ClAraC or FLAMSA Followed by Stem Cell Transplantation to Treat High Risk AML or Advanced MDS

NCT01423175 | Unknown Phase 2

• 1 other identifier: ClAraC-SCT-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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-intensity conditioning regimen (RIC) in the setting of allogeneic stem cell transplantation (SCT). The aim of the study is to explore the antileukemic, immunosuppressive effects and toxicity and safety of clofarabine in combination with ara-C in the setting of RIC allogeneic transplantation compared with the FLAMSA-protocol for patients with high-risk acute myeloid leukemia (AML) or advanced myelodysplastic syndrome (MDS).

Conditions

Acute Myeloid Leukemia; MDS

Keywords

high risk acute myeloid leukemia; advanced myelodysplastic syndrome; allogenic stem cell transplantation; clofarabine

Outcome Measures

Primary Outcomes (1)

• Event-free survival

Secondary Outcomes (6)

• Overall survival

• Morbidity after allogeneic SCT with focus on cardiac toxicity

• Rate of engraftment

• Kinetics of chimerism after allogeneic SCT

• Relapse-free survival

Study Arms (2)

ClAraC

EXPERIMENTAL

Drug: Clofarabine, ara-C

FLAMSA

ACTIVE COMPARATOR

Drug: FLAMSA

Interventions

Clofarabine, ara-C DRUG

ClAraC

FLAMSA DRUG

FLAMSA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent
• 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 must meet one of the following criteria:
• menopause since at least 1 year
• serum FSH levels \> 40 MIU/mL

You may not qualify if:

• 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

Sponsors & Collaborators

• Hannover Medical School: lead
• Genzyme, a Sanofi Company: collaborator

Study Sites (3)

Hannover Medical School

Hanover, 30625, Germany

RECRUITING

Universitaetsklinikum des Saarlandes

Homburg/Saar, 66421, Germany

NOT YET RECRUITING

Universitaetsklinikum Leipzig AoeR

Leipzig, 04103, Germany

NOT YET RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Clofarabine; Cytarabine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Adenine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Nucleotides; Ribonucleotides; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Arnold Ganser, Prof. Dr.

  Hannover Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefanie Buchholz, Dr.

CONTACT

++49-511-532-9601; buchholz.stefanie@mh-hannover.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Hematology, Hemostasis, Oncology and Stem Cell Transplantation

Study Record Dates

• First Submitted: August 24, 2011
• First Posted: August 25, 2011
• Study Start: July 1, 2011
• Primary Completion: January 1, 2015
• Last Updated: August 29, 2011

Record last verified: 2011-08

Locations

DE (3)