ClAraC or FLAMSA Followed by Stem Cell Transplantation to Treat High Risk AML or Advanced MDS (ClAraC-SCT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2011 by Hannover Medical School
Sponsor:
Collaborators:
Hannover Clinical Trial Center GmbH
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
A. Ganser, Hannover Medical School
ClinicalTrials.gov Identifier:
NCT01423175
First received: August 24, 2011
Last updated: August 26, 2011
Last verified: August 2011
  Purpose

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).


Condition Intervention Phase
Acute Myeloid Leukemia
MDS
Drug: Clofarabine, ara-C
Drug: FLAMSA
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Hannover Medical School:

Primary Outcome Measures:
  • Event-free survival

Secondary Outcome Measures:
  • Overall survival
  • Morbidity after allogeneic SCT with focus on cardiac toxicity
  • Rate of engraftment
  • Kinetics of chimerism after allogeneic SCT
  • Relapse-free survival
  • Mortality after allogeneic SCT with focus on cardiac toxicity

Estimated Enrollment: 60
Study Start Date: July 2011
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ClAraC Drug: Clofarabine, ara-C
Active Comparator: FLAMSA Drug: FLAMSA

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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. Patients fulfilling at least one of the following risk factors:

    • Contraindication for conventional conditioning therapy
    • Relapsed or refractory to induction therapy
  5. 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 %
  6. Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent
  7. Female patients of childbearing potential must have a negative serum pregnancy test at the day of inclusion
  8. 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
  9. 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 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
  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 > 2.5 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
  10. 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01423175

Contacts
Contact: Stefanie Buchholz, Dr. ++49-511-532-9601 buchholz.stefanie@mh-hannover.de

Locations
Germany
Hannover Medical School Recruiting
Hannover, Germany, 30625
Contact: Arnold Ganser, Prof. Dr.    ++49-511-532-3020    ganser.arnold@mh-hannover.de   
Universitaetsklinikum des Saarlandes Not yet recruiting
Homburg/Saar, Germany, 66421
Contact: Michael Pfreundschuh, Prof. Dr.    ++49-6841-16-23002    pfreundschuh@unikliniksaarland.de   
Universitaetsklinikum Leipzig AoeR Not yet recruiting
Leipzig, Germany, 04103
Contact: Dietger Niederwieser, Prof. Dr.    ++49-341-0713050    dietger.niederwieser@medizin.uni-leipzig.de   
Sponsors and Collaborators
Hannover Medical School
Hannover Clinical Trial Center GmbH
Genzyme, a Sanofi Company
Investigators
Principal Investigator: Arnold Ganser, Prof. Dr. Hannover Medical School
  More Information

No publications provided

Responsible Party: A. Ganser, Director of the Department of Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Hannover Medical School
ClinicalTrials.gov Identifier: NCT01423175     History of Changes
Other Study ID Numbers: ClAraC-SCT-01
Study First Received: August 24, 2011
Last Updated: August 26, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Hannover Medical School:
high risk acute myeloid leukemia
advanced myelodysplastic syndrome
allogenic stem cell transplantation
clofarabine

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms
Neoplasms by Histologic Type
Clofarabine
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014