 1
* any acute lymphoblastic leukemia (ALL) beyond CR1
* multiple myeloma (MM) at any relapse/progression, except refractory disease
* MM with unfavourable cytogenetic profile at diagnosis
* MM with less than a partial response (PR) after induction therapy
* Karnofsky Index ≥ 80 %
* Adequate contraception in female patients of child-bearing potential.
* Written informed consent
* Availability of one of the following:
* A matched related or unrelated donor (MRD or MUD)
Exclusion Criteria
* Active non-controlled infectious disease at the moment of inclusion
* Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
* Impaired liver function (Bilirubin \> 2.0 x upper normal limit; Transaminases \> 3.0 x upper normal limit)
* Impaired renal function (Creatinine-clearance \< 60 ml/min; Serum Creatinine \> 1.5 x upper normal limit).
* Pleural effusion or ascites \> 1.0 L
* Pregnancy or lactation
* Known hypersensitivity to treosulfan and/or fludarabine and/or rapamycin
* Non-co-operative behaviour or non-compliance
* Psychiatric diseases or conditions that might impair the ability to give informed consent
* Previous spinal cord radiotherapy with dose ≥ 45 Gy equivalent
18 Years
70 Years
ALL
No
Sponsors
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IRCCS San Raffaele
OTHER
Responsible Party
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Ciceri Fabio
Professor
Locations
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Ospedale San Raffaele
Milan, Lombardy, Italy
Countries
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Other Identifiers
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2013-002479-16
Identifier Type: -
Identifier Source: org_study_id
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