Clinical trial · Interventional
Reduced-Intensity Regimen Before Allogeneic Transplant for Patients With Relapsed Non-Hodgkin's or Hodgkin's Lymphoma
A Phase II Study of Reduced Intensity Allogeneic Bone Marrow Transplantation for the Treatment of Relapsed Non-Hodgkin and Hodgkin Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Allogeneic bone marrow transplantation | Procedure | — | UNRESOLVED |
| Cyclosporin (CSA) | Drug | — | UNRESOLVED |
| Extracorporeal Photopheresis | Procedure | — | UNRESOLVED |
| Methotrexate (MTX) | Drug | Methotrexate | ALIAS |
| Mycophenolate mofetil (MMF) | Drug | — | UNRESOLVED |
| Pentostatin | Drug | Pentostatin | ALIAS |
| Total body irradiation (TBI) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Transplant
- description
- 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).
- interventionNames
- 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)
Primary outcomes (1)
- measure
- Proportion of Participants With Successful Engraftment
- timeFrame
- Assessed daily during inpatient stay
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available