Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00423514 · ClinicalTrials.gov registry record · Phase 1
Clofarabine, Melphalan, and Thiotepa Followed By a Donor Stem Cell Transplant in Treating Patients With High-Risk and/or Advanced Hematologic Cancer or Other Disease
A Phase 1 study of Leukemia and Myelodysplastic Syndromes, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
- 1
- Study location
NCT00423514: Completed Phase 1 study of Leukemia and Myelodysplastic Syndromes, sponsored by Memorial Sloan Kettering Cancer Center.
NCT00423514 is a Phase 1 study of Leukemia and Myelodysplastic Syndromes that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 38 participants, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00423514, a Phase 1 study of Leukemia and Myelodysplastic Syndromes, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
- 1
- Study location
Study Summary
RATIONALE: Giving chemotherapy, such as clofarabine, melphalan, and thiotepa, before a donor stem cell transplant helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus and mycophenolate mofetil before the transplant may stop this from happening. PURPOSE: This phase I/II trial is studying the side effects and best dose of clofarabine when given together with melphalan and thiotepa, followed by a donor stem cell transplant and to see how well it works in treating patients with high-risk and/or advanced hematologic cancer or other disease.
Primary Outcome
* A complete response (CR) will be defined as less than 5% bone marrow blasts in the setting of a neutrophil count of \>/= 1.0 K/ul and a platelet count of \>/= 75,000/ul * A complete response except platelets (CRp) will be defined as less than 5% bone marrow blasts in the setting of a neutrophil count of \>/= 1.0 K/ul and a platelet count of \>/= 75,000/ul * A partial response (PR) will be defined as 5%-25% bone marrow blasts in the setting of a neutrophil count of \>/= 1.0 K/ul and a platelet
Conditions Studied
Interventions
- DRUG tacrolimus
- DRUG clofarabine
- DRUG melphalan
- BIOLOGICAL filgrastim
- DRUG mycophenolate mofetil
Study Locations (1)
New York
- Memorial Sloan-Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2006-11-20 |
| Est. Completion | 2021-06-18 |
| Phase | Phase 1 |
What the finished NCT00423514 record still lists
NCT00423514 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (92% lower).
The record links to 3 conditions, with Leukemia appearing as the primary indexed condition, and to 5 interventions - of which tacrolimus is the first listed.
NCT00423514 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT00423514 about?
NCT00423514 is a clinical study titled "Clofarabine, Melphalan, and Thiotepa Followed By a Donor Stem Cell Transplant in Treating Patients With High-Risk and/or Advanced Hematologic Cancer or Other Disease". RATIONALE: Giving chemotherapy, such as clofarabine, melphalan, and thiotepa, before a donor stem cell transplant helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infu...
What is the current status of trial NCT00423514?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2006-11-20. Estimated completion is 2021-06-18.
What conditions does trial NCT00423514 study?
This clinical trial studies the following conditions: Leukemia, Myelodysplastic Syndromes, Graft-Versus-Host Disease.
What interventions are being tested in trial NCT00423514?
The interventions under investigation include: tacrolimus (DRUG), clofarabine (DRUG), melphalan (DRUG), filgrastim (BIOLOGICAL), mycophenolate mofetil (DRUG).
Who is sponsoring clinical trial NCT00423514?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00423514 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
Similar trials for Leukemia
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 NCT00423514's enrollment target sits among peer trials
38 143rd of 233 higher than 90 of 233 other Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Leukemia 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Revumenib in Combination With 7+3 + Midostaurin in AML
RECRUITING · Phase 1
-
CIML NK Cells With Venetoclax for AML
RECRUITING · Phase 1
-
A Multi-Site Break Through Cancer Trial: Targeting Measurable Residual Disease in Patients With Acute Myeloid Leukemia: A Phase 1/2 Study of Tagraxofusp, Azacitidine, and Venetoclax
RECRUITING · Phase 1
-
Roginolisib (IOA-244) With Venetoclax and Rituximab for Refractory/Relapsed Chronic Lymphocytic Leukemia (CLL)
RECRUITING · Phase 1
-
A Prospective Trial of Dalbavancin-Based Prophylaxis in Children and Adolescents With High-Risk Leukemia
RECRUITING · Phase 1
-
Venetoclax and Chemotherapy as Frontline Therapy in Older Patients and Patients With Relapsed/Refractory ALL
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01684904 · 38 participants · NA
Proton Therapy for Esophageal Cancer
- NCT03310879 · 38 participants · Phase 2
Study of the CDK4/6 Inhibitor Abemaciclib in Solid Tumors Harboring Genetic Alterations in Genes Encoding D-Type Cyclins or Amplification of CDK4 or CDK6
- NCT03896269 · 38 participants · Phase 1
CPX-351 in Treating Patients With Relapsed or Refractory High Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia
- NCT04085315 · 38 participants · Phase 1
Alisertib in Combination With Osimertinib in Metastatic EGFR-mutant Lung Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI