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NCT03352765 · ClinicalTrials.gov registry record · Phase 1
A Phase I Study of Bendamustine and Melphalan Conditioning and Autologous Stem Cell Transplantation for Treatment of Multiple Myeloma and Relapsed/Refractory B-cell Lymphoma in Elderly Patients
A Phase 1 study of Lymphoma, sponsored by Memorial Sloan Kettering Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
- 1
- Study location
NCT03352765: Active Phase 1 study of Lymphoma, sponsored by Memorial Sloan Kettering Cancer Center.
NCT03352765 is a Phase 1 study of Lymphoma that is active but no longer recruiting, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 28 participants, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03352765, a Phase 1 study of Lymphoma, is active but no longer recruiting, sponsored by Memorial Sloan Kettering Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is testing a combination of chemo-immuno therapy called RBM. RBM consists of combination of drugs: rituximab, bendamustine, and melphalan followed by reinfusion of the participants own stem cells which is called autologous stem cell transplant (ASCT). Compared to the standard BEAM regimen, this RBM regimen may or may not be less effective in lymphoma, but will likely have fewer side effects.
Primary Outcome
are defined as grade \> 3, non-hematologic toxicity related to treatment excluding grade 3 nausea or vomiting responsive to anti-emetic treatment, grade 3 diarrhea responding to anti-diarrheal treatment, grade 3 fatigue, grade 3 skin rash responsive to topical or systemic steroids, grade 3 fevers (\> 40 degrees Celsius for \< 24 hours) and alopecia per CTCAE
Conditions Studied
Interventions
- DRUG melphalan
- DRUG rituximab
- DRUG bendamustine
- PROCEDURE Autologous Stem Cell Transplantation (ASCT)
Study Locations (1)
New York
- Memorial Sloan Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2017-11-20 |
| Est. Completion | 2026-11 |
| Phase | Phase 1 |
What the registry record for NCT03352765 still lists
NCT03352765 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Lymphoma appearing as the primary indexed condition, and to 4 interventions - of which melphalan is the first listed.
NCT03352765 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03352765 about?
NCT03352765 is a clinical study titled "A Phase I Study of Bendamustine and Melphalan Conditioning and Autologous Stem Cell Transplantation for Treatment of Multiple Myeloma and Relapsed/Refractory B-cell Lymphoma in Elderly Patients". This study is testing a combination of chemo-immuno therapy called RBM. RBM consists of combination of drugs: rituximab, bendamustine, and melphalan followed by reinfusion of the participants own stem cells which is called autologous stem cell transplant (ASCT). Compared to the standard BEAM regimen...
What is the current status of trial NCT03352765?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2017-11-20. Estimated completion is 2026-11.
What conditions does trial NCT03352765 study?
This clinical trial studies the following conditions: Lymphoma.
What interventions are being tested in trial NCT03352765?
The interventions under investigation include: melphalan (DRUG), rituximab (DRUG), bendamustine (DRUG), Autologous Stem Cell Transplantation (ASCT) (PROCEDURE).
Who is sponsoring clinical trial NCT03352765?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03352765 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03352765's enrollment target sits among peer trials
28 226th of 299 higher than 73 of 299 other Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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