Status:
UNKNOWN
ClAraC or FLAMSA Followed by Stem Cell Transplantation to Treat High Risk AML or Advanced MDS
Lead Sponsor:
Hannover Medical School
Collaborating Sponsors:
Genzyme, a Sanofi Company
Conditions:
Acute Myeloid Leukemia
MDS
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
ClAraC (consisting of one dose of clofarabine and ara-C for five days) or FLAMSA (consisting of one dose of fudarabine, amsacrine and ara-C for four days) will be administered followed by reduced-inte...
Eligibility Criteria
Inclusion
- Signed written informed consent
- Age \> 18 at the day of inclusion
- Patients with high risk AML or advanced MDS (IPSS score ≥ intermediate 2) scheduled for an allogeneic SCT from HLA-matched related or unrelated donor
- Patients fulfilling at least one of the following risk factors:
- Contraindication for conventional conditioning therapy
- Relapsed or refractory to induction therapy
- Adequate renal, hepatic and cardiac functions as indicated by the following values:
- Serum creatinine ≤ 1.0 mg/dL; if serum creatinine \> 1.0 mg/dL, then the estimated glomerular filtration rate (GFR) must be \> 60 mL/min/1.73 m2
- Serum bilirubin ≤ 1.5 x upper limit of normal (ULN)
- Aspartate transaminase (AST) / alanine transaminase ALT) ≤ 2.5 x ULN
- Alkaline phosphatase ≤ 2.5 x ULN
- Left ventricular ejection fraction ≥ 50 %
- Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent
- Female patients of childbearing potential must have a negative serum pregnancy test at the day of inclusion
- Female patients must meet one of the following criteria:
- For female patients ≥ 50 years of age at the day of inclusion: Menopause since at least 1 year
- Female patients \< 50 years of age at the day of inclusion who meet all of the following criteria:
- menopause since at least 1 year
- serum FSH levels \> 40 MIU/mL
- serum estrogen levels \< 30 pg/mL or negative estrogen test
- 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral ovariectomy with or without hysterectomy
- Correct use of two reliable contraception methods from the time of screening and during the study for a minimum of 90 days after the last administration of study medication. This includes every combination of a hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring) or of an intrauterine device (IUD) with a barrier method (diaphragm, cervical cap, Lea contraceptive, femidom or condom) or with a spermicide. In case the patient takes hormone preparations for suppression of menstruation during the period of aplasia, a suitable and effective method of contraception has to be discussed with the investigator and used by the patient
- General sexual abstinence from the time of screening, during the study until a minimum of 90 days after the last administration of study medication
- Having only female sexual partners
- Monogamous relationship with sterile male partner
- Male patients must meet one of the following criteria:
- 6 weeks after surgical sterilization by vasectomy
- Correct use of two reliable contraception methods from the time of screening and during the study for a minimum of 90 days after the last administration of study medication. This includes every combination of a hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring) or of an intrauterine device (IUD) with a barrier method (diaphragm, cervical cap, Lea contraceptive, femidom or condom) or with a spermicide.
- General sexual abstinence from the time of screening, during the study until a minimum of 90 days after the last administration of study medication
- Having only male sexual partners
- Monogamous relationship with sterile female partner
Exclusion
- Patients with acute promyelocytic leukemia with t(15;17)
- Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol
- Any anticancer therapy within 2 weeks before study entry with the exception of hydroxyurea. The patient must have recovered from all acute toxicities from any previous therapy
- Current participation in any other clinical trial and/or participation in another clinical trial within 30 days before the trial begins
- Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart (heart insufficiency ≥ NYHA II), kidney (serum creatinine \> 1.5 x normal serum level), liver (bilirubin \> 1.5 x normal serum level, AST / ALT, AP \> 2.5 x normal serum level), or other organ system that may place the patient at undue risk to undergo treatment
- Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
- Human immunodeficiency virus (HIV) positivity
- Pregnant or lactating patients
- Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results
- Have had a diagnosis of another malignancy, unless the patient has been disease-free for at least 3 years following the completion of curative intent therapy, with the following exceptions:
- Patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed
- Patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen (PSA) values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01423175
Start Date
July 1 2011
Last Update
August 29 2011
Active Locations (3)
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1
Hannover Medical School
Hanover, Germany, 30625
2
Universitaetsklinikum des Saarlandes
Homburg/Saar, Germany, 66421
3
Universitaetsklinikum Leipzig AoeR
Leipzig, Germany, 04103