Tandem Stem Cell Transplantation for Non-Hodgkin's Lymphoma

• Status: Active, not recruiting
• Trial end date: 2028-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a research study testing a new approach to treating high-risk non-Hodgkin's lymphoma consisting of an autologous hematopoietic (blood) stem cell transplant (using a patient's own hematopoietic cells) followed by a non-myeloablative allogeneic transplantation (transplant from another individual).

The investigators hypothesize that the addition of the second non-myeloablative transplant will improve the chances for long-term control of lymphoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Treatments: Antilymphocyte Serum; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Mycophenolate mofetil; Mycophenolic Acid; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Tacrolimus; Thymoglobulin

Criteria

Inclusion Criteria

• Age 18 to 70 years.

• Histologically proven non-Hodgkin's lymphoma

• High risk disease including at least one of the following:

• Relapsed or refractory disease

• Transformed lymphoma

• Aggressive T-cell lymphoma

• Failure to achieve completed remission (CR) following Auto SCT

• Less than a 20% chance of event-free survival from autologous transplant determined by the treating physician and the Principal Investigator

• ECOG performance status < or = 2

• Underwent Autologous SCT 60-120 days prior to registration including:

• BEAM conditioning (BCNU: 300 mg/m2 IV day -7, Etoposide: 100 mg/m2 IV BID days -6,-5,-4,-3, Cytarabine: 100 mg/m2 IV BID days -6,-5,-4,-3, Melphalan: 140 mg/m2 IV day -2)

• Minimum of 2 x 106 CD34+ cells/kg infused

• Full hematologic recovery following Auto HCT including:

• Absolute neutrophil count (ANC) >1000 µl

• Platelet count of ≥50,000 µl independent of transfusion for >7 days

• Available matched related or unrelated donor. Selected donor must be a complete match or have only a single antigen mismatch.

• Women of child-bearing potential and sexually active males must use an accepted and effective method of birth control.

• Bone marrow comprising of < 10% lymphoma on most recent biopsy/aspiration (within 9 months of Allo transplant; may have been performed prior to autologous transplant).

• Serum bilirubin < or = 2 x the institutional ULN

• Serum creatinine < or = 2 x the institutional ULN and measured or estimated creatinine clearance > 60 cc/min by the following formula

• Estimated Creatinine Clearance = (140 age)X WT(kg) X 0.85 if female 72X serum creatinine(mg/dl).

• Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.

Exclusion Criteria

• Prior autologous or allogeneic hematopoietic cell transplantation (other than autologous SCT 60-120 days prior to registration)

• Prior radioimmunotherapy

• Known or suspected progressive disease following autologous SCT

• Additional treatment for NHL administered from time of autologous SCT through registration

• Pregnant or breast-feeding women (due to the known birth defects association with the treatments used in this study)

• Human immunodeficiency virus (HIV)-positive (the concern for opportunistic infection and hematologic reserve are considered to be significantly greater in this population.)

• Any prior malignancy is allowed except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or other cancer for which the patients has been disease-free for five years.

• Active infection requiring oral or intravenous antibiotics.

Inclusion of Women and Minorities

-Both men and women and members of all races and ethnic groups are eligible for this trial.