Hematological MalignanciesPhase 1/2ECPNCT00930566
Extracorporal Photopheresis Pilot Study
A Phase 1/2 study testing methoxsalen and Extracoporal Photopheresis (ECP) in people with Hematological Malignancies, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
ECP will be given to the patients [UVAR®XTS TM Therakos system, Johnson \& Johnson] according to the following schedule: Starting at day 21 after transplant, if hematologic recovery allowed it: 2 ECP per week the first 2 weeks, and 1 ECP per week during 1 month. Total = 8 ECP after transplantation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hematological Malignancies
- What is being tested?
- methoxsalen and Extracoporal Photopheresis (ECP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesFrance
- Study dates
- Apr 2009to Sep 2015
- Phase
- Phase 1/2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years and < or = 65 years with an hematological malignancy indicated for an allogeneic transplantation after reduced intensity conditioning :
- due to the age : for patients between 55 and 65 years.
- or for patients between 18 and 55 years of age presenting a risk of increased toxicity for myeloablative conditioning (cardiac, renal or pulmonary pathology)
- CML and MPS in blastic phase achieving CR,
- MM stage II or III, relapse after autologous transplant, achieving a response ≥ 30% or on first line if high risk,
- NHL in 2nd CR, PR after chemotherapy or autologous transplant, chemo-sensible.
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- CLL in 2nd CR, PR after chemotherapy or autologous transplant, chemo-sensible.
- AML in 2nd CR or in first line for high risk criteria, secondary AML. In AML, high risk criteria are defined by : LAM 7, leukocytes>30000/mm3, cytogenetic abnormalities: t(6,9); 11q23, 17p, 11q, 20q, 21q, -5, del(5q), -7/del7q, del 9q and inv 3q,
- ALL in 2nd CR or in first line for high risk criteria defined by cytogenetic abnormalities: 11q23, t(9,22); t(1,19); t(4,11).
- MDS patients without prior chemotherapy
- HLA identical sibling donor
- Performans status < or = 2
- Patients member of a social security company
Who cannot join
- Age < 18 years or > 65 years
- Pregnant or lactating females
- Known HIV positivity
- Active infectious hepatitis, type A, B or C
- Performance status > 2 according to WHO
- Left ventricular ejection fraction < 40% and Alveolus-capillary diffusion < 50%
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- Uncontrollable hypertension with medical therapy
- Creatinine clearance < 60 ml/min
- Hypersensitivity or allergy to psoralen (methoxsalen)
- Disease associated with a photosensitivity
- Hypersensitivity or allergy to both heparin and citrate products
- Contra-indication to Busulfan, Fludarabine, SAT or methotrexate
- Hypersensitivity to ciclosporine, mycophenolate mofetil or mycophenolic acid
Trial locations and contacts
2 sites in 1 country.
France2 sites, 1 recruiting
- Active, not recruiting
Centre de Santé - Etablissement Français du Sang (EFS)
Lyon, 69003
- Recruiting
Hôpital Edouard Herriot, Service d'Hématologie
Lyon, 69003
Aline Praire, +33472117396, aline.praire@chu-lyon.fr
Mauricette Michallet, Professor
About this study
Official title: Allogenic Hematopoietic Stem Cell Transplantation (HSCT) From a Genoidentical Donor After a Reduced Intensity Conditioning Transplantation (RICT) Followed by an Early Preventive Treatment (Day 21) With Extracorporal Photopheresis After Transplantation.
ECP will be given to the patients [UVAR®XTS TM Therakos system, Johnson \& Johnson] according to the following schedule:
Starting at day 21 after transplant, if hematologic recovery allowed it: 2 ECP per week the first 2 weeks, and 1 ECP per week during 1 month.
Total = 8 ECP after transplantation.
- Conditions
- Hematological Malignancies
- Being tested
- methoxsalen, Extracoporal Photopheresis (ECP)
- Keywords
- Allogeneic Hematopoietic Stem Cell Transplantation, Extracorporeal Photopheresis
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methoxsalenDrug
Also called UVADEX®
UVADEX® is supplied in a 10 mL single-use vial. Each mL of solution contains 20 mcg of UVADEX®.
In the ECP process, UVADEX® will be injected directly into the Recirculation Bag of the extracorporal circuit after completion of the buffy coat collection, just prior to pressing the photoactivation button. The dose of UVADEX used to inoculate these cells will be calculated based on the treatment volume collected during the plasma/buffy coat collection process, usinge the following formula :
Treatment Volume in mL x 0.017 = Dose of UVADEX® (in mLs) required for administration into the recirculation bag.
After the cells are inoculated with UVADEX, the buffy coat/plasma suspension is irradiated with ultraviolet-A light and then reinfused back into the patient.
Extracoporal Photopheresis (ECP)Procedure or surgery
Also called ECP kits : UVAR®XTS™
In the ECP process, UVADEX® will be injected directly into the Recirculation Bag of the extracorporeal circuit after completion of the buffy coat collection, just prior to pressing the photoactivation button.
After the cells are inoculated with UVADEX, the buffy coat/plasma suspension is irradiated with ultraviolet-A light and then reinfused back into the patient.
| Study group | Role | What they receive |
|---|---|---|
| Extracorporal Photopheresis | Experimental | Not described Receives: Drug: methoxsalen; Procedure: Extracoporal Photopheresis (ECP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the toxicity at Day 100 (NCI/NIH Common Toxicity Criteria) of Extracorporal Photopheresis (ECP) administered for Graft-versus-host-disease (GVHD) prophylaxis and introduced early (Day 21) after an HSCT from a genoidentical donor.
All types of toxicity will be assessed and graded according to NCI/NIH Common Toxicity Criteria
Measured: Day 100
Secondary outcomes (9)
Efficacy: decrease in incidence of acute GVHD and chronic GVHD
Measured: during 2 years
Incidence of Infection (clinically et/or bacteriologically proved)
Measured: during 2 years
Documentation of chimerism [quantification of donor-type chimerism in bone marrow and/ or in peripheral blood (total blood, CD3+)]
Measured: during 2 years
Transplant-related Mortality
TRM at 3 months for acute GVHD and at 1 year for chronic GVHD
Measured: at 3 months and 1 year
Toxicity at Day 180 after HSC transplantation
Measured: Day 180
Disease-free survival (DFS)
Measured: at 1 and 2 years
progression-free survival (PFS)
Measured: at 1 and 2 years
Overall survival (OS)
Measured: at 1 and 2 years
cumulative incidence of relapse
Measured: at 1 and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2009 (estimated)
- Study startApr 2009
- Primary completionSep 2011
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematological MalignanciesStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mauricette Michallet, Professor, Principal investigator, Hospices Civils de LyonOlivier Hequet, MD, Principal investigator, Etablissement Français du Sang
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00930566
- Sponsor's protocol ID
- 2006.409
- Acronym
- ECP
- Status last verified
- Apr 2013
- First submitted
- 29 Jun 2009
- Last updated
- 24 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogenic Hematopoietic Stem Cell Transplantation (HSCT) From a Genoidentical Donor After a Reduced Intensity Conditioning Transplantation (RICT) Followed by an Early Preventive Treatment (Day 21) With Extracorporal Photopheresis After Transplantation.
- ClinicalTrials.gov ID
- NCT00930566
- Acronym / sponsor ID
- ECP / 2006.409
- Conditions
- Hematological Malignancies
- Keywords
- Allogeneic Hematopoietic Stem Cell Transplantation, Extracorporeal Photopheresis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2015 (estimated)
- First posted
- 30 Jun 2009 (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.
ECP will be given to the patients [UVAR®XTS TM Therakos system, Johnson \& Johnson] according to the following schedule:
Starting at day 21 after transplant, if hematologic recovery allowed it: 2 ECP per week the first 2 weeks, and 1 ECP per week during 1 month.
Total = 8 ECP after transplantation.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extracorporal Photopheresis | Experimental | Drug: methoxsalen, Procedure: Extracoporal Photopheresis (ECP) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients ≥ 18 years and < or = 65 years with an hematological malignancy indicated for an allogeneic transplantation after reduced intensity conditioning :
- due to the age : for patients between 55 and 65 years.
- or for patients between 18 and 55 years of age presenting a risk of increased toxicity for myeloablative conditioning (cardiac, renal or pulmonary pathology)
- CML and MPS in blastic phase achieving CR,
- MM stage II or III, relapse after autologous transplant, achieving a response ≥ 30% or on first line if high risk,
Key exclusion criteria (13 listed)
- Age < 18 years or > 65 years
- Pregnant or lactating females
- Known HIV positivity
- Active infectious hepatitis, type A, B or C
- Performance status > 2 according to WHO
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 |
|---|---|---|
| methoxsalenAlso: UVADEX®UVADEX® is supplied in a 10 mL single-use vial. Each mL of solution contains 20 mcg of UVADEX®. In the ECP process, UVADEX® will be injected directly into the Recirculation Bag of the extracorporal circuit after completion of the buffy coat collection, just prior to pressing the photoactivation button. The dose of UVADEX used to inoculate these cells will be calculated based on the treatment volume collected during the plasma/buffy coat collection process, usinge the following formula : Treatment Volume in mL x 0.017 = Dose of UVADEX® (in mLs) required for administration into the recirculation bag. After the cells are inoculated with UVADEX, the buffy coat/plasma suspension is irradiated with ultraviolet-A light and then reinfused back into the patient. | Drug | Extracorporal Photopheresis |
| Extracoporal Photopheresis (ECP)Also: ECP kits : UVAR®XTS™In the ECP process, UVADEX® will be injected directly into the Recirculation Bag of the extracorporeal circuit after completion of the buffy coat collection, just prior to pressing the photoactivation button. After the cells are inoculated with UVADEX, the buffy coat/plasma suspension is irradiated with ultraviolet-A light and then reinfused back into the patient. | Procedure or surgery | Extracorporal Photopheresis |
Primary outcome
Evaluation of the toxicity at Day 100 (NCI/NIH Common Toxicity Criteria) of Extracorporal Photopheresis (ECP) administered for Graft-versus-host-disease (GVHD) prophylaxis and introduced early (Day 21) after an HSCT from a genoidentical donor.
Time frame: Day 100
All types of toxicity will be assessed and graded according to NCI/NIH Common Toxicity Criteria
9 secondary outcomes
Efficacy: decrease in incidence of acute GVHD and chronic GVHD
Time frame: during 2 years
Incidence of Infection (clinically et/or bacteriologically proved)
Time frame: during 2 years
Documentation of chimerism [quantification of donor-type chimerism in bone marrow and/ or in peripheral blood (total blood, CD3+)]
Time frame: during 2 years
Transplant-related Mortality
Time frame: at 3 months and 1 year
Toxicity at Day 180 after HSC transplantation
Time frame: Day 180
Disease-free survival (DFS)
Time frame: at 1 and 2 years
progression-free survival (PFS)
Time frame: at 1 and 2 years
Overall survival (OS)
Time frame: at 1 and 2 years
cumulative incidence of relapse
Time frame: at 1 and 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2013.
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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.
Mauricette Michallet, Professor principal investigator
Hospices Civils de Lyon
Olivier Hequet, MD principal investigator
Etablissement Français du Sang
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing methoxsalen and Extracoporal Photopheresis (ECP) in people with Hematological Malignancies, run by Hospices Civils de Lyon at 2 sites 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 13 inclusion and 13 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 24 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 combined 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.
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 Mauricette Michallet, Professor (+33472117402, mauricette.michallet@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the toxicity at Day 100 (NCI/NIH Common Toxicity Criteria) of Extracorporal Photopheresis (ECP) administered for Graft-versus-host-disease (GVHD) prophylaxis and introduced early (Day 21) after an HSCT from a genoidentical donor. (time frame: Day 100). 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 24 Apr 2013.