Phase 2
N=42
Tandem Auto-Allo Transplant for Lymphoma
Diffuse, Large B-Cell, Lymphoma · Lymphoma, Low-Grade · T-Cell Lymphoma · Mantle-Cell Lymphoma · Hodgkin's Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT01181271 ↗Enrolled (actual)
42
Serious AEs
11.9%
Results posted
Mar 2017
Primary outcome: Primary: Peripheral Blood All-cell Donor Chimerism — 95 percentage of donor-derived elements
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Busulfan (conditioning for AUTO transplant) (Drug); Etoposide (conditioning for AUTO transplant) (Drug); Cyclophosphamide (conditioning for AUTO transplant) (Drug); Mesna (prior to AUTO transplant) (Drug); autologous (auto) peripheral blood stem cell transplantation (Other); Neupogen (Drug); Fludarabine (conditioning for ALLO Transplant) (Drug); Busulfan (conditioning for ALLO Transplant) (Drug); non-myeloablative allogeneic (allo) transplant (Other); Tacrolimus (Drug); Sirolimus (Drug); Methotrexate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peripheral Blood All-cell Donor Chimerism |
95 | — |
| SECONDARY Number of Days After Allogeneic Transplant Until Absolute Neutrophil Count Was Equal to or Greater Than 500/uL |
12 | — |
| SECONDARY Cumulative Incidence of Grades II to IV Acute Graft Versus Host Disease (GVHD) |
13.8 | — |
| SECONDARY Cumulative Incidence of Extensive Chronic Graft-versus-host-disease |
37.9 | — |
| SECONDARY Cumulative Incidence of Non-relapse Mortality |
11.1 | — |
| SECONDARY Cumulative Incidence of Disease Relapse |
17.2 | — |
| SECONDARY Estimated Two Year Progression Free Survival Rate for Participants Undergoing Both Autologous and Allogeneic Transplants |
72 | — |
| SECONDARY Estimated Two Year Overall Survival Rate for Participants Undergoing Both Autologous and Allogeneic Transplants |
89 | — |
| SECONDARY Estimated Two Year Progression Free Survival Rate for All Participants |
64 | — |
| SECONDARY Estimated Two Year Overall Survival Rate for All Participants |
83 | — |
| SECONDARY Estimated Two Year Progression Free Survival Rate for Participants Undergoing Only Autologous Transplant |
46 | — |
| SECONDARY Estimated Two Year Overall Survival Rate for Participants Undergoing Only Autologous Transplant |
69 | — |
Summary
Relapse remains a principle cause of treatment failure for patients with aggressive lymphoma after autologous transplantation. Non-myeloablative allogeneic transplantation allows patients to receive an infusion of donor cells in an attempt to induce a graft versus lymphoma effect. This study will assess the feasibility, safety and efficacy of the combination of autologous stem cell transplantation followed by non-myeloablative transplantation for patients with poor-risk aggressive lymphoma.
Eligibility Criteria
Inclusion Criteria
- Patients with high-risk diffuse large B cell or transformed low grade lymphoma defined as:
- Residual disease after at least 6 cycles of anthracycline-based chemotherapy (with residual disease defined as persistent bone marrow involvement and/or persistent measurable lymph node or solid organ masses that are PET or gallium avid)
- Progressive disease after at least 2 cycles of anthracycline-based chemotherapy
- Patients with an initial complete response but subsequent relapse within 6 months after completion of anthracycline-based chemotherapy
- Patients with any T-cell non-Hodgkin's lymphoma as defined as:
- Peripheral T-cell lymphoma (ALK negative PTCL-U) including PTCL-NOS, HSGD (hepato-splenic gamma-delta TCL), AITL (angioimmunoblastic T-cell lymphoma), EATL (enteropathy associated T-cell lymphoma), ALK-negative anaplastic large cell lymphoma
- Any T-cell histology (except LGL) with residual disease after at least 4 cycles of anthracycline-based chemotherapy (with residual disease defined as persistent bone marrow involvement and/or persistent measurable lymph node or solid organ masses that are PET or gallium avid)
- Patients with mantle cell lymphoma at any time in therapy
- Patients with "double-hit" lymphoma as characterized by the presence of concurrent overexpression of Bcl-2 and c-myc
- Patients with Hodgkin's lymphoma that is
- Refractory to first-line therapy and at least one second line chemotherapy regimen
- Relapsed Hodgkin's lymphoma which is refractory to at least one salvage chemotherapy regimen.
- Patients with CLL/SLL with 17p- cytogenetic abnormality
- Age 18 years and greater
- ECOG performance status 0-2
- Ability to understand and the willingness to sign a written informed consent document.
- Responsive disease to last therapy as determined by at least one of the following:
- At least PR by Revised Response Criteria
- At least PR by traditional Cheson Criteria
- 30% and no uncontrolled symptoms of congestive heart failure
- DLCO > 50% of predicted value (corrected for hemoglobin)
- Transaminases < 5X the institution upper limit of normal
- Bilirubin < 3X the institution upper limit of normal except when Gilbert's Syndrome or hemolysis is present
- ECOG PS ≤ 2
- No intravenous antimicrobials within 2 weeks
- No evidence of progressive disease, defined as a 25% increase from nadir in the sum of the product of the diameters (SPD) of any lymph node previously identified as abnormal prior to autologous transplant or the appearance of any new lymph node greater than 1.5 cm in greatest diameter, new bone marrow involvement, or new solid organ nodule greater than 1 cm in diameter. This restaging study will be performed at least 28 days after the autologous transplant and within 60 days prior to admission for allogeneic transplant. Status of stable disease (SD) is acceptable to proceed to allogeneic transplant.
Data sourced from ClinicalTrials.gov (NCT01181271). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.