Acute Myeloid LeukemiaPhase 1PRIMALNCT01455025
Study in Plerixafor and Granulocyte-colony Stimulating Factor Patients With Relapse Acute Myeloid Leukemia
A Phase 1 study testing Plerixafor granulocyte-colony stimulating factor in people with Acute Myeloid Leukemia, run by French Innovative Leukemia Organisation at 1 site in France.
Trial summary
This is a phase 1, dose escalation study of Plerixafor in combination with granulocyte-colony stimulating factor , Daunorubicin and Cytarabine in adults patients with relapsed acute myeloid leukemia . Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Plerixafor granulocyte-colony stimulating factor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2012to Aug 2015
- Phase
- Phase 1
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Acute Myeloid Leukemia in first relapse with first response duration > 9 months.
- Age between 18 and 65 years.
- Treatment with hydroxyurea or purinethol is allowed if discontinued at least 24 hours before the start of study treatment.
- White blood count less than 30 x 109/L
- Left ventricular ejection fraction more than 50% on echocardiography or multigated acquisition scan or similar radionuclide angiographic scan.
- Total bilirubin less than 1.5 x upper limit of normal= ULN or AST and ALT less than 2.5 x ULN or gammaGT less than 2.5 x ULN.
Show all 12Show fewer
- Serum creatinine less than 1.5 x ULN and/or creatinine clearance more than 50 ml/mn.
- ECOG performance status less than 2
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- Absence of pregnancy or lactation
- Affiliated to French social security system or similar
- Signed informed consent
Who cannot join
- AML evolving from MPD and/or secondary AML
- Patients treated with more than 270 mg/m2 of daunorubicin during first line therapy.
- Have any of the following within the last 9 months :
- Unstable supraventricular arrhythmia or patient with a pace-maker
- Any ventricular arrhythmia
- Congestive heart failure
Show all 29Show fewer
- Myocardial infarction, ischemia, stable coronary disease or angina pectoris
- Syncope with a known cardiovascular etiology
- Known hypersensitivity or contra-indication to drugs used in the protocol = G-CSF, daunorubicin, cytarabine or to excipients.
- Previous treatment with plerixafor.
- Previous hematopoietic stem cell transplantation = Allologous or autologous.
- White blood count more than 30 x 109/L despite treatment with hydroxyurea or purinethol.
- Treatment with chemotherapy or G-CSF within 3 months of screening.
- Uncontrolled active infection.
- Uncontrolled arrythmia
- Grade more than 3 renal dysfunction with serum creatinine more than 1.5 x ULN and/or creatinine clearance less than 50 ml/mn.
- Significant neurologic grade more than 2 or psychiatric disorder, dementia or seizures.
- Clinical symptoms suggesting active central nervous system leukemia.
- Pre-existing disorder predisposing the patient to serious or life-threatening infections = cystic fibrosis, congenital or acquired immunodeficiency, bleeding disorder or cytopenia
- Thrombocytopenia refractory to platelet transfusion
- Anticoagulant therapy
- Severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock or disseminated intravascular coagulation.
- Thrombocytopenia refractory to platelet transfusion.
- Prior total body irradiation more than 10 Gy.
- Known HIV, Hepatitis B or C positivity.
- Participation into a clinical study of an investigational agent within 14 days before study entry.
- Pregnancy or breastfeeding
- Adult patient protected by law
- Concurrent treatment with any other anti-cancer therapy except hydroxyurea
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Dose Escalation Study of Plerixafor in Combination With Induction and Consolidation Chemotherapy in Patients With Relapsed Acute Myeloid Leukemia
This is a phase 1, dose escalation study of Plerixafor in combination with granulocyte-colony stimulating factor , Daunorubicin and Cytarabine in adults patients with relapsed acute myeloid leukemia .
Read the detailed description
The Primary objective is to determine the maximal tolerated dose and Recommended Phase 2 Dose of plerixafor when used in combination with granulocyte-colony stimulating factor, Daunorubicin and Cytarabine during induction therapy Then determine the tolerability of plerixafor administered in combination with G-CSF and cytarabine during consolidation therapy.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Plerixafor granulocyte-colony stimulating factor
- Keywords
- Plerixafor granulocyte-colony stimulating factor, Chemotherapy in relapse, Acute Myeloid Leukemia
- 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.
Plerixafor granulocyte-colony stimulating factorDrug
Also called Plerixafor G CSF
Induction phase Plerixafor IV from D1 to D3 and from D8 to D10, granulocyte-colony stimulating factor IV 5 μg/kg/day from D1 to D10, Intravenous daunorubicin 60 mg/m2/day from D1 to D3 Cytarabine 500 mg/m2/day continuous infusion over 24h from D1 to D3 followed by cytarabine 2-hour bolus of 1000 mg/m2/12h from D8 to D10.
Consolidation phase Plerixafor at D1, D3 and D5, granulocyte-colony stimulating factor IV 5 μg/kg/day from D1 to D5, Cytarabine continuous infusion of 3-h bolus of 3000 mg/m2/12h D1, D3 and D5
| Study group | Role | What they receive |
|---|---|---|
| Plerixafor granulocyte-colony stimulating factor | Experimental | 4 steps of plerixafor doses from 240 to 480 microgram/kg per day concomitant with GCSF and chemotherapy 3 to 6 evaluable patients will be enrolled at each dose level in a modified 3 + 3 design. Receives: Drug: Plerixafor granulocyte-colony stimulating factor |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximal tolerated dose
4 steps of plerixafor doses from 240 to 480 microgram per kilogram per day concomitant with granulocyte-colony stimulating factor and chemotherapy Three to 6 evaluable patients will be enrolled at each dose level in a modified 3 + 3 design.
Measured: 40 days
Secondary outcomes (8)
safety and tolerability of plerixafor in combination with granulocyte-colony stimulating factor and chemotherapy
Number of Adverse Events and Serious Adverse Events :examined at each dose level by the Independent Data safety Monitoring Board
Measured: 9 months
Efficacy of plerixafor on leukemic blasts
study of the drop of leukemic blasts blood rate
Measured: 10 Days
Efficacy of combination plerixafor with granulocyte-colony stimulating factor, Daunorubicin and Cytarabine
-Minimal Residual Disease level after first consolidation
Measured: 2 months
Efficacy of combination plerixafor with granulocyte-colony stimulating factor, Daunorubicin and Cytarabine
- Time to remission
Measured: 5 weeks
Efficacy of combination plerixafor with granulocyte-colony stimulating factor, Daunorubicin and Cytarabine
-Rate of patients able to proceed to hematopoietic stel cell transplantation
Measured: 3 months
Efficacy of combination plerixafor with granulocyte-colony stimulating factor, Daunorubicin and Cytarabine
-disease free survival
Measured: 9 months
Efficacy of combination plerixafor with granulocyte-colony stimulating factor, Daunorubicin and Cytarabine
-event free survival
Measured: 9 months
Efficacy of combination plerixafor with granulocyte-colony stimulating factor, Daunorubicin and Cytarabine
overal survival
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2011 (estimated)
- Study startJan 2012
- Primary completionMar 2015
- Study completionAug 2015
Why it stopped: no recruitment on time
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Innovative Leukemia Organisation
- Sponsor type
- University, hospital or other
- Collaborators
- Acute Leukemia French Association, Genzyme, a Sanofi Company
- Responsible party
- Sponsor
- Investigators
- Xavier THOMAS, MD PD, Principal investigator, ALFADidier BOUSCARY, MD PD, Principal investigator, French Innovative Leukemia Organisation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01455025
- Sponsor's protocol ID
- Primal study
- Acronym
- PRIMAL
- Status last verified
- Aug 2015
- First submitted
- 24 Jun 2011
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Dose Escalation Study of Plerixafor in Combination With Induction and Consolidation Chemotherapy in Patients With Relapsed Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT01455025
- Acronym / sponsor ID
- PRIMAL / Primal study
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Plerixafor granulocyte-colony stimulating factor, Chemotherapy in relapse, Acute Myeloid Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: no recruitment on time
- Enrolment
- 11 participants (actual)
- Lead sponsor
- French Innovative Leukemia OrganisationUniversity, hospital or other
- Collaborators
- Acute Leukemia French Association, Genzyme, a Sanofi Company
- Study start
- Jan 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 19 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 1, dose escalation study of Plerixafor in combination with granulocyte-colony stimulating factor , Daunorubicin and Cytarabine in adults patients with relapsed acute myeloid leukemia .
Detailed description
The Primary objective is to determine the maximal tolerated dose and Recommended Phase 2 Dose of plerixafor when used in combination with granulocyte-colony stimulating factor, Daunorubicin and Cytarabine during induction therapy Then determine the tolerability of plerixafor administered in combination with G-CSF and cytarabine during consolidation therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Plerixafor granulocyte-colony stimulating factor | Experimental | Drug: Plerixafor granulocyte-colony stimulating factor4 steps of plerixafor doses from 240 to 480 microgram/kg per day concomitant with GCSF and chemotherapy 3 to 6 evaluable patients will be enrolled at each dose level in a modified 3 + 3 design. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients with Acute Myeloid Leukemia in first relapse with first response duration > 9 months.
- Age between 18 and 65 years.
- Treatment with hydroxyurea or purinethol is allowed if discontinued at least 24 hours before the start of study treatment.
- White blood count less than 30 x 109/L
- Left ventricular ejection fraction more than 50% on echocardiography or multigated acquisition scan or similar radionuclide angiographic scan.
Key exclusion criteria (29 listed)
- AML evolving from MPD and/or secondary AML
- Patients treated with more than 270 mg/m2 of daunorubicin during first line therapy.
- Have any of the following within the last 9 months :
- Unstable supraventricular arrhythmia or patient with a pace-maker
- Any ventricular arrhythmia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plerixafor granulocyte-colony stimulating factorAlso: Plerixafor G CSFInduction phase Plerixafor IV from D1 to D3 and from D8 to D10, granulocyte-colony stimulating factor IV 5 μg/kg/day from D1 to D10, Intravenous daunorubicin 60 mg/m2/day from D1 to D3 Cytarabine 500 mg/m2/day continuous infusion over 24h from D1 to D3 followed by cytarabine 2-hour bolus of 1000 mg/m2/12h from D8 to D10. Consolidation phase Plerixafor at D1, D3 and D5, granulocyte-colony stimulating factor IV 5 μg/kg/day from D1 to D5, Cytarabine continuous infusion of 3-h bolus of 3000 mg/m2/12h D1, D3 and D5 | Drug | Plerixafor granulocyte-colony stimulating factor |
Primary outcome
maximal tolerated dose
Time frame: 40 days
4 steps of plerixafor doses from 240 to 480 microgram per kilogram per day concomitant with granulocyte-colony stimulating factor and chemotherapy Three to 6 evaluable patients will be enrolled at each dose level in a modified 3 + 3 design.
8 secondary outcomes
safety and tolerability of plerixafor in combination with granulocyte-colony stimulating factor and chemotherapy
Time frame: 9 months
Efficacy of plerixafor on leukemic blasts
Time frame: 10 Days
Efficacy of combination plerixafor with granulocyte-colony stimulating factor, Daunorubicin and Cytarabine
Time frame: 2 months
Efficacy of combination plerixafor with granulocyte-colony stimulating factor, Daunorubicin and Cytarabine
Time frame: 5 weeks
Efficacy of combination plerixafor with granulocyte-colony stimulating factor, Daunorubicin and Cytarabine
Time frame: 3 months
Efficacy of combination plerixafor with granulocyte-colony stimulating factor, Daunorubicin and Cytarabine
Time frame: 9 months
Efficacy of combination plerixafor with granulocyte-colony stimulating factor, Daunorubicin and Cytarabine
Time frame: 9 months
Efficacy of combination plerixafor with granulocyte-colony stimulating factor, Daunorubicin and Cytarabine
Time frame: 9 months
Results and safety
The study was stopped early (reason given: no recruitment on time). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
- FILO websiteLink provided by the sponsor.
Related trials for Acute Myeloid Leukemia
RecruitingObservational study
A Long-term Follow-up Study of Patients With ARD103 CAR-T Cell Therapies
Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia, in Relapsed or Refractory
RecruitingPhase 2
MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
RecruitingPhase 1
225Ac-DOTA-Anti-CD38 Daratumumab Monoclonal Antibody With Fludarabine, Melphalan and Total Marrow and Lymphoid Irradiation as Conditioning Treatment for Donor Stem Cell Transplant in Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Myelodysplastic Syndrome
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingPhase 2
Testing the Addition of Venetoclax or Gemtuzumab Ozogamicin (GO) to Usual Treatment Regimen (Cytarabine and Daunorubicin, "7+3") for Core Binding Factor Acute Myeloid Leukemia (CBF-AML) to Improve Response (A MYELOMATCH Treatment Trial)
Core Binding Factor Acute Myeloid Leukemia
RecruitingPhase 1/2
Phase I/II Trial: Engineered Donor Graft (Orca Q) for Pediatric Hematopoietic Cell Transplant (HCT)
Acute Myeloid Leukemia, Acute Lymphoid Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier THOMAS, MD PD principal investigator
ALFA
Didier BOUSCARY, MD PD principal investigator
French Innovative Leukemia Organisation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Plerixafor granulocyte-colony stimulating factor in people with Acute Myeloid Leukemia, run by French Innovative Leukemia Organisation at 1 site in France.
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 12 inclusion and 29 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: stopped early, as of the sponsor's last update on 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: no recruitment on time). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maximal tolerated dose (time frame: 40 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Mar 2016.