Phase 2
Completed N=34
Bendamustine Bridge to Autologous or Allogeneic Transplant for Relapsed/Refractory Lymphoma
Hodgkin's Lymphoma · Non-Hodgkin's Lymphoma
Source: ClinicalTrials.gov NCT02059239 ↗
Enrolled (actual)
34
Serious AEs
25.4%
Results posted
Feb 2021
Primary outcomePrimary: Number of Patients Able to Proceed to Transplant — 16; 13; 1; 0 Participants
Summary
This clinical trial is for men and women with whose lymphoma (non-Hodgkin or Hodgkin) did not respond to treatment or has returned after responding to previous therapy, and who are in need of a stem cell transplant.
The purpose of this study is to test the safety and effectiveness of giving the drug Bendamustine, followed by high dose chemotherapy, within two weeks prior to a stem cell transplant for lymphoma that has not achieved a complete response to salvage (treatment used for relapsed disease) chemotherapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Able to Proceed to Transplant |
16; 13; 1; 0; 1; 3 | — |
| PRIMARY Number of Patients Achieving Neutrophil Engraftment |
16; 13 | — |
| PRIMARY Number of Patients Achieving Platelet Engraftment |
16; 12 | — |
| SECONDARY Overall Survival at Day 100 Post-Transplant |
16; 11; 0; 2 | — |
| SECONDARY Overall Survival at Day 365 Post-Transplant |
16; 6; 0; 7 | — |
| SECONDARY Transplant-Related Mortality |
0; 2 | — |
| SECONDARY Disease Response Following Salvage Chemotherapy |
4; 1; 8; 6; 4; 2 | — |
| SECONDARY Disease Response 30 Days Post-Transplant |
12; 7; 2; 3; 2; 1 | — |
| SECONDARY Disease Response at 1 Year Post-Transplant |
12; 4; 1; 0; 0; 0 | — |
| SECONDARY Progression-Free Survival After Stem Cell Transplant |
NA; 8 | — |
Eligibility Criteria
Inclusion Criteria
- must have histologically or cytologically confirmed relapsed or primary refractory lymphoma (including Hodgkin's Lymphoma) staged with Positron Emission Tomography (PET) scan to have
- Allogeneic arm:
- Progressive disease or
- No response to salvage therapy or
- Partial response to salvage therapy defined as > 50% reduction in bidirectional area of masses but standardized uptake value (SUV) remains ≥8 in at least some PET avid areas
- Prior autologous transplant
- Autologous arm:
- Partial response of >50% reduction in bidirectional area of masses and SUV reduction to 18 years.
- Karnofsky Performance Score (KPS) ≥ 50%
- For autologous transplants: Subjects must have an adequate number of CD34+ stem cells collected to allow for transplantation. This number is defined as ≥ 2x106 CD34+ cells / kg body weight. If not previously collected and stored, the subject must be willing to undergo stem cell mobilization and collection as per standard practice. If sufficient cells cannot be collected, subjects will be offered the option to proceed with the allogeneic arm of the study.
- Male and female subjects must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment. Female subjects of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
- Known to be positive for HIV
- Subjects may not be receiving any other investigational agents (defined as non FDA-approved agents) at the time of initiating bendamustine regimen. However, the salvage therapy for lymphoma can be part of an ongoing clinical trial with an investigational agent.
- Women who are pregnant or breast feeding. Women of childbearing age must use adequate contraception and have a negative pregnancy test.
- The risks to an unborn fetus or potential risks in nursing infants are unknown.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to any medications listed in the protocol.
- Subject with severely decreased Left Ventricular Ejection Fraction (LVEF) or severely impaired pulmonary function tests (PFT's)
- Uncontrolled illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Data sourced from ClinicalTrials.gov (NCT02059239). 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. Informational only — not medical advice.