EUCTR2010-021944-17-DE
Active, not recruiting
Phase 1
Randomized, Multi-centre, Phase II Trial to compare the Event-Free Survival of Clofarabine / Ara-C (ClAraC) or of FLAMSA Treatment in Patients with High Risk AML or Advanced MDS scheduled for Allogeneic Stem Cell Transplantation - ClAraC-SCT
ConditionsPatients with high risk acute myeloid leukemia (AML) or advanced myelodysplastic syndrome (MDS) scheduled for allogeneic stem cell transplantation (SCT).MedDRA version: 18.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.0Level: PTClassification code 10028533Term: Myelodysplastic syndromeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Patients with high risk acute myeloid leukemia (AML) or advanced myelodysplastic syndrome (MDS) scheduled for allogeneic stem cell transplantation (SCT).
- Sponsor
- Hannover Medical School
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Signed written informed consent
- •2\. Age \= 18 at the day of inclusion
- •3\. Patients with high risk AML or advanced MDS (IPSS score \= intermediate 2\) scheduled for an allogeneic SCT from HLA\-matched related or unrelated donor
- •4\.Amount of blasts \< 60% (bone marrow)
- •5\. Patients fulfilling at least one of the following risk factors:
- •Contraindication for conventional conditioning therapy
- •Relapsed or refractory to induction therapy
- •6\. 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
Exclusion Criteria
- •1\. Patients with acute promyelocytic leukemia with t(15;17\)
- •2\. Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol
- •3\. 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
- •4\. Current participation in any other clinical trial and/or participation in another clinical trial within 30 days before the trial begins (Exception: Parallel follow\-up of any other trial at least 30 days after end of intervention)
- •5\. 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 \> 5 x normal serum level), or other organ system that may place the patient at undue risk to undergo treatment
- •6\. 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)
- •7\. Human immunodeficiency virus (HIV) positivity
- •8\. Pregnant or lactating patients
- •9\. 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
Outcomes
Primary Outcomes
Not specified
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