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NCT04022239 · ClinicalTrials.gov registry record · Phase 1
Bendamustine With or Without Cyclophosphamide in Preventing GVHD in Patients Undergoing Stem Cell Transplant
A Phase 1 study of Hematopoietic and Lymphoid System Neoplasm, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT04022239: Recruiting Phase 1 study of Hematopoietic and Lymphoid System Neoplasm, sponsored by M.D. Anderson Cancer Center.
NCT04022239 is a Phase 1 study of Hematopoietic and Lymphoid System Neoplasm that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 25 participants, below the 1,358-participant average among 31 other Hematopoietic and Lymphoid System Neoplasm trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04022239, a Phase 1 study of Hematopoietic and Lymphoid System Neoplasm, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I/II trial studies the side effects and best dose of bendamustine when given with or without cyclophosphamide in preventing graft versus host disease (GVHD) in patients undergoing stem cell transplant. Drugs used in chemotherapy, such as bendamustine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy and total body irradiation before or after a stem cell transplant helps kills cancer cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. Sometimes, the transplanted cells from a donor can attack the body's normal cells called GVHD. Giving tacrolimus, mycophenolate mofetil, and filgrastim after the transplant may stop this from happening.
Primary Outcome
Will employ the time-to-event Bayesian optimal interval design to find the MTDL. After the trial is completed, the MTDL will be selected based on isotonic regression as specified in Yuan et al. Specifically, MTDL will be selected as the dose for which the isotonic estimate of the toxicity rate is closest to the target toxicity rate. If there are ties, the higher dose level when the isotonic estimate is lower than the target toxicity rate will be selected and the lower dose level when the isotoni
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Bendamustine
- PROCEDURE Allogeneic Hematopoietic Stem Cell Transplantation
- BIOLOGICAL Filgrastim-sndz
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2020-03-13 |
| Est. Completion | 2027-07-31 |
| Phase | Phase 1 |
What NCT04022239 shows while recruiting
NCT04022239 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 1,358-participant average among 31 other Hematopoietic and Lymphoid System Neoplasm trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Hematopoietic and Lymphoid System Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT04022239 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04022239 about?
NCT04022239 is a clinical study titled "Bendamustine With or Without Cyclophosphamide in Preventing GVHD in Patients Undergoing Stem Cell Transplant". This phase I/II trial studies the side effects and best dose of bendamustine when given with or without cyclophosphamide in preventing graft versus host disease (GVHD) in patients undergoing stem cell transplant. Drugs used in chemotherapy, such as bendamustine and cyclophosphamide, work in differen...
What is the current status of trial NCT04022239?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2020-03-13. Estimated completion is 2027-07-31.
What conditions does trial NCT04022239 study?
This clinical trial studies the following conditions: Hematopoietic and Lymphoid System Neoplasm.
What interventions are being tested in trial NCT04022239?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Bendamustine (DRUG), Allogeneic Hematopoietic Stem Cell Transplantation (PROCEDURE), Filgrastim-sndz (BIOLOGICAL).
Who is sponsoring clinical trial NCT04022239?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04022239 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04022239's enrollment target sits among peer trials
25 29th of 31 higher than 3 of 31 other Hematopoietic and Lymphoid System Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hematopoietic and Lymphoid System Neoplasm 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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