Hematologic MalignanciesPhase 2NCT00402714
A Trial of Extracorporeal Photopheresis, Pentostatin, and Total Body Irradiation in Patients Undergoing Reduced Intensity Allogeneic Stem Cell Transplantation for the Treatment of Malignancies
A Phase 2 study testing extracorporeal photopheresis, Pentostatin and Total Body Irradiation in people with Hematologic Malignancies, run by Yale University at 3 sites in United States.
Trial summary
This is a study to explore the use of a reduced intensity transplant conditioning regimen. A conditioning regimen is the treatment that is given to prepare a body for the new bone marrow that will be received from a donor. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hematologic Malignancies
- What is being tested?
- extracorporeal photopheresis, Pentostatin and Total Body Irradiation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2006to Aug 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must give informed consent to receive study treatment.
- Availability of a suitable 5/6 (Class I mismatch) or 6/6 HLA-matched related or 10 or 10 matched unrelated donor.
- Adequate cardiac function with an ejection fraction ≥ 35% by echocardiography or nuclear cardiography within three months of transplantation
- Adequate pulmonary function with corrected DLCO ≥ 40% by pulmonary function testing within the past three months of transplantation
- Adequate renal function with creatinine clearance ≥ 30 ml/min. as calculated by the Cockroft and Gault method.
- Adequate hepatic function with AST, ALT, alkaline phosphatase, and total bilirubin no more than 3 x ULN unless related to neoplastic disease.
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- Adequate vascular access, either by pheresis flow catheter or peripheral vein intravenous catheter, to perform ECP, should the patient be randomized to ECP.
- Patients with prior autologous stem cell transplantation are eligible.
- Age 18 to 75 years.
- Life expectancy of greater than 3 months.
- ECOG performance status of 0, 1, or 2.
- Platelet counts ≥ 20,000/microliter, with or without transfusion support, at the time of ECP, should the patient be randomized to ECP.
- Weight ≥ 40 kg.
- Systolic blood pressure ≥ 90 mmHg on the day randomization occurs
- Negative pregnancy test. The effects of ECP on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Able to receive 600 cGy of total body irradiation. If patient previously treated by TBI then must be able to receive 400cGY of total body irradiation.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Hypersensitivity or allergy to 8-methoxypsoralen.
- Prior allogeneic stem cell transplantation
- HLA-DR mismatch or no worse than one antigen-mismatched unrelated donor.
- Patients with acute leukemia or acute lymphocytic leukemia with > 5% circulating blasts in peripheral blood or > 5% blasts in bone marrow aspirate and biopsy at the time of registration
- Patients with chemorefractory non-Hodgkin's lymphoma or Hodgkin's disease or multiple myeloma
- Diagnosis of myelofibrosis
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- Patients known to be positive for antibodies to HIC or have evidence for active HIC viral replication.
- Participation in another clinical trial for prevention of GVHD.
- Patient is pregnant or lactating.
- Lack adequate vascular access for ECP.
- Systolic blood pressure < 90 mmHg at the time of randomization, should the patient be randomized to ECP.
- Evidence of active, ongoing infection.
- Unwilling to comply with all study procedures.
- Unable or unwilling to give signed informed consent.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Tufts-New England Medical Center
Boston, Massachusetts, 02111
Yale Comprehensive Cancer Center at Yale University School of Medicine
New Haven, Connecticut, 06520
Methodist Hospital - Texas Transplant Institute
San Antonio, Texas, 78229
About this study
Official title: A Randomized Trial of Extracorporeal Photopheresis, Pentostatin, and Total Body Irradiation Versus Pentostatin and Total Body Irradiation in Patients Undergoing Reduced Intensity Allogeneic Stem Cell Transplantation for the Treatment of Malignancies
This is a study to explore the use of a reduced intensity transplant conditioning regimen. A conditioning regimen is the treatment that is given to prepare a body for the new bone marrow that will be received from a donor. Reduced intensity conditioning uses lower doses of chemotherapy than conventional conditioning regimens. The use of lower doses of drugs and radiation cause fewer side effects. Reduced intensity regimens have been offered to older patients or patients at increased risk for transplant-related side effects and have been shown to be safe and effective. Reduced intensity conditioning regimens are now considered for many patients who are undergoing transplant.
Read the detailed description
One of the complications of allogeneic stem cell transplant (ASCT) is graft versus host disease (GVHD). This is when the donor cells that are infused attack the body organs. This can cause serious illness and even death. The chance of getting serious life threatening GVHD with conventional transplant conditioning regimens is 25-50% depending on whether the donor bone marrow is from a family member or an unrelated person. The reduced intensity conditioning regimen used in this study involves a drug called pentostatin as well as a reduced dose of radiation and a treatment called photopheresis. This regimen has been successfully used in 106 patients. The incidence of serious GVHD in those patients was much less than expected: 8% for patients getting bone marrow from a family member and 23% for those getting bone marrow from an unrelated person. The pentostatin and radiation parts of this reduced intensity conditioning regimen are similar to other types of reduced intensity regimens, which use drugs similar to pentostatin. The unique part of this regimen compared to others is the use of extracorporeal photopheresis (ECP).
While ECP has been used in 106 patients as part of a reduced intensity conditioning regimen, it is unknown whether adding ECP to pentostatin and radiation is what caused the reduced rate of GVHD that was seen in the previous study that was done. The use of ECP as part of a conditioning regimen is investigational. ECP is approved by the U.S. Food and Drug Administration (FDA) for the treatment of cutaneous T-cell lymphoma, but is not approved by the FDA for use prior to ASCT.
Because it is not known whether the use of ECP in the reduced intensity conditioning regimen was what caused the low incidence of GVHD, this research study will look at differences in getting GVHD based on whether you receive ECP. Half the patients in this research study will receive ECP as part of their reduced intensity-conditioning regimen and the other half will not. Patients will be randomized (50% chance you will receive ECP and 50% chance you will not). Both groups will receive pentostatin and reduced dose total body irradiation. The primary purpose of this research study is to look at the chance of developing serious GVHD within the first 100 days after transplant within each group.
- Conditions
- Hematologic Malignancies
- Being tested
- extracorporeal photopheresis, Pentostatin, Total Body Irradiation
- Keywords
- Allogeneic Stem Cell Transplant
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extracorporeal photopheresisProcedure or surgery
Also called UVAR® XTS Photopheresis System, UVADEX®, 8-methoxypsoralen, methoxsalen
Extracorporeal photopheresis (ECP) is the ex vivo exposure of the leukocyte rich fraction to ultraviolet light in the presence of 8-methoxypsoralen.
PentostatinDrug
Also called DCF, 2-Deoxycoformycin, Nipent
pentostatin 8mg/m2 over 48 hours by continuous infusion
Total Body IrradiationRadiation
600cGy TBI in 3 200cGy TBI fractions
PentostatinDrug
Also called DCF, 2-Deoxycoformycin, Nipent
pentostatin 8mg/m2 over 48 hours by continuous infusion
Total Body IrradiationRadiation
600cGy TBI in 3 200cGy TBI fractions
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Extracorporeal photopheresis, pentostatin and total body irradiation Receives: Procedure: extracorporeal photopheresis; Drug: Pentostatin; Radiation: Total Body Irradiation |
| 2 | Active comparator | Pentostatin and total body irradiation Receives: Drug: Pentostatin; Radiation: Total Body Irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Grade 2-4 Acute Graft Versus Host Disease Following Allogeneic Stem Cell Transplantation in Patients Randomized to Photopheresis vs. no Photopheresis
Measured: Day +100 following allogeneic stem cell transplant
Secondary outcomes (1)
Overall Survival
Measured: 2 years following stem cell transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2006 (estimated)
- Study startJul 2006
- Primary completionJul 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hematologic MalignanciesStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Hospira, now a wholly owned subsidiary of Pfizer
- Responsible party
- Sponsor
- Investigators
- Francine Foss, M.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00402714
- Sponsor's protocol ID
- 0508000433
- Status last verified
- Nov 2016
- First submitted
- 20 Nov 2006
- Last updated
- 18 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Extracorporeal Photopheresis, Pentostatin, and Total Body Irradiation Versus Pentostatin and Total Body Irradiation in Patients Undergoing Reduced Intensity Allogeneic Stem Cell Transplantation for the Treatment of Malignancies
- ClinicalTrials.gov ID
- NCT00402714
- Acronym / sponsor ID
- 0508000433
- Conditions
- Hematologic Malignancies
- Keywords
- Allogeneic Stem Cell Transplant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Hospira, now a wholly owned subsidiary of Pfizer
- Study start
- Jul 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 22 Nov 2006 (estimated)
- Results
- Posted 18 Jan 2017
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 study to explore the use of a reduced intensity transplant conditioning regimen. A conditioning regimen is the treatment that is given to prepare a body for the new bone marrow that will be received from a donor. Reduced intensity conditioning uses lower doses of chemotherapy than conventional conditioning regimens. The use of lower doses of drugs and radiation cause fewer side effects. Reduced intensity regimens have been offered to older patients or patients at increased risk for transplant-related side effects and have been shown to be safe and effective. Reduced intensity conditioning regimens are now considered for many patients who are undergoing transplant.
Detailed description
One of the complications of allogeneic stem cell transplant (ASCT) is graft versus host disease (GVHD). This is when the donor cells that are infused attack the body organs. This can cause serious illness and even death. The chance of getting serious life threatening GVHD with conventional transplant conditioning regimens is 25-50% depending on whether the donor bone marrow is from a family member or an unrelated person. The reduced intensity conditioning regimen used in this study involves a drug called pentostatin as well as a reduced dose of radiation and a treatment called photopheresis. This regimen has been successfully used in 106 patients. The incidence of serious GVHD in those patients was much less than expected: 8% for patients getting bone marrow from a family member and 23% for those getting bone marrow from an unrelated person. The pentostatin and radiation parts of this reduced intensity conditioning regimen are similar to other types of reduced intensity regimens, which use drugs similar to pentostatin. The unique part of this regimen compared to others is the use of extracorporeal photopheresis (ECP).
While ECP has been used in 106 patients as part of a reduced intensity conditioning regimen, it is unknown whether adding ECP to pentostatin and radiation is what caused the reduced rate of GVHD that was seen in the previous study that was done. The use of ECP as part of a conditioning regimen is investigational. ECP is approved by the U.S. Food and Drug Administration (FDA) for the treatment of cutaneous T-cell lymphoma, but is not approved by the FDA for use prior to ASCT.
Because it is not known whether the use of ECP in the reduced intensity conditioning regimen was what caused the low incidence of GVHD, this research study will look at differences in getting GVHD based on whether you receive ECP. Half the patients in this research study will receive ECP as part of their reduced intensity-conditioning regimen and the other half will not. Patients will be randomized (50% chance you will receive ECP and 50% chance you will not). Both groups will receive pentostatin and reduced dose total body irradiation. The primary purpose of this research study is to look at the chance of developing serious GVHD within the first 100 days after transplant within each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: extracorporeal photopheresis, Drug: Pentostatin, Radiation: Total Body IrradiationExtracorporeal photopheresis, pentostatin and total body irradiation |
| 2 | Active comparator | Drug: Pentostatin, Radiation: Total Body IrradiationPentostatin and total body irradiation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients must give informed consent to receive study treatment.
- Availability of a suitable 5/6 (Class I mismatch) or 6/6 HLA-matched related or 10 or 10 matched unrelated donor.
- Adequate cardiac function with an ejection fraction ≥ 35% by echocardiography or nuclear cardiography within three months of transplantation
- Adequate pulmonary function with corrected DLCO ≥ 40% by pulmonary function testing within the past three months of transplantation
- Adequate renal function with creatinine clearance ≥ 30 ml/min. as calculated by the Cockroft and Gault method.
Key exclusion criteria (14 listed)
- Hypersensitivity or allergy to 8-methoxypsoralen.
- Prior allogeneic stem cell transplantation
- HLA-DR mismatch or no worse than one antigen-mismatched unrelated donor.
- Patients with acute leukemia or acute lymphocytic leukemia with > 5% circulating blasts in peripheral blood or > 5% blasts in bone marrow aspirate and biopsy at the time of registration
- Patients with chemorefractory non-Hodgkin's lymphoma or Hodgkin's disease or multiple myeloma
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 |
|---|---|---|
| extracorporeal photopheresisAlso: UVAR® XTS Photopheresis System, UVADEX®, 8-methoxypsoralen, methoxsalenExtracorporeal photopheresis (ECP) is the ex vivo exposure of the leukocyte rich fraction to ultraviolet light in the presence of 8-methoxypsoralen. | Procedure or surgery | 1 |
| PentostatinAlso: DCF, 2-Deoxycoformycin, Nipentpentostatin 8mg/m2 over 48 hours by continuous infusion | Drug | 1 |
| Total Body Irradiation600cGy TBI in 3 200cGy TBI fractions | Radiation | 1 |
| PentostatinAlso: DCF, 2-Deoxycoformycin, Nipentpentostatin 8mg/m2 over 48 hours by continuous infusion | Drug | 2 |
| Total Body Irradiation600cGy TBI in 3 200cGy TBI fractions | Radiation | 2 |
Primary outcome
Incidence of Grade 2-4 Acute Graft Versus Host Disease Following Allogeneic Stem Cell Transplantation in Patients Randomized to Photopheresis vs. no Photopheresis
Time frame: Day +100 following allogeneic stem cell transplant
1 secondary outcome
Overall Survival
Time frame: 2 years following stem cell transplant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Francine Foss, M.D. principal investigator
Yale University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing extracorporeal photopheresis, Pentostatin and Total Body Irradiation in people with Hematologic Malignancies, run by Yale University at 3 sites in United States.
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 17 inclusion and 14 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: finished, as of the sponsor's last update on 18 Jan 2017. 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 United States. 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?
Yes. Results are posted in the registry (first posted 18 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence of Grade 2-4 Acute Graft Versus Host Disease Following Allogeneic Stem Cell Transplantation in Patients Randomized to Photopheresis vs. no Photopheresis (time frame: Day +100 following allogeneic stem cell transplant). 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 18 Jan 2017.