Intensive Consolidation and Stem Cell Mobilization Therapy Followed by Autologous Stem Cell Transplantation in High-risk Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
CompletedPhase 2Results postedLast updated 29 June 2022
What this trial tests
Phase 2 trial testing Ofatumumab in Diffuse Large Cell Lymphoma Relapsed/Refractory in 19 participants. Completed in 1 July 2021.
18 and older, any sex, with Diffuse Large Cell Lymphoma Relapsed/Refractory. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Patients Achieving Complete Response (CR) to the Treatment Upon Successful Stem Cell MobilizationPrimary· Day 42
CR will be calculated based on the PET/CT scan following 2 cycles of salvage therapy using the revised International Working Group (IWG) Criteria for a lymphoma response. This includes: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy, Post-treatment residual mass of any size is permitted as long as it is PET-, Spleen and/or liver, if enlarged before therapy based on physical exam or CT scan, should not be palpable on physical exam and should be considered normal size by imaging studies, and nodules related to lymphoma
Group
Value
95% CI
Treatment
10
Number of Patients Achieving Mobilization-adjusted Complete Response (maCR)Primary· Day 42
Number of patients achieving maCR to the treatment upon successful stem cell mobilization, defined as at least 2 x10\^6 cluster of differentiation 34 (CD34)+cells/Kg of actual body weight. Patients who require use of plerixafor or an autologous bone marrow harvest are considered mobilization failures and will be treated as non-responders.
Group
Value
95% CI
Treatment
10
Number of Patients Who Received OVA and Then Met Criteria to Proceed to ASCT and Achieved a CR/Partial Response (PR) Post-ASCTSecondary· Up to 5 months
Determination of CR or PR must meet the revised International Working Group (IWG) Criteria for lymphoma response
Group
Value
95% CI
Treatment
11
Number of Patients Who Advance From Partial Response (PR) to Complete (CR)Secondary· Up to 5 months
Fluorodeoxyglucose-positron emission tomography (FDG-PET) conversion rate was used determined the number of participants who improved following OVA Treatment.
Group
Value
95% CI
Treatment
2
Number of Participants With Successful Neutrophil EngraftmentsSecondary· Up to 24 months after ASCT
Neutrophil engraftment is defined as the first day of 3 consecutive days with absolute neutrophil count of \>500 cells/microlitre (uL). Response evaluation will occur at day +90 after ASCT, and at 6, 12 and 24 months thereafter
Group
Value
95% CI
Treatment
12
Number of Participants With Successful Platelet EngraftmentsSecondary· Up to 24 months after ASCT
Platelet engraftment is defined as the first of three consecutive measurements for which the platelet count was \> 20,000/uL, and must be at least 24 hours following the last platelet transfusion. Response evaluation will occur at day +90 after ASCT, and at 6, 12 and 24 months after ASCT
Group
Value
95% CI
Treatment
12
Median Time to ProgressionSecondary· Up to 48 months
Time to progression (TTP) is defined as the time from treatment after OVA until documented lymphoma progression or receipt of anti-lymphoma therapy (except for planned post-ASCT radiotherapy) or death due to lymphoma. Patients are to be censored at the time of last followup or death due to another cause
Group
Value
95% CI
Treatment
13.2
1.4 – 48
Progression Free Survival RateSecondary· Up to 24 months
The percentage of participants in the study still alive at time of censoring. The time frame defined as the time from day 0 of OVA treatment until lymphoma progression, receipt of anti-lymphoma therapy (except for planned post-ASCT radiotherapy), or death as a result of any cause. Patients will be censored at the time of median follow-up.
Group
Value
95% CI
Treatment
47
24 – 67
Overall Survival Rate (OS)Secondary· Up to 24 months
The percentage of participants in the study still alive at time of censoring. The time frame is defined as the time from day 0 of OVA treatment until death as a result of any cause. Patients will be censored at the time of last followup
Group
Value
95% CI
Treatment
59
33 – 78
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 5 years.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Treatment
Serious: 4/19 (21%)
Deaths: 3/19
Serious adverse events (4 terms)
Reaction
System
Treatment
Anal Pain
Gastrointestinal disorders
—
Pneumonitis
Respiratory, thoracic and mediastinal disorders
—
Sepsis
Infections and infestations
—
Allergic reaction
Immune system disorders
—
Other adverse events (26 terms — click to expand)
Reaction
System
Treatment
Platelet count decreased
Investigations
—
Neutrophil count decreased
Investigations
—
Febrile neutropenia
Blood and lymphatic system disorders
—
White blood cell decreased
Investigations
—
Mucositis oral
Gastrointestinal disorders
—
Anemia
Blood and lymphatic system disorders
—
Diarrhea
Gastrointestinal disorders
—
Nausea
Gastrointestinal disorders
—
Vomiting
Gastrointestinal disorders
—
Infections and infestations - Other
Infections and infestations
—
Cellulitis
Skin and subcutaneous tissue disorders
—
Alanine aminotransferase increased
Investigations
—
Aspartate aminotransferase increased
Investigations
—
Blood and lymphatic system disorders - Other, specify
The goal of this clinical trial is to show that incorporating ofatumumab instead of rituximab in combination with etoposide and cytarabine (OVA) is successful in collecting autologous stem cells for use in an autologous stem cell transplantation (autoSCT) and to examine its effectiveness in eliminating residual diffuse large B-Cell Lymphoma (DLBCL) in patients.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by C. Babis Andreadis
Last refreshed: 29 June 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01555541.