LymphomaPhase 2NCT00057954
Reduced-Intensity Regimen Before Allogeneic Transplant for Patients With Relapsed Non-Hodgkin's or Hodgkin's Lymphoma
A Phase 2 study testing Extracorporeal Photopheresis, Pentostatin and Total body irradiation (TBI) in people with Lymphoma, run by Eastern Cooperative Oncology Group at 19 sites in United States.
Trial summary
RATIONALE: Photopheresis allows patient white blood cells to be treated with ultraviolet (UV) light and drugs outside the body to inactivate T cells. Pentostatin may suppress the immune system and reduce the chance of developing graft-versus-host disease (GVHD) following bone marrow transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- Extracorporeal Photopheresis, Pentostatin and Total body irradiation (TBI)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 19 sitesUnited States
- Study dates
- 9 Nov 2005to May 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-Hodgkin's or Hodgkin's lymphoma that has relapsed following either a course of high dose chemotherapy or autologous stem cell transplantation.
- >= 90 days from prior transplant.
- Have a suitable human leukocyte antigen (HLA)-matched related bone marrow donor or a compatible matched unrelated bone marrow donor by molecular typing at HLA A, B, C, D, DR.
- Physically and psychologically capable of undergoing bone marrow transplantation and its attendant period of strict isolation.
- Age >= 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Show all 11Show fewer
- Be able to receive 400 cGy Total Body Irradiation (TBI).
- Pulmonary function tests: Diffusing capacity or Transfer factor of the lung for carbon monoxide (DLCO) >= 50% predicted, the forced expiratory volume in 1 second (FEV1) >= 50% predicted.
- Left ventricular ejection fraction (LVEF) at least 45% by Multi Gated Acquisition Scan (MUGA) or echocardiogram.
- Renal function: creatinine clearance > 50 ml/min.
- Liver function tests: < 3 x Upper Limit of Normal (ULN). Liver function test include serum glutamic oxaloacetic transaminase (SGOT) (Aspartate transaminase (AST)), Serum Glutamic Pyruvate Transaminase (SGPT) (Alanine transaminase (ALT)), and bilirubin.
Who cannot join
- Human immunodeficiency virus positive (HIV+) patients (test positive for P21 antibodies to HIV).
- Evidence of active infection (have received parenteral antibiotics <= 2 weeks prior to registration).
- Pregnant or breast-feeding women.
- Curable with any other therapeutic interventions.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Aurora Presbyterian Hospital
Aurora, Colorado, 80012
Tufts-NEMC Cancer Center
Boston, Massachusetts, 02111
Boulder Community Hospital
Boulder, Colorado, 80301-9019
Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, 80933
Porter Adventist Hospital
Denver, Colorado, 80210
Presbyterian - St. Luke's Medical Center
Denver, Colorado, 80218
St. Joseph Hospital
Denver, Colorado, 80218
Rose Medical Center
Denver, Colorado, 80220
CCOP - Colorado Cancer Research Program
Denver, Colorado, 80224-2522
Swedish Medical Center
Englewood, Colorado, 80110
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
Grand Junction, Colorado, 81502
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224
Sky Ridge Medical Center
Lone Tree, Colorado, 80124
Hope Cancer Care Center at Longmont United Hospital
Longmont, Colorado, 80502
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903
St. Mary - Corwin Regional Medical Center
Pueblo, Colorado, 81004
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
North Suburban Medical Center
Thornton, Colorado, 80229
About this study
Official title: A Phase II Study of Reduced Intensity Allogeneic Bone Marrow Transplantation for the Treatment of Relapsed Non-Hodgkin and Hodgkin Lymphoma
RATIONALE: Photopheresis allows patient white blood cells to be treated with ultraviolet (UV) light and drugs outside the body to inactivate T cells. Pentostatin may suppress the immune system and reduce the chance of developing graft-versus-host disease (GVHD) following bone marrow transplantation. Combining photopheresis with pentostatin and total-body irradiation may be effective in killing cancer cells before bone marrow transplantation.
PURPOSE: This phase II trial is studying how well giving photophoresis together with pentostatin and total-body irradiation as a reduced-intensity regimen before allogeneic bone marrow transplantation works in treating patients with relapsed non-Hodgkin's or Hodgkin's lymphoma.
Read the detailed description
OBJECTIVES:
- Determine the rate of stable engraftment of donor cells in patients with relapsed non-Hodgkin's or Hodgkin's lymphoma treated with a reduced toxicity conditioning regimen followed by allogeneic (sibling or unrelated) bone marrow transplantation.
- Determine the extent and duration of acute and chronic graft-versus-host disease in patients treated with this regimen.
- Determine the 100-day overall survival and long-term progression-free survival of patients treated with this regimen.
- Evaluate the feasibility of collection of molecular chimerism studies at baseline, days 30, 100, 6 months and one and two years and at relapse.
OUTLINE: This is a multicenter study.
- Conditioning regimen: Patients undergo extracorporeal photopheresis using methoxsalen and UV light on 2 consecutive days between days -7 to -4. Patients receive pentostatin intravenously (IV) continuously on days -3 to -2 and undergo total body irradiation on day -1.
- Allogeneic bone marrow transplantation: Patients undergo infusion of allogeneic bone marrow or stem cells on day 0.
- Graft-versus-host disease prophylaxis: Patients receive oral or IV cyclosporine beginning on day -1 and continuing until 6 months after transplantation, oral mycofenolate mofetil beginning on day 100 and continuing for 1 year, and methotrexate IV on days 1 and 3.
Patients are followed at day 100, every 3 months for 1 year, every 6 months for 2 years, and then annually for 2 years.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 1.8 years.
- Conditions
- Lymphoma
- Being tested
- Extracorporeal Photopheresis, Pentostatin, Total body irradiation (TBI), Allogeneic bone marrow transplantation, Cyclosporin (CSA)
- Keywords
- recurrent adult Hodgkin lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult Burkitt lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent mantle cell lymphoma, recurrent mycosis fungoides/Sezary syndrome, recurrent adult T-cell leukemia/lymphoma, anaplastic large cell lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma
- Medical subject headings
- Lymphoma, Hodgkin Disease, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Burkitt Lymphoma, Lymphoma, Large-Cell, Immunoblastic, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Follicular
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 extracorporeal photochemotherapy
Day -7 to -4: Extracorporeal Photopheresis may be given as an outpatient therapy on two consecutive days any time between days -7 to -4. This must be performed on UVAR or XTS photopheresis machines (Therakos, Inc.) according to standard procedure as per manufacturer's guidelines.
PentostatinDrug
Also called DCF,, 2-Deoxycoformycin,, Nipent
Day -3, -2: Pentostatin 4 mg/m²/d by continuous IV infusion (Total dose = 8 mg/m²)
Total body irradiation (TBI)Radiation
Also called radiation therapy
Day -1: TBI 400 cGy total dose given in two 200cGy doses. Patients who have received TBI for a previous transplant or radiation as part of previous treatment for a lymphoid malignancy will receive only 200 cGy in 1 dose.
Allogeneic bone marrow transplantationProcedure or surgery
Also called allogeneic stem cell transplantation
Day 0: Infusion of unmanipulated allogeneic bone marrow or stem cells. Minimum cell dose of 2 x 106 CD34 cells/kg recipient and no more than 10 x 10^6 CD34/kg
Cyclosporin (CSA)Drug
Also called Sandimmune,, cyclosporin A,, CSA,, Neoral,
Cyclosporin A or tacrolimus will be administered according to institutional GVHD prophylaxis protocols. Therapeutic levels will be maintained and patients will be switched to oral agents when they can tolerate
Mycophenolate mofetil (MMF)Drug
Also called Cellcept,, mycophenolic acid,, Lilly-68618,, RS-61443,
At day 100 MMF will be introduced at a dose of 250 mg po BID and cyclosporine or tacrolimus will be tapered according to the discretion of the investigator. The dosage will be escalated to a maximum of 2 g/d at the discretion of the attending physician and will be tapered and discontinued at 12 months if there is no active cGVHD. Doses should be given on an empty stomach
Methotrexate (MTX)Drug
Also called Methotrexate sodium,, MTX,, Mexate,, Mexate-AQ,
The dose of Methotrexate is based on the corrected ideal body weight for patients with > 33% above ideal weight.
Day +1 MTX 15 mg/m² IV push; Day +3 MTX 10 mg/m² IV push (May be omitted if patient develops mouth sores.)
| Study group | Role | What they receive |
|---|---|---|
| Transplant | Experimental | Reduced toxicity conditioning regimen followed by allogeneic sibling or unrelated transplant. The conditioning regimen includes Extracorporeal Photopheresis, Pentostatin and total body irradiation (TBI). After allogeneic bone marrow transplantation, cyclosporin, mycophenolate mofetil (MMF), and methotrexate (MTX) will be given to prevent graft-versus-host disease (GVHD). Receives: Procedure: Extracorporeal Photopheresis; Drug: Pentostatin; Radiation: Total body irradiation (TBI); Procedure: Allogeneic bone marrow transplantation; Drug: Cyclosporin (CSA); Drug: Mycophenolate mofetil (MMF); Drug: Methotrexate (MTX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With Successful Engraftment
Measured: Assessed daily during inpatient stay
Secondary outcomes (2)
100-day Overall Survival
Proportion of patients who survived 100 days or more after enrolled on the study
Measured: Assessed at least twice a week for the first 60 days and weekly until day 100.
Progression-free Survival
Progression-free survival was defined as time from enrollment to disease progression or death from any cause, whichever occurred first. Patients who did not have progression-free survival events were censored at last date of disease assessment.
Measured: Assessed day 100 post transplant and every 3 months during year 1, every 6 months during years 2-3, then every 12 months during years 4-5 or through diagnosis of disease progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2003 (estimated)
- Study start9 Nov 2005
- Primary completionApr 2008
- Study completionMay 2011
Why it stopped: Slow accrual
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 LymphomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Cooperative Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Francine M. Foss, MD, Study chair, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00057954
- Sponsor's protocol ID
- CDR0000285659
- Other IDs
- U10CA021115, E1402
- Status last verified
- Jun 2023
- First submitted
- 7 Apr 2003
- Last updated
- 28 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Reduced Intensity Allogeneic Bone Marrow Transplantation for the Treatment of Relapsed Non-Hodgkin and Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT00057954
- Acronym / sponsor ID
- CDR0000285659
- Conditions
- Lymphoma
- Keywords
- recurrent adult Hodgkin lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult Burkitt lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent grade 1 follicular lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Eastern Cooperative Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 9 Nov 2005 (actual)
- Primary completion
- Apr 2008 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 9 Apr 2003 (estimated)
- Results
- Posted 8 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Photopheresis allows patient white blood cells to be treated with ultraviolet (UV) light and drugs outside the body to inactivate T cells. Pentostatin may suppress the immune system and reduce the chance of developing graft-versus-host disease (GVHD) following bone marrow transplantation. Combining photopheresis with pentostatin and total-body irradiation may be effective in killing cancer cells before bone marrow transplantation.
PURPOSE: This phase II trial is studying how well giving photophoresis together with pentostatin and total-body irradiation as a reduced-intensity regimen before allogeneic bone marrow transplantation works in treating patients with relapsed non-Hodgkin's or Hodgkin's lymphoma.
Detailed description
OBJECTIVES:
- Determine the rate of stable engraftment of donor cells in patients with relapsed non-Hodgkin's or Hodgkin's lymphoma treated with a reduced toxicity conditioning regimen followed by allogeneic (sibling or unrelated) bone marrow transplantation.
- Determine the extent and duration of acute and chronic graft-versus-host disease in patients treated with this regimen.
- Determine the 100-day overall survival and long-term progression-free survival of patients treated with this regimen.
- Evaluate the feasibility of collection of molecular chimerism studies at baseline, days 30, 100, 6 months and one and two years and at relapse.
OUTLINE: This is a multicenter study.
- Conditioning regimen: Patients undergo extracorporeal photopheresis using methoxsalen and UV light on 2 consecutive days between days -7 to -4. Patients receive pentostatin intravenously (IV) continuously on days -3 to -2 and undergo total body irradiation on day -1.
- Allogeneic bone marrow transplantation: Patients undergo infusion of allogeneic bone marrow or stem cells on day 0.
- Graft-versus-host disease prophylaxis: Patients receive oral or IV cyclosporine beginning on day -1 and continuing until 6 months after transplantation, oral mycofenolate mofetil beginning on day 100 and continuing for 1 year, and methotrexate IV on days 1 and 3.
Patients are followed at day 100, every 3 months for 1 year, every 6 months for 2 years, and then annually for 2 years.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 1.8 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transplant | Experimental | Procedure: Extracorporeal Photopheresis, Drug: Pentostatin, Radiation: Total body irradiation (TBI), Procedure: Allogeneic bone marrow transplantation, Drug: Cyclosporin (CSA), Drug: Mycophenolate mofetil (MMF), Drug: Methotrexate (MTX)Reduced toxicity conditioning regimen followed by allogeneic sibling or unrelated transplant. The conditioning regimen includes Extracorporeal Photopheresis, Pentostatin and total body irradiation (TBI). After allogeneic bone marrow transplantation, cyclosporin, mycophenolate mofetil (MMF), and methotrexate (MTX) will be given to prevent graft-versus-host disease (GVHD). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Non-Hodgkin's or Hodgkin's lymphoma that has relapsed following either a course of high dose chemotherapy or autologous stem cell transplantation.
- >= 90 days from prior transplant.
- Have a suitable human leukocyte antigen (HLA)-matched related bone marrow donor or a compatible matched unrelated bone marrow donor by molecular typing at HLA A, B, C, D, DR.
- Physically and psychologically capable of undergoing bone marrow transplantation and its attendant period of strict isolation.
- Age >= 18 years
Key exclusion criteria (4 listed)
- Human immunodeficiency virus positive (HIV+) patients (test positive for P21 antibodies to HIV).
- Evidence of active infection (have received parenteral antibiotics <= 2 weeks prior to registration).
- Pregnant or breast-feeding women.
- Curable with any other therapeutic interventions.
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: extracorporeal photochemotherapyDay -7 to -4: Extracorporeal Photopheresis may be given as an outpatient therapy on two consecutive days any time between days -7 to -4. This must be performed on UVAR or XTS photopheresis machines (Therakos, Inc.) according to standard procedure as per manufacturer's guidelines. | Procedure or surgery | Transplant |
| PentostatinAlso: DCF,, 2-Deoxycoformycin,, NipentDay -3, -2: Pentostatin 4 mg/m²/d by continuous IV infusion (Total dose = 8 mg/m²) | Drug | Transplant |
| Total body irradiation (TBI)Also: radiation therapyDay -1: TBI 400 cGy total dose given in two 200cGy doses. Patients who have received TBI for a previous transplant or radiation as part of previous treatment for a lymphoid malignancy will receive only 200 cGy in 1 dose. | Radiation | Transplant |
| Allogeneic bone marrow transplantationAlso: allogeneic stem cell transplantationDay 0: Infusion of unmanipulated allogeneic bone marrow or stem cells. Minimum cell dose of 2 x 106 CD34 cells/kg recipient and no more than 10 x 10^6 CD34/kg | Procedure or surgery | Transplant |
| Cyclosporin (CSA)Also: Sandimmune,, cyclosporin A,, CSA,, Neoral,Cyclosporin A or tacrolimus will be administered according to institutional GVHD prophylaxis protocols. Therapeutic levels will be maintained and patients will be switched to oral agents when they can tolerate | Drug | Transplant |
| Mycophenolate mofetil (MMF)Also: Cellcept,, mycophenolic acid,, Lilly-68618,, RS-61443,At day 100 MMF will be introduced at a dose of 250 mg po BID and cyclosporine or tacrolimus will be tapered according to the discretion of the investigator. The dosage will be escalated to a maximum of 2 g/d at the discretion of the attending physician and will be tapered and discontinued at 12 months if there is no active cGVHD. Doses should be given on an empty stomach | Drug | Transplant |
| Methotrexate (MTX)Also: Methotrexate sodium,, MTX,, Mexate,, Mexate-AQ,The dose of Methotrexate is based on the corrected ideal body weight for patients with > 33% above ideal weight. Day +1 MTX 15 mg/m² IV push; Day +3 MTX 10 mg/m² IV push (May be omitted if patient develops mouth sores.) | Drug | Transplant |
Primary outcome
Proportion of Participants With Successful Engraftment
Time frame: Assessed daily during inpatient stay
2 secondary outcomes
100-day Overall Survival
Time frame: Assessed at least twice a week for the first 60 days and weekly until day 100.
Progression-free Survival
Time frame: Assessed day 100 post transplant and every 3 months during year 1, every 6 months during years 2-3, then every 12 months during years 4-5 or through diagnosis of disease progression
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- 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 M. Foss, MD study chair
Yale University
19 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 (TBI) in people with Lymphoma, run by Eastern Cooperative Oncology Group at 19 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 11 inclusion and 4 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 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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 8 Feb 2013). 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?
Proportion of Participants With Successful Engraftment (time frame: Assessed daily during inpatient stay). 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 28 Jun 2023.