Tandem Stem Cell Transplantation for Non-Hodgkin's Lymphoma
Autologous Followed by Non-myeloablative Allogeneic Transplantation for Non-Hodgkin's Lymphoma
1 other identifier
interventional
18
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started May 2009
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 15, 2009
CompletedFirst Posted
Study publicly available on registry
April 17, 2009
CompletedStudy Start
First participant enrolled
May 5, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
February 2, 2026
January 1, 2026
19.1 years
April 15, 2009
January 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Determine the event free survival
Up to 10 years from transplant
Determine the toxicities
Day 100
Secondary Outcomes (4)
To evaluate the kinetics of donor hematopoietic cell engraftment and chimerism.
Day 56, Day 100, Day 180, and Day 365
To evaluate the incidence and extent of acute and chronic GVHD.
Up to 10 years
To evaluate the overall and non-relapse mortality rate.
Up to 10 years
Incidence of chemotherapy-associated pneumonitis
Day 100
Study Arms (1)
Allogeneic Transplant
EXPERIMENTAL* TLI - 80 cGy on days -14, -11, -10, -9, -8, -7, -4, -3, -2, -1 * Anti-thymocyte globulin (ATG) 1.5 mg/kg on days -11, -10, -8, -7 * Solumedrol - 1 mg/kg on days -11, -10, -9, -8, -7 * Tacrolimus - beginning on day -3 with starting dose of 0.3 mg/kg PO BID. Will be continued per institutional guidelines. * Stem cell infusion - day 0 * Mycophenolate mofetil (MMF) - beginning on day 0 with dose of 15 mg/kg PO (5-10 hours after transplant)
Interventions
Eligibility Criteria
You may qualify if:
- 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
- +7 more criteria
You may not qualify if:
- 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.
- Both men and women and members of all races and ethnic groups are eligible for this trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University
St Louis, Missouri, 63110, United States
Related Publications (1)
Maloney DG, Molina AJ, Sahebi F, Stockerl-Goldstein KE, Sandmaier BM, Bensinger W, Storer B, Hegenbart U, Somlo G, Chauncey T, Bruno B, Appelbaum FR, Blume KG, Forman SJ, McSweeney P, Storb R. Allografting with nonmyeloablative conditioning following cytoreductive autografts for the treatment of patients with multiple myeloma. Blood. 2003 Nov 1;102(9):3447-54. doi: 10.1182/blood-2002-09-2955. Epub 2003 Jul 10.
PMID: 12855572BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Keith Stockerl-Goldstein, MD
Washington University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2009
First Posted
April 17, 2009
Study Start
May 5, 2009
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
June 1, 2028
Last Updated
February 2, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share