Phase 2
N=23
Autologous and Allogeneic Transplant for Relapsed Lymphoma
Non-Hodgkin's Lymphoma · Hodgkins Disease
Bottom Line
View on ClinicalTrials.gov: NCT00802113 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: Total Number of Subjects With a Complete Response (CR) Following Myeloablative Conditioning (MAC) and Autologous Stem Cell Transplantation (AutoSCT) — 4; 12 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fludarabine (Drug); Busulfan (Drug); Anti-Thymocyte Globulin (Drug)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Number of Subjects With a Complete Response (CR) Following Myeloablative Conditioning (MAC) and Autologous Stem Cell Transplantation (AutoSCT) |
4; 12 | — |
| PRIMARY Total Number of Subjects With a Disease Relapse or Progression Following MAC AutoSCT |
1; 3 | — |
| PRIMARY Total Number of Subjects With Partial Response or Stable Disease Following MAC AutoSCT |
4; 9 | — |
| SECONDARY Time to Neutrophil Engraftment |
16; 24 | — |
| SECONDARY Time to Platelet Engraftment |
22; 53 | — |
| SECONDARY Total Number of Subjects With Grade II-IV Acute Graft-versus-Host-Disease (GVHD) |
0; 7 | — |
| SECONDARY Total Number of Subjects That Experienced Transplant-related Mortality (TRM) |
2; 6 | — |
Summary
The sequential combination of myeloablative therapy and autologous stem cell transplantation (APBSCT) followed by a reduced intensity allogeneic stem cell transplant (Allo SCT) and post SCT adoptive cellular immunotherapy will be well tolerated in patients with refractory or recurrent non-Hodgkin's lymphoma (NHL) and Hodgkin's disease (HD).
Eligibility Criteria
Inclusion Criteria
Patient must have adequate organ function as below
- Adequate renal function defined as:
- Serum creatinine less than or equal to 2.0 x normal, or
- Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 40 ml/min/m2 or >60 ml/min/1.73 m2 or an equivalent GFR as determined by the institutional normal range
- Adequate liver function defined as:
- Total bilirubin 27% by echocardiogram, or
- Ejection fraction of >47% by radionuclide angiogram or echocardiogram
- Adequate pulmonary function defined as:
- Diffusing capacity of the lungs for carbon monoxide (DLCO) >50% by pulmonary function test for autologous transplant
- DLCO > 40% by pulmonary function test for reduced intensity allogeneic transplant
- For children who are uncooperative, no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry >94% in room air.
Disease Status (Eligibility)
- Patients with Non-Hodgkin's Lymphoma with either of the following:
- Primary induction failure (failure to achieve initial CR) who have a partial response (PR) or stable disease (SD) with reinduction chemotherapy. *All patients are required to have a biopsy regardless of positron emission tomography (PET)/Gallium results.
- Patients with 1st PR, 2nd CR, 2nd PR, or 2nd SD following reinduction chemotherapy
- Patients with 3rd CR, 3rd PR, 3rd SD following reinduction chemotherapy
- Patients with Hodgkin's Disease with either of the following:
- Primary induction failure (failure to achieve initial CR) and/or primary refractory disease.
- First relapse
- Early relapse (within 12 months off therapy) (excluding those who received no therapy or radiation therapy only for initial therapy)
- Late relapse (greater than 12 months off therapy). Only patients with recurrent Stage III or IV disease and/or those with B symptoms at relapse (all other late relapses are excluded).
- Second relapse.
- Third relapse.
- Patients must achieve a CR, PR or SD after reinduction chemotherapy.
Exclusion Criteria
- Patients with NHL or HD with 4th or greater CR, PR, and/or SD
- Patients with progressive disease (PD) unresponsive to reinduction chemo, radio, or immunotherapy
- Hodgkin's Disease in late relapse (other than those discussed above).
- Patients with post-transplant lymphoproliferative disease following a solid organ transplantation or AIDS associated NHL
- Patients who don't have an eligible donor
- Women who are pregnant
Data sourced from ClinicalTrials.gov (NCT00802113). 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.