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NCT05736419 · ClinicalTrials.gov registry record · Phase 2
A Study of Immune Suppression Treatment for People With Sickle Cell Disease or β-Thalassemia Who Are Going to Receive an Allogeneic Hematopoietic Cell Transplantation (HCT)
A Phase 2 study of Sickle Cell Disease and Thalassemia, sponsored by Memorial Sloan Kettering Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
- 6
- Study locations
NCT05736419 is a Phase 2 study of Sickle Cell Disease and Thalassemia that is actively recruiting participants, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 24 participants, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (92% lower). The trial reports 6 study locations across 2 states.
The verdict
NCT05736419, a Phase 2 study of Sickle Cell Disease and Thalassemia, is actively recruiting participants, sponsored by Memorial Sloan Kettering Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
- 6
- Study locations
Study Summary
Hematopoietic Cell Transplantation/HCT involves receiving healthy blood-forming cells (stem cells) from a donor to replace the diseased or damaged cells in participants' bone marrow. The researchers think giving participants treatment with fludarabine and dexamethasone, drugs that lower the activity of the body's immune system (immune suppression), before standard conditioning therapy and HCT may help prevent serious side effects, including graft failure and GvHD. In this study, depending on how participants' body responds to the fludarabine and dexamethasone, the study doctor may decide participants should receive another drug, called cyclophosphamide, instead of fludarabine. In addition, depending on the results of participants' routine blood tests, participants may receive the drugs bortezomib and rituximab, which also help with immune suppression.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Mycophenolate Mofetil
- DRUG Tacrolimus
- BIOLOGICAL Rabbit ATG
Study Locations (6)
New Jersey
- Memorial Sloan Kettering at Basking Ridge (Consent only) - Basking Ridge
- Memorial Sloan Kettering Monmouth (Consent only) - Middletown
- Memorial Sloan Kettering Bergen (Consent only) - Montvale
New York
- Memorial Sloan Kettering Suffolk - Commack (Consent only) - Commack
- Memorial Sloan Kettering Westchester (Consent only) - Harrison
- Memorial Sloan Kettering Nassau (All protocol activities) - Rockville Centre
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2023-02-09 |
| Est. Completion | 2027-02-09 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05736419
The ClinicalTrials.gov registry entry for NCT05736419 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (92% lower). The listed sponsor is Memorial Sloan Kettering Cancer Center, which has 1,884 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Sickle Cell Disease appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT05736419 reports 6 study locations spanning 2 distinct geographic areas - top geographies include New Jersey, New York.
Frequently Asked Questions
What is clinical trial NCT05736419 about?
NCT05736419 is a clinical study titled "A Study of Immune Suppression Treatment for People With Sickle Cell Disease or β-Thalassemia Who Are Going to Receive an Allogeneic Hematopoietic Cell Transplantation (HCT)". Hematopoietic Cell Transplantation/HCT involves receiving healthy blood-forming cells (stem cells) from a donor to replace the diseased or damaged cells in participants' bone marrow. The researchers think giving participants treatment with fludarabine and dexamethasone, drugs that lower the activity...
What is the current status of trial NCT05736419?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2023-02-09. Estimated completion is 2027-02-09.
What conditions does trial NCT05736419 study?
This clinical trial studies the following conditions: Sickle Cell Disease, Thalassemia, Thalassemia, Beta.
What interventions are being tested in trial NCT05736419?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Mycophenolate Mofetil (DRUG), Tacrolimus (DRUG), Rabbit ATG (BIOLOGICAL).
Who is sponsoring clinical trial NCT05736419?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05736419 being conducted?
This trial has 6 study locations across New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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