Study of Melphalan HCl for Injection (Propylene Glycol-free), Carmustine, Etoposide, Cytarabine (BEAM Regimen) and Autologous Stem Cell Transplantation for Lymphoma
CompletedPhase 2Results postedLast updated 13 February 2018
What this trial tests
Phase 2 trial testing Carmustine in Hodgkin Disease in 50 participants. Completed in 31 May 2017.
Adults 18 to 75, any sex, with Hodgkin Disease or Lymphoma, Non-Hodgkin. 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.
Safety and Toxicity as Measured by Treatment Related Non-hematologic Adverse EventsPrimary· Day -7 through Day 30
Adverse events will be assessed using the National Cancer Institute (NCI)-CTCAE version 4.0. Number of events, grade 2 or higher, occurring in 10% or greater of participants. Grade 2 diarrhea and Grade 2 nausea/vomiting were not recorded.
Efficacy as Measured by Response RatesSecondary· Up to Day 100
* The response rates according to each category of response Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD) will be summarized by the proportion of patients meeting each criterion.
* Evaluated using PET or CT scan and Revised Response Criteria for Malignant Lymphoma
Time frame: Reportable adverse events were collected from the first dose of study treatment (Day -7) through the Day +30 visit..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Phase II study is being conducted to confirm the safety and efficacy of high-dose Melphalan HCl for Injection (Propylene Glycol-Free) when included in the BEAM regimen for myeloablative conditioning in lymphoma patients undergoing ASCT
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
NCT06254495 — A Safety Study of PF-08046044/SGN-35C in Adults With Advanced Cancers
· Phase 1
· active not recruiting
NCT04671693 — A Post-treatment Program to Identify and Manage Complications Related to Oncology or Hematology Treatments in Cancer Sur
· NA
· active not recruiting
NCT02979522 — A Study of Brentuximab Vedotin + Adriamycin, Vinblastine, and Dacarbazine in Pediatric Participants With Advanced Stage
· Phase 1, PHASE2
· active not recruiting
NCT02682667 — Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols
· recruiting
NCT01676805 — Tissue Collection for Studies of Lymph Cancer
· recruiting
Other Washington University School of Medicine trials
Trials by the same sponsor.
NCT05521997 — Glutaminase Inhibition and Chemoradiation in Advanced Cervical Cancer
· Phase 2
· not yet recruiting
NCT07101666 — Total Neoadjuvant Therapy With Short Course Radiation Therapy in Gastric Cancer
· Phase 2
· not yet recruiting
NCT07200089 — Recombinant Human IL-7 (NT-I7) in Relapsed/Refractory Multiple Myeloma Following BCMA CAR-T Therapy (Cilta-cel)
· Phase 1
· not yet recruiting
NCT07313592 — Whole Genome Sequencing (ChromoSeq®) for Acute Lymphoblastic Leukemia (ALL) Patients
· not yet recruiting
NCT07419464 — 5-Fluorouracil Response and Optimization STudy (The FROST Trial)
· Phase 2
· not yet recruiting
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Washington University School of Medicine
Last refreshed: 13 February 2018
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/NCT01969435.