AzTrials
AzTrials

Acute Myeloid LeukemiaPhase 2ClAraC-SCTNCT01423175

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

A Phase 2 study testing Clofarabine, ara-C and FLAMSA in people with Acute Myeloid Leukemia and MDS, run by Hannover Medical School at 3 sites in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myeloid Leukemia, MDS
What is being tested?
Clofarabine, ara-C and FLAMSA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
3 sitesGermany
Study dates
Jul 2011to Jan 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 31Show fewer
  • 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

Who cannot join

  • 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)
Show all 12Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

Stefanie Buchholz, Dr. contact

++49-511-532-9601

buchholz.stefanie@mh-hannover.de

Germany3 sites, 3 recruiting

  • Hannover Medical School

    Hanover, 30625

    Arnold Ganser, Prof. Dr., ++49-511-532-3020, ganser.arnold@mh-hannover.de

    Recruiting

  • Universitaetsklinikum des Saarlandes

    Homburg/Saar, 66421

    Michael Pfreundschuh, Prof. Dr., ++49-6841-16-23002, pfreundschuh@unikliniksaarland.de

    Not yet recruiting

  • Universitaetsklinikum Leipzig AoeR

    Leipzig, 04103

    Dietger Niederwieser, Prof. Dr., ++49-341-0713050, dietger.niederwieser@medizin.uni-leipzig.de

    Not yet recruiting

Other trials in Germany

About this study

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

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).

Being tested
Clofarabine, ara-C, FLAMSA
Keywords
high risk acute myeloid leukemia, advanced myelodysplastic syndrome, allogenic stem cell transplantation, clofarabine
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Clofarabine, ara-CDrug

  • FLAMSADrug

Study groups in NCT01423175
Study groupRoleWhat they receive
ClAraCExperimentalNot described
Receives: Drug: Clofarabine, ara-C
FLAMSAActive comparatorNot described
Receives: Drug: FLAMSA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event-free survival

Secondary outcomes (6)

  1. Overall survival

  2. Morbidity after allogeneic SCT with focus on cardiac toxicity

  3. Rate of engraftment

  4. Kinetics of chimerism after allogeneic SCT

  5. Relapse-free survival

  6. Mortality after allogeneic SCT with focus on cardiac toxicity

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2011 (estimated)
  2. Study startJul 2011
  3. Primary completionJan 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01423175
Sponsor's protocol ID
ClAraC-SCT-01
Acronym
ClAraC-SCT
Status last verified
Aug 2011
First submitted
24 Aug 2011
Last updated
29 Aug 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Clofarabine, ara-C and FLAMSA in people with Acute Myeloid Leukemia and MDS, run by Hannover Medical School at 3 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 31 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Stefanie Buchholz, Dr. (++49-511-532-9601, buchholz.stefanie@mh-hannover.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event-free survival. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01423175.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2011.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in