A Phase 2 interventional study of Extracorporeal Photopheresis and Pentostatin in Lymphoma, sponsored by Eastern Cooperative Oncology Group. Terminated at 19 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-28.
Sponsored by Eastern Cooperative Oncology Group · Phase 2, Interventional, and Treatment
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.
OBJECTIVES:
OUTLINE: This is a multicenter study.
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 6 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Eastern Cooperative Oncology Group is the lead sponsor of 173 studies on the registry; 7 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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).
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)
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.
Also known as: extracorporeal photochemotherapy
Day -3, -2: Pentostatin 4 mg/m²/d by continuous IV infusion (Total dose = 8 mg/m²)
Also known as: DCF,, 2-Deoxycoformycin,, Nipent
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.
Also known as: radiation therapy
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
Also known as: allogeneic stem cell transplantation
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
Also known as: Sandimmune,, cyclosporin A,, CSA,, Neoral,, Gengraf
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
Also known as: Cellcept,, mycophenolic acid,, Lilly-68618,, RS-61443,, MMF
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.)
Also known as: Methotrexate sodium,, MTX,, Mexate,, Mexate-AQ,, Folex,, Folex PFS,, Abitrexate,, Rheumatrex,, Amethopterin
Proportion of Participants With Successful Engraftment
Time frame: Assessed daily during inpatient stay
100-day Overall Survival
Proportion of patients who survived 100 days or more after enrolled on the study
Time frame: 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.
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
Participants were recruited from ECOG member institutions between June 1, 2005 and October 10, 2007 with the first patient accrued on November 9, 2005.
| Milestone | Transplant |
|---|---|
| Started | 6 |
| Completed | 4 |
| Not completed | 2 |
| Withdrew: Death | 1 |
| Withdrew: Disease progression | 1 |
| Proportion of participants | Transplant |
|---|---|
| Proportion of Participants With Successful Engraftment | 1 (0.5 to 1.0) |
Proportion of patients who survived 100 days or more after enrolled on the study
| Proportion of participants | Transplant |
|---|---|
| 100-day Overall Survival | 0.83 (0.54 to 1.0) |
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.
| days | Transplant |
|---|---|
| Progression-free Survival | 104 (66 to NA) |
Collected over Assessed every 30 days while on treatment and for 30 days after the end of treatment.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Transplant | — | 6/6 (100%) | 6/6 (100%) |
| Event | Transplant |
|---|---|
| Leukopenia (Leukocytes, decreased)Investigations | 6/6 |
| LymphopeniaInvestigations | 6/6 |
| Neutropenia (Neutrophils, decreased)Investigations | 6/6 |
| Thrombocytopenia (Platelets, decreased)Investigations | 4/6 |
| HypoalbuminemiaMetabolism and nutrition disorders | 4/6 |
| FatigueGeneral disorders | 2/6 |
| AnorexiaMetabolism and nutrition disorders | 2/6 |
| HyponatremiaMetabolism and nutrition disorders | 2/6 |
| Abdomen, painGastrointestinal disorders | 2/6 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 2/6 |
| Event | Transplant |
|---|---|
| AnemiaBlood and lymphatic system disorders | 6/6 |
| Leukopenia (Leukocytes, decreased)Investigations | 6/6 |
| Thrombocytopenia (Platelets, decreased)Investigations | 6/6 |
| HypoalbuminemiaMetabolism and nutrition disorders | 6/6 |
| Blood bilirubin increasedInvestigations | 6/6 |
| LymphopeniaInvestigations | 5/6 |
| Neutropenia (Neutrophils, decreased)Investigations | 5/6 |
| Creatinine, increasedInvestigations | 5/6 |
| Aspartate aminotransferase increasedInvestigations | 4/6 |
| Alanine aminotransferase increasedInvestigations | 3/6 |
| Age, Continuous(years) | Transplant |
|---|---|
| Median | 47 (21 to 60) |
| Sex: Female, Male(Participants) | Transplant |
|---|---|
| Female | 2 |
| Male | 4 |
| Region of Enrollment(participants) | Transplant |
|---|---|
| United States | 6 |
This study is terminated, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Eastern Cooperative Oncology Group